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Intermediate, Posterior and Panuveitis

US-IMM-190099

For the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older

HUMIRA IS THE ONLY
FDA-APPROVED TREATMENT FOR HS

Not an actual HS patient

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The Role
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HomeModerate to Severe Hidradenitis SuppurativaOverviewThe Role of HUMIRA

The Role of HUMIRA in HS

The overexpression of proinflammatory cytokines, such as TNF-α, is believed to play a key role in fueling HS inflammation that may cause abscesses, inflammatory nodules, and draining fistulas. HUMIRA, the only FDA-approved treatment for moderate to severe HS (≥12 years of age) is a subcutaneous injectable biologic that helps address inflammation by targeting and blocking TNF-α.1-4*

*The relationship between these pharmacodynamic activities and the mechanism(s) by which HUMIRA exerts its clinical effect is unknown.1

HUMIRA is the first & only FDA approved treatment for hidradenitis suppurativa

Clinically Meaningful Improvement

Primary endpoint in PIONEER I and II trials:

42% (PIONEER I) and 59% (PIONEER II) of HUMIRA-treated adult patients achieved HiSCR† at Week 12, vs 26% and 28% on placebo, respectively.1,5†

HiSCR requires:

with

and

†HiSCR=Hidradenitis Suppurativa Clinical Response.

Results HS Patients Can See Results HS Patients Can See
Week 12 Efficacy Data Week 12 Efficacy Data
Flare Data Flare Data

Results your patients can see: visualizing HiSCR

STUDY DESIGN INTRO

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining-fistula count.2

View full study design and baseline characteristics

EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation; LOCF=last observation carried forward

Significantly more adult patients achieved clinically meaningful improvement at week 12 with HUMIRA vs control1,5

PIONEER I1,5   P=0.003

42% vs 26%

ACHIEVED HiSCR

PIONEER II1,5   P<0.001

59% vs 28%

ACHIEVED HiSCR

  • HUMIRA 40 mg EW (PIONEER I, n=64/153, control=placebo; PIONEER II, n=96/163, control=placebo+/- antibiotic)
  • Control (PIONEER I, n=40/154, control=placebo; PIONEER II, n=45/163, control=placebo+/- antibiotic)
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Efficacy in adolescents extrapolated from adult data

HUMIRA efficacy in adolescent HS patients is extrapolated from the adult HS patient data based on the likelihood that the disease course and drug effects are similar to that of adults at the same exposure levels determined through pharmacokinetic modeling.1

STUDY DESIGN INTRO

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining-fistula count.5

View full study design and baseline characteristics

EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation

Flare incidence through 3 months

Lower occurrence of flare in the short term vs control10

Pre-specified other secondary endpoint

Graphic showing flare incidence through 3 months. Graphic showing flare incidence through 3 months. Graphic showing flare incidence through 3 months.

For those experiencing flares, the duration of flares was shorter for patients on HUMIRA vs control.10

 

Integrated analysis of PIONEER I and PIONEER II through 12 weeks.

 

Flare: ≥25% increase in AN count and an absolute increase of ≥2 relative to baseline1,10

 

DATA LIMITATIONS
Flare was a pre-specified other secondary endpoint in Period A. Since PIONEER I did not reach statistical significance at the first key secondary endpoint, all endpoints in this integrated analysis cannot be regarded as statistically significant.5,8

PIONEER I control=placebo
PIONEER II control=placebo +/- antibiotic
AN=abscess and inflammatory nodules
DMARDs=disease-modifying antirheumatic drugs
EOW=every other week
EW=every week

22% (of 100) patients who were withdrawn from HUMIRA after 12 weeks experienced flare.1

STUDY DESIGN INTRO

PIONEER I (N=307) and II (N=326) were randomized, double-blind, placebo-controlled clinical trials in adult patients with moderate to severe HS receiving HUMIRA 40 mg weekly (after initial doses). Primary endpoint: HiSCR at week 12 (Period A), defined as ≥50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining-fistula count.5

View full study design and baseline characteristics

Well-Studied Safety Profile of HUMIRA

HUMIRA has clinical trial experience across 10 immune-mediated diseases. HUMIRA has been studied in adults with HS in 3 controlled studies and an open-label extension study, and the safety profile for adult patients with HS treated with weekly dosing was consistent with the known safety profile of HUMIRA.1

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8,000+ patients

treated in clinical studies1

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20+ years

of clinical trial experience beginning with rheumatoid arthritis in 199711

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3 years

Up to 3 years of safety data in HS,
including open-label extension6

Safety Profile and Adverse Events in Adult Patients
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Anticipated safety in adolescents

Safety of the recommended HUMIRA dose in the adolescent HS population is anticipated to be consistent with the known safety profile of HUMIRA based on a cross-indication safety profile of HUMIRA in both adults and pediatric patients at similar or higher exposure determined through pharmacokinetic modeling.1

HUMIRA Legacy of Experience in Immune-mediated Diseases

Patients
currently being treated worldwide13‡

‡Estimated as of December 2018.   

Graphic of a wheel representing the 10 indications of HUMIRA

 

 

 

10 Indications

including 2 pediatric indications and the first and only FDA-approved treatment for moderate to severe HS1,4

Dermatology
Legacy

10+ years

of clinical experience in dermatology14

30,000+ patients

have been prescribed HUMIRA for HS since its FDA approval in 201515§

§Information derived from PatientSource data provided by Symphony Health and IQVIA (NSP) for HS (Sep 2015) through Mar 2020

 

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Dermatologists have experience with advanced treatment options, such as biologics.16,17

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A 50% improvement… I almost can’t picture it. Oh, the shirts I would wear!

– Insight from actual HS female patient

Dr. Cather discusses

HUMIRA clinical trial data: moderate to severe HS

Dermatologist Dr. Cather discusses HUMIRA safety and efficacy. HUMIRA is a biologic that targets TNF-α, and the first and only FDA-approved treatment for moderate to severe hidradenitis suppurativa. See safety data for this HS treatment.

Transcript
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INDICATION(S) and IMPORTANT SAFETY INFORMATION FOR HUMIRA (adalimumab)1

INDICATION(S)1

Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue HUMIRA if a patient develops a serious infection or sepsis. 

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start HUMIRA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
  • In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

  • Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

  • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
  • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

  • TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
  • Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.

AUTOIMMUNITY

  • Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

  • Patients on HUMIRA should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

INDICATIONS1

  • Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

  • Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

  • Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

  • Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

  • Adult Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

  • Pediatric Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

  • Ulcerative Colitis: HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti-TNF agents.

  • Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

  • Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

  • Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

Please see Full Prescribing Information.

US-HUM-181930

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. van der Zee HH, de Ruiter L, van den Broecke DG, Dik WA, Laman JD, Prens EP. Elevated levels of tumour necrosis factor (TNF)-α, interleukin (IL)-1ß and IL-10 in hidradenitis suppurativa skin: a rationale for targeting TNF-α and IL-1ß. Br J Dermatol. 2011;164(6):1292-1298. 3. van der Zee HH, Laman JD, Boer J, Prens EP. Hidradenitis suppurativa: viewpoint on clinical phenotyping, pathogenesis and novel treatments. Exp Dermatol. 2012;21(10):735-739. 4. AbbVie's HUMIRA® (adalimumab) receives first and only U.S. Food and Drug Administration approval for moderate to severe hidradenitis suppurativa [press release]. North Chicago, IL: AbbVie Inc.; September 10, 2015. Accessed April 29, 2020. https://news.abbvie.com/news/abbvies-humira-adalimumab-receives-first-and-only-us-food-and-drug-administration-approval-for-moderate-to-severe-hidradenitis-suppurativa.htm. 5. Kimball AB, Okun MM, Williams DA, et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med. 2016;375(5):422-434. 6. Zouboulis CC, Okun MM, Prens EP, et al. Long-term adalimumab efficacy in patients with moderate-to-severe hidradenitis suppurativa/acne inversa: 3-year results of phase 3 open-label extension study. J Am Acad Dermatol. 2019;80(1):60-69.e2. 7. Data on file, AbbVie Inc. ABVRRTI61790. 8. Kimball AB, Okun MM, Williams DA, et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med. 2016;375(5)(suppl):1-27. 9. Data on file, AbbVie Inc. ABVRRTI61787. 10. van der Zee HH, Longcore M, Geng Z, Garg A. Weekly adalimumab treatment decreased disease flare in hidradenitis suppurativa over 36 weeks: integrated results from the phase 3 PIONEER trials. J Eur Acad Dermatol Venereol. 2020;34(5):1050-1056. 11. Burmester GR, Mease P, Dijkmans BAC, et al. Adalimumab safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases. Ann Rheum Dis. 2009;68(12):1863-1869. 12. Data on file, AbbVie Inc. ABVRRTI61791. 13. Data on file, AbbVie Inc. IMS NPA and IMS NSP cumulative data as of December 2018. 14. Multicenter study of the safety and efficacy of adalimumab in subjects with moderate to severe chronic plaque psoriasis. ClinicalTrials.gov identifier: NCT00645814. https://www.clinicaltrials.gov/ct2/show/NCT02116010. Updated March 28, 2008. Accessed June 29, 2020. 15. Data on file, AbbVie Inc. HUMIRA Treated Psoriasis Patient Counts. March 2020. 16. Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009;60(4):539-561. 17. Kimball AB, Jemec GBE, eds. Hidradenitis Suppurativa: A Disease Primer. Switzerland: Springer International Publishing AG; 2017.

Touch & Drag Image

REVEAL STUDY DESIGN1,9,14

HUMIRA REVEAL study design

REVEAL was a randomized, double-blind, placebo-controlled study of 1212 patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12, and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).

In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, patients who maintained at least a PASI 75 response at week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive HUMIRA 40 mg EOW or placebo for an additional 19 weeks. Primary efficacy endpoints at week 16 were proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.

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US-HUMD-200130

ADEPT STUDY DESIGN1,7,11,12

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HUMIRA ADEPT study design

EOW=every other week

a315 patients were initially randomized; however, 2 patients did not receive study drug.12

  • A 24-week, randomized, double-blind, placebo-controlled trial of HUMIRA in adult patients with moderately to severely active psoriatic arthritis (PsA) (≥3 swollen joints and ≥3 tender joints) who had an inadequate response to NSAIDs.11,12
  • Patients must have active psoriatic skin lesions or a documented history of psoriasis.12
  • Co-primary endpoints were American College of Rheumatology (ACR) 20 response at week 12 and mean change from baseline in modified total Sharp score (mTSS) for HUMIRA-treated patients at week 48 vs placebo patients at week 24.1,12
  • Select secondary endpoints include ACR20 at week 24, ACR50/70 at weeks 12 and 24, and HAQ-DI score at week 12 and 24.12
  • After week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.12
  • Patients who completed the original 24-week, double-blind ADEPT study (n=289) were eligible for open-label treatment through week 144, for which over 98% (n=285) elected to enroll.7,11
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US-HUMD-200130

PIONEER I and II STUDY DESIGNS1,3,13,16

The first and only completed Phase 3 trials in HS

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HUMIRA PIONEER I and PIONEER II study designs
  • HUMIRA
    40 mg EW
  • HUMIRA
    40 mg EOW
  • Control
  • Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
  • Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
  • Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,† or if they did not achieve HiSCR and experienced worsening or absence of improvement.‡
  • Throughout the OLE, all patients received HUMIRA 40 mg weekly.

aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).

b160 mg week 0; 80 mg week 2; 40 mg from week 4.

cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.

d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.

*Weeks of efficacy and patient-reported outcomes analysis.

†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.

‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.

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US-HUMD-200130

Overview of treatment-emergent adverse events per 100 patient-years (PYs) in adults12

Adverse reaction rates observed in clinical trials may not predict the rates observed in a broader patient population in clinical practice.

aOther than lymphoma, hepatosplenic T-cell lymphoma, leukemia, non-melanoma skin cancer, or melanoma.

RISK OF SERIOUS INFECTION1

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA.

•  Do not start HUMIRA in patients with an active infection, including localized infections

•  Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection

RISK OF MALIGNANCY1

Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.

•  More cases of malignancies were observed among HUMIRA-treated patients compared to control patients in clinical trials

•  Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in patients with a known malignancy

•  Examine all patients, especially patients with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of PUVA treatment, for the presence of non-melanoma skin cancer (NMSC) prior to and during treatment with HUMIRA

RISK OF TUBERCULOSIS1

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death; including active tuberculosis (TB), which includes reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease.

•  Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use

•  Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the development of TB in patients who tested negative for latent TB infection prior to initiating therapy

RISK OF LYMPHOMA1

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which HUMIRA is a member.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including HUMIRA.

The rate of lymphoma in controlled and uncontrolled clinical trials of HUMIRA in patients with RA, PsA, AS, CD, UC, and Ps was approximately 3-fold higher than expected in the general population.

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US-HUMD-200052

Assess disease severity in your HS patients with the Hurley Staging System7,8

It is a widely used classification tool categorizing disease severity based largely on scarring and sinuses.

PIONEER trials enrolled patients whose disease state was classified as Hurley Stage II and Hurley Stage III1,2,5,9

Hurley Stage II

Hurley Stage III

See PIONEER Study designs

aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).

b160 mg week 0; 80 mg week 2; 40 mg from week 4.

cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.

d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.

*Weeks of efficacy and patient-reported outcomes analysis.

†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.

‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.

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US-HUMD-200052

PIONEER I and II STUDY DESIGNS1,5-7

Touch & Drag Image
HUMIRA PIONEER I and PIONEER II study designs
  • HUMIRA
    40 mg EW
  • HUMIRA
    40 mg EOW
  • Control
  • Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
  • Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
  • Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,† or if they did not achieve HiSCR and experienced worsening or absence of improvement.‡
  • Throughout the OLE, all patients received HUMIRA 40 mg weekly.
PIONEER I control=placebo   PIONEER II control=placebo +/- antibiotic

aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).

b160 mg week 0; 80 mg week 2; 40 mg from week 4.

cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.

d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.

*Weeks of efficacy and patient-reported outcomes analysis.

†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.

‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.

SELECT BASELINE PATIENT CHARACTERISTICS5,8

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SELECT BASELINE DISEASE CHARACTERISTICS5,8,9

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SELECT BASELINE LESION TYPE5,8,9

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Baseline characteristics identified as different between PIONEER I and PIONEER II are2:

  • baseline weight
  • baseline lesion count

These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.

eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.

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US-HUMD-200052

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US-HUMD-200052

SO LONG FOR NOW...

By clicking this link, you will be leaving this site and connecting to a site neither owned nor operated by AbbVie. AbbVie is not responsible for the contents of any such website or any further links from such website. AbbVie is providing these links as a convenience, and the inclusion of any link does not imply endorsement of the linked website by AbbVie. You should also be aware that the linked website may be governed by its own set of terms and conditions and privacy policy, for which AbbVie has no responsibility.

 

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US-HUMD-200052

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HUMIRA® for HCPs
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HUMIRA® for HCPs
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SkyRizi™ for HCPs
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US-IMM-190077

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REVEAL STUDY DESIGN1,2,8

HUMIRA REVEAL study design

REVEAL was a randomized, double-blind, placebo-controlled study of 1212 patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12, and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).

In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, patients who maintained at least a PASI 75 response at week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive HUMIRA 40 mg EOW or placebo for an additional 19 weeks. Co-primary efficacy endpoints at week 16 were proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.

CHAMPION STUDY DESIGN1,3

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HUMIRA CHAMPION study design

Eligible adult patients had moderate to severe plaque psoriasis (defined as ≥10% BSA and PASI ≥10).

  • Patients were to have plaque psoriasis for at least 1 year and stable plaque psoriasis for at least 2 months
  • Patients were candidates for systemic therapy or phototherapy
  • All patients were naïve to anti-TNF therapy and MTX
  • Concomitant psoriasis therapies were not permitted during the study, with the exception of shampoos free of corticosteroids, bland emollients, and low-potency topical corticosteroids for the palms, soles, face, inframammary areas, and groin only, provided they were not used within 24 hours of a study visit

aPatients were randomized to receive HUMIRA (80 mg followed by 40 mg EOW beginning 1 week later) or placebo in a 2:1 ratio.

Co-primary efficacy endpoints were proportion of patients achieving PASI 75 relative to baseline and proportion of patients achieving a PGA of clear or minimal by week 16.

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US-HUMD-200130

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REVEAL STUDY DESIGN1,8,13

HUMIRA REVEAL study design

REVEAL was a randomized, double-blind, placebo-controlled study of 1212 patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12, and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).8,9

In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, patients who maintained at least a PASI 75 response at week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive HUMIRA 40 mg EOW or placebo for an additional 19 weeks. Primary efficacy endpoints at week 16 were proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.

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US-HUMD-190337

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ADEPT STUDY DESIGN1,6,10,11

HUMIRA ADEPT study design

EOW=every other week

a315 patients were initially randomized; however, 2 patients did not receive study drug.11

  • A 24-week, randomized, double-blind, placebo-controlled trial of HUMIRA in adult patients with moderately to severely active psoriatic arthritis (PsA) (≥3 swollen joints and ≥3 tender joints) who had an inadequate response to NSAIDs.10,11
  • Patients must have active psoriatic skin lesions or a documented history of psoriasis.11
  • Co-primary endpoints were American College of Rheumatology (ACR) 20 response at week 12 and mean change from baseline in modified total Sharp score (mTSS) for HUMIRA-treated patients at week 48 vs placebo patients at week 24.1,11
  • Select secondary endpoints include ACR20 at week 24, ACR50/70 at weeks 12 and 24, and HAQ-DI at week 12 and 24.11
  • After week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.11
  • Patients who completed the original 24-week, double-blind ADEPT study (n=289) were eligible for open-label treatment through week 144, for which over 98% (n=285) elected to enroll.6,10
Close

US-HUMD-190337

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ADEPT STUDY DESIGN1-3,5

HUMIRA ADEPT study design

EOW=every other week

a315 patients were initially randomized; however, 2 patients did not receive study drug.3

  • A 24-week, randomized, double-blind, placebo-controlled trial of HUMIRA in adult patients with moderately to severely active psoriatic arthritis (PsA) (≥3 swollen joints and ≥3 tender joints) who had an inadequate response to NSAIDs.2,3
  • Patients must have active psoriatic skin lesions or a documented history of psoriasis.3
  • Co-primary endpoints were American College of Rheumatology (ACR) 20 response at week 12 and mean change from baseline in modified total Sharp score (mTSS) for HUMIRA-treated patients at week 48 vs placebo patients at week 24.1,3
  • Select secondary endpoints include ACR20 at week 24, ACR50/70 at weeks 12 and 24, and HAQ-DI score at week 12 and 24.3
  • After week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.3
  • Select additional endpoints include: ACR components at week 2 and pain data at weeks 2 and 24.1,6
  • Patients who completed the original 24-week, double-blind ADEPT study (n=289) were eligible for open-label treatment through week 144, for which over 98% (n=285) elected to enroll.2,5
Close

US-HUMD-200130

PIONEER I and II STUDY DESIGNS1,12,14,15

The first and only completed Phase 3 trials in HS

Touch & Drag Image
HUMIRA PIONEER I and PIONEER II study designs
  • HUMIRA
    40 mg EW
  • HUMIRA
    40 mg EOW
  • Control
  • Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
  • Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
  • Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,† or if they did not achieve HiSCR and experienced worsening or absence of improvement.‡
  • Throughout the OLE, all patients received HUMIRA 40 mg weekly.
PIONEER I control=placebo   PIONEER II control=placebo +/- antibiotic

aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).

b160 mg week 0; 80 mg week 2; 40 mg from week 4.

cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.

d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.

*Weeks of efficacy and patient-reported outcomes analysis.

†Loss of response=defined as a loss of ≥50% in improvement in AN count achieved from baseline to week 12.

‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.

Close

US-HUMD-190337

HUMIRA demonstrated significant improvements from baseline in ACR components of disease activity (P<0.001)1

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  HUMIRAa 40 mg EOW (n=151) Placebo EOW (n=162)
Parameter: median Baseline 24 Weeks Baseline 24 Weeks
Tender joint countb 20.0 5.0 23.0 17.0
Swollen joint countc 11.0 3.0 11.0 9.0
Physician global assessmentd 55.0 16.0 53.0 49.0
Patient global assessmentd 48.0 20.0 49.5 49.0
Paind 54.0 20.0 49.0 49.0
Disability index (HAQ)e 1.0 0.4 1.0 0.9
CRP (mg/dL)f 0.8 0.2 0.8 0.7

aP<0.001 for HUMIRA vs placebo; comparisons based on mean changes.
bScale 0-78.
cScale 0-76.
dVisual analog scale; 0=best, 100=worst.

eDisability Index of the Health Assessment Questionnaire (HAQ-DI); 0=best, 3=worst; measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity.
fNormal range: 0-0.287 mg/dL.

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US-HUMD-200130

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HUMIRA demonstrated significant improvements from baseline in every ACR component (P<0.001)1

Touch & Drag Image
  HUMIRA 40 mg EOW (n=151) Placebo EOW (n=162)
Parameter: median Baseline 24 Weeks Baseline 24 Weeks
Number of tender joints 20.0 5.0 23.0 17.0
Number of swollen joints 11.0 3.0 11.0 9.0
Physician global assessment 55.0 16.0 53.0 49.0
Patient global assessment 48.0 20.0 49.5 49.0
Pain 54.0 20.0 49.0 49.0
Disability index (HAQ) 1.0 0.4 1.0 0.9
CRP (mg/dL) 0.8 0.2 0.8 0.7

aP<0.001 for HUMIRA vs placebo; comparisons based on mean changes.
bScale 0-78.
cScale 0-76.
dVisual analog scale; 0=best, 100=worst.

eDisability Index of the Health Assessment Questionnaire (HAQ-DI); 0=best, 3=worst; measures the patient’s ability to perform the following: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity.
fNormal range: 0-0.287 mg/dL.

Close

US-HUMD-200130

PIONEER I and II STUDY DESIGNS—88 PATIENTS STUDIED IN OLE1-4

88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.

Touch & Drag Image
HUMIRA PIONEER I and II study designs, including patients studied in OLE
  • HUMIRA
    40 mg EW
  • HUMIRA
    40 mg EOW
  • Control
  • Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
  • Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
  • Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,† or if they did not achieve HiSCR and experienced worsening or absence of improvement.‡
  • Throughout the OLE, all patients received HUMIRA 40 mg weekly.
PIONEER I control=placebo   PIONEER II control=placebo +/- antibiotic

aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).

b160 mg week 0; 80 mg week 2; 40 mg from week 4.

cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.

d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.

*Weeks of efficacy and patient-reported outcomes analysis.

†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.

‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.

Close

US-HUMD-200052

ADEPT STUDY DESIGN1-4

Touch & Drag Image
HUMIRA ADEPT study design

EOW=every other week

a315 patients were initially randomized; however, 2 patients did not receive study drug.2

  • A 24-week, randomized, double-blind, placebo-controlled trial of HUMIRA in adult patients with moderately to severely active psoriatic arthritis (PsA) (≥3 swollen joints and ≥3 tender joints) who had an inadequate response to NSAIDs.2,4
  • Patients must have active psoriatic skin lesions or a documented history of psoriasis.2
  • Co-primary endpoints were American College of Rheumatology (ACR) 20 response at week 12 and mean change from baseline in modified total Sharp score (mTSS) for HUMIRA-treated patients at week 48 vs placebo patients at week 24.1,2
  • Select secondary endpoints include ACR20 at week 24, ACR 50/70 at weeks 12 and 24, and HAQ-DI score at week 12 and 24.2
  • After week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.2
  • Patients who completed the original 24-week, double-blind ADEPT study (n=289) were eligible for open-label treatment through week 144, for which over 98% (n=285) elected to enroll.3,4
Close

US-HUMD-200130

PIONEER I and II STUDY DESIGNS1,3-5

Touch & Drag Image
HUMIRA PIONEER I and PIONEER II study designs
  • HUMIRA
    40 mg EW
  • HUMIRA
    40 mg EOW
  • Control
  • Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
  • Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
  • Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,† or if they did not achieve HiSCR and experienced worsening or absence of improvement.‡
  • Throughout the OLE, all patients received HUMIRA 40 mg weekly.
PIONEER I control=placebo   PIONEER II control=placebo +/- antibiotic

aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).

b160 mg week 0; 80 mg week 2; 40 mg from week 4.

cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.

d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.

*Weeks of efficacy and patient-reported outcomes analysis.

†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.

‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.

SELECT BASELINE PATIENT CHARACTERISTICS3,6

Touch & Drag Image
select baseline patient characteristics in PIONEER I and II

SELECT BASELINE DISEASE CHARACTERISTICS3,6,7

Touch & Drag Image
select baseline disease characteristics in PIONEER I and II

SELECT BASELINE LESION TYPE3,6,7

Touch & Drag Image
select baseline lesion type in PIONEER I and II

Baseline characteristics identified as different between PIONEER I and PIONEER II are:

  • baseline weight
  • baseline lesion count

These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.

eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.

Close

US-HUMD-190337

PIONEER I and II STUDY DESIGNS1,3,5,6

Touch & Drag Image
HUMIRA PIONEER I and PIONEER II study designs
  • HUMIRA
    40 mg EW
  • HUMIRA
    40 mg EOW
  • Control
  • Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
  • Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
  • Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,† or if they did not achieve HiSCR and experienced worsening or absence of improvement.‡
  • Throughout the OLE, all patients received HUMIRA 40 mg weekly.
PIONEER I control=placebo   PIONEER II control=placebo +/- antibiotic

aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).

b160 mg week 0; 80 mg week 2; 40 mg from week 4.

cRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.

d160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.

*Weeks of efficacy and patient-reported outcomes analysis.

†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.

‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.

SELECT BASELINE PATIENT CHARACTERISTICS3,4

Touch & Drag Image
chart of select baseline patient characteristics

SELECT BASELINE DISEASE CHARACTERISTICS3,4,7

Touch & Drag Image
chart of select baseline disease characteristics, including Hurley stage, previous systemic treatment, disease duration, family history of HS, and hs-CRP

SELECT BASELINE LESION TYPE3,4,7

Touch & Drag Image
chart of select baseline lesion types

Baseline characteristics identified as different between PIONEER I and PIONEER II are3:

  • Baseline weight
  • Baseline lesion count

These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.

eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.

Close

US-HUMD-200052

PIONEER I and II STUDY DESIGNS1,3,13,16

The first and only completed Phase 3 trials in HS.

Touch & Drag Image
HUMIRA PIONEER I and PIONEER II study designs
  • HUMIRA
    40 mg EW
  • HUMIRA
    40 mg EOW
  • Control
  • Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
  • Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
  • Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,† or if they did not achieve HiSCR and experienced worsening or absence of improvement.‡
  • Throughout the OLE, all patients received HUMIRA 40 mg weekly.

SELECT BASELINE PATIENT CHARACTERISTICS13,17

Touch & Drag Image
Chart of select baseline patient characteristics

SELECT BASELINE DISEASE CHARACTERISTICS13,17,18

Touch & Drag Image
Chart of select baseline disease characteristics, including Hurley stage, previous systemic treatment, disease duration, family history of HS, and hs-CRP

SELECT BASELINE LESION TYPE13,17,18

Touch & Drag Image
Chart of select baseline lesion types

Baseline characteristics identified as different between PIONEER I and PIONEER II are13:

  • baseline weight
  • baseline lesion count

These differences in baseline characteristics may in part account for the observed differences in magnitude between the 2 studies.

eControl=placebo.
fControl=placebo ± antibiotic.
gNumber of patients unless otherwise indicated EW.
hRace was self-reported.
iln PIONEER I, the “other” category included Asian (4 patients, 1.3%), American Indian or Alaskan native (2 patients, 0.7%), multiple races (1 patient, 0.3%), and other (4 patients,1.3%). In PIONEER II, the “other” category included Asian (10 patients, 3.1%), American Indian or Alaskan native (1 patient, 0.3%), Native Hawaiian or other Pacific Islander (1 patient, 0.3%), multiple races (3 patients, 0.9%), and other (9 patients, 2.8%).
jData reflect actual assessments, not the Hurley Stage stratification factor. A patient's overall Hurley Stage was documented as the highest stage across all affected anatomical regions. Stage I is defined as localized formation of single or multiple abscesses, without sinus tracts or scarring; Stage II as recurrent abscesses (single or multiple), with sinus tract formation and scarring; and Stage Ill as multiple abscesses, with extensive, interconnected sinus tracts and scarring.
kData missing for PIONEER II, HUMIRA EW (n=1).
lHigher values indicate a higher level of systemic inflammation.

Close

US-HUMD-200130

PIONEER I and II STUDY DESIGNS—88 PATIENTS STUDIED IN OLE1,3,13,16

88 patients who were studied in OLE received continuous HUMIRA weekly throughout the trial period (periods A and B) and throughout the OLE.

Touch & Drag Image
HUMIRA PIONEER I and II study designs, including patients studied in OLE
  • HUMIRA
    40 mg EW
  • HUMIRA
    40 mg EOW
  • Control
  • Enrolled patients had a total abscess and inflammatory nodule (AN) count of ≥3 with lesions in ≥2 anatomic areas, one of which was Hurley Stage II or III.
  • Primary efficacy endpoint was Hidradenitis Suppurativa Clinical Response (HiSCR) at week 12.
  • Period B explored the safety and efficacy of different maintenance regimens (continuous HUMIRA EW, reduction to HUMIRA EOW, or treatment withdrawal) over 24 weeks.
  • At or after week 16, patients were instructed to discontinue from Period B and enter the OLE phase if they achieved HiSCR in Period A and subsequently had a loss of response,† or if they did not achieve HiSCR and experienced worsening or absence of improvement.†
  • Throughout the OLE, all patients received HUMIRA 40 mg weekly.
PIONEER I control=placebo   PIONEER II control=placebo +/- antibiotic

aStratified by baseline Hurley Stage II vs III (PIONEER I & II) and baseline concomitant antibiotic use (PIONEER II).

160 mg week 0; 80 mg week 2; 40 mg from week 4.

bRe-randomization at entry to Period B, stratified by week 12 HiSCR status and baseline Hurley Stage II vs III.

c160 mg week 12; 80 mg week 14; 40 mg weekly from week 16.

dWeeks of efficacy and patient-reported outcomes analysis.

†Loss of response=defined as a loss of ≥ 50% in improvement in AN count achieved from baseline to week 12.

‡Worsening or absence of improvement=an AN count ≥ the baseline AN count at 2 consecutive visits (excluding week 12) occurring at least 14 days apart.

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US-HUMD-200130

Safety data from randomized control and OLE periods in PIONEER I and II3,8,13,15

Adverse reaction rate observed in clinical trials and open-label extension (OLE) studies may not predict the rates observed in a broader HS patient population in clinical practice.

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Chart of safety data from randomized control and OLE periods in PIONEER I and II

Malignancies: Lymphoma, including a rare type of T-cell lymphoma, and other malignancies, some fatal, have been reported in patients treated with TNF blockers, including HUMIRA.

Serious Infections: Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include active tuberculosis (TB), reactivation of latent TB, invasive fungal infections, and bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Adverse reaction rate observed in clinical trials and OLE studies may not predict the rates observed in a broader HS patient population in clinical practice.

*Safety data for PIONEER I, Period B not shown as there is no comparable control group.
†Study design dosing: HUMIRA EW/HUMIRA EW.
‡Study design dosing: HUMIRA EW/HUMIRA EW/HUMIRA EW.
§Other than lymphoma, HSTCL, leukemia, NMSC or melanoma.

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ADEPT Study Design1-4

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HUMIRA PIONEER I and PIONEER II study designs
EOW=every other week

a315 patients were initially randomized; however, 2 patients did not receive study drug.2

  • A 24-week, randomized, double-blind, placebo-controlled trial of HUMIRA in adult patients with moderately to severely active psoriatic arthritis (PsA) (≥3 swollen joints and ≥3 tender joints) who had an inadequate response to NSAIDs.2,4

  • Patients must have active psoriatic skin lesions or a documented history of psoriasis.2

  • Co-primary endpoints were American College of Rheumatology (ACR) 20 response at Week 12 and mean change from baseline in modified total Sharp score (mTSS) for HUMIRA-treated patients at Week 48 vs placebo patients at Week 24.1,2

  • After Week 12, patients who failed to have at least a 20% decrease in both swollen and tender joint counts on 2 consecutive visits could receive rescue therapy with corticosteroids or DMARDs.2

  • Select additional endpoints include ACR20 response rates at week 2, VAS pain scores at Week 2 and 24, and change from baseline in individual ACR components by visit.2

    • Select secondary endpoints include ACR20 at Week 24, ACR 50/70 at Weeks 12 and 24, HAQ-DI score at Weeks 12 and 24, and PASI 75 at Week 24.2

  • Patients who completed the original 24-week double-blind ADEPT study (n=289) were eligible for open-label treatment through Week 144, for which over 98% (n=285) elected to enroll.3,4

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REVEAL STUDY DESIGN1,2,5

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HUMIRA REVEAL study design

REVEAL was a randomized, double-blind, placebo-controlled study of 1212 patients with chronic plaque psoriasis and ≥10% BSA involvement, PASI score ≥12, and PGA of at least moderate disease severity. Patients had a clinical diagnosis of psoriasis for at least 6 months and stable disease for at least 2 months before screening. Evaluations were performed over 3 treatment periods totaling 52 weeks. For the first 16 weeks (Period A), patients received either HUMIRA (n=814), at an initial dose of 80 mg SC at week 0 followed by 40 mg EOW SC starting at week 1, or placebo (n=398).

In Period B, patients who achieved at least a PASI 75 response at week 16 received open-label HUMIRA 40 mg EOW for 17 weeks. In Period C, patients who maintained at least a PASI 75 response at week 33 and were originally randomized to HUMIRA in Period A were re-randomized to receive HUMIRA 40 mg EOW or placebo for an additional 19 weeks. Primary efficacy endpoints at week 16 were proportion of patients achieving a PASI 75 response relative to baseline and proportion of patients achieving a PGA score of clear or minimal disease.

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US-HUMD-190337

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Fingernail Psoriasis Study Design1,2,9,13

A Phase 3, randomized, double-blind study evaluated adult subjects with moderate to severe fingernail psoriasis who also had moderate to severe chronic plaque psoriasis.1,2

Fingernail Psoriasis Study Design

BSA=body surface area; EOW=every other week, mNAPSI=modified Nail Psoriasis Severity Index;

PGA-F=Physician’s Global Assessment of Fingernail Psoriasis; PGA-S=Physician’s Global Assessment of Skin Psoriasis.

Key inclusion criteria were adult subjects with:2

  • Moderate to severe chronic plaque psoriasis with disease duration of at least 6 months and psoriasis in at least one fingernail
  • Fingernail involvement ≥ moderate as measured by 5-point PGA-F scale
  • mNAPSI score of target fingernail ≥8
  • BSA ≥10%, or ≥5% BSA with a total mNAPSI score for all fingernails ≥20

Primary endpoint was proportion of subjects achieving PGA-F of 0 (clear) or 1 (minimal) and at least 2-grade improvement from baseline at Week 26.

Key secondary endpoint was proportion of subjects achieving ≥75% improvement from baseline in mNAPSI (mNAPSI 75) at Week 26.

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US-HUMD-200052

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient

INDICATION(S)1

Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue HUMIRA if a patient

INDICATION(S)1

Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking

INDICATION(S) and IMPORTANT SAFETY INFORMATION FOR HUMIRA (adalimumab)1

INDICATION(S)1

Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION1

SERIOUS INFECTIONS

Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Discontinue HUMIRA if a patient develops a serious infection or sepsis. 

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HUMIRA use and during therapy. Initiate treatment for latent TB prior to HUMIRA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start HUMIRA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.
  • Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HUMIRA with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including HUMIRA. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

  • Consider the risks and benefits of HUMIRA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among HUMIRA-treated patients compared to control patients.
  • Non-melanoma skin cancer (NMSC) was reported during clinical trials for HUMIRA-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy, for the presence of NMSC prior to and during treatment with HUMIRA.
  • In HUMIRA clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

  • Anaphylaxis and angioneurotic edema have been reported following HUMIRA administration. If a serious allergic reaction occurs, stop HUMIRA and institute appropriate therapy.

HEPATITIS B VIRUS REACTIVATION

  • Use of TNF blockers, including HUMIRA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
  • Exercise caution in patients who are carriers of HBV and monitor them during and after HUMIRA treatment.
  • Discontinue HUMIRA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HUMIRA after HBV treatment.

NEUROLOGIC REACTIONS

  • TNF blockers, including HUMIRA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering HUMIRA for patients with these disorders; discontinuation of HUMIRA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.

HEMATOLOGIC REACTIONS

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with HUMIRA.
  • Consider stopping HUMIRA if significant hematologic abnormalities occur.

CONGESTIVE HEART FAILURE

  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with HUMIRA; exercise caution and monitor carefully.

AUTOIMMUNITY

  • Treatment with HUMIRA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

  • Patients on HUMIRA should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HUMIRA therapy.
  • Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to HUMIRA in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

  • The most common adverse reactions in HUMIRA clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

INDICATIONS1

  • Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

  • Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

  • Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

  • Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

  • Adult Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy, and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

  • Pediatric Crohn’s Disease: HUMIRA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.

  • Ulcerative Colitis: HUMIRA is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine, or 6-mercaptopurine. The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to anti-TNF agents.

  • Plaque Psoriasis: HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

  • Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

  • Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older.

Please see Full Prescribing Information.

US-HUM-181930