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Navigating the Unknown

Listen to actual HUMIRA-treated patients describe the impact of HS, and watch HS-treating dermatologists discuss why they choose HUMIRA for moderate to severe HS

HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older.

Flare data in HS

HomeModerate to Severe Hidradenitis SuppurativaEfficacy Flare Data in HS

Analyses of flares in HUMIRA-treated patients2

HUMIRA’s flare data is an integrated analysis of PIONEER I and II. In the analyses, flare occurrence data was examined through 3 months, and 3 through 9 months. PIONEER I and II are the only completed Phase 3 trials in HS. In the PIONEER clinical trials, flare was defined as a ≥25% increase in AN count and an absolute increase of ≥2 relative to baseline.1,2

HUMIRA is the only FDA approved treatment for hidradenitis suppurativa.

Also see:

Efficacy data in HS

Lesion spread data in HS

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.1,3*

*HiSCR=Hidradenitis Suppurativa Clinical Response.

Through 3 months Through 3 months
3 through 9 months 3 through 9 months

Flare incidence through 3 months

Lower occurrence of flare in the short term vs control2

Pre-specified other secondary endpoint

Graph explaining flare data in HUMIRA-treated patients vs. control patients. Graph explaining flare data in HUMIRA-treated patients vs. control patients. Graph explaining flare data in HUMIRA-treated patients vs. control patients.

Integrated analysis of PIONEER I and PIONEER II through 12 weeks (Period A)

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

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.3,4

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22% (of 100) patients who were withdrawn from HUMIRA after 12 weeks experienced flare.1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.3

View full study design and baseline characteristics

Flare incidence from 3 through 9 months

80% of HUMIRA (adalimumab) treated patients did not experience flares from 3 through 9 months2

A post-hoc analysis with a proportion of OLE patients†

Graph explaining flare data for HUMIRA-treated patients from 3 through 9 months. Graph explaining flare data for HUMIRA-treated patients from 3 through 9 months. Graph explaining flare data for HUMIRA-treated patients from 3 through 9 months.

Integrated analysis of PIONEER l and PIONEER ll through 36 weeks

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

DATA LIMITATIONS

Flare was a pre-specified other secondary endpoint in Period A. Non-ranked endpoints are not controlled for multiplicity and thus require careful interpretation. Control comparator group not available past week 12 due to study design allowing early escape to OLE.‡ Period B flare results analyzed post-hoc. 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.3,4

OLE=open-label extension

PIONEER I control=placebo
PIONEER II control=placebo +/- antibiotic
†Including 11 ADAew/ew patients who escaped period B early due to loss of response or worsening or absence of improvement and continued ADAew treatment in the OLE.
‡Patients who underwent early escape experienced either a loss of response following achievement of HiSCR at week 12 or worsening or absence of improvement for patients not achieving HiSCR at week 12. Loss of response was defined as loss of at least 50% of AN improvement from baseline to week 12. Worsening or absence of improvement was defined as AN count ≥ baseline AN count at 2 consecutive visits (excluding week 12) occurring ≥14 days apart on or after week 16.

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 2 similarly designed clinical trials in adult patients with 2 double-blind, placebo-controlled periods. In Period A, patients were assigned to either HUMIRA 40 mg weekly (after initial doses) or placebo for 12 weeks. In period B, patients were reassigned to HUMIRA weekly or EOW, or placebo for 24 weeks. PRIMARY ENDPOINT was HiSCR at week 12, defined as at least a 50% reduction from baseline in abscess and inflammatory nodule count, with no increase in abscess and draining-fistula counts.3

View full study design and baseline characteristics
View study design for HUMIRA EW population
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Formulary coverage

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.

  • Crohn’s Disease: HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

  • Ulcerative Colitis: HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

    Limitations of Use:
    The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

  • 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-210183

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. Revised January 2019. 2. 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. 3. 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. 4. 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. 5. 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 a phase 3 open-label extension study. J Am Acad Derm. 2019(1):60-69.e2. 6. Data on file, ABVRRTI61790. 7. Data on file, ABVRRTI61787. 8. Data on file, ABVRRTl67918.