Recognizing
HS
For the treatment of moderate to severe hidradenitis
suppurativa (HS) in patients 12 years of age and older
Not an actual HS patient
Looking to
treat with
HUMIRA?
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
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.
Moderate/Stage II:
BEFORE
AFTER
BEFORE
Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Martin Miehe. Photos were taken at various time points (≥12 weeks) during treatment. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
Actual HUMIRA-treated patient achieving HiSCR. Photos were taken at various time points (≥12 weeks) during treatment. |
AFTER
Moderate/Stage II:
BEFORE
AFTER
BEFORE
Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Andreas Pinter. Photos were taken at various time points (≥12 weeks) during treatment. |
AFTER
Severe/Stage III:
BEFORE
AFTER
BEFORE
Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. |
AFTER
Severe/Stage III:
BEFORE
AFTER
BEFORE
Actual HUMIRA-treated patient achieving HiSCR. Photos courtesy of Dr. Marc Bourcier. Photos were taken at various time points (≥12 weeks) during treatment. |
AFTER
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
EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation; LOCF=last observation carried forward
42% vs 26%
ACHIEVED HiSCR
59% vs 28%
ACHIEVED HiSCR
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
EW=every week; EOW=every other week; HiSCR=Hidradenitis Suppurativa Clinical Response; SD=standard deviation
Flare incidence through 3 months
Pre-specified other secondary endpoint
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
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
treated in clinical studies1
of clinical trial experience beginning with rheumatoid arthritis in 199711
Up to 3 years of safety data in HS,
including open-label extension6
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
‡Estimated as of December 2018.
10 Indications
including 2 pediatric indications and the first and only FDA-approved treatment for moderate to severe HS1,4
Dermatology
Legacy
of clinical experience in dermatology14
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
Partner with a dermatologist
Dermatologists have experience with advanced treatment options, such as biologics.16,17
– 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.
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.
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:
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.
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.
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.