HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in patients 12 years of age and older.
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
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.
Flare incidence through 3 months
Pre-specified other secondary endpoint
For those experiencing flares, the duration of flares was shorter for patients on HUMIRA vs control.2
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22% (of 100) patients who were withdrawn from HUMIRA after 12 weeks experienced flare.1
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
Flare incidence from 3 through 9 months
A post-hoc analysis with a proportion of OLE patients†
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
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
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. 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.