Original article
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

https://doi.org/10.1016/j.jaad.2018.05.040Get rights and content

Background

The optimal long-term dosing strategy for adalimumab (ADA) in hidradenitis suppurativa/acne inversa (HS) was evaluated by pooling the results of the PIONEER phase 3 trials and an open-label extension (OLE) study.

Objective

To assess the response to and tolerability of long-term administration of ADA in HS.

Methods

The durations of the PIONEER I/II periods A, B, and OLE were 12, 24, and 52 or more weeks, respectively. Patients who entered the OLE and received ADA (40 mg every week continuously) and responders plus partial responders (PRRs) were evaluated. Primary efficacy assessments included measurement of HS clinical response (HiSCR), lesion counts, skin pain, and Dermatology Life Quality Index (DLQI). Treatment-emergent adverse events were assessed.

Results

At week 12, 52.3% of those receiving ADA weekly and 73.0% of PRRs achieved HiSCR. Achievement of HiSCR was maintained through week 168 in 52.3% of patients who received ADA weekly and 57.1% of PRRs. Sustained improvement in lesion counts, skin pain, and DLQI score were also observed. The safety profile throughout the OLE was similar to the profiles observed in the PIONEER studies.

Limitations

The OLE was uncontrolled.

Conclusion

Continuous weekly dosing with ADA, 40 mg, is a reasonable treatment option for long-term control of moderate-to-severe HS.

Section snippets

Patients

The PIONEER I and II patient eligibility criteria are described in detail elsewhere.12 Briefly, patients were eligible if they were at least 18 years of age, had not previously received anti–tumor necrosis factor-α treatment, and had moderate-to-severe HS (total abscess and inflammatory nodule [AN] count of ≥3 at baseline and HS lesions in 2 distinct body areas, 1 of which was classified as Hurley stage II or III) with inadequate response to oral antibiotic treatment. In PIONEER I, patients

Patients

In this analysis of results across PIONEER I and II (pooled data) into the OLE trial, 88 patients comprised the ADA weekly population and 63 comprised the PRR population. All patients were followed for at least 96 weeks (36 weeks in PIONEER I or PIONEER II and at least 60 weeks in the OLE), but follow-up time varied depending on when patients entered the OLE. Key demographics are summarized in Table I. The population treated with ADA weekly was mostly female (64%) and white (92%), with a median

Discussion

Efficacy and safety results derived from pooling the pivotal phase 3 trials with the OLE trial confirm that ADA sustains efficacy and has an acceptable safety profile following a strategy of continuous weekly treatment. Pooling of the data from the 2 PIONEER trials was prespecified in the protocol for period A and period B results. The combined analysis was appropriate on the basis of the similarities in study design and provided a more robust assessment by combining the somewhat limited sample

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    • A Practical Guide for Primary Care Providers on Timely Diagnosis and Comprehensive Care Strategies for Hidradenitis Suppurativa

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      Significantly greater improvements in lesion counts, pain, and modified Sartorius score for disease activity were observed in patients who received adalimumab vs placebo.93 Furthermore, in an open-label extension follow-up study, sustained improvements in hidradenitis suppurativa clinical response, lesion counts, skin pain, and Dermatology Life Quality Index score were maintained through week 168 with continuous weekly dosing with adalimumab.94 Although limited studies are available, some have demonstrated the efficacy of infliximab,95,96 ustekinumab,97,98 anakinra,99,100 bimekizumab,101 and secukinumab95 for the treatment of patients with hidradenitis suppurativa.

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    Funding sources: Supported by AbbVie, Inc.

    Disclosure: Dr Zouboulis has received honoraria from AbbVie Inc, Bayer Healthcare, Biogen, and PPM for his participation as an advisor and speaker; he has also received honoraria from Allergan, Almirall, Celgene, GlaxoSmithKline, Inflarx, Novartis, and UCB for his participation as an advisor and from Jenapharm and Pierre Fabre as a speaker. His department has received grants from AbbVie Inc, AOTI, AstraZeneca, Biogen, Celgene, Dr. Reddy's, Galderma, Novartis, and UCB for his participation as an investigator. Dr Okun has received honoraria from AbbVie Inc for advisory board participation, speaker services, and consultant services, as well as from Crescendo Biosciences and Gilead for consultant services; he was an AbbVie employee at the initiation of this study. Dr Prens has received honoraria from AbbVie Inc, Amgen, AstraZeneca, Biogen, Celgene, Janssen, Leo Pharma, Novartis, Pfizer, and UCB as an advisor and speaker; his department has received investigator-initiator grants from AstraZeneca, Celgene, Janssen, and Pfizer. Dr Gniadecki has received honoraria from AbbVie Inc, Janssen, Novartis, and Amgen for participation on advisory boards and for services as an investigator and a speaker; his department has received grants from AbbVie Inc, Janssen, and Novartis for his participation as an investigator. Dr Foley has served as a consultant, investigator, speaker, and/or advisor for and/or received travel grants from Galderma, LEO/Peplin, Ascent, Clinuvel, Cutanea, Celtaxsys, Dermira, Janssen-Cilag, Eli Lilly and Company, Australian Ultraviolet Services, Roche, CSL, 3M/iNova/Valeant, GSK/Stiefel, Abbott/AbbVie, Biogen Idec, Merck Serono, Schering-Plough/MSD, Wyeth/Pfizer, Amgen, Novartis, Celgene, Aspen, Boehringer Ingelheim, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, and Bristol-Myers Squibb. Dr Lynde has received honoraria as a principal investigator, speaker, and consultant for AbbVie Inc, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly and Company, Janssen, Leo Pharma, Merck, Novartis, and Regeneron. Dr Weisman has received research grants for investigator services from AbbVie Inc, Allergan, Amgen, Astra Zeneca, Boehringer Ingelheim, Braintree, Celgene, Eli Lilly and Company, Glaxo Smith Klein, Janssen, Leo Pharma, Merck, Novartis, Pfizer, Regeneron, Steifel, and Tigercat; he has also received honoraria for service on advisory boards and speaker's bureaus from AbbVie Inc, Amgen, Celgene, Eli Lilly and Company, and Janssen. Ms Gu and Dr Williams are employees of AbbVie Inc and may hold stock and/or stock options. Dr Jemec has acted as investigator for AbbVie, Actelion, Coloplast, Janssen-Cilag, Pfizer, Pierre Fabre, Inflarx, Merck Sharp & Dome, Galderma, Leo Pharma, Novartis, Regeneron, and UCB, and he has received honoraria for speaking and/or advisory boards from AbbVie, Coloplast, Pierre Fabre, Inflarx, Merck Sharp & Dome, Galderma, Leo Pharma, Novartis, and UCB, and research grants from AbbVie, Leo Pharma, and Novartis.

    In addition to funding this study, AbbVie, Inc, participated in the study design; study research; collection, analysis, and interpretation of data; and writing, review, and approval of this article for publication. All authors had access to the data and participated in the development, review, and approval of the article, as well as in the decision to submit it for publication.

    Some of the data reported in this article were presented at the American Academy of Dermatology Annual Meeting in Orlando, Florida, March 3-7, 2017.

    Reprints not available from the authors.

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