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 - 13/12/18
, Martin M. Okun, MD b, Errol P. Prens, MD, PhD c, Robert Gniadecki, MD, PhD d, Peter A. Foley, MBBS, BMedSc, MD, FACD e, Charles Lynde, MD, FRCPC f, Jamie Weisman, MD g, Yihua Gu, MS h, David A. Williams, MD, MPH h, Gregor B.E. Jemec, MD, DMSc iAbstract |
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.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Key Words : acne inversa, adalimumab, continuous, dose, hidradenitis suppurativa, longitudinal, long-term, weekly
Abbreviations used : ADA, AN, DLQI, HiSCR, HS, OLE, PRRs
Plan
| Funding sources: Supported by AbbVie, Inc. |
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| 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. |
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| 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. |
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| 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. |
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| Reprints not available from the authors. |
Vol 80 - N° 1
P. 60 - janvier 2019 Retour au numéro
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