Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator–controlled phase 3 AMAGINE-2 trial - 09/01/20
Abstract |
Background |
Randomized controlled trials have shown the efficacy and safety of brodalumab in patients with moderate to severe plaque psoriasis.
Objective |
To evaluate the efficacy and safety of brodalumab through 120 weeks of treatment in the AMAGINE-2 trial.
Methods |
Patients received ustekinumab through week 52 followed by brodalumab 210 mg every 2 weeks, continuous brodalumab 210 mg every 2 weeks, or any dose of brodalumab. Efficacy data were reported through 120 weeks by using observed data, last observation carried forward, and nonresponder imputation analyses.
Results |
Of patients who received brodalumab 210 mg every 2 weeks, 84.4%, 75.6%, and 61.1% achieved 75%, 90%, and 100% improvement from baseline in Psoriasis Area and Severity Index at 120 weeks (observed data analysis), respectively. Patients who received brodalumab 210 mg every 2 weeks after receiving ustekinumab through 52 weeks achieved a similar skin clearance response as patients who received continuous brodalumab 210 mg every 2 weeks. Safety through 120 weeks was comparable to that of the blinded study periods.
Limitations |
A large number of discontinuations toward the end of the study (31% in the final 6 months) were due to early termination and led to differences between observed data and nonresponder imputation results.
Conclusions |
Brodalumab is well tolerated and showed robust efficacy for more than 2 years.
Le texte complet de cet article est disponible en PDF.Key words : AMAGINE-2, brodalumab, efficacy, long-term, psoriasis, safety
Abbreviations used : AE, IL, LOCF, NRI, PASI, PASI 75, PASI 90, PASI 100, SIB, sPGA, TEAE
Plan
Funding sources: Supported by Ortho Dermatologics. The AMAGINE-2 study was supported by Amgen. |
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Disclosure: Dr Puig has received consulting fees, speaking fees, and/or honoraria from AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, Leo, Eli Lilly and Company, Merck-Serono, MSD, Novartis, Pfizer, Regeneron, Roche, and Sandoz and has received institutional research funding related to the treatment of psoriasis from AbbVie, Amgen, Janssen, Eli Lilly and Company, Novartis, and Pfizer. Dr Lebwohl is an employee of Mount Sinai and receives research funds from Abbvie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen, Johnson & Johnson, Leo, MedImmune/AstraZeneca, Novartis, Pfizer, SciDerm, Valeant, and Vidac and is also a consultant for Allergan, Aqua, Boehringer-Ingelheim, Leo, Menlo, and Promius. Dr Bachelez has served as a consultant, speaker, steering committee member, investigator, or advisory board member for AbbVie, Almirall, Amgen, Baxalta, Boehringer-Ingelheim, Celgene, Dermavant, Janssen, Leo, Lilly, Mylan, Novartis, Pfizer, Sun, Takeda, and UCB and has received grant support from Pfizer. Dr Sobell has served as an investigator, consultant, and/or speaker for Amgen, AbbVie, Janssen Biotech, Celgene, Merck, Sun, Lilly, Novartis, UCB, Regeneron, and Sanofi. Ms Jacobson is an employee of Ortho Dermatologics and holds stocks and/or stock options in Bausch Health. |
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Reprints not available from the authors. |
Vol 82 - N° 2
P. 352-359 - février 2020 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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