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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

Doi : 10.1016/j.jaad.2019.05.095 
Luis Puig, MD a, , Mark Lebwohl, MD b, Hervé Bachelez, MD c, d, Jeffrey Sobell, MD e, Abby A. Jacobson, PA-C f
a Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain 
b Icahn School of Medicine at Mount Sinai, New York, New York 
c Sorbonne Paris Cité Université Paris Diderot, Paris, France 
d AP-HP Hôpital Saint-Louis, Paris, France 
e SkinCare Physicians, Chestnut Hill, MA 
f Ortho Dermatologics, Bridgewater, NJ 

Correspondence to: Luis Puig, MD, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Dept of Dermatology, Mas Casanovas 90, Block A, 5th Floor, Module 3, 08041 Barcelona, Spain.Hospital de la Santa Creu i Sant PauUniversitat Autònoma de BarcelonaDept of DermatologyMas Casanovas 90, Block A, 5th Floor, Module 3Barcelona08041Spain

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.

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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.
 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.
 Reprints not available from the authors.


© 2019  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 82 - N° 2

P. 352-359 - février 2020 Retour au numéro
Article précédent Article précédent
  • Immunogenicity and skin clearance recapture in clinical studies of brodalumab
  • Jerry Bagel, Mark Lebwohl, Robert J. Israel, Abby Jacobson
| Article suivant Article suivant
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