Abstract
Introduction
We evaluated the efficacy of brodalumab in patients with nail or scalp psoriasis in three phase 3 studies (AMAGINE-1/-2/-3).
Methods
In AMAGINE-1, scalp clearance, measured by the psoriasis scalp severity index (PSSI), was reported for patients who received brodalumab 210 mg every 2 weeks (Q2W) or placebo through 12 weeks. In AMAGINE-2/-3, nail clearance, measured by the nail psoriasis severity index (NAPSI), was reported for patients receiving either brodalumab 210 mg Q2W or ustekinumab continuously through 52 weeks.
Results
At week 12, significantly more patients receiving brodalumab achieved 75% and 100% improvement rates from baseline PSSI and had lower mean PSSI across 12 weeks compared with placebo, with significant improvement in PSSI evident with brodalumab 210 mg Q2W vs placebo by week 2. Across 52 weeks, patients receiving brodalumab achieved significantly greater complete clearance of nail psoriasis (NAPSI 0), lower mean NAPSI, and higher mean percent improvement rates from baseline NAPSI than patients receiving ustekinumab. At week 52, 63.8% of patients receiving brodalumab achieved NAPSI 0 vs 39.1% of patients receiving ustekinumab.
Conclusions
Brodalumab was associated with clearance of scalp psoriasis through 12 weeks and improvements in nail psoriasis, including complete nail clearance, through 52 weeks.
Acknowledgements
Editorial assistance was provided under the direction of the authors by Deirdre Rodeberg, PhD, and Jenna Lewis, MA, ELS, at MedThink SciCom with support from Ortho Dermatologics. Ortho Dermatologics is a division of Bausch Health US, LLC.
Disclosure statement
Boni Elewski has received grants for clinical trials and served as a consultant for AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, LEO Pharma, Merck, Novartis, Ortho Dermatologics (division of Bausch Health US, LLC), Pfizer, Regeneron, and Sun Pharma. Phoebe Rich has served as principal investigator and has received grants for clinical trials from AbbVie, Bristol-Myers Squibb, Dermavant, Eli Lilly, Janssen, Kadmon, Novartis, Pfizer, Sun Pharma, and UCB. Edward Lain has served as an investigator, consultant, and speaker for Ortho Dermatologics (division of Bausch Health US, LLC). Jennifer Soung has received compensation from or served as an investigator, consultant, advisory board member, or speaker for AbbVie, Amgen, Bausch Health, Boehringer Ingelheim, Cassiopea, Celgene, Dermira, Eli Lilly, Galderma, GlaxoSmithKline, Janssen Pharmaceuticals, Kyowa Kirin, LEO Pharma, Medimmune, Menlo, Merck & Co, Novan, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, and UCB. George Michael Lewitt has served as an investigator, consultant, advisory board member, or speaker for AbbVie, AOBiome, Galderma Laboratories, Janssen, Lilly, Novartis, Ortho Dermatologics (division of Bausch Health US, LLC), and Sol-Gel. Abby Jacobson is an employee of Ortho Dermatologics (division of Bausch Health US, LLC) and holds stock and/or stock options in Bausch Health US, LLC.