343 Mease, et al: Brodalumab PSI in PsA Personal non-commercial use only. The Journal of Rheumatology Copyright © 2016. All rights reserved. Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis Philip J. Mease, Mark C. Genovese, Alex Mutebi, Hema N. Viswanathan, Dina Chau, Jingyuan Feng, Ngozi Erondu, and Ajay Nirula ABSTRACT. Objective. To evaluate the effect of brodalumab on psoriasis signs and symptoms assessed by the Psoriasis Symptom Inventory (PSI) in patients with psoriatic arthritis (PsA). Methods. This prespecified analysis of a phase II study (NCT01516957) evaluated patients with active PsA and psoriasis-affected body surface area ≥ 3%, randomized to brodalumab (140 or 280 mg) or placebo every 2 weeks (Q2W) for 12 weeks with loading dose at Week 1. At Week 12, patients entering an open-label extension received brodalumab 280 mg Q2W. The PSI measures 8 psoriasis signs and symptoms: itch, redness, scaling, burning, stinging, cracking, flaking, and pain. PSI response is defined as total PSI ≤ 8 (range 0-32), each item ≤ 1 (range 0-4). PSI scores were assessed at weeks 12 and 24. Results. There were 107 eligible patients. At Week 12, mean improvement in PSI scores was 7.8, 11.2, and 1.5 in brodalumab 140 mg, 280 mg, and placebo groups, respectively; by Week 24, improvement was 10.2, 12.4, and 11.7. At Week 12, 75.0%, 81.8%, and 16.7% of patients receiving brodalumab 140 mg, 280 mg, and placebo, respectively, achieved PSI response; improvement was sustained through Week 24, when 83.9% of prior placebo recipients achieved response. At Week 12, 25.0%, 36.4%, and 2.8% of patients receiving brodalumab 140 mg, 280 mg, and placebo, respectively, achieved PSI 0. Percentages improved through Week 24: 40.0% brodalumab 140 mg, 42.9% brodalumab 280 mg, and 48.4% placebo. Conclusion. Significantly more brodalumab-treated patients with PsA achieved patient-reported improvements in psoriasis signs and symptoms than did those receiving placebo. Improvements were comparable between brodalumab groups. (First Release January 15 2016; J Rheumatol 2016;43:343–9; doi:10.3899/jrheum.150182) Key Indexing Terms: PSORIATIC ARTHRITIS BIOLOGICAL PRODUCTS PATIENT OUTCOME ASSESSMENT PSORIASIS From the Swedish Medical Center; University of Washington, Seattle, Washington; Stanford University, Stanford; Amgen Inc., Thousand Oaks, California, USA. Study funded by Amgen Inc. PJM has received research grants, consulting fees, and/or speaker honoraria from Amgen Inc. MCG has received research grants and consulting fees from Amgen Inc. AM, HNV, and DC are employees and shareholders of Amgen Inc. JF, NE, and AN are former employees and shareholders of Amgen Inc. P.J. Mease, MD, Swedish Medical Center and University of Washington; M.C. Genovese, MD, Stanford University; A. Mutebi, PhD, Amgen Inc.; H.N. Viswanathan, PhD, Amgen Inc.; D. Chau, PharmD, Amgen Inc.; J. Feng, MS, formerly with Amgen Inc.; A. Nirula, MD, PhD, formerly with Amgen Inc.; N. Erondu, PhD, formerly with Amgen Inc. Address correspondence to Dr. P.J. Mease, Seattle Rheumatology Associates, 601 Broadway, Suite 600, Seattle, Washington 98122, USA. E-mail: pmease@philipmease.com Accepted for publication August 31, 2015. Psoriatic arthritis (PsA) is an inflammatory disease that frequently presents with cutaneous symptoms associated with psoriasis and inflammatory joint disease 1,2,3 . Prevalence of PsA among patients with psoriasis varies widely and is estimated to be between 6% and 42% 1,2,4,5 . The clinical features of PsA include psoriasis, arthritis, dactylitis, enthe- sitis, spondylitis, and nail disease 6 . Most patients with PsA have active psoriasis or have had a history of psoriasis 7 , and as PsA progresses, joint damage associated with arthritis increases 1,7,8,9 . Psoriasis symptoms in patients with PsA are likely to be associated with a greater effect on health-related quality of life (HRQOL) 10,11 : patients with psoriasis who also have PsA have worse health status and lower HRQOL than patients with psoriasis alone, as measured by the Health Assessment Questionnaire (HAQ), the Medical Outcomes Study Short Form-36 (SF-36) questionnaire, the Derma- tology Life Quality Index (DLQI), and EQ-5D 12,13 . Patients with PsA with mild psoriasis are believed to experience minimal effect on quality of life, whereas patients with moderate to severe psoriasis experience a more than minimal effect on quality of life 14 . Interleukin (IL)-17 pathways may play a role in the patho- www.jrheum.org Downloaded on January 17, 2022 from