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Background GO-VIBRANT is a Phase 3 trial of intravenous (IV) golimumab (GLM) in adult patients (pts) with active psoriatic arthritis (PsA). Clinically meaningful improvements in skin and nail psoriasis (PsO) and in Dermatology Life Quality index (DLQI) that were significantly greater than placebo (PBO) at weeks (wks) 14 & 24 were previously reported.1 Objectives To evaluate improvement in skin and nail PsO and DLQI with IV GLM through wk52. Methods Adult bio-naive PsA pts with active disease(≥5 swollen & tender joints, CRP ≥0.6mg/dL, active plaque psoriasis or documented history), despite treatment w/csDMARDs &/or NSAIDs, were randomized to IV GLM 2mg/kg at wks 0/4 & every 8 wks thereafter or PBO at wks 0/4/12/20 with crossover to GLM at wk24. Pts with ≥3% body surface area (BSA) psoriasis at baseline (BL) were assessed using Psoriasis area and Severity index (PASI, 0-72) of 75/90/100% improvement scale, modified Nail Psoriasis Severity index (mNAPSI, 0-130) in pts with mNAPSI >0 at BL, and DLQI (0-30) scale. Results 394 pts (PBO:n=198; GLM:n=196) had ≥3% BSA psoriasis at BL; 76.5% had mNAPSI>0 at BL(mean 18.6). Pts on IV GLM achieved a greater PASI 75 response rate (RR) vs PBO at wk24 (64.8% vs 13.1%, p 1 at baseline, rate of simultaneous achievement of both PASI 50 response & improvement in DLQI ≥5 was greater at wk24 with IV GLM (59.2%) vs PBO (8.1%, p Conclusion Clinically meaningful improvements in skin and nail psoriasis and psoriasis quality of life after IV GLM treatment of PsA pts were maintained from 24 to 52 weeks of treatment. References [1] Mease P, et al. EULAR. June2018, amsterdam, NL. Disclosure of interests M Elaine Husni Grant/research support from: Janssen, Philip J Mease Grant/research support from: abbVie, amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: abbVie, amgen, BMS, Galapagos, Gilead Sciences, inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: abbVie, amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB, Soumya D Chakravarty Shareholder of: Johnson & Johnson, Employee of: Johnson & Johnson, Shelly Kafka Shareholder of: J&J, Employee of: J&J, Diane D Harrison Employee of: Janssen Research & Development, LLC, Dennis Parenti Employee of: Janssen Research & Development, LLC, Lilianne Kim Employee of: Janssen Research & Development, LLC, Kim Hung Lo Employee of: Janssen Research & Development, LLC, Elizabeth C Hsia Employee of: Employee of Janssen Research & Development, LLC, arthur Kavanaugh Grant/research support from: UCB Pharma |
