SAT0346 Clinically meaningful improvement in skin and nail psoriasis in bio-naÏve active psoriatic arthritis patients treated with intravenous golimumab: results through week 24 of the go-vibrant study

Abstract

Background GO-VIBRANT was a Ph3 trial of IV golimumab (GLM) in adult pts w/active PsA. Objectives To evaluate improvement in skin, nail psoriasis and Dermatology Life Quality Index (DLQI) w/IV GLM. Methods Adult bio-naïve PsA pts w/active disease(≥5 swollen and tender joints, CRP ≥0.6 mg/dl, active plaque PsO or documented history, and despite treatment w/csDMARDs and /or NSAIDs)were randomised to IV GLM 2 mg/kg at wks0, 4, and q8wks thereafter or PBO at wks0, 4, 12, and 20 w/crossover to GLM at wk24. Pts w/≥3% body surface area(BSA)PsO at baseline (BL) were assessed using Psoriasis Area and Severity Index(PASI,0–72) 75/90/100% and modified Nail Psoriasis Severity Index(mNAPSI,0–130) at BL, wks14 and 24(in pts w/mNAPSI>0 at BL). DLQI was assessed at BL, wks8, 14 and 24. Results 394 pts(PBO:n=198;GLM:n=196) had ≥3% BSA PsO at BL; 76.5% had mNAPSI >0 at BL(mean 18.6).Pts on GLM achieved a greater PASI75 response vs PBO(59.2% vs 13.6%,p<0.001) at wk14 and wk24(64.8% vs 13.1%,p<0.001). At wk14, pts on GLM achieved greater PASI 90/100 responses vs PBO(39.3/16.8% vs 6.6/4.5%;p<0.001 for all) and at wk24(42.9/25.5% vs 7.6/5.6%;p<0.001 for all) (table 1). At wk14, similar proportions of pts in GLM grps, regardless of BL MTX use, achieved PASI 90/100 responses. At wk24, greater proportions of pts on GLM+MTX and GLM only achieved PASI100 vs PBO(+MTX:30.5% vs 7%, p<0.001;–MTX:15.4% vs 1.8%,p<0.010) (table 1).Mean decrease(improvement) from BL in mNAPSI score was greater in GLM vs PBO(−9.6 vs −1.9,p<0.001) at wk14 and wk24(−11.4 vs −3.7,p<0.001). At wk8, mean decrease(improvement) from BL in DLQI was greater in GLM vs PBO(−7.2 vs −1.7,p<0.001),at wk14(−7.7 vs −1.8,p<0.001) and wk24(−8.1 vs −1.9,p<0.001). At wk14, 55.1% of pts treated w/GLM achieved a PASI50 response and improvement in DLQI≥5 vs 7.1% treated w/PBO(p<0.001) and at wk24, 59.2% vs 8.1%(p<0.001).View this table:View inline View popup Abstract SAT0346 – Table 1 Change from Baseline in PASI 90/100 Through Wk24View this table:View inline View popup Abstract SAT0346 – Table 2 Change from Baseline in mNAPSI Through Wk24 Conclusions As early as wk14, IV GLM demonstrated clinically meaningful improvements in skin PsO irrespective of MTX use and nail PsO. Improvement in DLQI was seen as early as wk8, w/continued improvement at wks14 and 24. Disclosure of Interest P. Mease Grant/research support from: Janssen Research and Development, LLC, M. Husni Grant/research support from: Janssen Research and Development, LLC, S. Chakravarty Employee of: Janssen Scientific Affairs, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, D. Harrison Employee of: Janssen Research and Development, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, L. Kim Employee of: Janssen Research and Development, LLC, K. Lo Employee of: Janssen Research and Development, LLC, E. Hsia Employee of: Janssen Research and Development, LLC, A. Kavanaugh Grant/research support from: Janssen Research and Development, LLC