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

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). 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.