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
Authors: P.J. Mease, M.E. Husni, S.D. Chakravarty, S. Kafka, D.D. Harrison, D. Parenti, L. Kim, K.H. Lo, E.C. Hsia, A. Kavanaugh
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> GO-VIBRANT was a Ph3 trial of IV golimumab (GLM) in adult pts w/active PsA. <h3>Objectives</h3> To evaluate improvement in skin, nail psoriasis and Dermatology Life Quality Index (DLQI) w/IV GLM. <h3>Methods</h3> 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&gt;0 at BL). DLQI was assessed at BL, wks8, 14 and 24. <h3>Results</h3> 394 pts(PBO:n=198;GLM:n=196) had ≥3% BSA PsO at BL; 76.5% had mNAPSI &gt;0 at BL(mean 18.6).Pts on GLM achieved a greater PASI75 response vs PBO(59.2% vs 13.6%,p&lt;0.001) at wk14 and wk24(64.8% vs 13.1%,p&lt;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&lt;0.001 for all) and at wk24(42.9/25.5% vs 7.6/5.6%;p&lt;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&lt;0.001;–MTX:15.4% vs 1.8%,p&lt;0.010) (table 1).Mean decrease(improvement) from BL in mNAPSI score was greater in GLM vs PBO(−9.6 vs −1.9,p&lt;0.001) at wk14 and wk24(−11.4 vs −3.7,p&lt;0.001). At wk8, mean decrease(improvement) from BL in DLQI was greater in GLM vs PBO(−7.2 vs −1.7,p&lt;0.001),at wk14(−7.7 vs −1.8,p&lt;0.001) and wk24(−8.1 vs −1.9,p&lt;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&lt;0.001) and at wk24, 59.2% vs 8.1%(p&lt;0.001). <h3>Conclusions</h3> 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. <h3>Disclosure of Interest</h3> 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