Logo image
Back
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
Journal article   Open access   Peer reviewed

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

P.J Mease, M.E Husni, S.D Chakravarty, S Kafka, D.D Harrison, D Parenti, L Kim, K.H Lo, E.C Hsia and A Kavanaugh
Annals of the rheumatic diseases, v 77(Suppl 2), p1038
Jun 2018
DOI: https://doi.org/10.1136/annrheumdis-2018-eular.1766
url
https://doi.org/10.1136/annrheumdis-2018-eular.1766View
Published, Version of Record (VoR)Maybe Open Access (Publisher Bronze),  Open

Abstract

BackgroundGO-VIBRANT was a Ph3 trial of IV golimumab (GLM) in adult pts w/active PsA.ObjectivesTo evaluate improvement in skin, nail psoriasis and Dermatology Life Quality Index (DLQI) w/IV GLM.MethodsAdult 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.Results394 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).Abstract SAT0346 – Table 1Change from Baseline in PASI 90/100 Through Wk24Wk14Wk24 PBOGLMPBOGLM Pts evaluable for improvement fr/BL in PASI, n198196198196PASI 90 (%)% Diff (95% CI)6.639.332.7 (25.10, 40.40)*7.642.935.3 (27.52, 43.16)*PASI 100 (%)% Diff (95% CI)4.516.812.3 (6.34, 18.30)*5.625.520.0 (13.22, 26.85)*+BL MTX, n142131142131PASI 90 (%)% Diff (95% CI)7.741.233.5 (23.97, 42.98)*9.245.836.6 (26.88, 46.41)*PASI 100 (%)% Diff (95% CI)5.617.611.9 (4.39, 19.46)**7.030.523.5 (14.55, 32.43)*- BL MTX, n56655665PASI 90 (%)% Diff (95% CI)3.635.431.8 (19.21, 44.41)*3.636.933.4 (20.65, 46.05)*PASI 100 (%)% Diff (95% CI)1.815.413.6 (4.17, 23.03)***1.815.413.6 (4.17, 23.03)***p<0.001; **p=0.002; ***p=0.010Abstract SAT0346 – Table 2Change from Baseline in mNAPSI Through Wk24Wk14Wk24 PBOGLMPBOGLM Pts (mNAPSI>0) evaluable for change fr/BL, n170197170197Mean (SD)LS Mean diff (95% CI)−1.9 (13.05)−9.6 (15.71)−8.4 (-10.71,–6.05)*−3.7 (14.45)−11.4 (16.38)−8.4 (-10.82,–6.01)**p<0.001ConclusionsAs 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 InterestP. 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

Metrics

9 Record Views
1 citations in Web of Science

Details

InCites Highlights

Data related to this publication, from InCites Benchmarking & Analytics tool:

Collaboration types
Industry collaboration
Domestic collaboration
Web of Science research areas
Rheumatology
Logo image