Objective To compare the efficacy and safety of treatment with infliximab plus methotrexate with methotrexate alone in methotrexate-naive patients with active psoriatic arthritis (PsA).
Methods In this open-label study, patients 18 years and older with active PsA who were naive to methotrexate and not receiving disease-modifying therapy (N=115) were randomly assigned (1:1) to receive either infliximab (5 mg/kg) at weeks 0, 2, 6 and 14 plus methotrexate (15 mg/week); or methotrexate (15 mg/week) alone. The primary assessment was American College of Rheumatology (ACR) 20 response at week 16. Secondary outcome measures included psoriasis area and severity index (PASI), disease activity score in 28 joints (DAS28) and dactylitis and enthesitis assessments.
Results At week 16, 86.3% of patients receiving infliximab plus methotrexate and 66.7% of those receiving methotrexate alone achieved an ACR20 response (p<0.02). Of patients whose baseline PASI was 2.5 or greater, 97.1% receiving infliximab plus methotrexate compared with 54.3% receiving methotrexate alone experienced a 75% or greater improvement in PASI (p<0.0001). Improvements in C-reactive protein levels, DAS28 response and remission rates, dactylitis, fatigue and morning stiffness duration were also significantly greater in the group receiving infliximab. In the infliximab plus methotrexate group, 46% (26/57) had treatment-related adverse events (AE) and two patients had serious AE, compared with 24% with AE (13/54) and no serious AE in the methotrexate-alone group.
Conclusions Treatment with infliximab plus methotrexate in methotrexate-naive patients with active PsA demonstrated significantly greater ACR20 response rates and PASI75 improvement compared with methotrexate alone and was generally well tolerated. This trial is registered in the US National Institutes of Health clinicaltrials.gov database, identifier NCT00367237.
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↵* See list of RESPOND investigators at the end of the paper.
Funding Financial support for this study was provided by Schering-Plough Corporation, now Merck, Sharp & Dohme Corporation, Whitehouse Station, New Jersey, USA.
Competing interests A Baranauskaite, H Raffayová, N Kungurov, A Kubanova, and A Venalis have nothing to disclose. LH and SS were employees of Schering-Plough Corporation, now Merck, Sharp & Dohme Corporation (MSD), at the time this paper was written. EN has been a speaker for Roche, Schering-Plough Corporation and MSD. NV is an employee and stockholder of MSD.
Ethics approval The study protocol was approved by the ethics committee at each of the participating study sites.
Patient consent Obtained.
RESPOND investigators R Nasyrova, Central Rheumatology Institute, Moscow, Russia; E Parsik, North Estonian Regional Hospital, Tallinn, Estonia; K Otsa, East-Tallinn's Central Hospital, Tallinn, Estonia; I Butrimiene, Vilnius University Hospital, Vilnius, Lithuania; M Pileckyte, Kaunas Medical University Hospital, Kaunas, Lithuania; W Tlustochowicz, Centralny Szpital Kliniczny, Warszawa, Poland; E Kucharz, Samodzielny Publiczny Szpital, Katowice-Ochojec, Poland; Z Szekanecz, University of Debrecen, Debrecen, Hungary; G Poor, National Institute of Rheumatology and Physiotherapy, Budapest, Hungary; E Koo, Polyclinic of the Hospitaller Brothers of St John of God, Budapest, Hungary; L Hodinka, National Institute of Rheumatology and Physiotherapy, Budapest, Hungary; Z Macejova, L Pasteur's Faculty Hospital, Kosice, Slovak Republic; H Direskeneli, Marmara Universitesi Tip Fakultesi, Istanbul, Turkey; N Akkoc, Dokuz Eylul Universitesi Tip Fakultesi, Izmir, Turkey; Y Kabasakal, Ege Universitesi Tip Fakultesi, Izmir, Turkey; I Ertenli, Hacettepe Universitesi Tip Fakultesi, Ankara, Turkey; F Khatib, Arwyp Medical Suites, Kempton Park, South Africa; EM van Duuren, Jacaranda Hospital, Pretoria, South Africa; C Spargo, Vincent Pallotti Hospital, Pinelands, South Africa; I Louw, Panorama Hospital Medical Centre, Cape Town, South Africa; C Codreanu, Centrul de Boli, Bucharest, Romania; R Ionescu, Sp Clinic Sf Maria, Bucharest, Romania; RM Chireac, Sp Clinic de Recuperare, Iasi, Romania; S Rednic, Sp Clinic Judetean Cluj, Cluj, Romania; M Hammoudeh, Hamad Medical Corporation, Doha, Qatar; J Szechinski, Prywatny Gabinet Internistyczno-Reumatologiczny, Wroclaw, Poland; M Rell-Bakalarska, Przychodnia Przykliniczna, Warszawa, Poland; D Avraham, Meir MC Dermatology, Kfar Saba, Israel; D Andersone, P Stradins Clinical University Hospital, Riga, Latvia; P Keszthelyi, Bekes County Pandy Kalman Hospital, Gyula, Hungary; P Suranyi, Hajdu-Bihar County Kenezy Gyula Hospital, Debrecen, Hungary
Provenance and peer review Not commissioned; externally peer reviewed.
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