Clinical and epidemiological research EXTENDED REPORT Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results of the GO-RAISE study Jürgen Braun,1 Atul Deodhar,2 Robert D Inman,3 Désirée van der Heijde,4 Michael Mack,5 Stephen Xu,5 Benjamin Hsu5 1Rheumazentrum Ruhrgebiet, Herne, Germany 2Oregon Health and Science University, Portland, Oregon, USA 3University of Toronto, Toronto Western Hospital, Canada 4Leiden University Medical Center, Leiden, The Netherlands 5Centocor Research & Development, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Malvern, Pennsylvania, USA Correspondence to Jürgen Braun, Rheumazentrum Ruhrgebiet, Landgrafenstrasse 15, D-44652 Herne, Germany; j.braun@rheumazentrum- ruhrgebiet.de Accepted 27 August 2011 Published Online First 19 October 2011 ABSTRACT Objective To assess the efﬁcacy and safety of golimumab over 104 weeks in patients with active ankylosing spondylitis. Methods At baseline, patients with active ankylosing spondylitis (n=356) were randomly assigned (1:1.8:1.8) to subcutaneous injections of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3) every 4 weeks. At week 16, patients in groups 1 and 2 with <20% improvement in total back pain and morning stiffness entered early escape to 50 or 100 mg, respectively. At week 24, patients still receiving placebo crossed over to golimumab 50 mg. Findings through week 24 were previously reported; those through week 104 are presented herein. Results At week 104, 38.5%, 60.1% and 71.4% of patients in groups 1, 2 and 3, respectively, had at least 20% improvement in the Assessment in SpondyloArthritis international Society response criteria (ASAS20); 38.5%, 55.8% and 54.3% had an ASAS40 response and 21.8%, 31.9% and 30.7% were in ASAS partial remission. Mean Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores were <3 at week 104 for all the treatment regimens. Golimumab safety through week 104 was similar to that through week 24. Conclusion Clinical response that was achieved by patients receiving golimumab through 24 weeks was sustained through 52 and 104 weeks. The golimumab safety proﬁle appeared to be consistent with the known safety proﬁle of tumour necrosis factor inhibitors. Golimumab is a human monoclonal antibody to tumour necrosis factor (TNF) α that is administered subcutaneously every 4 weeks. We previously reported the 24-week results of the double-blind, randomised, placebo-controlled GO-RAISE (A Multicenter Randomized, Double-blind, Placebo- controlled Trial of Golimumab, a Fully Human Anti-TNFα Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Ankylosing Spondylitis) study, in which we evaluated the efﬁ- cacy and safety of golimumab in patients with ankylosing spondylitis (AS).1 The primary end point of the GO-RAISE study was achieved; 59% of patients in the 50-mg group and 60% of patients in the 100-mg group achieved at least 20% improve- ment in the Assessment in SpondyloArthritis international Society response criteria (ASAS20) at week 14 compared with 22% in the placebo Ann Rheum Dis 2012;71:661–667. doi:10.1136/ard.2011.154799 group (p<0.001 for comparisons of placebo with each golimumab group). No unexpected adverse events were observed through 24 weeks of goli- mumab treatment. Patients were followed up for up to 5 years, with the blind maintained through week 104 (for the type of treatment, placebo or golimumab, through week 24 and, following cross- over, for the golimumab dose through week 104) to assess the long-term effects of golimumab therapy. Here we present the 104-week efﬁcacy and safety ﬁndings from the GO-RAISE study. PATIENTS AND METHODS Details of the GO-RAISE study design, along with complete patient inclusion criteria, have been pre- viously published.1 Brieﬂy, patients had AS, as deﬁned according to the 1984 New York Criteria,2 for at least 3 months before the ﬁrst administration of study agent and an inadequate response to cur- rent or previous treatment with non-steroidal anti- inﬂammatory drugs (NSAIDs) or disease-modifying antirheumatic drugs (DMARDs). Patients were ran- domly assigned in a 1:1.8:1.8 ratio to receive subcu- taneous injections of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3) every 4 weeks (ﬁgure 1). Concomitant use of meth- otrexate, sulphasalazine, hydroxychloroquine, corticosteroids and NSAIDs at stable doses was permitted as previously described.1 At week 16, patients with less than 20% improve- ment from baseline in total back pain and morning stiffness entered early escape, such that their study medication was adjusted in a double-blind fash- ion. Patients in group 1 initiated treatment with golimumab 50 mg instead of placebo injections, and patients in group 2 had their golimumab dose increased from 50 to 100 mg; patients in group 3 did not have their study medication adjusted even if they met the early escape criteria. At week 24, all remaining patients in group 1 who had been receiving placebo injections began receiving golimumab 50 mg; all other patients con- tinued to receive their assigned treatment (from ran- domisation or early escape). Injections continued to be administered subcutaneously every 4 weeks through week 100, with ﬁnal study assessments at week 104. While the placebo-controlled portion of the study ended at week 24, study participants and investigators remained blinded through week 104 as to the golimumab dose (50 or 100 mg). After 661