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.
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Funding This study was funded by Centocor Research & Development, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and Schering-Plough Research Institute, Inc.
Competing interests Dr Braun has received honoraria for talks, advisory boards and grants for studies from Centocor Research & Development, Celltrion, Amgen, Abbott, Roche, BMS, Novartis, Pfizer (Wyeth), MSD (Schering-Plough), Sanofi-Aventis and UCB. Dr Deodhar has received payments for educational lectures, teleconferences and serving on advisory boards for Centocor Research & Development. This potential conflict of interest has been reviewed and managed by OHSU. Dr Inman has received consulting fees from Merck, Schering-Plough, Abbott, Amgen and Sanofi-Aventis. Dr van der Heijde has received consulting fees and/or research grants from Abbott, Amgen, BMS, Centocor R&D, Chugai, Merck, Novartis, Pfizer, Roche, Sanofi-Aventis, Schering-Plough, UCB and Wyeth. Drs Mack and Hsu and Mr Xu are employees of Centocor Research & Development, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and own stock and/or stock options in Johnson & Johnson, Inc.
Ethics approval This study was conducted with the approval of the institutional review board or independent ethics committee at each site.
Provenance and peer review Not commissioned; externally peer reviewed.