Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results of the GO-RAISE study.
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.


CONCLUSIONS
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.
Rheumazentrum Ruhrgebiet, Landgrafenstrasse 15, D-44652 Herne, Germany. j.braun@rheumazentrum-ruhrgebiet.de
Jürgen
J
Braun
Atul
A
Deodhar
Robert D
RD
Inman
Désirée
D
van der Heijde
Michael
M
Mack
Stephen
S
Xu
Benjamin
B
Hsu
D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D001416:Back Pain / Q000188:drug therapy / Q000209:etiology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004351:Drug Resistance / Q000187:drug effects; D057915:Drug Substitution; D004359:Drug Therapy, Combination; D006304:Health Status; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D007596:Joints / Q000187:drug effects / Q000473:pathology / Q000503:physiopathology; D012720:Severity of Illness Index; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007155:Immunologic Factors; C529000:golimumab