Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis:
104-week results of the GO-RAISE study.
Author(s): Braun J, Deodhar A, Inman RD, van der Heijde D, Mack M, Xu S, Hsu B.
Affiliation(s): Rheumazentrum Ruhrgebiet, Landgrafenstrasse 15, D-44652 Herne, Germany.
j.braun@rheumazentrum-ruhrgebiet.de
Publication date & source: 2012, Ann Rheum Dis. , 71(5):661-7
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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