Subcutaneous Golimumab in Ankylosing Spondylitis
Subcutaneous Golimumab in Ankylosing Spondylitis
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 efficacy and safety of golimumab in patients with ankylosing spondylitis (AS). 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% improvement in the Assessment in SpondyloArthritis international Society response criteria (ASAS20) at week 14 compared with 22% in the placebo group (p<0.001 for comparisons of placebo with each golimumab group). No unexpected adverse events were observed through 24 weeks of golimumab 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 crossover, 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.
Abstract and Introduction
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.
Introduction
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 efficacy and safety of golimumab in patients with ankylosing spondylitis (AS). 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% improvement in the Assessment in SpondyloArthritis international Society response criteria (ASAS20) at week 14 compared with 22% in the placebo group (p<0.001 for comparisons of placebo with each golimumab group). No unexpected adverse events were observed through 24 weeks of golimumab 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 crossover, 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.
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