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

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.

Figure 1

Study schema showing randomisation (A) and major study time points (B).

Figure 2

Patient disposition through week 104. AEs, adverse events.

Figure 3

The proportions of patients who had an ASAS20 or ASAS40 response through week 104. Treatment regimen 1 consisted of patients who were originally assigned to placebo at baseline and either entered early escape at week 16 to receive golimumab 50 mg through week 104 or crossed over at week 24 to receive golimumab 50 mg through week 104. Treatment regimen 2 consisted of patients who were originally assigned to golimumab 50 mg at baseline and either entered early escape at week 16 to receive golimumab 100 mg through week 104 or continued 50 mg through week 104. Treatment regimen 3 consisted of patients who were originally assigned to golimumab 100 mg at baseline and did not receive study medication adjustments. Observed data are presented without imputation. ASAS20, at least 20% improvement in the Assessment of SpondyloArthritis international Society (ASAS) criteria; ASAS40, at least 40% improvement in the criteria.

Figure 4

Mean BASDAI, BASMI and BASFI scores through week 104. Treatment regimen 1 consisted of patients who were originally assigned to placebo at baseline and who either entered early escape at week 16 to receive golimumab 50 mg through week 104 or crossed over at week 24 to receive golimumab 50 mg through week 104. Treatment regimen 2 consisted of patients who were originally assigned to golimumab 50 mg at baseline and who either entered early escape at week 16 to receive golimumab 100 mg through week 104 or continued 50 mg through week 104. Treatment regimen 3 consisted of patients who were originally assigned to golimumab 100 mg at baseline and who did not receive study medication adjustments. Observed data are presented without imputation. BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index.