In AS, Immunosuppressant Appears Effective Through 1 Year

Intravenous golimumab remains safe and effective through 1 year for patients with active ankylosing spondylitis (AS), according to a new study.

To evaluate golimumab’s efficacy, the researchers of the GO-ALIVE study randomly assigned 208 participants to either intravenous infusions of golimumab, 2mg/kg, or a placebo. In all, there were 105 participants who received golimumab at weeks 0, 4, and every 8 weeks thereafter for 1 year and 103 participants who received a placebo at weeks 0, 4, and 12 and then golimumab at weeks 16, 20, and every 8 weeks thereafter through 1 year.

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The Assessment of Spondyloarthritis International Society (ASAS) criteria, Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath AS Disease Activity Index (BASDAI), and Bath AS Functional Index (BASFI) were used to measure the immunosuppressant’s efficacy, while the AS Quality of Life (ASQoL) was used to assess for health-related quality of life.

At week 16, the primary endpoint (ASAS20) and all controlled endpoints were achieved.

After 1 year, participants in the golimumab group achieved better outcomes than the placebo-to-golimumab group in terms of ASAS20 (69.5% vs 65.0%), ASAS40 (56.2% vs 51.5%), BASDAI50 (56.2% vs 55.3%), and ASAS partial remission (24.8% and 24.3%).

ASDAS inactive disease criteria was met by 25.7% of those in the golimumab group and by 26.2% in the placebo-to-golimumab group.

The 2 groups had similar mean changes from baseline to week 52 in BASFI and ASQoL scores.

Through week 60, 55.4% of the participants treated with golimumab experienced 1 or more adverse events and 3.4% had 1 or more serious adverse events, which is consistent with the known safety profile of golimumab.

—Colleen Murphy

Reference:

Reveille JD, Deodhar A, Caldron PH, et al. Safety and efficacy of intravenous golimumab in adults with ankylosing spondylitis: results through 1 year of the GO-ALIVE study [published online March 1, 2019]. J Rheumatol. https://doi.org/10.3899/jrheum.180718.