Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 5-year results of the GO-RAISE study.

ABSTRACT:

Objective

Assess golimumab efficacy/safety through 5 years in patients with active ankylosing spondylitis (AS).

Methods

356 patients with AS were randomly assigned to placebo, golimumab 50 mg or 100 mg every 4 weeks. At week 16, patients with inadequate response early escaped with blinded dose adjustments (placebo to 50 mg, 50 mg to 100 mg). At week 24, all patients receiving placebo crossed over to 50 mg. Blinded active therapy continued through week 104; from week 104 to week 252, the golimumab dose could be adjusted. Intent-to-treat and observed efficacy data were assessed by randomised treatment groups.

Results

At week 256, and with >4.5 years of golimumab, overall intent-to-treat Assessment in SpondyloArthritis international Society criteria for 20% improvement (

SUBMITTER: Deodhar A 

PROVIDER: S-EPMC4392310 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature