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Improvements were seen in some patients participating in a phase 3 clinical trial as quickly as 4 weeks after the first treatment.
Golimumab (Simponi) produces a rapid improvement in a majority of patients with non-radiographic axial spondyloarthritis (nr-axSpA)-with results seen after the first injection of the tumor necrosis-alpha (TNF-Î±) inhibitor, according to results of a multicenter phase 3 clinical trial.
The GO-AHEAD trial, a randomized, double-blind placebo-controlled trial involving 198 nr-axSpA patients, shows that a majority achieved a 20% response with golimumab according to the Assessment of SpondyloArthritis International Society criteria (ASAS20) at 16 weeks compared to placebo (71.1% vs. 40%).
A subgroup of patients achieving ASAS 20 at week 16 with baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) had a greater response with golimumab versus placebo (73.8% vs. 37.9%, respectively).
Improvements were seen as quickly as 4 weeks, the investigators say.
The injectable TNF blocker also improved function, spinal mobility and quality of life, with a similar incidence of both adverse events and serious adverse events among those given golimumab and placebo.
A little more than half of the patients, randomized in 52 centers in 13 countries, are men in their 30s, with an intolerance or inadequate response to NSAIDs. The patients all had nr-axSpA for less than a year and chronic back pain for 3 or more months.
During the first part (16 weeks) of the trial, patients were randomized equally to receive 50 mg subcutaneous golimumab or a placebo at weeks 0, 4, 8 and 12. Those who completed the first part of the trial were eligible for the 2nd part of the trial, 16 to 60 weeks.
The standard first-line treatment in the US for nr-axSpA is non-steroidal anti-inflammatory drugs (NSAIDs). TNFÎ± inhibitors are approved in Europe-but not yet in the US-for axSpA. Goliumumab is approved here for ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).
The results of the GO-AHEAD trial show that efficacy in nr-axApA is similar to AS and golimumab performed as well as other TNF drugs tested among nr-axSpA patients, but head-to-head trials are needed to determine differences in responses, the researchers note.
Sieper J, van der Heijde D, Dougados M, et al. A randomized, double-blind, placebo-controlled, 16-week study of subcutaneous golimumab in patients with active non-radiographic axial spondyloarthritis. Arthritis Rheumatol. 2015. Accepted Article. Online July 2, 2015. DOI: 10.1002/art.39257 Open Access.