medwireNews: The tumor necrosis factor (TNF) inhibitor certolizumab pegol could be an option for patients with active nonradiographic axial spondyloarthritis (axSpA) and objective signs of inflammation, indicate phase III trial results.
These findings “highlight the efficacy of [certolizumab pegol] in the [nonradiographic]-axSpA population, with clinically relevant and statistically significant differences observed in the primary and all but one of the secondary endpoints addressing different aspects of the disease (e.g. disease activity, physical function, pain),” says the research team.
The C-axSpAnd study included 317 individuals who had not responded to at least two different nonsteroidal anti-inflammatory drugs and who either had evidence of active sacroiliitis on magnetic resonance imaging or a C-reactive protein level above the upper limit of normal at intake. Participants were randomly assigned in a double-blind fashion to receive alongside their current nonbiologic medication either certolizumab pegol – at a loading dose of 400 mg at weeks 0, 2, and 4, and 200 mg every 2 weeks thereafter – or placebo for 52 weeks.
The primary endpoint of major improvement in ASDAS, defined as a decrease of 2.0 points or more from baseline or achievement of the lowest possible score of 0.6 points, at week 52 was achieved by 47.2% of the 159 patients in the certolizumab pegol group and 7.0% of the 158 patients in the placebo group, a significant difference.
Similar significant improvements with certolizumab pegol versus placebo were also observed at the 52-week timepoint for secondary endpoints such as the proportion of patients achieving an ASAS40 response, the change from baseline in BASDAI and BASFI scores, and nocturnal spinal pain.
The incidence of anterior uveitis flares during the course of the study was numerically lower in the certolizumab pegol than placebo arm, at 2.5% versus 5.1%, but this was the only secondary endpoint for which the difference did not reach statistical significance. The researchers say, however, that this result “should be interpreted with caution due to the small number of affected patients in each treatment group.”
They also point out that the “safety outcomes were in line with those published previously” for certolizumab pegol and other TNF inhibitors.
Furthermore, the protocol allowed participants in either arm to switch to open-label treatment with certolizumab pegol or another biologic if required due to worsening of disease activity. Patients assigned to receive certolizumab pegol were less likely to switch than their counterparts given placebo, at rates of 12.6% and 60.8%, respectively, and certolizumab pegol-treated participants were also less likely to make changes to their background medication, with corresponding rates of 27.7% and 69.6%.
“These results indicate that remission in [nonradiographic]-axSpA treated without biologics occurs infrequently, demonstrating the need for treatment beyond non-biologic therapy,” conclude Atul Deodhar (Oregon Health & Science University, Portland, USA) and co-investigators in Arthritis & Rheumatology.
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