Research suggests some ankylosing spondylitis patients might benefit from a COX-II/TNF inhibitor combo.
Adding an NSAID to golimumab treatment in patients with radiographic axial spondyloarthritis does not significantly reduce the risk of radiographic progression, researchers have found.
However, they say, it may be useful for some patients.
A German team, led by Professor Denis Poddubnyy of the Charite Universitatsmedizin Berlin, investigated change in radiographic spinal progression over two years of treatment in patients with r-axSpA, comparing golimumab monotherapy with golimumab plus the selective COX-II inhibitor celecoxib.
While the differences between the two groups were not statistically significant or clinically relevant, there was a numerical difference in favour of the combined therapy.
With no significant differences in terms of adverse events, the authors suggested in the Annals of the Rheumatic Diseases that the observed numerical benefit from adding celecoxib means it’s worth considering.
“We did not observe major differences on the group level in terms of clinical outcomes, meaning that a sufficient disease activity control is well possible with TNFi alone, and NSAIDs should only be given if this is not the fact,” the authors wrote.
“The observed numerical difference in favour of combined treatment might be, however, relevant for patients at high risk in a situation, where combination therapy is indicated clinically.”
The multicentre CONSUL study was an open-label trial involving 109 patients who’d already shown a good clinical response to the TNF inhibitor golimumab. The patients had failed first-line treatment with NSAIDs, and had at least one risk factor for radiographic spinal progression: elevated CRP and/or existing structural damage.
They were randomised 1:1 to receive either 50mg subcutaneous golimumab every four weeks plus 400mg celecoxib daily, or golimumab alone.
The primary endpoint of the study was change in radiographic spinal progression measured by the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) over two years of treatment.
The mean mSASSS change was numerically higher in the monotherapy group (1.7; 95% CI 0.8 to 2.6) than the combination therapy group (1.1; 95% CI 0.4 to 1.8), which was not statistically significant.
Tolerability and adverse events were comparable for both treatment strategies, although there were more dropouts in the combined treatment arm.
Study limitations included the small sample sizes, with the authors suggesting larger samples are needed to more reliably detect differences between groups. They also suggested that a longer trial period, such as four years, may provide greater differences.
The authors noted that according to current management recommendations for axSpA, NSAIDs are considered as a treatment option for symptomatic patients and can also be given in combination with biologics to obtain better control of disease activity if necessary. However, in patients with good control of disease activity, NSAIDs are not required.
“This strategy is reinforced now by the results of the CONSUL study: even in patients with high risk of structural damage progression (patients with syndesmophytes and/or elevated CRP), NSAIDs should be given in addition to bDMARDs only if clinically indicated,” they wrote.
“At the same time, our results showing a numerical difference in the mSASSS progression and syndesmophyte progression might help to make a decision to use an NSAID (COX-II inhibitors) more consequently in patients who are not symptom free and inflammation free despite use of TNFi.”
