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Combination therapy with an NSAID and TNF inhibitor only slightly slows spinal progression of radiographic axial spondyloarthritis

Presenter: Fabian Proft, MD, Department of Gastroenterology, Infectious Disease and Rheumatol-ogy, Charité — Universitätsmedizin Berlin, Berlin, Germany

Comparison of the effect of treatment with NSAIDS added to anti-TNF therapy versus anti-TNF ther-apy alone on progression of structural damage in the spine over two years in patients with ankylos-ing spondylitis (CONSUL): An open-label, randomized controlled, multicenter trial. Abstract 0546. Presented November 12, 2022.

This study found no significant benefit from combined treatment with an NSAID and a TNF-inhibitor in reducing spinal progression in patients with radiographic axial spondyloarthritis; however, this therapy may have efficacy in some high-risk patients.


Combining a nonsteroidal anti-inflammatory drug (NSAID) and a tumor necrosis factor (TNF) inhibitor does not significantly slow spinal progression in patients with radiographic axial spondyloarthritis. However, this combination may be relevant for patients with a high risk for radiographic progres-sion or with residual symptoms despite biologic disease-modifying anti-rheumatic drugs (DMARD) therapy.

“Reduction of clinical burden and prevention of disability can probably be best achieved by early and adequate treatment targeting both inflammation and new bone formation,” said presenter Fa-bian Proft, MD, Charité — Universitätsmedizin Berlin, Berlin, Germany. “There is some evidence that NSAIDs, in particular celecoxib, might possess not only symptomatic efficacy but also disease-modifying properties in ankylosing spondylitis, retarding progression of structural damage in the spine if taken continuously.”

For biological DMARDs, retardation of structural damage progression has also been demonstrated, but at least 4 years of treatment seem to be necessary, at least for TNF inhibitors, to see such an effect, Profit said. Therefore, a combination of an NSAID with a TNF inhibitor might bring additional benefits in terms of retardation of structural damage progression, especially in high-risk patients. 

“The effect on radiographic progression in radiographic axial spondyloarthritis of a combined treatment of biologic DMARD plus NSAID has not been investigated so far. We wanted to evaluate the impact of celecoxib when added to a biologic DMARD,” Proft said.

This prospective, randomized, controlled trial used the TNF inhibitor golimumab with celecoxib versus golimumab alone to determine the effect on progressive structural damage in the spine over 2 years in patients with active radiographic axial spondyloarthritis. Eligible patients were re-cruited from centers throughout Germany. All had a clinical diagnosis of radiographic axial spondy-loarthritis, fulfilled the modified New York criteria for ankylosing spondylitis, had high disease activ-ity despite NSAID therapy, and had at least 1 additional risk factor for radiographic progression, such as elevated C-reactive protein or already existing syndesmophytes. 

The trial consisted of 2 phases. The first was a 12-week run-in phase in which participants received 50 mg of golimumab every 4 weeks. Those who had a good clinical response were randomized to the combination group receiving celecoxib at 400 mg/day plus golimumab or to the golimumab-only control group for 96 weeks. 

A total of 109 patients were randomized and 97 patients completed the trial. Patients in the com-bination group had a 1.1-point change in the Stoke Ankylosing Spondylitis Spine Score compared to a 1.7-point change in the control group (P = .79). Three blinded readers identified new syndesmo-phytes in 11% of the combination group versus 25% in the golimumab-only group (P = .12). A total of 14 serious adverse events were reported, 7 in the combination group, 5 in the golimumab-alone group, and 2 during the run-in phase. 

“Overall, the observed differences between the combination treatment and monotherapy did not reach statistical significance,” Proft said. “We did not expect that. It’s possible that the findings would have become statistically significant with a larger sample size or longer follow-up, such as 4 years.”

“Based on our data, continuous treatment with NSAIDs in addition to a biologic DMARD solely to inhibit future radiographic progression cannot be generally recommended,” he added. “However, the observed effect of a combined treatment might be relevant in patients with a high risk for ra-diographic progression or with residual symptoms despite biologic DMARD therapy.”

Reference

Proft F, Muche B, Rios-Rodriguez V, et al. Comparison of the effect of treatment with NSAIDS added to anti-TNF therapy versus anti-TNF therapy alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis (CONSUL): an open-label, randomized con-trolled, multicenter trial [abstract 0546]. Arthritis Rheumatol 2022; 74(suppl 9). doi:10.1136/annrheumdis-2022-eular.568

Disclosures

Fabian Proft: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen Pharma-ceuticals, Merck & Co, Novartis, Pfizer, Roche, UCB

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