New research presented this week at ACR Convergence 2022, the annual meeting of the American College of Rheumatology, showed that the combination of a nonsteroidal anti-inflammatory drug and a TNF inhibitor did not significantly slow progression x-ray of the spine in patients with x-ray axial spondyloarthritis (Abstract #0546).
Axial spondyloarthritis (axSpA) is a chronic inflammatory condition with two subsets: non-radiographic axial spondyloarthritis and radiographic axial spondyloarthritis, the advanced stage of the disease. X-ray axial spondylitis was formerly known as ankylosing spondylitis. Unlike non-radiographic axSpA, radiographic axSpA is marked by signs of structural damage on X-rays. The main clinical symptom is back pain, with active inflammation of the sacroiliac joints and spine and, in some patients, excessive bone formation may impair function.
Reducing clinical burden and preventing disability can probably be best achieved by early and adequate treatment targeting both inflammation and new bone formation.”
Fabian Proft, MD, rheumatologist and senior researcher at Charité Universitätsmedizin Berlin and lead study author
Continued use of celecoxib, a selective nonsteroidal anti-inflammatory drug (NSAID), may be associated with less radiographic progression in patients with radiographic axSpA. Biologic disease-modifying antirheumatic drugs (DMARDs) are often used to treat high disease activity, and the extent to which they alter structural damage remains ambiguous, Proft says.
“The effect on radiographic progression of radiographic axSpA of a combined biologic DMARD plus NSAID treatment has not been studied so far. We wanted to assess the impact of celecoxib when added to a biologic DMARD This study used the tumor necrosis factor (TNFi) inhibitor golimumab plus celecoxib and compared it to golimumab alone on progressive structural damage to the spine over two years in patients with active radiographic axSpA. . »
Patients eligible for this prospective randomized controlled trial were recruited from centers across Germany. All had a clinical diagnosis of radiographic axSpA, met the modified New York criteria for ankylosing spondylitis, had high disease activity despite treatment with NSAIDs, and had at least one additional risk factor for radiographic progression (protein C- high reactive and/or existing syndesmophytes [bony growths inside spinal ligaments]).
The trial had two phases. The first was a 12-week run-in phase in which participants received 50 mg of golimumab every four weeks. Those who had a good clinical response were equally randomized to the combination group (400 mg daily of celecoxib plus golimumab) or to the golimumab alone control group for 96 weeks.
Ninety-seven of the original 109 randomized patients completed the trial. Patients in the combined group showed a change in Stoke Ankylosing Spondylitis Spine score of 1.1 points compared to a change of 1.7 in the control group. Three blinded readers identified new syndesmophytes in 11% of the combination group versus 25% of the golimumab alone group, respectively. During the study, seven serious adverse events were reported in the combination group versus five in the control group. Two occurred during the break-in phase.
Overall, the observed differences between combination therapy and monotherapy did not reach statistical significance.
“We didn’t expect this,” says Dr. Proft. “[It might be possible that] the results would have become statistically significant with a larger sample or longer follow-up, such as four years. [But] based on our data, continued treatment with NSAIDs in addition to a biologic DMARD solely to inhibit future radiographic progression generally cannot be recommended. However, the observed effect of a combination treatment might be relevant in patients at high risk of radiographic progression or with residual symptoms despite biological DMARD therapy. »
American College of Rheumatology