Celecoxib added to golimumab fails to slow spine damage vs monotherapy in axial SpA
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PHILADELPHIA — Combination therapy with celecoxib plus golimumab failed to show significant superiority to golimumab alone in slowing spine damage in radiographic axial spondyloarthritis, according to data presented at ACR Convergence 2022.
“The 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,” Fabian Proft, MD, a rheumatologist and senior researcher at Charité Universitätsmedizin Berlin, said during a press conference. “Whereas inflammation can be effectively targeted by available treatments, clear evidence for the inhibition of new bone formation is missing.”
To analyze the impact of adding celecoxib to golimumab (Simponi, Janssen), compared with golimumab alone, on the progression of spinal structural damage over 2 years in patients with radiographic axial SpA, Proft and colleagues conducted a randomized controlled trial. To be eligible for inclusion, patients with radiographic axial SpA had to demonstrate high disease activity — defined as a BASDAI score of four or greater — NSAID failure and risk factors for radiographic spinal progression, defined as C-reactive protein >5 mg per liter and/or 1 syndesmophyte.
The trial featured two phases. First, a 12-week run-in phase saw all included patients receive monotherapy with golimumab 50 mg every 4 weeks subcutaneously. The subsequent second phase was a 96-week controlled treatment period, in which patients who achieved a BASDAI improvement of at least two points were randomly assigned to combination therapy with golimumab plus celecoxib 200 mg twice daily or golimumab alone.
The primary endpoint was radiographic spinal progression, as determined by the change in the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS), after 108 weeks in the intent-to-treat population. Endpoint data were assessed by independent readers blinded for the treatment arm and the timepoint, according to Proft and colleagues.
Among the 157 screened patients, 128 were enrolled in the run-in phase. Of these, 109 achieved the required BASDAI response at week 12 to enter randomization. In all, 54 patients received combination therapy while 55 remained on monotherapy. A total of 97 patients — 45 in the combination therapy group and 52 in the monotherapy arm — completed all 108 weeks of the study.
According to the researchers, change in mSASSS after week 108 was 1.1 (95% CI, 0.2-2) in the combination therapy group, compared with 1.7 (95% CI, 0.8-2.6) for golimumab alone. Based on the opinions of the three independent readers, new syndesmophytes occurred in 11% of those receiving combination therapy vs. 25% in the monotherapy arm (P = .12). A total of 14 serious adverse events were reported during the study, including seven in the combination group, five in the monotherapy arm and two during the run-in phase.
“The combination therapy with celecoxib and added to a biological DMARD did not show significant superiority over the biological DMARD monotherapy in retarding radiographic spinal progression over 2 years in radiographic axial SpA patients with a high risk for radiographic progression,” Proft said. “However, the observed numerical reduction in radiographic spinal progression associated with the combined treatment of biological DMARD plus a COX-II-selective NSAID might be of relevance in high-risk patients.
“The other important point is the safety aspect,” he added. “There were no significant differences in terms of safety data between the monotherapy and the combination therapy over the 2 years. However, a higher number of dropouts in the combination arm, at nine, and only two patients dropping out of the monotherapy arm, needs to be taken into account when making those treatment decisions in our clinical routine.”
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Proft F. Abstract 0546. Presented at: ACR Convergence 2022; Nov. 11-14, 2021; Philadelphia (hybrid meeting).
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