Comparison of the effect of treatment with NSAIDs added to anti-TNF therapy versus anti-TNF therapy alone on the progression of structural damage in the spine over 2 years in patients with radiographic axial spondyloarthritis from the randomised-controlled CONSUL trial.

Denis Poddubnyy, Swen Jacki, Maren Sieburg, Jan Brandt-Juergens, Anne-Katrin Weber, Laura Spiller, Hildrun Haibel, Mikhail Protopopov, Joachim Listing, Judith Rademacher, Fabian Proft, Uta Kiltz, Joachim Sieper, Maryna Verba, Valeria Rios Rodriguez, Burkhard Muche, Murat Torgutalp

Journal: Annals of the rheumatic diseases 2024;83(5):599-607

PMID: 38228361

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Abstract

OBJECTIVES

The study aimed to evaluate the effect of adding a non-steroidal anti-inflammatory drug (NSAID), celecoxib (CEL), to a tumour necrosis factor inhibitor (TNFi), golimumab (GOL), compared with TNFi monotherapy on radiographic spinal progression in patients with radiographic axial spondyloarthritis (r-axSpA) over 2 years.

METHODS

R-axSpA patients, having risk factors for radiographic progression (high disease activity plus C reactive protein >5 mg/L and/or ≥1 syndesmophyte(s)), underwent a 12-week run-in phase with GOL 50 mg every 4 weeks. In the core phase (96 weeks), only patients with a good clinical response at week 12 were randomised (1:1) to GOL+CEL 200 mg two times per day (combination therapy) or GOL monotherapy. The primary endpoint was radiographic progression assessed by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change at week 108 in the intent-to-treat population.

RESULTS

A total of 128 patients were enrolled in the run-in phase; and 109 patients were randomised at week 12 to monotherapy (n=55) or combination therapy (n=54). At week 108, 97 (52 vs 45) patients completed the study. The change in mSASSS at week 108 was 1.7 (95% CI 0.8 to 2.6) in the monotherapy vs 1.1 (95% CI 0.4 to 1.8) in the combination therapy groups (p=0.79). New syndesmophytes occurred in 25% of patients in the monotherapy vs 11% of patients in the combination therapy groups (p=0.12). During the study, no significant differences in adverse events and serious adverse events were observed between the groups.

CONCLUSIONS

Combination therapy with GOL+CEL did not demonstrate statistically significant superiority over GOL monotherapy in retarding radiographic spinal progression over 2 years in r-axSpA.

Address: Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany [email protected].; Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.; Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.; Department of Rheumatology CCM, Charite Universitatsmedizin Berlin, Berlin, Germany.; German Rheumatism Research Center Berlin, Berlin, Germany.; Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany.; BIH, Berlin, Germany.; Rheumatology, Private Practice, Berlin, Germany.; Rheumazentrum Ruhrgebiet, Herne, Germany.; Rheumatologische Facharztpraxis, Magdeburg, Germany.; Rheumatologische Schwerpunktpraxis, Tübingen, Germany.

DOI: 10.1136/ard-2023-224699