Spondyloarthritis & psoriatic arthritis
Comparison of the effect of treatment with non-steroidal anti-inflammatory drug (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
Authors' conclusion
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.
Study context
- Population
- Radiographic axial spondyloarthritis (r-axSpA) patients with risk factors for radiographic progression (high disease activity plus CRP >5 mg/L and/or ≥1 syndesmophyte(s)) and good clinical response to golimumab (GOL) at week 12128 enrolled in run-in
- Participants
- 109 patients
- Comparison
- GOL+celecoxib (CEL) 200 mg twice daily vs GOL monotherapy
- Combination therapyn = 54
- Monotherapyn = 55reference
- Primary endpoint
- Radiographic progression: Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change, ITT population
- Follow-up
- Week 108
Methodological details12-week run-in phase with GOL, randomised 1:1 after good clinical response at week 12
- 12-week run-in phase with GOL
- Randomised 1:1 after good clinical response at week 12
Primary result
As reported in the abstract
Change in mSASSS
Monotherapy
1.7
95% CI 0.8–2.6
Combination therapy
1.1
95% CI 0.4–1.8
P = 0.79
Further findings
New syndesmophytes
P = 0.12
Safety
Adverse events and serious adverse events · During the study
- No significant differences between the groups
Original publication
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. Ann Rheum Dis. Published 11 April 2024. doi:10.
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