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Randomized Controlled Trial
. 2024 Apr 11;83(5):599-607.
doi: 10.1136/ard-2023-224699.

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

Fabian Proft  1 , Murat Torgutalp  2 , Burkhard Muche  2   3 , Valeria Rios Rodriguez  2 , Joachim Listing  4 , Mikhail Protopopov  2 , Judith Rademacher  2   5 , Hildrun Haibel  2 , Laura Spiller  2 , Anne-Katrin Weber  2 , Maryna Verba  2 , Jan Brandt-Juergens  6 , Uta Kiltz  7 , Maren Sieburg  8 , Swen Jacki  9 , Joachim Sieper  2 , Denis Poddubnyy  2
Affiliations
Randomized Controlled Trial

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

Fabian Proft et al. Ann Rheum Dis. .

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.

Keywords: Anti-Inflammatory Agents, Non-Steroidal; Biological Therapy; Spondylitis, Ankylosing; Tumor Necrosis Factor Inhibitors.

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Conflict of interest statement

Competing interests: FP reports grants and personal fees from Novartis, Eli Lilly and UCB and personal fees from AbbVie, AMGEN, BMS, Celgene, Janssen, Hexal, Medscape, MSD, Pfizer and Roche outside the presented work. MT reports grants and personal fees from Abbvie and UCB. BM reports personal fees from Alexion, Amgen, Galapagos Biopharma, Novartis, Stadapharm and UCB outside the presented work. VRR, JL, LS, AKW, MV, JBJ, MS and SJ: nothing to disclose. MP: reports consulting fees from Novartis and support for attending meetings and/or travel from Janssen, UCB Pharma, Abbvie and Pfizer outside the presented work. JR: reports financial support for attending meetings and/or travel from Abbvie, Novartis, UCB and Janssen outside the presented work. HH: reports personal fees from Novartis, Abbvie, Janssen, Pfizer, Roche, Novartis and UCB and grants and personal fees from SOBI outside the presented work. UK: reports grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. JS: reports personal fees from AbbVie, Merck, Novartis, UCB and UpToDate outside the presented work. DP: reports grants and personal fees from AbbVie, Eli Lilly, MSD, Novartis and Pfizer, and personal fees from AbbVie, Biocad, Bristol-Myers Squibb, Canon, DKSH, Eli Lilly, Janssen, Moonlake, MSD, Medscape, Novartis, Peervoice, Pfizer and UCB outside the presented work.

Figures

Figure 1
Figure 1
Study design of the 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 study.
Figure 2
Figure 2
Flow chart of the 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 study.
Figure 3
Figure 3
The mean mSASSS change (A) and the proportion of patients with new syndesmophytes (B) over 2 years of treatment in the intention-to-treat population of the 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 study. mSASSS, modified stoke ankylosing spondylitis spinal score.
Figure 4
Figure 4
Cumulative probability plot of radiographic progression in the 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 study. ITT, intention to treat; mSASSS, modified stoke ankylosing spondylitis spinal score.
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