Ankylosing spondylitis: Combining biologics with NSAID does not imply reduced radiographic progression

When comparing treatment with golimumab alone with a combined therapy that adds celecoxib, the latter was unable to slow down the progression of radiographic axial spondyloarthritis (r-axSpA). Only patients with a high risk for progression might benefit from combination therapy.

To date, it is still unclear whether or not a potential additional value of NSAID treatment exists for the prevention of radiographic spinal progression in r-axSpA [1]. Therefore, Dr Fabian Proft (Charité University Hospital, Germany) and his team conducted the phase 4 CONSUL study (NCT02758782) that investigated if combining anti-TNF with an NSAID, i.e. celecoxib could result in delayed onset of structural damage of the spine in r-axSpA.

Before entering the trial, all included patients had high disease activity with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4. Furthermore, the participants showed risk factors for radiographic progression as indicated by increased C-reactive protein (CRP) or the presence of syndesmophytes. During a run-in over 12 weeks, 128 enrolled patients were treated with golimumab 50 mg every 4 weeks. Those who responded with a reduction of at least 2 points in BASDAI (n=109) at week 12 were randomised to 96 weeks of either continuing on monotherapy with the TNF inhibitor or a daily addition of celecoxib 400 mg. The primary endpoint consisted of the difference in change of modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) between groups at week 108.

Baseline features of the study cohort showed a mean age of 38.7, 74.3% men and a mean BASDAI of 6.1. More than half already had ≥1 syndesmophyte, 87.6% were HLA-B27 positive, and the mean mSASSS was 11.9. As for the primary outcome of change in mSASSS, the difference between groups failed to reach statistical significance: 1.1 versus 1.7 (P=0.79). The growth of new syndesmophytes numerically favoured the combination treatment but also lacked statistical significance (11.1% on combination therapy vs 25% on golimumab monotherapy; P=0.12).

Overall, 327 adverse events were noted with golimumab alone and 353 with the combination with celecoxib, most commonly in terms of infections. Serious adverse events during phase 2 of the study occurred in 12 participants, with 5 in the monotherapy group. Study discontinuation due to side effects was also higher in the combination arm (4:1).

“The observed numerical reduction in radiographic spinal progression associated with the combined treatment of celecoxib plus golimumab might be relevant in high-risk patients,” Dr Proft remarked during his conclusions.

 

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   1. Proft F, et al. 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 (CONSUL): an open-label, randomised controlled, multicentre trial. 0546, ACR Convergence 2022, 10–14 November, Philadelphia, USA.

 

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Posted on 1 December 202217 May 2024