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Signs of benefit for T2T in axial spondyloarthritis

Conference
ACR 2020
Trial
Cohort study, TICOSPA
Although a treat-to-target strategy for managing patients with axial spondyloarthritis failed to meet its primary efficacy endpoint, there were several signs of benefit in the secondary outcomes compared with standard-of-care in the TICOSPA trial.

The treat-to-target (T2T) management strategy is already adopted in rheumatoid arthritis (RA) patients and also recommended for axial spondylarthritis (axSpA), but no study has evaluated its benefit. The TICOSPA study (NCT03043846) aimed to assess whether patients with axSpA benefit from this approach [1]. The trial was performed at 10 French centres and 4 centres each in Belgium and the Netherlands. Included patients had an Ankylosing Spondylitis Disease Activity Score (ASDAS) >2.1 and had not yet received a biologic. Patients (n=160) were randomised 1:1 to either T2T or standard-of-care. Patients in the T2T group attended consultations every 4 weeks rather than every 3 months with standard-of-care and required a pre-defined management strategy aiming at a target (ASDAS <2.1).

The primary efficacy endpoint was an improvement of at least 30% in the Assessment of Spondyloarthritis International Society Health Index (ASAS HI), a measure of health-related quality-of-life. After 12 months, the 80 axSpA patients assigned to the T2T regimen had a 47% rate of attainment of the primary endpoint, compared with 36% of the patients assigned to standard-of-care, an 11% absolute between-group difference that, nonetheless, failed to achieve statistical significance. However, 6 secondary outcomes showed statistically significant improvements compared with the control patients, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and the ASAS20 and ASAS40 response rates.

Interestingly, a cost-efficacy analysis demonstrated the superiority of T2T over standard-of-care: better outcomes were produced with lower total costs although twice as many patients on T2T strategy received a biologic compared with patients in the standard-of-care group. “Statistical significance was not achieved for the primary efficacy endpoint, but a general trend in favour of T2T was observed in other outcomes with a similar safety profile,” concluded Dr Anna Moltó (Cochin Hospital, France). In T2T strategies in RA, the target –joint synovitis– is visible, so the clinician can see what they are aiming for. In SpA, however, the target of inflammation is invisible and hidden in the spinal column, which renders the T2T strategy more challenging. Therefore, the challenge is more difficult but progress is being made.

  1. Moltó A, et al. Cluster-randomized pragmatic clinical trial evaluating the potential benefit of a tight-control and treat-to-target strategy in axial spondyloarthritis: the results of the TICOSPA trial. 1444, ACR Convergence 2020, 5-9 Nov.




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