Background/Purpose: Recommendations for axial spondyloarthritis (axSpA) management include tight control and treat-to-target (TC), but no study has evaluated its potential benefit. The objective of this trial was to evaluate the benefit of TC strategies in comparison to usual care (UC) in patients with axSpA.

Methods: Study design: Pragmatic, prospective, cluster-randomized controlled (2 arms), one-year trial (NCT03043846). Centers: 18 axSpA expert centers randomly allocated (1:1) to the treatment arm: TC vs. UC. Patients: axSpA diagnosis and ASAS criteria, non-optimally treated with NSAIDs, bDMARD-naïve, and ASDAS > 2.1 at inclusion. Study treatment: a) TC: the strategy was pre-specified by the scientific committee based on current axSpA recommendations and aiming at a target (ASDAS < 2.1); visits every 4w; b) UC arm: treatment decisions were at the rheumatologist’s discretion with visits every 12w. Outcomes: the % of patients with a significant ( >30%) improvement in the ASAS-HI score over one-year follow-up was the main outcome. Other outcomes (disease activity, quality of life, treatment, …) over follow-up were evaluated (Table 1). The number/type of adverse events were collected. Statistical analysis: this was an intention-to-treat analysis. To take into account the cluster-randomization design, for all outcomes, two models were performed: first a two-level mixed model with 2 random effects was used to estimate the % of responders/the change of the outcome over follow-up (i.e. mod1); in a second step, the imbalanced variables observed at baseline were included in the model (i.e.mod2). Cost-effectiveness was assessed by estimating the (baseline- and cluster-adjusted) incremental cost per quality-adjusted life-year (QALY) gained for TC vs. UC.

Results: 160 patients were included (80 in TC and 80 in UC). Mean age was 37.9(11.0) years with a disease duration of 3.7(6.2) years, 51.2% were males. A radiographic damage of the SI-joints, a (ever) positive MRI sacroiliitis and HLA-B27+ were seen in 46.9%, 81.9% and 75.0% patients respectively. Mean ASDAS at inclusion was 3.0 (0.7) and mean ASASHI was 8.6 (3.7). 72 patients per group attended the one-year visit. Although 47.3% vs. 36.1% patients in the TC and UC arms achieved a significant improvement in ASASHI at the one-year visit, the difference was not statistically significant, with either model. Across all other outcomes a trend was observed in favor of the TC arm (Table 1). The number of bDMARDs was significantly higher in TC arm (56.2% vs. 27.2%). The number of infections was comparable in both groups (15 vs. 16 in the TC and UC, respectively), with only 2 severe infections occurring in the UC arm. From a societal perspective, TC resulted in an additional 0.04 QALY and saved €265 when compared to UC and a 67% probability of being cost-effective at a cost-effectiveness threshold of €20,000 per QALY.

Conclusion: In this setting of SpA expert centers, UC resulted in a good outcome in a substantial number of patients but the TC was not superior for the primary outcome despite a greater number of bDMARDs prescription. Nevertheless, a general trend in favor of the tight control was observed, with a comparable safety profile and was found to be favorable from a societal health economic perspective.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/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/