Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial.

Abstract

OBJECTIVES:

To compare the benefits of a tight-control/treat-to-target strategy (TC/T2T) in axial spondyloarthritis (axSpA) with those of usual care (UC).

METHODS:

Pragmatic, prospective, cluster-randomised, controlled, open, 1-year trial (NCT03043846). 18 centres were randomised (1:1). Patients met Axial Spondylo Arthritis International Society (ASAS) criteria for axSpA, had an Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥2.1, received non-optimal treatment by non-steroidal anti-inflammatory drugs and were biologic-naive.

INTERVENTIONS:

(1) TC/T2T: visits every 4 weeks and prespecified strategy based on treatment intensification until achieving target (ie, ASDAS <2.1); (2) UC: visits every 12 weeks and treatment at the rheumatologist's discretion.

MAIN OUTCOME:

Percentage of patients with a ≥30% improvement on the ASAS-Health Index (ASAS-HI). Other efficacy outcomes and adverse events were recorded. A health economic evaluation was performed.

STATISTICAL ANALYSIS:

Two-level mixed models were used to estimate efficacy outcomes. Cost-effectiveness was assessed by the incremental cost per quality-adjusted life-year (QALY) gained for TC/T2T versus UC.

RESULTS:

160 patients were included (80/group). Mean (SD) age was 37.9 (11.0) years and disease duration was 3.7 (6.2) years; 51.2% were men. ASDAS at inclusion was 3.0 (0.7), and ASAS-HI was 8.6 (3.7). ASAS-HI improved by ≥30% in 47.3% of the TC/T2T arm and in 36.1% of those receiving UC (non-significant). All secondary efficacy outcomes were more frequent in the TC/T2T arm, although not all statistically significant. Safety was similar in both arms. From a societal perspective, TC/T2T resulted in an additional 0.04 QALY, and saved €472 compared with UC.

CONCLUSION:

TC/T2T was not significantly superior to UC for the primary outcome, while many secondary efficacy outcomes favoured it, had a similar safety profile and was favourable from a societal health economic perspective.

TRIAL REGISTRATION NUMBER:

NCT03043846.

• Authors: Anna Molto, Clementina López-Medina, Filip E Van den Bosch, Annelies Boonen, Casper Webers, Emanuelle Dernis, Floris A van Gaalen, Martin Soubrier, Pascal Claudepierre, Athan Baillet, Mirian Starmans-Kool, Anneke Spoorenberg, Peggy Jacques, Philippe Carron, Rik Joos, Jan Lenaerts, Laure Gossec, Sophie Pouplin, Adeline Ruyssen-Witrand, Laetitia Sparsa, Astrid van Tubergen, Désirée van der Heijde, Maxime Dougados
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 80 Issue 11 Pg. 1436-1444 (Nov 2021) ISSN: 1468-2060 [Electronic] England
• PMID: 33958325 (Publication Type: Journal Article, Pragmatic Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Antirheumatic Agents
• Biological Products

Topics

• Adult
• Antirheumatic Agents (economics, therapeutic use)
• Biological Products (economics, therapeutic use)
• Cost-Benefit Analysis
• Female
• Humans
• Male
• Middle Aged
• Patient Care Planning
• Quality-Adjusted Life Years
• Spondylarthropathies (drug therapy, economics, physiopathology)
• Treatment Outcome