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

Anna Molto (1, 2) , Clementina López-Medina (2) , Filip van den Bosch (3) , Annelies Boonen (4) , Casper Webers (4) , Emanuelle Dernis (5) , Floris van Gaalen (6) , Martin Soubrier (7) , Pascal Claudepierre (8, 9) , Athan Baillet (8) , Mirian Starmans-Kool , Anneke Spoorenberg (10) , Peggy Jacques (4, 11) , Philippe Carron (11, 3) , Rik Joos (12) , Jan Lenaerts , Laure Gossec (13, 14) , Sophie Pouplin , Adeline Ruyssen-Witrand (15) , Laetitia Sparsa , Astrid van Tubergen (16) , Désirée van Der Heijde (6) , Maxime Dougados (1)

1 Service de rhumatologie [CHU Cochin]
2 ECaMO - [CRESS - U1153 / UMR_A 1125] - Clinical Epidemiology Applied to Osteoarticular Diseases | Épidémiologie clinique appliquée aux maladies rhumatismales et musculo-squelettiques
3 Ghent University Hospital
4 Maastricht University [Maastricht]
5 Centre Hospitalier Le Mans (CH Le Mans)
6 LUMC - Leiden University Medical Center
7 CHU Clermont-Ferrand
8 EpiDermE - Epidemiology in Dermatology and Evaluation in Therapeutics
9 CHU Henri Mondor [Créteil]
10 UMCG - University Medical Center Groningen [Groningen]
11 IRC - VIB-UGent Center for Inflammation Research [Gand, Belgique]
12 ZNA - Ziekenhuis Netwerk Antwerpen
13 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
14 CHU Pitié-Salpêtrière [AP-HP]
15 UT3 - Université Toulouse III - Paul Sabatier
16 MUMC - Maastricht University Medical Centre

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.

Mots clés: ankylosing; healthcare; outcome and process assessment; spondylitis; therapeutics

Domaines: Sciences du Vivant [q-bio]

Anna Molto, Clementina López-Medina, Filip van den Bosch, Annelies Boonen, Casper Webers, et al.. Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial. Annals of the Rheumatic Diseases, 2021, pp.annrheumdis-2020-219585. ⟨10.1136/annrheumdis-2020-219585⟩. ⟨hal-03222492⟩