RT Journal Article
T1 Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial.
A1 Molto, Anna
A1 López-Medina, Clementina
A1 Van den Bosch, Filip E
A1 Boonen, Annelies
A1 Webers, Casper
A1 Dernis, Emanuelle
A1 van Gaalen, Floris A
A1 Soubrier, Martin
A1 Claudepierre, Pascal
A1 Baillet, Athan
A1 Starmans-Kool, Mirian
A1 Spoorenberg, Anneke
A1 Jacques, Peggy
A1 Carron, Philippe
A1 Joos, Rik
A1 Lenaerts, Jan
A1 Gossec, Laure
A1 Pouplin, Sophie
A1 Ruyssen-Witrand, Adeline
A1 Sparsa, Laetitia
A1 van Tubergen, Astrid
A1 van der Heijde, Désirée
A1 Dougados, Maxime
K1 ankylosing
K1 healthcare
K1 outcome and process assessment
K1 spondylitis
K1 therapeutics
AB To compare the benefits of a tight-control/treat-to-target strategy (TC/T2T) in axial spondyloarthritis (axSpA) with those of usual care (UC). 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. (1) TC/T2T: visits every 4 weeks and prespecified strategy based on treatment intensification until achieving target (ie, ASDAS  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. 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. 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. 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. NCT03043846.
YR 2021
FD 2021-05-06
LK https://hdl.handle.net/10668/25758
UL https://hdl.handle.net/10668/25758
LA en
DS RISalud
RD Apr 6, 2025