Molto, AnnaLópez-Medina, ClementinaVan den Bosch, Filip EBoonen, AnneliesWebers, CasperDernis, Emanuellevan Gaalen, Floris ASoubrier, MartinClaudepierre, PascalBaillet, AthanStarmans-Kool, MirianSpoorenberg, AnnekeJacques, PeggyCarron, PhilippeJoos, RikLenaerts, JanGossec, LaurePouplin, SophieRuyssen-Witrand, AdelineSparsa, Laetitiavan Tubergen, Astridvan der Heijde, DésiréeDougados, Maxime2025-01-072025-01-072021-05-06https://hdl.handle.net/10668/25758To 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.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/ankylosinghealthcareoutcome and process assessmentspondylitistherapeuticsAdultAntirheumatic AgentsBiological ProductsCost-Benefit AnalysisFemaleHumansMaleMiddle AgedPatient Care PlanningQuality-Adjusted Life YearsSpondylarthropathiesTreatment Outcomeresearch article33958325open access10.1136/annrheumdis-2020-2195851468-2060PMC8522451https://ard.bmj.com/content/annrheumdis/80/11/1436.full.pdfhttps://pmc.ncbi.nlm.nih.gov/articles/PMC8522451/pdf