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Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8522451/ https://www.ncbi.nlm.nih.gov/pubmed/33958325 http://dx.doi.org/10.1136/annrheumdis-2020-219585 |
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author | Molto, Anna López-Medina, Clementina Van den Bosch, Filip E Boonen, Annelies Webers, Casper Dernis, Emanuelle van Gaalen, Floris A Soubrier, Martin Claudepierre, Pascal Baillet, Athan Starmans-Kool, Mirian Spoorenberg, Anneke Jacques, Peggy Carron, Philippe Joos, Rik Lenaerts, Jan Gossec, Laure Pouplin, Sophie Ruyssen-Witrand, Adeline Sparsa, Laetitia van Tubergen, Astrid van der Heijde, Désirée Dougados, Maxime |
author_facet | Molto, Anna López-Medina, Clementina Van den Bosch, Filip E Boonen, Annelies Webers, Casper Dernis, Emanuelle van Gaalen, Floris A Soubrier, Martin Claudepierre, Pascal Baillet, Athan Starmans-Kool, Mirian Spoorenberg, Anneke Jacques, Peggy Carron, Philippe Joos, Rik Lenaerts, Jan Gossec, Laure Pouplin, Sophie Ruyssen-Witrand, Adeline Sparsa, Laetitia van Tubergen, Astrid van der Heijde, Désirée Dougados, Maxime |
author_sort | Molto, Anna |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8522451 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-85224512021-10-29 Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial Molto, Anna López-Medina, Clementina Van den Bosch, Filip E Boonen, Annelies Webers, Casper Dernis, Emanuelle van Gaalen, Floris A Soubrier, Martin Claudepierre, Pascal Baillet, Athan Starmans-Kool, Mirian Spoorenberg, Anneke Jacques, Peggy Carron, Philippe Joos, Rik Lenaerts, Jan Gossec, Laure Pouplin, Sophie Ruyssen-Witrand, Adeline Sparsa, Laetitia van Tubergen, Astrid van der Heijde, Désirée Dougados, Maxime Ann Rheum Dis Spondyloarthritis 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. BMJ Publishing Group 2021-11 2021-05-06 /pmc/articles/PMC8522451/ /pubmed/33958325 http://dx.doi.org/10.1136/annrheumdis-2020-219585 Text en © 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. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Spondyloarthritis Molto, Anna López-Medina, Clementina Van den Bosch, Filip E Boonen, Annelies Webers, Casper Dernis, Emanuelle van Gaalen, Floris A Soubrier, Martin Claudepierre, Pascal Baillet, Athan Starmans-Kool, Mirian Spoorenberg, Anneke Jacques, Peggy Carron, Philippe Joos, Rik Lenaerts, Jan Gossec, Laure Pouplin, Sophie Ruyssen-Witrand, Adeline Sparsa, Laetitia van Tubergen, Astrid van der Heijde, Désirée Dougados, Maxime Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial |
title | Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial |
title_full | Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial |
title_fullStr | Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial |
title_full_unstemmed | Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial |
title_short | Efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised TICOSPA trial |
title_sort | efficacy of a tight-control and treat-to-target strategy in axial spondyloarthritis: results of the open-label, pragmatic, cluster-randomised ticospa trial |
topic | Spondyloarthritis |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8522451/ https://www.ncbi.nlm.nih.gov/pubmed/33958325 http://dx.doi.org/10.1136/annrheumdis-2020-219585 |
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