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Abstract Number: 1444

Cluster-randomized Pragmatic Clinical Trial Evaluating the Potential Benefit of a Tight-control and Treat-to-target Strategy in Axial Spondyloarthritis: The Results of the TICOSPA Trial

Anna Molto1, Clementina Lopez-Medina2, Filip Van den Bosch3, Annelies Boonen4, Casper Webers4, Emmanuelle Dernis5, Floris van Gaalen6, Martin Soubrier7, Pascal Claudepierre8, Athan Baillet9, Mirian Starsman-Kool10, Anneke Spoorenberg11, Désirée van der Heijde12 and Maxime Dougados13, 1Rheumatology Department, Cochin Hospital, APHP, Paris, France, Paris, France, 2INSERM U1153, Universtity of Paris, PAris, France, 3Ghent University Hospital, Ghent, Belgium, 4Maastricht University Medical Center, Maastricht, Netherlands, 5CH Le Mans, department of rheumatology, Le Mans, France, 6Leiden University Medical Center (LUMC), Leiden, Netherlands, 7CHU Gabriel Montpied, Clermont-Ferrand, France, 8Hôpital Henri Mondor, Université Paris Est Créteil, EA 7379 EpiDermE, department of rheumatology, Créteil, France, 9CHU Grenoble, Echirolles, France, 10ATRIUM Medical Center, Heerlen, 11University Medical Centre Groningen and Medical centre Leeuwarden, Groningen, Netherlands, 12Leiden University Medical Center, Leiden, Netherlands, 13Université de Paris, Department of Rheumatology, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France

Meeting: ACR Convergence 2020

Keywords: Randomized Trial, spondyloarthritis

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Session Information

Date: Sunday, November 8, 2020

Session Title: Plenary Session III (1441–1446)

Session Type: Plenary Session

Session Time: 11:30AM-1:00PM

Background/Purpose: Recommendations for axial spondyloarthritis (axSpA) management include tight control and treat-to-target (TC), but no study has evaluated its potential benefit. The objective of this trial was to evaluate the benefit of TC strategies in comparison to usual care (UC) in patients with axSpA.

Methods: Study design: Pragmatic, prospective, cluster-randomized controlled (2 arms), one-year trial (NCT03043846). Centers: 18 axSpA expert centers randomly allocated (1:1) to the treatment arm: TC vs. UC. Patients: axSpA diagnosis and ASAS criteria, non-optimally treated with NSAIDs, bDMARD-naïve, and ASDAS > 2.1 at inclusion. Study treatment: a) TC: the strategy was pre-specified by the scientific committee based on current axSpA recommendations and aiming at a target (ASDAS < 2.1); visits every 4w; b) UC arm: treatment decisions were at the rheumatologist’s discretion with visits every 12w. Outcomes: the % of patients with a significant ( >30%) improvement in the ASAS-HI score over one-year follow-up was the main outcome. Other outcomes (disease activity, quality of life, treatment, …) over follow-up were evaluated (Table 1). The number/type of adverse events were collected. Statistical analysis: this was an intention-to-treat analysis. To take into account the cluster-randomization design, for all outcomes, two models were performed: first a two-level mixed model with 2 random effects was used to estimate the % of responders/the change of the outcome over follow-up (i.e. mod1); in a second step, the imbalanced variables observed at baseline were included in the model (i.e.mod2). Cost-effectiveness was assessed by estimating the (baseline- and cluster-adjusted) incremental cost per quality-adjusted life-year (QALY) gained for TC vs. UC.

Results: 160 patients were included (80 in TC and 80 in UC). Mean age was 37.9(11.0) years with a disease duration of 3.7(6.2) years, 51.2% were males. A radiographic damage of the SI-joints, a (ever) positive MRI sacroiliitis and HLA-B27+ were seen in 46.9%, 81.9% and 75.0% patients respectively. Mean ASDAS at inclusion was 3.0 (0.7) and mean ASASHI was 8.6 (3.7). 72 patients per group attended the one-year visit. Although 47.3% vs. 36.1% patients in the TC and UC arms achieved a significant improvement in ASASHI at the one-year visit, the difference was not statistically significant, with either model. Across all other outcomes a trend was observed in favor of the TC arm (Table 1). The number of bDMARDs was significantly higher in TC arm (56.2% vs. 27.2%). The number of infections was comparable in both groups (15 vs. 16 in the TC and UC, respectively), with only 2 severe infections occurring in the UC arm. From a societal perspective, TC resulted in an additional 0.04 QALY and saved €265 when compared to UC and a 67% probability of being cost-effective at a cost-effectiveness threshold of €20,000 per QALY.

Conclusion: In this setting of SpA expert centers, UC resulted in a good outcome in a substantial number of patients but the TC was not superior for the primary outcome despite a greater number of bDMARDs prescription. Nevertheless, a general trend in favor of the tight control was observed, with a comparable safety profile and was found to be favorable from a societal health economic perspective.


Disclosure: A. Molto, ABBVIE, 5, BMS, 5, 8, LILLY, 5, NOVARTIS, 5, 8, UCB, 5, 8, GILEAD, 5; C. Lopez-Medina, None; F. Van den Bosch, AbbVie, 5, 8, Celgene, 5, 8, Eli Lilly, 5, 8, Galapagos, 5, 8, Novartis, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Gilead, 5, Merck, 5, 8; A. Boonen, AbbVie, 2, Galapagos, 5, Lilly, 5, Celgene, 2, UC, 5; C. Webers, None; E. Dernis, Abbvie, 5, BMS, 5, Celgene, 5, Roche-Chugai, 5, Janssen, 5, Lilly, 5, Medac, 5, MSD, 5, Nordic Pharma, 5, Novartis, 5, Sanofi, 5, UCB, 5; F. van Gaalen, Reuma Nederland, 1, Stichting vrienden van Sole Mio, 1, MSD, 1, Abbvie, 1, Novartis, 1; M. Soubrier, None; P. Claudepierre, Abbvie, 5, 8, Pfizer, 5, 8, UCB, 5, 8, Merk, 5, 8, novartis, 5, 8, Lilly, 5, 8, Janssen, 5, 8, BMS, 5, 8; A. Baillet, None; M. Starsman-Kool, None; A. Spoorenberg, Pfizer, 1, 2, Novartis, 1, 2, Abbvie pharmaceuticals, 1, 2, MSD, 1, UCB, 1; D. van der Heijde, AbbVie, 5, Bristol-Myers Squibb, 5, Cyxone, 5, Galapagos NV, 5, Gilead Sciences, Inc., 5, GlaxoSmithKline, 5, Eli Lilly, 5, Novartis, 5, Pfizer, 5, UCB Pharma, 5, Amgen Inc., 5, Astellas, 5, AstraZeneca, 5, Boehringer Ingelheim, 5, Celgene, 5, Daiichi-Sankyo, 5, Janssen, 5, Merck, 5, Regeneron, 5, Roche, 5, Sanofi, 5, Takeda, 5, Imaging Rheumatology bv, 3, Eisai, 5; M. Dougados, Pfizer, 5, 8, AbbVie, 5, 8, Roche, 5, 8, Bristol-Myers Squibb, 5, 8, Eli Lilly, 5, 8, Novartis, 5, 8, Sanofi, 5, 8, Biogen, 5, 8, Merck Sharp & Dohme, 5, 8, UCB Pharma, 5, 8.

To cite this abstract in AMA style:

Molto A, Lopez-Medina C, Van den Bosch F, Boonen A, Webers C, Dernis E, van Gaalen F, Soubrier M, Claudepierre P, Baillet A, Starsman-Kool M, Spoorenberg A, van der Heijde D, Dougados M. Cluster-randomized Pragmatic Clinical Trial Evaluating the Potential Benefit of a Tight-control and Treat-to-target Strategy in Axial Spondyloarthritis: The Results of the TICOSPA Trial [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/cluster-randomized-pragmatic-clinical-trial-evaluating-the-potential-benefit-of-a-tight-control-and-treat-to-target-strategy-in-axial-spondyloarthritis-the-results-of-the-ticospa-trial/. Accessed February 24, 2021.
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