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Early arthritis
Is a 1-year course of methotrexate in patients with arthralgia at-risk for rheumatoid arthritis cost-effective? A cost-effectiveness analysis of the randomised, placebo-controlled TREAT EARLIER trial
  1. Elise van Mulligen1,2,
  2. Sterre S Bour3,
  3. Lucas M A Goossens3,
  4. Pascal Hendrik Pieter de Jong2,
  5. Maureen Rutten-van Mölken3,4,
  6. Annette van der Helm-van Mil1,2
  1. 1Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  2. 2Rheumatology, Erasmus Medical Center, Rotterdam, The Netherlands
  3. 3Health Technology Assessment, Erasmus School of Health Policy and Management, Rotterdam, The Netherlands
  4. 4Erasmus Universiteit Rotterdam Institute for Medical Technology Assessment, Rotterdam, Zuid-Holland, The Netherlands
  1. Correspondence to Elise van Mulligen; e.van_mulligen{at}lumc.nl

Abstract

Objectives Rheumatoid arthritis (RA) has a considerable disease burden with life-long physical limitations, reduced work productivity and high societal costs. Trials on arthralgia at-risk for RA are therefore conducted, aiming to intercept evolving RA and reduce the disease burden. A 1-year course of methotrexate in patients with clinically suspect arthralgia (CSA) caused sustained improvements in subclinical joint inflammation and physical impairments. Since the cost-effectiveness of treatment in CSA has never been investigated, we investigated whether methotrexate is cost-effective.

Methods Cost-effectiveness was assessed using the TREAT EARLIER trial. 236 patients with CSA with subclinical joint inflammation were randomised to 1-year treatment with methotrexate, or placebo, and followed for 2 years. Cost-effectiveness was analysed by computing costs and effects. For costs, both a societal perspective (healthcare-productivity and work-productivity costs) and a healthcare perspective (healthcare costs only) were used. For effects, quality adjusted life years (QALYs) were used.

Results Treatment increased QALYs by 0.041 (95% CI −0.050 to 0.091), and reduced costs with €−4809 (95% CI −12 382 to 2726) over the course of 2 years using a societal perspective, with a probability of 88.1% that treatment was cost-effective. From a healthcare perspective, the cost-difference between treatment and placebo was estimated at €−418 (95% CI −1198 to 225).

Conclusion A fixed treatment course in individuals with arthralgia at-risk for RA and MRI-detected subclinical joint inflammation resulted in better work productivity, lower healthcare costs and improved quality of life over the course of 2 years; with the largest gain in productivity costs. This is the first evidence that methotrexate treatment aiming at secondary prevention in arthralgia at-risk for RA is cost-effective.

  • Treatment
  • Methotrexate
  • Rheumatoid Arthritis
  • Economics

Data availability statement

Data are available upon reasonable request. The data are available upon reasonable request via the corresponding author.

https://doi.org/10.1136/ard-2024-226286

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    Data availability statement

    Data are available upon reasonable request. The data are available upon reasonable request via the corresponding author.

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    Footnotes

    • Handling editor Josef S Smolen

    • X @elisevmulligen

    • Contributors All authors made substantial contributions to the design of the work, acquisition of data or their interpretation. EvM and AvdH-vM had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design of the study: AvdH-vM and EvM. Acquisition, analysis or interpretation of data: All authors. Drafting of the manuscript: EvM. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: EvM, SSB and LMAG. Obtained funding: AvdH-vM. Administrative, technical or material support: AvdH-vM, SSB and EvM. Supervision: AvdH-vM. EvM is the guarantor.

    • Funding The TREAT EARLIER trial was funded by the Dutch Research Council (NWO) and the Dutch Arthritis Society. This work was funded by ZonMW, Efficiency grant number 10390012110002 and the Dutch Arthritis Society.

    • Competing interests None declared.

    • Patient and public involvement Patient partners were involved in the design of the TREAT EARLIER trial.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.