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  • No impact of concomitant methotrexate use on serious adverse event and serious infection risk in patients with rheumatoid arthritis treated with bDMARDs: a systematic literature review and meta-analysis

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Rheumatoid arthritis
Original article
No impact of concomitant methotrexate use on serious adverse event and serious infection risk in patients with rheumatoid arthritis treated with bDMARDs: a systematic literature review and meta-analysis
  1. Claire Baradat1,2,
  2. Yannick Degboé1,2,3,
  3. Arnaud Constantin1,2,3,
  4. Alain Cantagrel1,2,3 and
  5. Adeline Ruyssen-Witrand1,2,4
  1. 1Rheumatology Center, Purpan Teaching Hospital, CHU of Toulouse, Toulouse, France
  2. 2Paul Sabatier University, Toulouse, France
  3. 3Inserm, UMR 1043, Toulouse, France
  4. 4Inserm, UMR 1027, Toulouse, France
  1. Correspondence to Dr Adeline Ruyssen-Witrand; ruyssen-witrand.a{at}chu-toulouse.fr

Abstract

Objectives To compare the risk of serious adverse events, serious infections and death caused by methotrexate and biological disease-modifying antirheumatic drug (bDMARD) combination therapy versus a bDMARD prescribed as monotherapy in rheumatoid arthritis (RA).

Methods A systematic literature review was conducted until February 2016 in PubMed, Embase and Cochrane Library databases by selecting randomised controlled trials comparing methotrexate and bDMARD combination therapy to bDMARD monotherapy in RA. The meta-analysis compared the occurrence of (1) serious adverse events, (2) serious infections and (3) death among these groups by the Mantel-Haenszel method.

Results The literature review selected 16 controlled trials comparing methotrexate and bDMARD combination therapy to bDMARD monotherapy. After meta-analysis comparing patients under monotherapy to those under combination therapy: (1) the risk of occurrence of serious adverse events was comparable in 12 trials: RR (95% CI) 0.92 (0.78 to 1.08). (2) No significant difference was observed in the risk of occurrence of serious infections in 13 trials: RR (95% CI) 1.15 (0.84 to 1.58). We noted a trend, although insignificant, towards a high risk of the occurrence of tuberculosis in 10 studies: RR (95% CI) 1.78 (0.63 to 4.99). (3) The risk of death was comparable in 12 trials: RR (95% CI) 0.73 (0.40 to 1.35).

Conclusions The results showed no significant difference between the two groups, confirming that the use of methotrexate and bDMARD combination therapy in RA does not cause an increased risk of serious adverse events or serious infections or death compared with bDMARD monotherapy.

  • Rheumatoid Arthritis
  • DMARDs (biologic)
  • Methotrexate

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 and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/rmdopen-2016-000352

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    Footnotes

    • Contributors CB and AR-W equally contributed to the conception of the study, the article selection process, the data collection, the data analysis, the results interpretation, the manuscript writing and approval. YD, AC and AlC contributed to the conception of the study, results interpretation and manuscript approval. All the authors take responsibility for the integrity of the work as a whole, from inception to published article, and they should indicate that they had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. They give permission to reproduce published material, report sensitive personal information, use illustrations of identifiable persons or name persons for their contributions.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The Ethics Committee approvals of each trial were obtained for all the studies selected in this meta-analysis.

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

    • Data sharing statement This study involved only published reports and no unpublished information. No database was used for this study.