Article Text

Protocol
Risk of infections and cardiovascular and venous thromboembolic events associated with JAK inhibitors in rheumatoid arthritis: protocols of two systematic reviews and network meta-analyses
  1. Carlos Alves1,2,
  2. Ana Penedones2,
  3. Diogo Mendes2,
  4. Francisco Batel-Marques1,2
  1. 1Faculty of Pharmacy, Laboratory of Social Pharmacy and Public Health, University of Coimbra, Coimbra, Portugal
  2. 2Coimbra Regional Pharmacovigilance Unit—UFC, Centre for Health Technology Assessment and Drug Research—CHAD, Association for Innovation and Biomedical Research on Light and Image—AIBILI, Coimbra, Portugal
  1. Correspondence to Dr Carlos Alves; carlosmiguel.costaalves{at}gmail.com

Abstract

Introduction Janus kinases (JAK) inhibitors demonstrated to be effective in the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA) but have been associated with serious cardiovascular and serious events. Two systematic reviews and network meta-analyses will be carried aiming to compare the relative safety of the different JAK inhibitors with regard to the risk of (1) cardiovascular and thromboembolic events and (2) serious infections in patients with RA.

Methods and analysis PUBMED, Embase, Cochrane Controlled Register of Trials and ClinicalTrials.gov will be searched in order to identify randomised controlled trials evaluating the efficacy and safety of JAK inhibitors in patients with RA. The following events will be assessed: (1) any cardiovascular event; major adverse cardiovascular events and venous thromboembolism and (2) any infection; serious infections; herpes zoster infection and tuberculosis. Search terms will comprise RA and drugs names, including the thesaurus terms and the International Nonproprietary Names. The assessment of the methodological quality of the included studies will be performed through the RoB 2 tool: a revised Cochrane risk of bias tool for randomised trials. Network meta-analyses will be performed using STATA V.13.0. For each outcome, treatments will be ranked according to the probability of being the safest (best) alternative using the surface under the cumulative ranking curve.

Ethics and dissemination Ethical approval is not required as no primary data are collected. This systematic review will be disseminated through peer-reviewed publications and at conference meetings.

  • rheumatology
  • clinical pharmacology
  • epidemiology
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Footnotes

  • Contributors CA designed the study, drafted the paper and approved the final version to be published. AP wrote and reviewed the draft paper. DM and FB-M reviewed and approved the paper.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • 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.

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