Real-world effectiveness of tofacitinib in patients with rheumatoid arthritis: a prospective observational study

Aniela Shouval, Merav Lidar, Tatiana Reitblat, Devy Zisman, Alexandra ,md Balbir-Gurma, Tanya Mashiach, Ronit Almog, Ori Elkayam

Research output: Contribution to journalArticlepeer-review


Objective Tofacitinib is an approved treatment for rheumatoid arthritis (RA), but data on its use in the "real-world"are limited. We sought to analyse tofacitinib drug survival in the Israeli registry and compare it to other biologic agents. Methods We included RA patients treated with tofacitinib, etanercept, golimumab, tocilizumab, or abatacept between 2010-2019. The primary endpoint was event-free survival (EFS), defined as the time from treatment initiation to a treatment failure event from any cause (i.e. inefficacy or intolerability). EFS was compared between agents using Cox regression and Kaplan-Meier analysis, stratifying patients by treatment line. Results A total of 964 eligible treatment courses were included (tocilizumab [325], etanercept [284], abatacept [127], tofacitinib [139], and golimumab [109]). In a univariate analysis, EFS with tofacitinib in the complete cohort was similar to etanercept, golimumab, and abatacept but was lower than tocilizumab) 3-year EFS 43% vs. 53%, HR 0.65). In a multivariable analysis, tofacitinib was similar to all other drugs, except for etanercept, which was inferior (HR 1.70); advanced treatment line was also associated with greater risk for failure (HR 1.64). In a univariable analysis stratified by the treatment line, tofacitinib had similar or better drug survival than other agents in the first and second lines. In the third line and beyond, tocilizumab had a higher EFS compared to tofacitinib (HR 0.57). Conclusion Drug survival with tofacitinib is related to treatment line. Early introduction is associated with similar or better survival than other agents, whereas tocilizumab was superior in the third line or later.

Original languageEnglish
Pages (from-to)1378-1384
Number of pages7
JournalClinical and Experimental Rheumatology
Issue number6
StatePublished - Nov 2021
Externally publishedYes

Bibliographical note

Publisher Copyright:
© Copyright Clinical and Experimental Rheumatology 2021.


  • Abatacept/therapeutic use
  • Antirheumatic Agents/adverse effects
  • Arthritis, Rheumatoid/diagnosis
  • Biological Products/adverse effects
  • Humans
  • Piperidines
  • Pyrimidines/adverse effects
  • Pyrroles/therapeutic use

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology


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