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

1, 2, 3, 4, 5, 6, 7, 8


  1. Department of Rheumatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.
  2. Sackler Faculty of Medicine, Tel Aviv University, and Rheumatology Unit, The Zabludowicz Center for Autoimmune Diseases, Tel-Hashomer, Ramat Gan, Israel.
  3. Rheumatology Unit, Barzilai Medical Center, Ashkelon, Israel.
  4. Department of Rheumatology, Carmel Medical Center, Haifa, and The Ruth and Bruce Rappaport Faculty of Medicine, Technion, Haifa, Israel.
  5. B Shine Rheumatology Institute, Rambam Health Care Campus, Haifa, Israel.
  6. Epidemiology and Biostatistics Unit, Rambam Health Care Campus, Haifa, Israel.
  7. Epidemiology and Biostatistics Unit, Rambam Health Care Campus, Haifa, Israel.
  8. Department of Rheumatology, Tel Aviv Sourasky Medical Center, Israel.

2021 Vol.39, N°6
PI 1378, PF 1384
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PMID: 33427626 [PubMed]

Received: 28/05/2020
Accepted : 23/11/2020
In Press: 10/01/2021
Published: 25/11/2021


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.
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.
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). CONLUSIONS: 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.

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