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Postapproval Comparative Safety Study of Tofacitinib and Biological Disease-Modifying Antirheumatic Drugs: 5-Year

Joel M Kremer1, Clifton O Bingham2, Laura C Cappelli2

  • 1Albany Medical College, Center for Rheumatology, Albany, New York.

ACR Open Rheumatology
|February 11, 2021
PubMed
Abstract

Insights

Tofacitinib and biologic DMARDs showed similar rates for major adverse cardiovascular events, serious infections, malignancies, and death in rheumatoid arthritis patients. However, herpes zoster events were significantly higher with tofacitinib.

Area of Science:

  • Rheumatology
  • Immunology
  • Pharmacovigilance

Background:

  • Tofacitinib is an oral Janus kinase inhibitor used for rheumatoid arthritis (RA).
  • Comparative safety data for tofacitinib versus biologic disease-modifying antirheumatic drugs (bDMARDs) in real-world RA populations are crucial.

Purpose of the Study:

  • To compare the 5-year incidence rates of adverse events (AEs) between patients initiating tofacitinib and new bDMARDs in the US Corrona RA registry.
  • To assess the safety profiles of tofacitinib and bDMARDs concerning major adverse cardiovascular events (MACE), serious infections (SIEs), herpes zoster (HZ), malignancies, and death.

Main Methods:

  • Retrospective analysis of the US Corrona RA registry from November 2012 to July 2019.
  • Propensity score methods were employed to balance baseline characteristics between tofacitinib and bDMARD initiators.
  • Incidence rates (IRs) and Hazard Ratios (HRs) were calculated for various AEs using multivariable-adjusted Cox regression.

Main Results:

  • AE rates were comparable between tofacitinib and bDMARD cohorts, with the exception of herpes zoster (HZ).
  • HZ incidence was significantly higher in the tofacitinib group compared to the bDMARD group (PS-trimmed adjusted HR 2.32; 95% CI 1.43-3.75).
  • Rates for MACE, SIEs, malignancies, death, and venous thromboembolic events (VTEs) were similar across both treatment groups.

Conclusions:

  • In this US registry analysis, tofacitinib and bDMARD initiators exhibited similar rates of MACE, SIEs, malignancies, death, and VTEs.
  • A higher incidence of HZ was observed in patients initiating tofacitinib compared to those initiating bDMARDs.
  • These findings contribute to understanding the comparative safety of tofacitinib in RA management.

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