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Safety of Janus Kinase Inhibitors: A Real-World Multicenter Retrospective Cohort Study

Marco Lanzillotta1, Nicola Boffini2, Elisa Barone3

  • 1M. Lanzillotta, MD, Unit of Immunology, Rheumatology, Allergy, and Rare diseases (UnIRAR), IRCCS San Raffaele Scientific Institute, and Vita-Salute San Raffaele University.

The Journal of Rheumatology
|August 1, 2023
PubMed
Abstract

Insights

Janus kinase inhibitors (JAKis) are effective for rheumatoid arthritis (RA). Real-world data show JAKis have a low risk of adverse events, particularly in patients without cardiovascular risk factors.

Area of Science:

  • Rheumatology
  • Immunology
  • Pharmacology

Background:

  • Oral Janus kinase inhibitors (JAKis) are a key treatment for rheumatoid arthritis (RA).
  • Previous studies suggested tofacitinib (TOF) may increase cardiovascular (CV) and neoplastic risks compared to TNF inhibitors.
  • Real-world data are needed to clarify the safety and efficacy of various JAKis in RA management.

Purpose of the Study:

  • To investigate the safety and efficacy of available JAKis (tofacitinib, baricitinib, upadactinib, filgotinib) in a multicenter RA cohort.
  • To compare real-world outcomes with previous findings on JAKi safety.
  • To analyze safety events, particularly cardiovascular events and adverse events of special interest (AESIs), in relation to patient risk factors.

Main Methods:

  • Retrospective evaluation of 685 RA patients treated with one JAKi (baricitinib, tofacitinib, upadactinib, or filgotinib) across 4 Italian tertiary care centers.
  • Recording of safety outcomes, including major CV events, AESIs (serious infections, opportunistic infections, VTE, herpes zoster, liver injury, malignancies, deaths), and treatment retention rates.
  • Analysis of AESI frequency in patients with risk factors associated with tofacitinib safety.

Main Results:

  • Baricitinib was the most common JAKi (48%), followed by tofacitinib (31%), upadactinib (14%), and filgotinib (7%).
  • Over 1137 patient-years, 1 stroke and 123 (18%) AESIs were recorded, including 3 deaths primarily from severe infections.
  • Patients with higher CV risk exhibited a greater frequency of AESIs (23%).

Conclusions:

  • Real-world data indicate JAKis are effective for RA with a low risk of AESIs, especially in patients without baseline CV risk factors.
  • No significant differences in safety profiles were identified among the studied JAKis in this cohort.
  • Larger prospective studies are recommended to further define the distinct safety profiles of individual JAKis.

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