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Real-world efficacy and safety profile of four JAK inhibitors in rheumatoid arthritis: a French single-center observational study

Clinical Rheumatology·June 4Open Access
RheumatologyConfirms priorSafety signalRheumatoid ArthritisRetrospective Observational Cohort StudyJAK InhibitorAdultOlder AdultJyselecaOlumiantRinvoqXeljanzBaricitinibFilgotinibTofacitinibUpadacitinib

Summary

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What was studied

Real-world treatment maintenance, effectiveness, and safety of four JAK inhibitors (tofacitinib, baricitinib, upadacitinib, filgotinib) in 120 RA patients at a single French center (April 2018–November 2023), including a before-vs-after comparison of the October 2022 EMA PRAC prescribing restrictions.

Key findings

Overall drug survival was 73% at 12 months, 62% at 24 months, and 57% at 36 months. All four JAKi reduced DAS28-CRP by –1.57 ± 1.26 at 6 months and –1.13 ± 1.63 at 12 months. Serious cardiovascular/thromboembolic events (3 pulmonary embolisms, 1 myocardial infarction) occurred only in high-risk patients treated before PRAC; zero such events occurred after PRAC.

Study limitations

- Single-center retrospective design limits generalizability. - Filgotinib had much shorter follow-up than other agents, making long-term persistence comparisons unreliable. - Adverse events were only captured when they caused discontinuation, likely underestimating the true safety burden.

Clinical implications

Screen RA patients carefully for cardiovascular and thromboembolic risk before starting any JAK inhibitor — all serious vascular events in this cohort occurred in high-risk patients predating PRAC restrictions. After PRAC-aligned patient selection, baricitinib suits older, more comorbid patients; upadacitinib fits high-disease-burden cases; and filgotinib is a reasonable choice for younger, lower-risk women.

Caveats

  • Adverse events not leading to discontinuation were not systematically captured, so non-severe infections and minor adverse effects are likely underreported.
  • Filgotinib was prescribed exclusively to women in this cohort due to early spermatogenesis concerns, limiting the generalizability of its effectiveness and persistence data to male patients.
  • Inter-JAKi comparisons are confounded by substantial differences in patient selection, timing of drug availability, and follow-up duration rather than true pharmacological differences.
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  • Tofacitinib subgroup was very small (n=10), so any efficacy or safety conclusions for that agent alone should be interpreted with caution.

Related Questions

Explore related topics

Which JAK inhibitor has the best long-term persistence in real-world rheumatoid arthritis patients?How did the 2022 EMA PRAC recommendations change JAK inhibitor prescribing in rheumatoid arthritis?What is the cardiovascular and thromboembolic risk of JAK inhibitors in older RA patients with comorbidities?

Publication Details

Year
2026
Journal
Clinical Rheumatology
Sample Size
n=120
Source
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