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<p>Janus kinase inhibitors (JAKis) are highly effective drugs for treating inflammatory rheumatic diseases. The randomized ORAL surveillance trial showed that patients with rheumatoid arthritis (RA) aged 50&#xa0;years and older with at least 1 more cardiovascular risk factor had an increased risk of malignant diseases with the JAKi tofacitinib compared to tumor necrosis factor inhibitors; however, this result has not been replicated in subsequent studies. An analysis of the German RABBIT register now revealed an overall slightly increased cancer risk in RA patients ever treated with JAKi compared to those ever treated with biological (b) disease-modifying antirheumatic drugs (DMARDs). During or after 2285 JAKi treatment episodes and 4259 bDMARD treatment episodes, 88&#xa0;and 135 malignant diseases occurred, respectively, resulting in a&#xa0;rate of 11.6 (95% confidence interval, CI: 9.3–14.3) events for JAKis and 8.9 (95% CI: 7.4–10.5) events for bDMARDs per 1000 patient years. The adjusted hazard ratio was 1.40 (95% CI: 1.09–1.80), which is comparable to the results from the ORAL surveillance study. Particularly affected by the observed risk increase were patients aged 60&#xa0;years and older, those with high disease activity and those who had already received ≥ 3 treatments with conventional synthetic DMARDs. Other above-average affected groups included smokers, male patients and patients with an RA duration of &gt; 10&#xa0;years. When treating patients with an increased risk, clinicians should carefully consider together with them whether this observed risk outweighs the potential risks of discontinuing or withholding a&#xa0;highly effective treatment such as JAKis, bearing in mind that inadequate disease control is also associated with an increased risk of cancer. When in doubt, the results from RABBIT should not discourage physicians from prescribing a&#xa0;JAKi treatment to patients who need it. It could be a way forward to ensure that a close cancer screening is carried out for risk patients treated with JAKis.</p>

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Neue Erkenntnisse aus dem RABBIT-Register zum Krebsrisiko von Patient:innen mit rheumatoider Arthritis bei Therapie mit Januskinaseinhibitoren

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  • 发表日期：

    2025年10月20日

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  • Martin Schäfer,
  • Anja Strangfeld

摘要

Janus kinase inhibitors (JAKis) are highly effective drugs for treating inflammatory rheumatic diseases. The randomized ORAL surveillance trial showed that patients with rheumatoid arthritis (RA) aged 50 years and older with at least 1 more cardiovascular risk factor had an increased risk of malignant diseases with the JAKi tofacitinib compared to tumor necrosis factor inhibitors; however, this result has not been replicated in subsequent studies. An analysis of the German RABBIT register now revealed an overall slightly increased cancer risk in RA patients ever treated with JAKi compared to those ever treated with biological (b) disease-modifying antirheumatic drugs (DMARDs). During or after 2285 JAKi treatment episodes and 4259 bDMARD treatment episodes, 88 and 135 malignant diseases occurred, respectively, resulting in a rate of 11.6 (95% confidence interval, CI: 9.3–14.3) events for JAKis and 8.9 (95% CI: 7.4–10.5) events for bDMARDs per 1000 patient years. The adjusted hazard ratio was 1.40 (95% CI: 1.09–1.80), which is comparable to the results from the ORAL surveillance study. Particularly affected by the observed risk increase were patients aged 60 years and older, those with high disease activity and those who had already received ≥ 3 treatments with conventional synthetic DMARDs. Other above-average affected groups included smokers, male patients and patients with an RA duration of > 10 years. When treating patients with an increased risk, clinicians should carefully consider together with them whether this observed risk outweighs the potential risks of discontinuing or withholding a highly effective treatment such as JAKis, bearing in mind that inadequate disease control is also associated with an increased risk of cancer. When in doubt, the results from RABBIT should not discourage physicians from prescribing a JAKi treatment to patients who need it. It could be a way forward to ensure that a close cancer screening is carried out for risk patients treated with JAKis.