[Posted 02/04/2021]
Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine
AUDIENCE: Patient, Health Professional, Pharmacy, Rheumatology, Gastroenterology, Cardiology, Oncology
ISSUE: The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.
In February 2019 and July 2019, FDA warned that interim trial results showed an increased risk of blood clots and death with the higher 10 mg twice daily dosage, and as a result, approved a Boxed Warning to the tofacitinib prescribing information. The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis (RA) patients treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.
BACKGROUND: Tofacitinib was approved in 2012 to treat adults with RA who did not respond well to the medicine methotrexate. In 2017, FDA approved tofacitinib to treat patients with a second condition that causes joint pain and swelling, psoriatic arthritis (PsA), who did not respond well to methotrexate or other similar medicines. In 2018, FDA approved the medicine to treat ulcerative colitis, which is a chronic, inflammatory disease affecting the colon. Tofacitinib works by decreasing the activity of the immune system; an overactive immune system contributes to RA, PsA, and ulcerative colitis.
RECOMMENDATION:
Patients should not stop taking tofacitinib without first consulting with your health care professionals, as doing so may worsen your condition. Talk to your health care professionals if you have any questions or concerns.
Health care professionals should consider the benefits and risks of tofacitinib when deciding whether to prescribe or continue patients on the medicine. Continue to follow the recommendations in the tofacitinib prescribing information.
Read more about the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://reurl.cc/9ZRqov
美國FDA發布藥物安全警訊，一項由該局要求進行之安全性臨床試驗初步結果顯示，治療關節炎及潰瘍性結腸炎之藥物Xeljanz、Xeljanz XR (tofacitinib)與腫瘤壞死因子(tumor necrosis factor, TNF)抑制劑相比，tofacitinib會增加嚴重心臟相關問題及癌症的風險。該試驗亦評估了其他潛在風險，包括肺部之血塊和死亡。目前最終結果尚未出爐。
在2019年2月和2019年7月，美國FDA發布藥物安全警訊，根據其中分析結果顯示，使用tofacitinib 10 mg一天兩次的高劑量，可能增加血塊和死亡的風險，因此核准於仿單中加入黑框警告。現該臨床試驗已完成，初步結果顯示，與接受TNF抑制劑治療的患者相比，接受tofacitinib兩種劑量治療的RA患者，發生嚴重心臟相關事件和癌症的可能性更高。美國FDA正在等待該試驗的其他結果出爐。
Tofacitinib於2012年核准用於治療對methotrexate藥物反應不佳的類風濕性關節炎（rheumatoid arthritis, RA）成人。2017年，美國FDA核准tofacitinib用於對methotrexate或其他類似藥物反應不佳之乾癬性關節炎（psoriatic arthritis, PsA）。2018年，美國FDA核准該藥物用於治療慢性、發炎性的結腸疾病：潰瘍性結腸炎。過度活化的免疫系統會導致RA、PsA和潰瘍性結腸炎的發生，tofacitinib藉由降低免疫系統的活性而發揮作用。
建議病人：
在尚未事先諮詢醫療專業人員之前，不應自行停止服用tofacitinib，因為可能會使病情惡化。如有任何疑慮，請與醫療專業人員聯繫。
建議醫療專業人員：
醫療專業人員在決定是否開立處方或繼續給病人服用前，應考慮tofacitinib的益處和風險。並建議遵循tofacitinib仿單中的建議。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/9ZRqov
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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