P004：在实际临床实践中接受托法替布治疗的溃疡性结肠炎患者实现无类固醇缓解
P004 Steroid-Free Remission in Patients With Ulcerative Colitis Receiving Tofacitinib in Real Clinical Practice.
作者信息
Knyazev Oleg, Kagramanova Anna, Lishchinskaya Albina, Babayan Anait, Kulakov Dmitriy, Li Irina, Shkurko Tatyana
机构信息
Moscow Clinical Scientific Center Named After A. S. Loginov, Moscow, Russia.
Research Institute of Health Organization and Medical Managemen, Moscow, Russia.
出版信息
Am J Gastroenterol. 2021 Dec 1;116(Suppl 1):S1. doi: 10.14309/01.ajg.0000798616.20791.8c.
BACKGROUND
Tofacitinib is a selective immunosuppressant, the first representative of the inhibitors of the janus kinase family, which has high selectivity against other kinases of the human genome. According to the results of the study, tofacitinib inhibits JAK-1, JAK-2, and in high concentrations - JAK-3 and tyrosine kinase-2. The drug is registered in Russia for the treatment of patients with ulcerative colitis. According to the OCTAVE Sustain study, steroid-free remission in patients with ulcerative colitis receiving tofacitinib at a dose of 10 and 20 mg per day is 27.7% and 27.6%, respectively.
OBJECTIVE
To identify the frequency of steroid-free remission in patients with ulcerative colitis receiving tofacitinib in real clinical practice.
METHODS
In the Department of Inflammatory Bowel Diseases of the Moscow Clinical Scientific and Practical Center named after A. S. Loginov, 58 patients with ulcerative colitis (UC) who received tofacitinib were observed. The effectiveness of therapy was evaluated (the value of the Mayo index less than 2, ESR, CRP, hemoglobin, fecal calprotectin (FCP) and the need for the appointment of glucocorticosteroids (GCS). The follow-up period was 12 months from the start of tofacitinib therapy.
RESULTS
During the follow-up period, out of 58 (100%) UC patients treated with tofacitinib, 9 (15.5%) patients did not respond to therapy. A prolonged induction course at a dose of 20 mg of tofacitinib was required in 14 (24.1%) patients who had previously received anti-TNF-α drugs. All patients at the time of initiation received GCS at an average therapeutic dose of 40 mg. After the induction course, corticosteroids were discontinued in 49 (100%) patients who responded to treatment. All patients achieved remission within 12 months of therapy (Meyo < 2). Repeated administration of corticosteroids for exacerbation or "eluding" of the response to tofacitinib was required in 11 of 49 (22.4%) patients.
CONCLUSION
Steroid-free remission in patients with ulcerative colitis, receiving tofacitinib for 12 months, in real clinical practice is 77.6%.
背景
托法替布是一种选择性免疫抑制剂，是Janus激酶家族抑制剂中的首个代表药物，对人类基因组的其他激酶具有高度选择性。根据研究结果，托法替布可抑制JAK-1、JAK-2，在高浓度时还可抑制JAK-3和酪氨酸激酶-2。该药物在俄罗斯注册用于治疗溃疡性结肠炎患者。根据OCTAVE Sustain研究，接受每日10毫克和20毫克剂量托法替布治疗的溃疡性结肠炎患者的无类固醇缓解率分别为27.7%和27.6%。
目的
确定在实际临床实践中接受托法替布治疗的溃疡性结肠炎患者的无类固醇缓解频率。
方法
在以A.S.洛吉诺夫命名的莫斯科临床科学与实践中心炎症性肠病科，观察了58例接受托法替布治疗的溃疡性结肠炎（UC）患者。评估了治疗效果（梅奥指数小于2、血沉、C反应蛋白、血红蛋白、粪便钙卫蛋白（FCP）的值以及是否需要使用糖皮质激素（GCS））。随访期为从开始使用托法替布治疗起12个月。
结果
在随访期间，58例（100%）接受托法替布治疗的UC患者中，9例（15.5%）患者对治疗无反应。14例（24.1%）曾接受抗TNF-α药物治疗的患者需要延长使用20毫克剂量托法替布的诱导疗程。所有患者在开始治疗时均接受平均治疗剂量为40毫克的GCS。诱导疗程后，49例（100%）对治疗有反应的患者停用了糖皮质激素。所有患者在治疗12个月内均实现缓解（梅奥评分<2）。49例患者中有11例（22.4%）因病情加重或对托法替布治疗“无反应”而需要再次使用糖皮质激素。
结论
在实际临床实践中，接受托法替布治疗12个月的溃疡性结肠炎患者的无类固醇缓解率为77.6%。
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