Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025
Endo-histologic outcomes in patients with ulcerative colitis responding to tofacitinib.
СтатьяНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Singh Arshdeep, Bhardwaj Arshia, Jain Devanshi, Sharma Riya, Singh Dharmatma, Mahajan Ramit, Kaur Kirandeep, Singh Aminder, Narang Vikram, Kaur Harpreet, Singh Manavjot, Gupta Pritish, Sehgal Tanisha, Midha Vandana, Sood Ajit
Аннотация
BACKGROUND: The therapeutic target for ulcerative colitis (UC) has shifted towards deeper disease control. The real-world data on efficacy of tofacitinib in inducing histologic remission (HR) remains limited. We evaluated the real-world efficacy of tofacitinib in achieving endoscopic remission (ER) and HR.
METHODS: A prospective observational cohort study was conducted from January 2022 to June 2024. Adult patients with moderate-to-severe UC (Mayo score ≥ 6, endoscopic subscore ≥ 2) who responded to tofacitinib induction by week 16 were included. Paired endoscopic and histologic assessments were performed at baseline and week 48. Endoscopic disease activity was graded using the Mayo endoscopic score (MES), while histologic activity was evaluated using the Nancy index (NI). The primary outcome was combined endoscopic-histologic remission (EHR), defined as MES of 0 and a NI of 0, at week 48. The key secondary outcomes included ER, HR, histologic endoscopic mucosal improvement (HEMI) and endoscopic improvement histologic remission (EIHR).
RESULTS: Total 86 patients who received tofacitinib induction therapy were evaluated. Nine non-responders at 16 weeks were excluded and 77 patients (median age 37 years, 38 [49%] females) were analyzed. At week eight, clinical response and remission were achieved in 66 (85.7%) and 37 (48.1%) patients, respectively. At week 48, 57 (74.02%) patients maintained clinical response. Median MES and NI were 1 (IQR 0-3) and 3 (IQR 0-3), respectively. Combined EHR was achieved in 22 (28.6%) patients, while ER and HR were observed in 30 (38.9%) and 29 (37.6%) patients, respectively. HEMI was noted in 32 (41.6%) patients, while EIHR was seen in 27 (35.1%) patients. No significant predictors of ER, HR or combined EHR were identified. No serious adverse effects were reported.
CONCLUSIONS: Tofacitinib is effective in achieving combined EHR, ER and HR. These findings support the potential for histologic healing as a therapeutic target for UC in real world.
METHODS: A prospective observational cohort study was conducted from January 2022 to June 2024. Adult patients with moderate-to-severe UC (Mayo score ≥ 6, endoscopic subscore ≥ 2) who responded to tofacitinib induction by week 16 were included. Paired endoscopic and histologic assessments were performed at baseline and week 48. Endoscopic disease activity was graded using the Mayo endoscopic score (MES), while histologic activity was evaluated using the Nancy index (NI). The primary outcome was combined endoscopic-histologic remission (EHR), defined as MES of 0 and a NI of 0, at week 48. The key secondary outcomes included ER, HR, histologic endoscopic mucosal improvement (HEMI) and endoscopic improvement histologic remission (EIHR).
RESULTS: Total 86 patients who received tofacitinib induction therapy were evaluated. Nine non-responders at 16 weeks were excluded and 77 patients (median age 37 years, 38 [49%] females) were analyzed. At week eight, clinical response and remission were achieved in 66 (85.7%) and 37 (48.1%) patients, respectively. At week 48, 57 (74.02%) patients maintained clinical response. Median MES and NI were 1 (IQR 0-3) and 3 (IQR 0-3), respectively. Combined EHR was achieved in 22 (28.6%) patients, while ER and HR were observed in 30 (38.9%) and 29 (37.6%) patients, respectively. HEMI was noted in 32 (41.6%) patients, while EIHR was seen in 27 (35.1%) patients. No significant predictors of ER, HR or combined EHR were identified. No serious adverse effects were reported.
CONCLUSIONS: Tofacitinib is effective in achieving combined EHR, ER and HR. These findings support the potential for histologic healing as a therapeutic target for UC in real world.