Effect of Tofacitinib on One-Year Colectomy Risk in Anti-TNF Refractory Ulcerative Colitis: A Prospective Multicenter Italian Study

被引:2
作者
Gabrielli, Anna Maria Carvalhas [1 ]
Ferretti, Francesca [1 ]
Monico, Camilla Maria [1 ]
Tombetti, Enrico [2 ,3 ]
Maconi, Giovanni [1 ,3 ]
Romeo, Samanta [4 ]
Sed, Nicole Piazza O. [5 ]
Caprioli, Flavio [5 ,6 ]
Mazzola, Anna Maria [7 ]
Alicante, Saverio [4 ]
Berte, Roberto [4 ]
Lolli, Elisabetta [8 ]
Scribano, Maria Lia [9 ]
Buscarini, Elisabetta [4 ]
Ricci, Chiara [7 ,10 ]
Carmagnola, Stefania [1 ]
Ardizzone, Sandro [1 ]
Cannatelli, Rosanna [1 ]
机构
[1] ASST Fatebenefratelli Sacco L Sacco Hosp, Gastroenterol Unit, Via Giovanni Battista Grassi 74, I-20157 Milan, MI, Italy
[2] Internal Med & Rheumatol Unit, ASST Fatebenefratelli Sacco, Milan, Italy
[3] Univ Milan, Dept Biomed & Clin Sci, Milan, Italy
[4] ASST Osped Maggiore Crema, Gastroenterol & Digest Endoscopy Dept, Crema, Italy
[5] Osped Maggiore Policlin Milano, Fdn IRCCS Ca Granda, Gastroenterol & Endoscopy Unit, Milan, Italy
[6] Univ Milan, Dept Pathophysiol & Transplantat, Milan, Italy
[7] Univ Brescia, Dept Clin & Sperimental Sci, Brescia, Italy
[8] Gastroenterol Dept, Policlin Tor Vergata, Rome, Italy
[9] Villa Stuart Multispecial Clin, Rome, Italy
[10] Gastroenterol Unit, Spedali Civili Brescia, Brescia, Italy
关键词
JAK-inhibitor; Inflammatory bowel disease; Biologic therapy; Surgery; INFLAMMATORY-BOWEL-DISEASE; THERAPY; SAFETY;
D O I
10.1007/s10620-024-08394-w
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
BackgroundTofacitinib is an oral Janus kinase inhibitor recently approved to induce and maintain remission in ulcerative colitis (UC).AimsConsidering the number of anti-TNF non-responders, this study aims to assess the effectiveness and safety of tofacitinib in a cohort of multi-failure patients with moderate-to-severe UC at 52 weeks.MethodsFrom January 2021 to March 2023, we performed a prospective multicenter study observing adult patients with moderate-to-severe UC starting tofacitinib after an anti-TNF failure for a 52-week-long period. Effectiveness and safety were assessed in terms of colectomy rate, clinical remission and response, endoscopic remission, steroid-free clinical remission, and rate of adverse events.ResultsWe included 58 patients with UC with an age of 42 +/- 14.4 years, 59% males, 96.6% left-sided or pancolitis, who were failure to a single (65.5%) or more than one anti-TNF (34.5%). Only 6 (10.3%) patients underwent colectomy. Colectomy was clinically associated with the necessity and the number of extra cycles of tofacitinib 10 mg bid at W8 (p = 0.023) and W24 (p = 0.004), and with a higher partial Mayo score at W8 (p = 0.025). At W52, clinical remission, clinical response, and steroid-free clinical remission were 53.4%, 43.1%, and 48.3%, respectively. Of 22 performed colonoscopies at W52, 11 (50%) showed endoscopic remission. Adverse events occurred in 14 (24.1%) patients, but only 2 (3.4%) led to tofacitinib discontinuation.ConclusionsIn a real-life setting of patients with anti-TNF refractory UC, tofacitinib has proved to be effective in preventing colectomy and inducing clinical and endoscopic remission at 52 weeks with a good safety profile.
引用
收藏
页码:1785 / 1792
页数:8
相关论文
共 25 条
[1]   One-year effectiveness and safety of vedolizumab therapy for inflammatory bowel disease: a prospective multicentre cohort study [J].
Amiot, A. ;
Serrero, M. ;
Peyrin-Biroulet, L. ;
Filippi, J. ;
Pariente, B. ;
Roblin, X. ;
Buisson, A. ;
Stefanescu, C. ;
Trang-Poisson, C. ;
Altwegg, R. ;
Marteau, P. ;
Vaysse, T. ;
Bourrier, A. ;
Nancey, S. ;
Laharie, D. ;
Allez, M. ;
Savoye, G. ;
Moreau, J. ;
Vuitton, L. ;
Viennot, S. ;
Aubourg, A. ;
Pelletier, A. -L. ;
Bouguen, G. ;
Abitbol, V. ;
Gagniere, C. ;
Bouhnik, Y. .
ALIMENTARY PHARMACOLOGY & THERAPEUTICS, 2017, 46 (03) :310-321
[2]   Short-term effectiveness and safety of tofacitinib in ulcerative colitis-real world data from tertiary medical centers in Israel [J].
Avni-Biron, Irit ;
Shitrit, Ariella Bar-Gil ;
Koslowsky, Benjamin ;
Levartovsky, Asaf ;
Kopylov, Uri ;
Weisshof, Roni ;
Cohen, Nathaniel Aviv ;
Maharshak, Nitsan ;
Hovel, David ;
Israeli, Eran ;
Naftali, Timna ;
Goren, Idan ;
Snir, Yfat ;
Ollech, Jacob E. ;
Banai-Eran, Hagar ;
Broitman, Yelena ;
Sharar-Fischler, Tali ;
Dotan, Iris ;
Yanai, Henit .
DIGESTIVE AND LIVER DISEASE, 2022, 54 (02) :192-197
[3]   PROGNOSIS IN ULCERATIVE-COLITIS [J].
BROSTROM, O .
MEDICAL CLINICS OF NORTH AMERICA, 1990, 74 (01) :201-218
[4]  
Chaparro M., 2023, AM J GASTROENTEROL, V118, P1237, DOI [DOI 10.14309/AJG.0000000000002145, 10.14309/ajg.0000000000002145]
[5]   Update on anti-tumor necrosis factor agents and other new drugs for inflammatory bowel disease [J].
Cohen, Benjamin L. ;
Sachar, David B. .
BMJ-BRITISH MEDICAL JOURNAL, 2017, 357
[6]   Real-world comparative risks of herpes virus infections in tofacitinib and biologic-treated patients with rheumatoid arthritis [J].
Curtis, Jeffrey R. ;
Xie, Fenglong ;
Yun, Huifeng ;
Bernatsky, Sasha ;
Winthrop, Kevin L. .
ANNALS OF THE RHEUMATIC DISEASES, 2016, 75 (10) :1843-1847
[7]   Clinical and Endoscopic Outcomes Through 78 Weeks of Tofacitinib Therapy for Ulcerative Colitis in a US Cohort [J].
Dalal, Rahul ;
Sharma, Puza ;
Bains, Kanwal ;
Pruce, Jordan ;
Allegretti, Jessica .
INFLAMMATORY BOWEL DISEASES, 2023, 30 (10) :1707-1713
[8]   An Update on Current Pharmacotherapeutic Options for the Treatment of Ulcerative Colitis [J].
Ferretti, Francesca ;
Cannatelli, Rosanna ;
Monico, Maria Camilla ;
Maconi, Giovanni ;
Ardizzone, Sandro .
JOURNAL OF CLINICAL MEDICINE, 2022, 11 (09)
[9]   Natural History of Adult Ulcerative Colitis in Population-based Cohorts: A Systematic Review [J].
Fumery, Mathurin ;
Singh, Siddharth ;
Dulai, Parambir S. ;
Gower-Rousseau, Corinne ;
Peyrin-Biroulet, Laurent ;
Sandborn, William J. .
CLINICAL GASTROENTEROLOGY AND HEPATOLOGY, 2018, 16 (03) :343-+
[10]   Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis [J].
Lair-Mehiri, Loriane ;
Stefanescu, Carmen ;
Vaysse, Thibaut ;
Laharie, David ;
Roblin, Xavier ;
Rosa, Isabelle ;
Treton, Xavier ;
Abitbol, Vered ;
Amiot, Aurelien ;
Bouguen, Guillaume ;
Dib, Nina ;
Fumery, Mathurin ;
Pariente, Benjamin ;
Carbonnel, Franck ;
Peyrin-Biroulet, Laurent ;
Simon, Marion ;
Viennot, Stephanie ;
Bouhnik, Yoram .
DIGESTIVE AND LIVER DISEASE, 2020, 52 (03) :268-273