Epistemonikos: Database della migliore assistenza sanitaria basate su prove di efficacia

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Rapid prediction of 1-year efficacy of tofacitinib for treating refractory ulcerative colitis.

Autori » Shimizu H , Fujii T , Hibiya S , Motobayashi M , Suzuki K , Takenaka K , Saito E , Nagahori M , Ohtsuka K , Watanabe M

Giornale » Intestinal research

Year » 2021

Links » Pubmed DOI PubMed Central

Questo articolo fa parte di 2 Systematic reviews Systematic reviews (2 references)

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Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry.

Autori » Chaparro M , Garre A , Mesonero F , Rodríguez C , Barreiro-de Acosta M , Martínez-Cadilla J , Arroyo MT , Manceñido N , Sierra-Ausín M , Vera-Mendoza I , Casanova MJ , Nos P , González-Muñoza C , Martínez T , Boscá-Watts M , Calafat M , Busquets D , Girona E , Llaó J , Martín-Arranz MD , Piqueras M , Ramos L , Surís G , Bermejo F , Carbajo AY , Casas-Deza D , Fernández-Clotet A , García MJ , Ginard D , Gutiérrez-Casbas A , Hernández L , Lucendo AJ , Márquez L , Merino-Ochoa O , Rancel FJ , Taxonera C , López Sanromán A , Rubio S , Domènech E , Gisbert JP

Giornale » Journal of Crohn's & colitis

Year » 2021

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Questo articolo fa parte di 3 Systematic reviews Systematic reviews (3 references)

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AIM: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. METHODS: Patients from the prospectively maintained ENEIDA registry and treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score [PMS]. Short-term response/remission was assessed at Weeks 4, 8, and 16. RESULTS: A total of 113 patients were included. They were exposed to tofacitinib for a median time of 44 weeks. Response and remission at Week 8 were 60% and 31%, respectively. In multivariate analysis, higher PMS at Week 4 (odds ratio [OR] = 0].2; 95% confidence interval [CI] = 0].1-0.4) was the only variable associated with lower likelihood of achieving remission at Week 8. Higher PMS at Week 4 [OR = 0.5; 95% CI = 0.3-0.7] and higher PMS at Week 8 [OR = 0.2; 95% CI = 0.1-0.5] were associated with lower probability of achieving remission at Week 16. A total of 45 patients [40%] discontinued tofacitinib over time. Higher PMS at Week 8 was the only factor associated with higher tofacitinib discontinuation [hazard ratio = 1.5; 95% CI = 1.3-1.6]. A total of 34 patients had remission at Week 8; of these, 65% had relapsed 52 weeks after achieving remission; the dose was increased to 10 mg/12 h in nine patients, and five of them reached remission again. Seventeen patients had adverse events. CONCLUSIONS: Tofacitinib is effective and safe in UC patients in real practice, even in a highly refractory cohort. A relevant proportion of patients discontinue the drug over time, mainly due to primary failure.

Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis.

Autori » Lair-Mehiri L , Stefanescu C , Vaysse T , Laharie D , Roblin X , Rosa I , Treton X , Abitbol V , Amiot A , Bouguen G , Dib N , Fumery M , Pariente B , Carbonnel F , Peyrin-Biroulet L , Simon M , Viennot S , Bouhnik Y

Giornale » Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver

Year » 2020

Links » Pubmed DOI

Questo articolo fa parte di 3 Systematic reviews Systematic reviews (3 references)

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BACKGROUND: Phase III trials demonstrated effectiveness of tofacitinib, an oral Janus kinase inhibitor, to induce and maintain remission in patients with moderate-to-severe active ulcerative colitis (UC). AIMS: We report the real-world effectiveness and safety of tofacitinib in patients with UC in France. METHODS: From February 2017 to December 2018, we performed a national French cohort study, which included all consecutive patients with an active UC refractory to anti-TNF and vedolizumab, who received tofacitinib. Outcomes were survival without colectomy, survival without tofacitinib discontinuation and steroid-free clinical remission at weeks 14, 24 and 48. RESULTS: Thirty-eight patients were included, with a median follow-up of 41.5 (18.5-56.8) weeks. Survival without colectomy was 77% [95% confidence interval (95%CI): 59.3-87.9] at week 24 and 70% (95%CI: 50.9-82.8) at week 48. Survival without treatment discontinuation was 70% (95%CI: 52.6-82.3) at week 24. Steroid-free clinical remission was observed in 13 (34%) patients at week 48. Adverse events occurred in 14 (37%) patients, including 6 severe adverse events and three herpes zoster infections. CONCLUSION: In a highly refractory UC population, one third of patients treated with tofacitinib achieved steroid-free clinical remission at week 14 and 70% of patients avoided colectomy at one year, with an acceptable safety profile. These data confirm tofacitinib effectiveness in UC, especially after multiple biologic failures.

Efficacy and safety of tofacitinib in patients with moderate-to-severe ulcerative colitis: a real-world retrospective study

Autori » Yoshimura N , Okano S , Sako M , et al

Giornale » J Crohn’s Colitis

Year » 2020

Questo articolo fa parte di 2 Systematic reviews Systematic reviews (2 references)

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P512 Efficacy of tofacitinib for the treatment of moderate-to-severe ulcerative colitis: real-world data

Autori » Xiao, Y , Lakatos, PL , Bourdages, R , Bitton, A , Afif, W , Kohen, R , Berberi, M , Bessissow, T

Giornale » Journal of Crohn's and Colitis

Year » 2020

Questo articolo fa parte di 2 Systematic reviews Systematic reviews (2 references)

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Tofacitinib for ulcerative colitis: results of the prospective Dutch Initiative on Crohn and Colitis (ICC) registry.

Autori » Biemans VBC , Sleutjes JAM , de Vries AC , Bodelier AGL , Dijkstra G , Oldenburg B , Löwenberg M , van Bodegraven AA , van der Meulen-de Jong AE , de Boer NKH , Srivastava N , West RL , Römkens TEH , Horjus Talabur Horje CS , Jansen JM , van der Woude CJ , Hoekstra J , Weersma RK , van Schaik FDM , Hoentjen F , Pierik MJ , Dutch Initiative on Crohn and Colitis (ICC)

Giornale » Alimentary pharmacology & therapeutics

Year » 2020

Links » Pubmed DOI PubMed Central

Questo articolo fa parte di 3 Systematic reviews Systematic reviews (3 references)

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BACKGROUND: Tofacitinib is a Janus kinase inhibitor approved for the treatment of ulcerative colitis (UC). AIM: To evaluate effectiveness, safety and use of tofacitinib in daily practice. METHODS: UC patients initiating tofacitinib were prospectively enrolled in 15 hospitals in the Netherlands. Corticosteroid-free clinical remission (short clinical colitis activity index [SCCAI] ≤2), biochemical remission (faecal calprotectin level ≤250 µg/g), combined corticosteroid-free clinical and biochemical remission, predictors of remission, safety outcomes, treatment dose and effect on lipids were determined at weeks 12 and 24. Endoscopic outcomes were evaluated in centres with routine endoscopic evaluation. RESULTS: In total, 123 UC patients (95% anti-TNF, 62% vedolizumab and 3% ustekinumab experienced) were followed for a median duration of 24 weeks (interquartile range 12-26). The proportion of patients in corticosteroid-free clinical, biochemical, and combined corticosteroid-free clinical and biochemical remission rate at week 24 was 29% (n: 22/77), 25% (n: 14/57), and 19% (n: 11/57) respectively. Endoscopic remission (Mayo = 0) was achieved in 21% of patients at week 12 (n: 7/33). Prior vedolizumab exposure was associated with reduced clinical remission (odds ratio 0.33, 95% confidence interval [CI] 0.11-0.94). At week 24, 33% (n: 14/42) of patients still on tofacitinib treatment used 10 mg twice daily. In total, 33 tofacitinib-related adverse events (89 per 100 patient years) occurred, 7 (6% of total cohort) resulted in discontinuation. Cholesterol, HDL and LDL levels increased during induction treatment by 18% (95% CI 9-26), 18% (95% CI 8-28) and 21% (95% CI 14-39) respectively. CONCLUSION: Tofacitinib is an effective treatment for UC after anti-TNF and vedolizumab failure. However, a relatively high rate of adverse events was observed resulting in discontinuation in 6% of patients.