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Tofacitinib in ulcerative colitis: a profile of its use

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posted on 15.10.2020 by Young-A Heo

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Disclosure: The preparation of this review was not supported by any external funding.

Conflict of interest: Young-A Heo is an employee of Adis International Ltd./Springer Nature, is responsible for the article content and declares no conflicts of interest.

Additional information about this Adis Drug Review can be found here


Abstract


Oral tofacitinib (Xeljanz®) is a irst-in-class, small molecule janus kinase (JAK) inhibitor that is approved for the treatment of moderate to severe ulcerative colitis in adults who have inadequately responded to, or are intolerant of, conventional therapy or a biological agent in the EU and in adults who have inadequately responded to, or are intolerant of, a tumour necrosis factor antagonist in the USA. In the pivotal phase 3 trials, tofacitinib induction (10 mg twice daily) and maintenance (5 or 10 mg twice daily) treatment signiicantly improved clinical and endoscopic indings of ulcerative colitis and health-related quality of life relative to placebo, with clinical beneits maintained longer term with lexible dosing strategy. Tofacitinib had a manageable tolerability proile in ulcerative colitis patients that was consistent with that established in rheumatoid arthritis patients and longer-term safety data revealed no new safety signals.


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