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NICE recommends XELJANZ®? (tofacitinib citrate) as a new treatment option for adults with moderately to severely active ulcerative colitis

Pfizer Ltd, Walton Oaks, UK – November 2018: Pfizer announced that the National Institute for Health and Care Excellence (NICE) has published final guidance recommending the use of XELJANZ®(tofacitinib citrate), 5 mg and 10 mg twice daily (BID) twice-daily oral tablet, as a treatment option for adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.[i]


UC is a chronic and often debilitating inflammatory bowel disease that affects approximately 2.1 million people in Europe and 1 in every 420 (roughly 146,000) in the UK alone.[ii],[iii],[iv],5 Paul Mason, Head of Pfizer Immunology & Inflammation UK, commented:  “Ulcerative colitis has a significant physical and mental impact on the many people in the UK living with the disease. NICE’s recommendation signifies a step forward for patients seeking new treatments for ulcerative colitis and demonstrates Pfizer’s continued commitment to medical innovation and advancing patient care.”


Symptoms of UC include chronic diarrhoea with blood, abdominal pain and cramping, weight loss,6 and people living with the condition have a 5-20% risk of colectomy.7 Further symptoms of UC include fatigue and sleep disturbances which can have significant effects on work, family and social activities as simple daily routines can become difficult for patients living with UC to perform.6 UC affects men and women equally 8 and usually occurs in young adults aged between 15 and 30 years old, with a second peak of onset occurring between 50 – 70 years old.9


The NICE recommendation was based on data from three pivotal Phase 3 studies from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis global clinical development programme (OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain), and OCTAVE Open, an ongoing open label long-term extension study.10,11

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Last Updated: 06-Dec-2018