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Ulcerative colitis (UC) is a chronic inflammatory bowel disease that affects the mucosa and submucosa of the colon and rectum. Common etiologies of UC includes infections, environmental, genetic and immunologic factors.1 Management of UC depends on the location and severity of the disease. Oral or topical mesalamine and topical steroids are first-line agents for distal colitis. Oral sulfasalazine or an alternate aminosalicylate is first-line in active mild to moderate extensive colitis.2 Corticosteroids are administered when patients with moderate to severe active disease fail to respond to oral aminosalicylates such as mesalamine, or when rapid induction is necessary due to disabling symptoms.2,3 Other medications that may be used for patients who do not adequately respond to corticosteroids include immunosuppressant agents (6-mercaptopurine or azathioprine) and anti-tumor necrosis factor (TNF) agents (infliximab and adalimumab).2,4 The current treatment options for active UC may have suboptimal efficacy for some patients due to delayed treatment effects and limiting adverse effects.3 The limited treatment options led to the investigation of new treatment options such as tofacitinib, an oral drug which recently received FDA approval for rheumatoid arthritis.5 Tofacitinib acts as a selective inhibitor of Janus kinases (JAK), JAK-1 and JAK-3. JAK-1 and JAK-3 are tyrosine kinases that mediate signal-transduction activity of the gamma chains on the surface receptors of cytokines. These cytokines include interleukins 2, 4, 7, 9, 15, and 21, which promote the suppression of T and B cells involved in autoimmune diseases.6

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Sandborn and colleagues6 conducted an 8-week, phase II, multicenter, randomized, double-blind, placebo-controlled trial to determine the effective dose of tofacitinib to achieve clinical response in patients with moderate or severe active UC. Patients included were at least 18 years old with confirmed diagnosis of UC for at least 3 months, a score of 6-12 on the Mayo scale for assessment of UC activity (comprised of 4 subscores between 0-3 for stool frequency, rectal bleeding, endoscopic findings and the Physicians Global Assessment), and moderate to severe active disease on sigmoidoscopy. Patients were allowed to take oral mesalamine or a stable oral prednisone dose of 30 mg or less daily. Patients were randomized to one of five groups: 0.5 mg, 3 mg, 10 mg, 15 mg, or placebo, all administered twice daily for 8 weeks. The primary efficacy outcome was clinical response defined by a decrease in the total Mayo score (score range 0-12 with 12 being more severe) by 3 or more and at least a 30% relative decrease in the score from baseline with a 1 or more point decrease in the subcategory of rectal bleeding or an absolute rectal bleeding score of 0 or 1. The secondary efficacy outcomes included clinical remission (Mayo score ≤ 2 with no subscore >1), endoscopic response and endoscopic remission.6

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Of the 194 patients included in the trial, 157 (80.9%) completed the trial. Baseline characteristics were similar among all groups except for a significant increase in glucocorticoid use in ...

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