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Tofacitinib may effectively treat moderate-to-severe ulcerative colitis
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Patients with moderate-to-severe ulcerative colitis achieved clinical response and remission more frequently after receiving tofacitinib than those who received placebo in a recent study.
In a multicenter, double blind trial, researchers randomly assigned 194 patients with moderate-to-severe ulcerative colitis (UC) to receive either placebo (n=48) or 0.5 mg (n=31), 3 mg (n=33), 10 mg (n=33) or 15 mg (n=49) tofacitinib (Pfizer) orally twice a day for 8 weeks, with 4 weeks of follow-up. Patients also underwent colonoscopy or flexible sigmoidoscopy at baseline and at 8 weeks. Decrease in UC activity following treatment was measured according to the Mayo scoring system. Incidents of clinical and endoscopic response and remission were recorded, with clinical response at 8 weeks as the primary endpoint.
Clinical response occurred in 42% of the placebo group, compared with 32% of the 0.5 mg group (P=.39), 48% of the 3 mg group (P=.55), 61% of the 10 mg group (P=.10) and 78% of the 15 mg group (P<.001). Remission occurred in 10% of patients receiving placebo, compared with 13% receiving 0.5 mg (P=.76), 33% receiving 3 mg (P=.01), 48% receiving 10 mg (P<.001) and 41% receiving 15 mg (P<.001). Incidence of endoscopic response compared with placebo was only significant in the 15-mg group (78% of patients vs. 46%, P=.001), with endoscopic remission significantly more common than placebo (2%) in the 0.5-mg (18%, P=.01), 10-mg (30%, P<.001) and 15-mg (27%, P<.001) groups.
Investigators observed an increase in low- and high-density lipoprotein cholesterol at 8 weeks, which was found to be dose-dependent and reversed following completion of treatment. Common adverse events included headache, influenza and nasopharyngitis. No significant difference from placebo was found for the incidence or severity of adverse events.
“Patients with moderately or severely active [UC] treated with tofacitinib had a clinical response and clinical remission more frequently than those receiving placebo,” the researchers concluded. “The mechanism for the alterations in cholesterol profile is unknown. The clinical consequences of these laboratory abnormalities require further study.”
Disclosure: The study was sponsored by Pfizer, which aided in study design and data analysis. See the study for a full list of relevant disclosures.
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