The effectiveness and safety of tofacitinib in treating ulcerative colitis
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Reviewed by Dat Tien Nguyen, B.A, ScM.
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Posted on January 25th, 2023
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Tofacitinib is an oral Janus Kinase (JAK) inhibitor that interferes with the STAT activation needed for pro-inflammatory cytokine production. After the positive results from the OCTAVE clinical trial, the agent was approved to manage ulcerative colitis. However, the observation period of the initial trial was too short, and it lacked generalizability. Thus, a recent study was conducted to assess the long-term efficacy and safety of Tofacitinib.
The prospective study sourced its data from the Netherland-based ICC registry. The health outcome of 110 adult patients with ulcerative colitis was observed for 24 months. These patients were initially treated with 10 mg of Tofacitinib twice a day for 8 weeks with the dose reduced to 5 mg afterward. The study reported that 31.8% of these patients managed to achieve corticosteroid-free clinical remission, defined as a Simple Clinical Colitis Activity Index [SCCAI] score less than 2, after 104 weeks of treatment. The study also analyzed the clinical parameters of the cohort in the form of C-reactive protein and fecal calprotectin level, set at below 5 mg/L and 250 μg/g respectively. 23.4% of the study population achieved biochemical remission, and 18.7% of them achieved both clinical and biological remission. In terms of tolerability, 18% of the patients discontinued treatment due to adverse events, with headache and skin reaction being the most commonly reported side effects.
The prospective study sourced its data from the Netherland-based ICC registry. The health outcome of 110 adult patients with ulcerative colitis was observed for 24 months. These patients were initially treated with 10 mg of Tofacitinib twice a day for 8 weeks with the dose reduced to 5 mg afterward. The study reported that 31.8% of these patients managed to achieve corticosteroid-free clinical remission, defined as a Simple Clinical Colitis Activity Index [SCCAI] score less than 2, after 104 weeks of treatment. The study also analyzed the clinical parameters of the cohort in the form of C-reactive protein and fecal calprotectin level, set at below 5 mg/L and 250 μg/g respectively. 23.4% of the study population achieved biochemical remission, and 18.7% of them achieved both clinical and biological remission. In terms of tolerability, 18% of the patients discontinued treatment due to adverse events, with headache and skin reaction being the most commonly reported side effects.