According to a study published in Inflammatory Bowel Diseases, the oral Janus kinase (JAK) inhibitor, tofacitinib, safely and effectively improved patient-reported outcomes (PROs) for disease activity in patients with ulcerative colitis (UC) during induction therapy.
The trial included 96 patients and collected PROs for the simple clinical colitis activity index (SCCAI), PRO measurement identification systems, and adverse events for the first 14 days of induction therapy and on days 28 and 56. The researchers used paired t- and P-value tests to evaluate SCCAI changes over time, as well as bivariate analyses and logistic regression to assess treatment response and remission.
The authors noted that 67% of the cohort had failed 2 or more biologics, and 61.5% used concomitant steroids. The report describes that PROs started to significantly decline on day 3, including mean SCCAI (‒1.1; P<.0001) and SCCAI subscores for stool frequency (‒0.3; P<.003), bleeding (‒0.3; P<.0002), and urgency (‒0.2; P<.001).
Furthermore, 25.0%, 30.2%, and 29.2% of patients achieved steroid-free remission by days 14, 28, and 56, respectively. Prior biologic therapies and endoscopic severity were not predictive factors for response or remission. Patients also exhibited numerical improvements in anxiety, depression, and social satisfaction measures throughout the follow-up period.
The investigators noted that no new safety signals were observed, and they ultimately advanced that tofacitinib resulted in quick and durable improvements in disease activity PROs from patients with UC.
Reference: Long MD, Afzali A, Fischer M, et al. Tofacitinib response in ulcerative colitis (TOUR): early response after initiation of tofacitinib therapy in a real-world setting. Inflamm Bowel Dis. 2022; izac121. doi:10.1093/ibd/izac121