More than half of the patient population achieved a defined response at both day 14 and week 6.
While tofacitinib, a Janus kinase inhibitor, is currently approved to treat moderate to severe ulcerative colitis (UC), there has been limited prospective real-world data on the treatment in ulcerative colitis patients.
A team, led by Millie D. Long, MD, MPH, FACG, Associate Professor of Medicine at the University of North Carolina, used an electronic system to evaluate patient reported outcomes in real-time to measure the clinical response during the induction phase of tofacitinib in ulcerative colitis patients.
In the study presented at the annual American College of Gastroenterology (2020) conference, the investigators examined 65 patients initiating tofacitinib from 13 academic and community gastroenterology practices. The research team obtained demographic information, disease, and medication for each patient.
In addition, the patients completed surveys on days 1-14, as well as week 6, 10, and 14.
The investigators sought outcome data of the simple clinical colitis activity index (SCCAI), and patient reported outcome measure information system (PROMIS) measures of depression, anxiety, and social satisfaction. A score larger than 4 with a decrease greater than 1.5 points was considered a response.
The investigators calibrated PROMIS measures using a T score (mean of the US population equal to 50, standard deviation (SD) of 10), where a higher PROMIS score equates to more of the measure (higher scores worse for depression, anxiety, and better for social satisfaction).
Overall, 62 (95%) patients completed the electronic PRO data through week 6. The mean age of the patient population was 38.4 (SD, 14.9), while 61.5% of the patients were male. The mean disease duration was 9.6 years and 58.5% of the patients were on concomitant steroids at baseline.
The mean disease activity at baseline was active (SCCAI of 5.6 (SD 3.2)), with reductions in mean disease activity to SCCAI 3.1 on day 14, 2.7 on week 14. When the first in-person clinical visit occurred in week 2-6, only 18.2% remained on steroids. Of the patients initiating tofacitinib without concomitant corticosteroid use (n = 27), early reductions in SCCAI was found (mean SCCAI 5.4 at baseline, reduced to SCCAI 3.8 by day 4).
Improvements in all PROMIS measures were seen through week 14 and a total of 54.2% met the criteria for response at day 14, while 52.2% met this criteria at week 6.
“Real time electronic PRO data capture provided the ability to assess cessation of steroids and time to response to tofacitinib via important PRO outcomes,” the authors wrote. “Tofacitinib was associated with a rapid response in this ongoing prospective multi-center real-world cohort, independent of steroid use. Continued enrollment and long-term data, planned through week 30, will enhance our understanding of UC.”
The study, “Time to Improvement in Patient-Reported Outcomes With Tofacitinib in Ulcerative Colitis: Initial Results From a Real World Prospective Multicenter Study (TOUR),” was published online by ACG.