Tofacitinib (TOF) is an oral, small molecule Janus kinase inhibitor approved for the treatment of moderate to severe ulcerative colitis (UC). The objective of this study is to describe real-world experience with TOF since emerging real-world data in UC in the US is limited.
Commercial and Medicare Advantage plan members from the Optum Research Database with a diagnosis of UC who initiated treatment with TOF between May 2018 and July 2019 were included. Demographic and baseline characteristics including age, gender, comorbidities, insurance type, and prior therapies were evaluated. Drug adherence (proportion of days covered [PDC]) was assessed in the 6-month follow-up period after TOF initiation. Analyses were stratified based on prior biologic drug use (1 or 2+ agents).
Of the 182 patients who initiated TOF, 92 patients (51%) had 1 prior biologic and 90 patients (49%) had 2+ prior biologic use. Mean (SD) age was 45.5(15.4) and 45.2(17.4) years for patients with 1 and 2+ biologics, respectively. 53% of the cohort with 1 biologic was female vs. 47% with 2+ biologics. Most patients had commercial coverage – 84% (1 biologic) and 89% (2+ biologics). Among TOF patients with 1 prior biologic use, 82.6% were previously treated with a tumor necrosis factor inhibitor (TNFi) and 17.4% vedolizumab (VDZ). Among TOF patients with 2+ biologics, 54.4% were treated with VDZ + a TNFi, 16.7% were treated with two TNFis, and the remaining 28.9% were treated with 3 or more biologics prior to baseline. Approximately half of the sample in both cohorts were treated with 5-ASA and one-third were treated with immunomodulators in the 6 months prior to TOF treatment initiation. Mean (SD) 12-month baseline Charlson score was 0.72(1.49) and 0.66(1.16) for patients with 1 and 2+ biologics, respectively. Most patients, 73.9% (1 biologic) and 77.8% (2+ biologics), were treated with an oral corticosteroid (OCS) in the 12 months prior to the index, with a mean total day supply of 102.5 days (1 biologic) and 113.0 days (2+ biologics). Among OCS users during baseline, the average prednisone-equivalent daily dose was 32.5 mg (1 biologic cohort) and 29.3 mg (2+ biologics cohort). Use of OCS decreased to 25% (1 biologic cohort) and 23% (2+ biologic cohort) 3-6 months after TOF initiation. Mean PDC with TOF over the 6-month follow-up was 0.74 in both cohorts with median PDC of 0.89 (1 biologic) and 0.82 (2+ biologics).
Among UC patients starting TOF in a real-world cohort, half had been exposed to 2 or more biologics. Post-initiation adherence was generally high and OCS utilization decreased regardless of the number of previous biologics. These findings provide insights into early real-world utilization and experience with a new therapeutic for moderate to severe UC.