Efficacy of Ustekinumab for Ulcerative Colitis Through 2 Years: Results of the UNIFI Maintenance Study and Long-term Extension

Background/Aims The UNIFI maintenancestudy evaluated subcutaneous ustekinumab (UST) (IL12/23p40 mAb) through 1-year in patients with moderate-to-severe ulcerative colitis (UC) who responded to UST IV induction. We report efficacy of subcutaneous UST through 92weeks for patients randomized in the UNIFI maintenancestudy.

Methods Patients in clinical response 8-weeks after UST induction were randomized to subcutaneous placebo (n = 175), UST 90mg q12w (n = 172), or UST 90mg q8w (n = 176). Patients who completed week-44 were eligible to enter and continue the long-term extension (LTE) at the investigator’s discretion. Subsequent to study unblinding after all patients completed maintenance, patients on placebo were discontinued from LTE. During LTE, patients were eligible to receive dose-adjustment (q12w to q8w or q8w to q8w [sham dose-adjustment]) starting at week-56 based on investigator assessment of UC disease-activity. Symptomatic remission (stool frequency subscore of 0 or 1, and rectal bleeding subscore of 0) and partial-Mayo remission (partial Mayo score ≤2) were evaluated through week-92. Analyses of symptomatic remission and partial Mayo score over time handled doseadjustment separately as part of treatment experience (i.e., not a treatment failure) or as a treatment failure.

Results Symptomatic and partial Mayo remission were sustained through week-92, with no clinically meaningful differences between the q12w and q8w groups. When dose-adjustment was not considered a treatmentfailure, 66.1 % (q12w) and 67.0 % (q8w) of patients were in symptomatic and partial-Mayo remission at week-92. When dose-adjustment was considered a treatment failure, 53.2 % and 54.0 % of patients were in symptomatic and partial-Mayo remission, respectively. The safety profile of UST through week-96 was consistent with that previously reported for 1-year.

Conclusion The efficacy of UST in patients with moderate-to-severe UC was maintained through 92weeks with q12w or q8w subcutaneous dosing, when dose-adjustment was considered to be part of treatment experience.

Publication History

Article published online:
26 May 2020