Corticosteroid Sparing Effects of Ustekinumab Therapy for Ulcerative Colitis Through 2 Years: UNIFI Long-term Extension

Background/Aims In the UNIFI maintenance-study of patients with moderatetosevere ulcerative colitis (UC) treated with ustekinumab (UST),  > 90 % achieved clinical response or remission at week-44 and were able to eliminate corticosteroids (CS). We report the CS sparing effects of UST treatment through week-92 among patients in the UNIFI long-term extension (LTE).

Methods UST responders, 8-weeks after intravenous induction, entered the maintenance-study and were randomized to UST 90mg subcutaneous (q12w or q8w) or placebo. UST non-responders received a dose of UST 90mg subcutaneous at week-8 and were evaluated at week-16. Patients in clinical response at week-16 (delayed-responders) were not randomized on entry into maintenance-study and received UST 90mg q8w. Patients who completed maintenance-study week-44 were eligible to enter LTE and continued the same dose. UST dose-adjustment was allowed during LTE (q12w to q8w or q8w to q8w [sham dose-adjustment]) from week-56 onward. Patients on placebo were discontinued from LTE after maintenance-study unblinding. During the maintenance-study, CS tapering was recommended for patients receiving CS at maintenance baseline. At LTE week-92, CSfree symptomatic remission rates and CS use were calculated using intention-to-treat analyses with doseadjustment considered and not-considered as treatment-failure.

Results Of 284 LTE randomized patients treated with UST, 139 received CS at maintenance baseline and 92.8 % (n = 129) were CS-free at week-92. CS-free symptomatic remission rates at week-92 were similar for q8w and q12w maintenance doses (Table). Of the UST-treated patients who were in symptomatic remission at week 92, 98.4 % (182/185) were CS-free; results were similar when dose-adjustment was not considered as treatment failure. Of 116 delayed responders, 92 achieved symptomatic remission at week-92, with 94.6 % (87/92) CS-free.

Conclusions UST maintenance-therapy (both q8w and q12w regimens) was effective in reducing and eliminating use of CS in patients with moderatetosevere UC. Majority of patients in the LTE who achieved symptomatic remission at week-92 were CS-free.

Publikationsverlauf

Artikel online veröffentlicht:
26. Mai 2020