DOSE ADJUSTMENT IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS: RESULTS FROM THE UNIFI MAINTENANCE STUDY LONG-TERM EXTENSION

Background: The UNIFI randomized-withdrawal maintenance study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) in patients (pts) with moderately to severely active ulcerative colitis (UC) who had responded to intravenous (IV) UST during induction. We evaluated the efficacy of UST dose adjustment during the long-term extension (LTE). Methods: At Week (Wk) 0 of the 44wk maintenance study, 523 pts who had responded to IV UST induction were randomly assigned in a 1:1:1 ratio to placebo (PBO) SC, UST SC 90 mg q12w, or UST SC 90 mg q8w. Pts who completed the maintenance study were eligible to enter the LTE if the investigator thought they would benefit from continued treatment. PBO pts were discontinued from the LTE after the maintenance study was unblinded and the analysis was complete. Based on the investigator’s clinical judgement of their UC disease activity, pts in the LTE were eligible to receive dose adjustment starting at Wk 56: PBO to q8w, q12w to q8w, and q8w to q8w (sham adjustment). PBO pts were only eligible for dose adjustment before unblinding. Pts were assessed for symptomatic remission, partial Mayo scores, and inflammatory markers ≥16 wks after dose adjustment. Results: Symptomatic remission was maintained through Wk 92 among pts treated with UST regardless of dose adjustment in the LTE (Figure). Overall, 40 (28.4%) and 37 (25.9%) pts in the q12w and q8w groups, respectively, underwent dose adjustment (or sham dose adjustment) prior to Wk 92 of the LTE. Among pts who received dose adjustment at Wk 76 or before and had data ≥16 wks after dose adjustment, symptomatic remission was observed in 70.0% in the q12w-to-q8w group and 71.4% in the q8w-to-q8w group, the majority of whom were in symptomatic remission at the time of the dose adjustment (Table). The safety profile of UST in pts who received dose adjustment was generally consistent with the overall safety profile of UST. Conclusion: Pts may benefit from UST dose adjustment to q8w. However, the majority of UST-treated pts were in symptomatic remission at the time of dose adjustment in this study. No new safety signals were observed among pts who dose adjusted.