Subcutaneous ustekinumab as maintenance therapy in UC

The efficacy of ustekinumab through 92 weeks in patients with moderate-to-severe ulcerative colitis (UC) who had been randomised in the UNIFI maintenance study was presented [1]. This study evaluated subcutaneous ustekinumab through 1 year in responders to intravenous ustekinumab induction. Patients who completed the maintenance study could enter a long-term extension (LTE) through 220 weeks.

During the LTE, participants were eligible to receive dose adjustment (every 12 weeks [Q12W] to every 8 weeks [Q8W] or sham dose adjustment of Q8W to Q8W) starting at week 56. 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. When dose adjustment was considered to be part of the treatment experience (i.e., not a treatment failure), ustekinumab efficacy was maintained through 2 years of treatment. Of patients randomised to Q12W and Q8W, 66.1 % and 67.0% respectively, were in symptomatic and partial Mayo remission after 2 years. There were no clinically meaningful differences between the Q12W and Q8W dose groups. When dose adjustment was considered to be a treatment failure in the analysis, 53.2% and 54.0% of patients were in symptomatic and partial Mayo remission, respectively. There were no new safety signals in the second year.

A subanalysis of the UNIFI maintenance study looked at health-related quality of life through week 92 in patients who continued ustekinumab maintenance therapy in the LTE [2]. The majority of patients who received ustekinumab in the LTE maintained the improvements in Inflammatory Bowel Disease Questionnaire (IBDQ) and Short-Form Health Survey (SF-36) that were achieved after intravenous induction. Of 284 patients receiving ustekinumab, 158 (55.6%) were in IBDQ remission at week 92; of 169 patients who were in IBDQ remission at maintenance baseline, 114 (67.5%) were in IBDQ remission at week 92. In 179 of 284 patients (63.0%) a ≥16-point improvement in IBDQ score was observed.

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   1. Panaccione R, et al. ECCO-IBD 2020, DOP12.
   2. Sandborn WJ, et al. ECCO-IBD 2020, DOP56.

Posted on 14 April, 20208 April, 2024