Subcutaneous ustekinumab as maintenance therapy in UC

Subcutaneous ustekinumab every 8 or 12 weeks achieved clinical remission in ulcerative colitis (UC) patients as maintenance therapy after receiving a single ustekinumab induction dose. The safety for ustekinumab in UC patients was consistent with the known safety profile of ustekinumab.

Prof. Silvio Danese (Humanitas University, Milan, Italy) presented the phase 3, double-blind, randomised withdrawal study in patients with moderate-to-severe active UC who failed conventional or biologic therapy and who had a clinical response 8 weeks after receiving a single ustekinumab intravenous induction dose [1]. Patients (n=523) were randomised 1:1:1 at week 0 to receive subcutaneous placebo or ustekinumab 90 mg subcutaneously every 8 or 12 weeks. The primary endpoint was clinical remission at week 44 (52 weeks after intravenous induction); key secondary endpoints were maintenance of clinical response, endoscopic healing, corticosteroid-free clinical remission, and maintenance of clinical remission among patients who achieved clinical remission at baseline.

Baseline patient characteristics were similar among treatment groups. Significantly greater proportions of ustekinumab-treated patients were in clinical remission at week 44 (43.8% and 38.4%, for patients treated every 8 or 12 weeks, respectively) compared with placebo (24.0%; P<0.001 and P=0.002, respectively). Also, significantly greater proportions of ustekinumab-treated patients maintained clinical response through week 44 and achieved endoscopic healing and corticosteroid-free clinical remission versus patients on placebo (see Table). Clinical remission through week 44 was maintained for a significantly greater proportion of patients treated every 12 weeks and a numerically greater proportion of patients treated every 8 weeks, compared with placebo-treated patients.

Table. Primary and key secondary endpoints [1]



The proportions of patients with all adverse events, infections, and serious infections in the ustekinumab groups were comparable to the placebo group. The proportions of patients who discontinued study agent were lower with ustekinumab than placebo.

1. Danese S, et al. UEG Week 2019, Abstract LB07.

Posted on 23 October 20198 April 2024