Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension.

Overview

abstract

BACKGROUND AND AIMS: The UNIFI long-term extension (LTE) study reports the efficacy and safety of subcutaneous 90 mg ustekinumab through three years of maintenance therapy. METHODS: Patients randomized to ustekinumab q12w or q8w at maintenance baseline (N=348) and randomized ustekinumab-treated patients in the LTE (N=284) were evaluated. Symptomatic remission (Mayo stool frequency=0/1, rectal bleeding=0) was assessed. Safety included all LTE patients (N=188 placebo and N=457 ustekinumab). RESULTS: Among patients randomized to the ustekinumab q12w and q8w groups at maintenance baseline, 54.1% and 56.3% achieved symptomatic remission at week 152. Overall, 20% of patients discontinued ustekinumab, 10% of biologicnaïve and 30% of biologic-exposed patients. Among patients in symptomatic remission at year 3, 94.6% and 98.0% of patients were also corticosteroid free. Corticosteroid-free symptomatic remission rates in the ustekinumab q12w and q8w groups were 51.2% and 55.1% at week 152. Remission rates were higher for biologic-naïve patients than those with a history of biologic failure. Biochemical evidence of response was demonstrated by stable, decreased CRP and fecal calprotectin measurements over 3 years.From weeks 96-156, no deaths, major adverse cardiovascular events, or tuberculosis occurred. Nasopharyngitis, ulcerative colitis and upper respiratory tract infection were most frequently reported. One ustekinumab-treated patient with a history of basal cell carcinoma (BCC) reported 2 BCC. One patient in the q8w ustekinumab group who was receiving concomitant 6-mercaptopurine experienced SAEs of neutropenic sepsis and oral herpes. CONCLUSION: Efficacy of ustekinumab in patients with ulcerative colitis was confirmed through 3 years. No new safety signals were observed.