Efficacy and Safety of Maintenance Ustekinumab for Ulcerative Colitis Through 3 Years: UNIFI Long-term Extension. (3rd March 2022)

• Record Type: Journal Article
• Authors: Abreu, Maria T; Rowbotham, David S; Danese, Silvio; Sandborn, William J; Miao, Ye; Zhang, Hongyan; Tikhonov, Ilia; Panaccione, Remo; Hisamatsu, Tadakazu; Scherl, Ellen J; Leong, Rupert W; Arasaradnam, Ramesh P; Afif, Waqqas; Peyrin-Biroulet, Laurent; Sands, Bruce E; Marano, Colleen
• Is Part Of: Journal of Crohn's and colitis. Volume 16:Number 8(2022)
• Page Start: 1222
• Page End: 1234
• Publication Date: 2022-03-03
• Subjects: Ustekinumab -- ulcerative colitis -- symptomatic remission; Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjac030
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: Background and Aims: The UNIFI long-term extension [LTE] study reports the efficacy and safety of subcutaneous 90 mg ustekinumab through 3 years of maintenance therapy. Methods: Patients randomised to ustekinumab every 12 weeks [q12w] or every 8 weeks [q8w] at maintenance baseline [ N = 348] and randomised 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 randomised to the ustekinumab q12w and q8w groups at maintenance baseline, 54.1% and 56.3% achieved symptomatic remission at Week 152, respectively. Overall, 20% of patients discontinued ustekinumab, 10% of biologic-naïve 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, respectively. Corticosteroid-free symptomatic remission rates in the ustekinumab q12w and q8w groups were 51.2% and 55.1% at Week 152, respectively. Remission rates were higher for biologic-naïve patients than for those with a history of biologic failure. Biochemical evidence of response was demonstrated by stable, decreased C-reactive protein and faecal calprotectin measurements over 3 years. From Weeks 96 to 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 two BCCs. One patient in the q8w ustekinumab group, who was receiving concomitant 6-mercaptopurine, experienced serious adverse events of neutropenic sepsis and oral herpes. Conclusions: Efficacy of ustekinumab in patients with ulcerative colitis was confirmed through 3 years. No new safety signals were observed. Graphical Abstract: