P796 Effectiveness and safety of ustekinumab for patients with ulcerative colitis: A single-centre retrospective study
Kimura, M.(1)*;Shimizu, M.(1);Shirai, M.(1);Sakaguchi, Y.(1);Kobayashi, K.(1);Iruya, R.(1);Seki, S.(1);Naitou, D.(1);Nishimiya, T.(1);Oouchi, Y.(1);Shibamoto, M.(1);Iwashita, H.(1);Miyamura, M.(1);Kikuchi, H.(1);Yamada, A.(1);Nakamura, K.(1);Matsuoka, K.(1);
(1)Toho University Sakura Medical Center, Gastroenterology, Sakura, Japan;
Background
Ustekinumab, a monoclonal antibody directed against the interleukin 12/23 p40 subunit, was approved worldwide in 2020 for the treatment of ulcerative colitis. The efficacy of ustekinumab in inducing and maintaining remission in moderate to severe ulcerative colitis was demonstrated in the phase 3 clinical study, the UNIFI trial; however, real-world data on the effectiveness and safety of ustekinumab for patients with ulcerative colitis is still scarce. We aimed to investigate the real-world effectiveness and safety of ustekinumab in patients with ulcerative colitis.
Methods
This was a single-centre retrospective study enrolling patients with ulcerative colitis who were aged 16 years or more and administered ustekinumab between March 2022 and March 2022 at Toho University Sakura Medical Center, a tertiary center. Data were extracted by chart review. Ustekinumab was administered as a single intravenous infusion (approximately 6 mg/kg) followed by 90mg subcutaneous injection at week 8 and then by 90mg subcutaneous injection every 8-12 weeks. The endpoints were 1) the proportion of patients achieving symptomatic remission, defined as a rectal bleeding score of 0 and a stool frequency score of 0 or 1 in patient-reported outcome-2 (PRO-2), at week 8, 2) time to discontinuation, and 3) safety during the observation periods.
Results
We enrolled 53 patients in this study, with a median age of 45 years (interquadrant range: 27-57). Thirty patients (56.6%) were male and 23 (43.4%) were female. The majority of patients (n=39; 73.6%) had extensive colitis. Notably, 21 (38.9%) patients were naïve to advanced therapies. Thiopurines had been administered to 24 (45.3%) patients. Twenty-one (39.6%) patients achieved symptomatic remission at week 8 after a single intravenous infusion. The proportion of patients with symptomatic remission was numerically higher in advanced therapy-naïve patients compared with advanced therapy-experienced patients (47.6% versus 34.4%) (Figure 1). Univariate analysis failed to identify clinical predictors for symptomatic remission at week 8. The time to discontinuation were significantly longer in advanced-therapy naïve patients compared with advanced therapy experienced patients, with a median observation period of 296 days (Figure 2). As for safety, one patient discontinued ustekinumab due to skin disorder. One death due to pneumonia was observed, which was unrelated to ustekinumab.
Conclusion
Ustekinumab was effective and safe in the real-world setting. Advanced-therapy naïve patients were more likely to continue ustekinumab compared with advanced therapy experienced patients.