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• W2913017612 abstract "Introduction: Tolerance to therapy is critical for patients to receive the maximal treatment benefit. In Phase 3 clinical trials for ustekinumab (UST) for moderate to severe Crohn's disease (CD), UNITI-1 enrolled anti-TNF failures and UNITI-2 enrolled conventional therapy failures. In UNITI-1, 36.4% had previous intolerance (infusion-related reactions [IRR], delayed hypersensitivity reactions, or injection site reactions [ISR]) that led to discontinuation of the anti-TNF. UNITI-2 enrolled patients that were not intolerant to anti-TNFs, but some were intolerant to immunomodulators (39%) or corticosteroids (15%). Here we assess tolerability as measured by IRR, delayed hypersensitivity, or ISR to UST in the Phase 3 CD trials. Methods: All enrolled patients in UNITI-1 and UNITI-2 were given an intravenous (IV) induction infusion of UST 130mg, UST ˜6 mg/kg, or placebo (PBO). The IM-UNITI maintenance study began 8 weeks after IV induction; UST IV responders were randomized to UST 90mg SQ Q8W, UST 90mg Q12W, or PBO. Non-randomized patients could receive 130mg IV UST, then continued to SC PBO, UST 90mg Q8W, UST 90mg Q12W maintenance therapy, or discontinued. Results: Overall, IRR were infrequent: 4.0 % and 1.9 % of all patients in UNITI 1 & 2, respectively, experienced infusion reactions to the single IV dose. There were no differences in IRR between PBO & UST, or between UST doses (Table 1). During IM-UNITI, IRR to PBO and UST 130mg were similar and infrequent (Table 1). There were no anaphylactic or delayed hypersensitivity reactions to any IV dose. ISRs were infrequent and not different across groups (Table 2). In the combined (randomized and non- randomized) population, ISRs were 1.7 % with PBO, and 3.0% with UST. No serious ISRs were reported. The most common ISR was erythema, reported in 1.1 % of PBO, and 1.7% of UST. There were no anaphylactic or delayed hypersensitivity reactions to any SC dose. Amongst randomized patients, ISRs were infrequent and consistent between groups. ISRs occurred in 3/418 (0.7 %) of all UST 90mg Q12W injections and in 12/599 (2.0 %) of all UST 90mg Q8W injections. One patient in the entire phase 3 program discontinued therapy due to ISR.Table: Table. Infusion-related reactions*Table: Table. Injection site reactionsConclusion: In a broad population of patients with Crohn's disease, many of whom were intolerant to previous therapies, UST had a tolerable profile. Rates of IRR and ISR were minimal, and were not obviously different between groups, nor populations." @default.
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• W2913017612 date "2017-10-01" @default.
• W2913017612 modified "2023-09-25" @default.
• W2913017612 title "Tolerability of Ustekinumab in Induction and Maintenance for the Treatment of Crohnʼs Disease" @default.
• W2913017612 doi "https://doi.org/10.14309/00000434-201710001-00658" @default.
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