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Key clinical point: Adalimumab was effective and well tolerated in children with moderate-to-severe ulcerative colitis (UC).
Major finding: A significantly higher proportion of patients receiving high-dose induction adalimumab vs external placebo were in partial Mayo score (MS) remission at week 8 (60% vs 19.8%; P = .0001). The full MS remission at week 52 was achieved by a significantly higher proportion of patients receiving high-dose maintenance adalimumab vs external placebo (45% vs 18.4%; P = .0001). No new safety signals were identified.
Study details: The phase 3 ENVISION I trial included 93 children with moderate-to-severe UC despite stable doses of concurrent oral corticosteroids or immunosuppressants randomly assigned to either high-dose or standard-dose induction adalimumab. Patients with a response at week 8 were randomly assigned to either high-dose or standard-dose maintenance adalimumab or placebo up to week 52.
Disclosures: The study was funded by AbbVie. Some of the authors including the lead author reported receiving research funding, advisory board fees, consultation fees, and honoraria from various sources including AbbVie. Six of the authors declared being full-time employees at AbbVie and/or owning stocks/stock options.
Source: Croft NM et al. Lancet Gastroenterol Hepatol. 2021 Jun 18. doi: 10.1016/S2468-1253(21)00142-4.
Key clinical point: Adalimumab was effective and well tolerated in children with moderate-to-severe ulcerative colitis (UC).
Major finding: A significantly higher proportion of patients receiving high-dose induction adalimumab vs external placebo were in partial Mayo score (MS) remission at week 8 (60% vs 19.8%; P = .0001). The full MS remission at week 52 was achieved by a significantly higher proportion of patients receiving high-dose maintenance adalimumab vs external placebo (45% vs 18.4%; P = .0001). No new safety signals were identified.
Study details: The phase 3 ENVISION I trial included 93 children with moderate-to-severe UC despite stable doses of concurrent oral corticosteroids or immunosuppressants randomly assigned to either high-dose or standard-dose induction adalimumab. Patients with a response at week 8 were randomly assigned to either high-dose or standard-dose maintenance adalimumab or placebo up to week 52.
Disclosures: The study was funded by AbbVie. Some of the authors including the lead author reported receiving research funding, advisory board fees, consultation fees, and honoraria from various sources including AbbVie. Six of the authors declared being full-time employees at AbbVie and/or owning stocks/stock options.
Source: Croft NM et al. Lancet Gastroenterol Hepatol. 2021 Jun 18. doi: 10.1016/S2468-1253(21)00142-4.
Key clinical point: Adalimumab was effective and well tolerated in children with moderate-to-severe ulcerative colitis (UC).
Major finding: A significantly higher proportion of patients receiving high-dose induction adalimumab vs external placebo were in partial Mayo score (MS) remission at week 8 (60% vs 19.8%; P = .0001). The full MS remission at week 52 was achieved by a significantly higher proportion of patients receiving high-dose maintenance adalimumab vs external placebo (45% vs 18.4%; P = .0001). No new safety signals were identified.
Study details: The phase 3 ENVISION I trial included 93 children with moderate-to-severe UC despite stable doses of concurrent oral corticosteroids or immunosuppressants randomly assigned to either high-dose or standard-dose induction adalimumab. Patients with a response at week 8 were randomly assigned to either high-dose or standard-dose maintenance adalimumab or placebo up to week 52.
Disclosures: The study was funded by AbbVie. Some of the authors including the lead author reported receiving research funding, advisory board fees, consultation fees, and honoraria from various sources including AbbVie. Six of the authors declared being full-time employees at AbbVie and/or owning stocks/stock options.
Source: Croft NM et al. Lancet Gastroenterol Hepatol. 2021 Jun 18. doi: 10.1016/S2468-1253(21)00142-4.