Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

Summary

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

Timeline

Start

2018-03-29

Primary completion

2020-12-15

Completion

2021-05-21

Publications

• Venkat S, Zeeman M, Hart A, Bhagat S, Galbraith DA, Hoops T, Ufberg PJ, Izanec J, Freeman TC, Mcrae B, Shinzaki S, Jairath V, Panaccione R, Sands BE, Branigan P. Serum protein profiles differ with adalimumab and ustekinumab treatment in moderately to severely active Crohn's disease. J Crohns Colitis. 2025 Dec 5;19(11):jjaf197. doi: 10.1093/ecco-jcc/jjaf197.
• Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
• Sands BE, Irving PM, Hoops T, Izanec JL, Gao LL, Gasink C, Greenspan A, Allez M, Danese S, Hanauer SB, Jairath V, Kuehbacher T, Lewis JD, Loftus EV Jr, Mihaly E, Panaccione R, Scherl E, Shchukina OB, Sandborn WJ; SEAVUE Study Group. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022 Jun 11;399(10342):2200-2211. doi: 10.1016/S0140-6736(22)00688-2.

Drugs

Indications