The Lancet publishes results from phase III induction and maintenance programs evaluating risankizumab in Crohn's Disease.- AbbVie.
AbbVie has announced The Lancet published results from three pivotal Phase III clinical trials – ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study) – evaluating risankizumab (Skyrizi) in patients with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.
Data from the three studies formed the basis of the company's application for approval by the global health authorities.
The publication of ADVANCE and MOTIVATE reports the efficacy and safety results of the two induction studies evaluating clinical remission and endoscopic response with intravenous (IV) risankizumab versus placebo over 12 weeks. The publication of FORTIFY shares the results of the maintenance study evaluating the safety and efficacy of subcutaneous (SC) risankizumab versus placebo (the withdrawal from IV risankizumab) over 52 weeks in patients who achieved clinical response during the ADVANCE and MOTIVATE studies.
Data from these studies has been reported in earlier notifications.
See- D'Haens G Panaccione R Baert F et al. "Risankizumab as induction therapy for Crohn's disease: results from the phase III ADVANCE and MOTIVATE induction trials". Lancet. 2022; 399: 2015-2030.
Ferrante M, Panaccione R, Baert F et al. "Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase III FORTIFY maintenance trial". Lancet. 2022; 399: 2031-2046.
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