[en] INTRODUCTION: Ustekinumab is a humanized monoclonal antibody, targeting the p40 subunit common to both human interleukin 12 and 23, approved by the European Medicines Agency and US Food and Drug Administration for the treatment of moderate-to-severe ulcerative colitis.
AREAS COVERED: In this review, the results of the phase 3 UNIFI and the real-world studies assessing the efficacy and safety of ustekinumab in moderate-to-severe ulcerative colitis are discussed, as well as limitations of these studies. Predictive factors of response, the interest of therapeutic drug monitoring and the positioning of ustekinumab in specific situations are also addressed. Finally, in the light of data presented, the positioning of ustekinumab in the therapeutic algorithm of ulcerative colitis will also be considered.
EXPERT OPINION: Ustekinumab has been shown to be effective to induce and maintain clinical, endoscopic and histologic remission in moderate-to-severe ulcerative colitis both in phase 3 and real-world studies, with a favorable safety profile. Overall, its favorable risk-benefit ratio, its efficacy on extra-intestinal manifestations and in biologics failure patients make ustekinumab an ideal candidate as first, second, or third-line therapy in ulcerative colitis.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Vieujean, Sophie ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Louis, Edouard ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Danese, Silvio ; Department of Gastroenterology and Endoscopy, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy
Peyrin-Biroulet, Laurent; CHRU-Nancy, Department of Gastroenterology, University of Lorraine, Nancy, France ; Inserm, NGERE, University of Lorraine, Nancy, France
Language :
English
Title :
A critical review of ustekinumab for the treatment of active ulcerative colitis in adults.
The ability of ustekinumab to improve the clinic, endoscopy and histology of UC patients was supported by biomarkers improvement. Biochemical remission was achieved in 14% at the end of induction in the study of Thunberg et al. (without significant decrease of fecal calprotectin) and 32% at long term []. A significant decrease in CRP and fecal calprotectin in response to ustekinumab treatment has been reported in several studies [,,,].
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