Citations 1
The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results From the SUCCESS Consortium
Johnson, Amanda M. , Barsky, Maria, Ahmed, Waseem , Zullow, Samantha, Galati, Jonathan S. , Jairath, Vipul , Narula, Neeraj , Peerani, Farhad , Click, Benjamin , Coburn, Elliot, Dang, ThucNhi T. , Garg, Rajat , Aggarwal, Manik , Mohammad, Danah, Halloran, Brendan P. , Kochhar, Gursimran , Todorowski, Hannah, Din, Nabeeha Mohy Ud, Izanec, James , Teeple, Amanda, Gasink, C, Muser, Erik, Ding, Zhijie , Lakhani, Komal, Hogan, Dan, Datta, Samit, Boland, Brigid S. , Bohm, Matthew , Fischer, Monika , Sagi, Sashidhar , Afzali, Anita , Ullman, Thomas, Lawlor, Garrett , Baumgart, Daniel C. , Chang, Shannon, Scherl, Ellen , Sandborn, William J. , Bruining, David H. , Kane, Sunanda V. , Loftus, Edward V. , Dulai, Parambir S. , Jairath, Vipul , Jairath, Vipul , Bruining, David, Jairath, V , Jairath, V , Loftus, Edward V , Jairath, Vipul , Gold, Stephanie Lauren , Agrawal, Manasi , Swaminath, Arun C. , Hogan, Dan, Ungaro, Ryan C. , Chang, Shannon, Hudesman, David , Lukin, Dana J. , Colombel, Jean‐Frédéric , Sands, Bruce E , Siegel, Corey A , Regueiro, Miguel
American Journal of Gastroenterology | October 3, 2022 | Volume: 118 | Issue: 2 | Pages: 317-328
INTRODUCTION: We evaluated the real-world effectiveness and safety of ustekinumab (UST) in patients with Crohn's disease (CD). METHODS: This study used a retrospective, multicenter, multinational consortium of UST-treated CD patients. Data included patient demographics, disease phenotype, disease activity, treatment history, and concomitant medications. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions were assessed using time-to-event analysis, and clinical predictors were assessed by using multivariate Cox proportional hazard analyses. Serious infections and adverse events were defined as those requiring hospitalization or treatment discontinuation. RESULTS: A total of 1,113 patients (51.8% female, 90% prior antitumor necrosis factor exposure) were included, with a median follow-up of 386 days. Cumulative rates of clinical, steroid-free, endoscopic, and radiographic remissions at 12 months were 40%, 32%, 39%, and 30%, respectively. Biologic-naive patients achieved significantly higher rates of clinical and endoscopic remissions at 63% and 55%, respectively. On multivariable analyses, prior antitumor necrosis factor (hazard ratio, 0.72; 95% confidence interval, 0.49–0.99) and vedolizumab exposure (hazard ratio, 0.65; 95% confidence interval, 0.48–0.88) were independently associated with lower likelihoods of achieving endoscopic remission. In patients who experienced loss of remission, 77 of 102 (75%) underwent dose optimization, and 44 of 77 (57%) achieved clinical response. An additional 152 of 681 patients (22.3%) were dose-optimized because of primary nonresponse incomplete response to UST, of whom 40.1% (61 of 152) responded. Serious infections occurred in 3.4% of patients while other noninfectious adverse events (lymphoma [n = 1], arthralgia [n = 6], rash [n = 6], headache [n = 3], hepatitis [n = 3], hair loss [n = 3], neuropathy [n = 1], and vasculitis [n = 1]) occurred in 2.4% of patients. DISCUSSION: UST represents a safe and effective treatment option for CD, with 40% of patients from a highly refractory cohort achieving clinical remission by 12 months. The greatest treatment effect of UST was seen in biologic-naive patients, and dose escalation may recapture clinical response.