The Real-World Effectiveness and Safety of Ustekinumab in the Treatment of Crohn's Disease: Results From the SUCCESS Consortium.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Johnson Amanda M, Barsky Maria, Ahmed Waseem, Zullow Samantha, Galati Jonathan, Jairath Vipul, Narula Neeraj, Peerani Farhad, Click Benjamin H, Coburn Elliot S, Dang ThucNhi Tran, Gold Stephanie, Agrawal Manasi, Garg Rajat, Aggarwal Manik, Mohammad Danah, Halloran Brendan, Kochhar Gursimran S, Todorowski Hannah, Ud Din Nabeeha Mohy, Izanec James, Teeple Amanda, Gasink Chris, Muser Erik, Ding Zhijie, Swaminath Arun, Lakhani Komal, Hogan Dan, Datta Samit, Ungaro Ryan C, Boland Brigid S, Bohm Matthew, Fischer Monika, Sagi Sashidhar, Afzali Anita, Ullman Thomas, Lawlor Garrett, Baumgart Daniel C, Chang Shannon, Hudesman David, Lukin Dana, Scherl Ellen J, Colombel Jean-Frederic, Sands Bruce E, Siegel Corey A, Regueiro Miguel, Sandborn William J, Bruining David, Kane Sunanda, Loftus Edward V, Dulai Parambir S
Аннотация
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.