Omeed Alipour1, Alakh Gualti2, Ling Shao3, Bing Zhang4,5. 1. Department of Medicine, Division of Gastroenterology, University of Washington, 1959 NE Pacific Street, Box 356424, Seattle, WA, 98195, USA. 2. Department of Medicine, Division of Gastroenterology and Hepatology, University of California San Francisco - Fresno, 155 N Fresno Street, Fresno, CA, 93721, USA. 3. Department of Medicine, Division of Gastrointestinal and Liver Diseases, Keck School of Medicine, University of Southern California, 2011 Zonal Avenue, HMR 101, Los Angeles, CA, 90033, USA. 4. Department of Medicine, Division of Gastrointestinal and Liver Diseases, Keck School of Medicine, University of Southern California, 2011 Zonal Avenue, HMR 101, Los Angeles, CA, 90033, USA. bingz@usc.edu. 5. Department of Medicine, Division of Gastroenterology and Hepatology, University of California San Francisco, 513 Parnassus Avenue, Room S-237, San Francisco, CA, 94143, USA. bingz@usc.edu.
Abstract
BACKGROUND: Deep remission (DR) is a treatment target in IBD associated with reduced hospitalization and improved outcome. Randomized control trial (RCT) data demonstrates efficacy of anti-TNFα agents in achieving DR; however, real-world data (RWD) can provide information complementary to RCTs, specifically regarding treatment duration. In this systematic review with meta-analysis, we use real-world data (RWD) to determine rates of DR in IBD treated with anti-TNFα. METHODS: We completed a systematic search of MEDLINE and EMBASE on July 8, 2019 with review of major gastrointestinal conference abstracts from 2012 to 2019. Studies utilizing RWD (data not from phase I-III RCTs) of adult IBD patients treated with anti-TNFα agents were included. DR was defined by clinical and endoscopic remission at minimum. DR was assessed at 8 weeks, 6 months, 1 year, and 2 years. Risk of bias was assessed with the Newcastle Ottawa Scale. RESULTS: 29,033 publications were identified. Fifteen publications, nine manuscripts and six conference abstracts, were included encompassing 1212 patients (769 Crohn's disease-CD, 443 ulcerative colitis-UC), and analyzed using Comprehensive Meta-Analysis. Rate of DR was 36.4% (95% CI 12.6-69.4%) at 8 weeks, 39.1% (95% CI 10.4-78%) at 6 months, 44.4% (95% CI 34.6-54.6%) at 1 year, and 36% (95% CI 18.7-58%) at 2 years. DR in CD at 1 year was 48.6% (95% CI 32.8-64.7%) and in UC was 43.6% (95% CI 32.8-55.1%). CONCLUSIONS: The rate of DR was highest after 1 year of therapy, in nearly 45% of IBD patients treated with anti-TNFα. Similar rates were achieved between patients with UC and CD. The findings highlight the efficacy of anti-TNFα in real-world setting. Future studies using RWD can determine efficacy of newer IBD therapeutics in routine clinical practice.
BACKGROUND: Deep remission (DR) is a treatment target in IBD associated with reduced hospitalization and improved outcome. Randomized control trial (RCT) data demonstrates efficacy of anti-TNFα agents in achieving DR; however, real-world data (RWD) can provide information complementary to RCTs, specifically regarding treatment duration. In this systematic review with meta-analysis, we use real-world data (RWD) to determine rates of DR in IBD treated with anti-TNFα. METHODS: We completed a systematic search of MEDLINE and EMBASE on July 8, 2019 with review of major gastrointestinal conference abstracts from 2012 to 2019. Studies utilizing RWD (data not from phase I-III RCTs) of adult IBDpatients treated with anti-TNFα agents were included. DR was defined by clinical and endoscopic remission at minimum. DR was assessed at 8 weeks, 6 months, 1 year, and 2 years. Risk of bias was assessed with the Newcastle Ottawa Scale. RESULTS: 29,033 publications were identified. Fifteen publications, nine manuscripts and six conference abstracts, were included encompassing 1212 patients (769 Crohn's disease-CD, 443 ulcerative colitis-UC), and analyzed using Comprehensive Meta-Analysis. Rate of DR was 36.4% (95% CI 12.6-69.4%) at 8 weeks, 39.1% (95% CI 10.4-78%) at 6 months, 44.4% (95% CI 34.6-54.6%) at 1 year, and 36% (95% CI 18.7-58%) at 2 years. DR in CD at 1 year was 48.6% (95% CI 32.8-64.7%) and in UC was 43.6% (95% CI 32.8-55.1%). CONCLUSIONS: The rate of DR was highest after 1 year of therapy, in nearly 45% of IBDpatients treated with anti-TNFα. Similar rates were achieved between patients with UC and CD. The findings highlight the efficacy of anti-TNFα in real-world setting. Future studies using RWD can determine efficacy of newer IBD therapeutics in routine clinical practice.
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