Abstract
BackgroundDeep 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.MethodsWe 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.Results29,033 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%).ConclusionsThe 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.
Highlights
Deep remission (DR) is a treatment target in inflammatory bowel disease (IBD) associated with reduced hospitalization and improved outcome
Data sources and searches We completed a systematic search of MEDLINE and EMBASE up to July 8, 2019, using the following search terms: (“inflammatory bowel disease” OR “IBD” OR “crohn*” OR “ulcerative colitis” OR “UC” or “colitis”) AND (“mucosal healing” OR “deep remission” OR “complete remission” OR “full remission” OR “endoscopic remission”)
A diagnosis of Crohn’s disease (CD) was captured for 769 patients, and a diagnosis of UC was provided for 443 patients
Summary
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; real-world data (RWD) can provide information complementary to RCTs, regarding treatment duration. RCTs, though the ideal study design to demonstrate effectiveness and safety of a medication, are carried out in selective and controlled manner leading to high internal validity, but leaving uncertainty about their generalizability for an ethnically diverse and heterogenous population [9] This possible lack of generalizability has been demonstrated within the IBD population [10], and creates a role for real world data (RWD) to fill [11]. In this systematic review with meta-analysis, we aim to provide complementary information by using RWD to determine rates of deep remission in IBD with anti-TNFα agents in clinical practice. We explored the treatment duration at which DR is most likely to be seen, and the rate of DR in patients not previously treated with anti-TNFα
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