Systematic review and meta-analysis: real-world data rates of deep remission with anti-TNFα in inflammatory bowel disease

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.

Efficacy and Safety of Infliximab Versus Adalimumab in Adult Subjects With Moderate to Severe Ulcerative Colitis: A Systematic Review and Meta-Analysis

“…This study's findings agree with the previous indirect meta-analyses that reported the superiority of IFX in the induction phase in terms of significantly better clinical response [ 4 - 11 ]. This superiority was particularly evident given that out of the three studies that assessed induction phase clinical response [ 15 , 23 , 25 ], two studies reported significantly higher baseline disease severity in the IFX group [ 23 , 25 ].…”

“…Notably, there was an equal clinical response (OR = 1) and quite equal mucosal healing in the two groups (OR = 0.99). These findings are supported by previously reported comparable efficacy of both drugs at the maintenance phase [ 4 - 11 ].…”

Lack of Benefit for Early Escalation to Advanced Therapies in Ulcerative Colitis: Critical Appraisal of Current Evidence

“…Whilst the field of IBD has stepped away from symptom control as the only treatment target to a more stringent target of tissue healing on the level of endoscopy, histology, and barrier function, deep mucosal healing remains an elusive target in many UC patients. 57 For example, there is an increasing body of evidence that suggests that achieving histological remission [traditionally defined by resolution of neutrophilic inflammation] in UC patients is associated with a reduced risk of clinical relapse, corticosteroid use, hospitalization, and colectomy compared with achieving clinical remission or even endoscopic remission alone. 58–60 In systematic reviews of pharmacological therapies in RCTs for UC, histological remission is achieved in ~60% of patients treated with 5-ASA.…”

A scoping review on quality assessment tools used in systematic reviews and meta-analysis of real-world studies

“…Only one [23] of the included studies utilised very specific tools for methodological quality assessment. Three [24][25][26] of the included studies employed validated QA tools. In order to validate the tools used in the included studies, they employed 39 non-randomised studies [24], 131 cohort studies [25] and 30 cost-effectiveness studies [26].…”

“…Three [24][25][26] of the included studies employed validated QA tools. In order to validate the tools used in the included studies, they employed 39 non-randomised studies [24], 131 cohort studies [25] and 30 cost-effectiveness studies [26]. On the other hand, the QA tools utilised to the remaining thirteen of the included studies were not validated.…”