J Dig Dis. 2021 May 28. doi: 10.1111/1751-2980.13026. Online ahead of print.
ABSTRACT
OBJECTIVE: The current concern exists regarding the efficacy and safety of biological agent monotherapy versus combination therapy with an immunomodulator (IM) in patients with inflammatory bowel disease (IBD). We performed a meta-analysis of results from randomized controlled trials (RCTs) to compare the efficacy and safety of biological and immunosuppressive combination therapy with biological monotherapy in IBD.
METHODS: We comprehensively and systematically identified eligible studies from Embase, PubMed, and Cochrane library and compared the biological and immunomodulator treatment with biological monotherapy. Raw data from RCTs fulfilling inclusion criteria were extracted for meta-analysis, and pooled relative risk (RR) and 95% confidence interval (CI) were performed using fixed-effect and inverse variance methods. Funnel plots were performed to analyze the publication bias.
RESULTS: Of 3625 identified studies, 12 were eligibly included in this meta-analysis. Overall, there was statistical benefit for combination treatment over anti-TNF monotherapy in inducing clinical remission and preventing the relapse in both UC and CD patients (RR = 0.89; 95% CI = 0.80-0.98). There were benefits for combination treatment over monotherapy in further subgroup analysis of active CD patients (RR = 0.83, 95% CI = 0.73-0.94) but not quiescent CD (RR = 1.01; 95% CI = 0.84-1.22), active UC (RR = 0.82; 95% CI = 0.56-1.19), and quiescent UC patients (RR = 0.61; 95% CI = 0.12-3.00). There were significant benefits for combination therapy in subgroup of infliximab treatment (RR = 0.83; 95% CI = 0.70-0.97) but not in adalimumab treatment (RR = 0.95; 95% CI = 0.83-1.07). For safety analysis, no significant differences were observed in the overall pooled summary for adverse events (RR = 1.05; 95% CI = 0.89-1.23), opportunistic infections (RR = 1.13; 95% CI = 0.94-1.36), and serious infections (RR = 1.20; 95% CI = 0.83-1.73) of combination therapy versus monotherapy. However, an increase of risk of liver enzyme abnormality (RR = 3.47; 95% CI = 1.67-7.21) and a decrease of infusion reactions (RR = 0.43; 95% CI = 0.23-0.80) were seen in combination therapy.
CONCLUSION: The current study suggest that combination therapy among active CD patients shows slight benefits in inducing clinical remission compared with anti-TNF monotherapy. IBD patients who receive therapy with infliximab and IMs also have mild advantage in comparison to those with infliximab monotherapy. Further studies are warranted to define the efficacy and safety of combination therapy versus biological monotherapy in IBD.
PMID:34048629 | DOI:10.1111/1751-2980.13026
