OBJECTIVES: To conduct a systematic review and meta-analysis regarding the efficacy and safety of some biologics for inflammatory bowel disease (IBD), specifically, adalimumab (ADA), golimumab (GLM), infliximab (IFX), ustekinumab (UST), vedolizumab (VDZ), and the janus kinase (JAK) inhibitor, tofacitinib (TOFA).

METHODS: A literature search of the databases PubMed/Medline, The Cochrane Library, European Medicines Agency, International Clinical Trials Registry Platform and Science Direct, for randomized controlled trials on the above-mentioned drugs vs. placebo (PLB), was conducted and data relating to clinical remission, clinical response, adverse events (AE), serious adverse events (sAE), discontinuation due to AEs, infections and serious infections were extracted.

RESULTS: The literature search resulted in 1397 studies, 17 of which met the inclusion criteria. The meta-analysis included 7 comparisons (2 for ADA, IFX and UST, 1 for TOFA), but GLM and VDZ data could not be compared. The estimated RD (Risk Difference) values for clinical remission and clinical response favored: ADA over PLB with 40 mg/every week and 40 mg/every other week doses (p<0.00001), IFX over PLB for 5 mg and 10 mg doses (p<0.00001) for 8 and 30 weeks of therapy, TOFA over PLB (p<0.00001), UST 130 mg over PLB for 3, 6 and 8 weeks of therapy (p=0.02,p=0.0002,p<0.0001 and p=0.001,p<0.00001,p<0.00001, respectively) and UST 6 mg/kg over PLB for 3, 6 and 8 weeks of therapy (p<0.0001).For all comparisons, the estimated RD, were not statistically significant for incidence of AE and sAE, discontinuation due to AE and incidence of serious infections.The studies included in the meta-analysis were characterized as having a low to unclear risk of bias.

CONCLUSIONS: Based on clinical remission and clinical response data, the results of the meta-analysis suggest that the biologics ADA, IFX, UST, and the JAK inhibitor, TOFA, are more effective than PLB for IBD therapy, but safety data are inconclusive.