Efficacy and safety of biologic agents and tofacitinib in moderate‐to‐severe ulcerative colitis: A systematic overview of meta‐analyses

Abstract

Background: Ulcerative colitis (UC) is an inflammatory disease of the colon and rectum. Treatment options include biologics and tofacitinib. Objectives: We aim to summarize the evidence on efficacy and safety of biologics and tofacitinib in moderate-to-severe UC. Methods: PubMed, Embase, Scopus, and the Cochrane Library were systematically searched to identify meta-analyses of randomized controlled trials assessing adalimumab, golimumab, infliximab, vedolizumab, and tofacitinib in UC. Efficacy outcomes included induction and maintenance of clinical response, clinical remission and mucosal healing. Safety outcomes included adverse events and serious adverse events. Results: The overview involved 31 meta-analyses. All four biologics and tofacitinib were superior to placebo regarding efficacy. Indirect comparisons suggested that infliximab may be better than adalimumab and golimumab to induce clinical response and mucosal healing. Safety analyses indicated no increased rates of adverse events, except for infliximab. Conclusions: Biologics and tofacitinib are efficacious and safe for treating UC. These findings can support clinical decisionmaking.

Key patient related factors in the management of inflammatory bowel disease

“…Encouragingly, the HRQoL of patients did not differ significantly between those on conventional therapy, which tend to have milder symptoms, reflecting the authors' belief regarding the effectiveness of biologics in patients with IBD 1 . The authors also found differences in the effect of different biologics on HRQoL similar to other studies [47][48][49][50][51] , which needs further investigation to guide future treatment strategies. This includes whether any therapeutic drug monitoring (TDM) takes place as under-dosing impacts on their effectiveness in practice [52][53][54][55] .…”

Histological Hallmarks of Mucosal Healing in Inflammatory Bowel Diseases in the Era of Monoclonal Antibodies Therapy: New Insights and Perspectives

“…Therefore, it is correct to state that the assessment of the degree of disease activity cannot disregard the recognition, topographical description, and possible presence in the glandular (crypt abscess) of neutrophilic granulocytes, and that expressions such as “IBD in the quiescent phase” of mild/moderate disease activity may actually increase the diagnostic confusion that revolves around the concept of mucosal healing [ 21 , 23 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 67 , 68 , 69 , 70 , 71 , 72 , 73 ].…”

Adaptive Designs: Lessons for Inflammatory Bowel Disease Trials

“…In recent years, several molecules have been developed and approved for the treatment of IBD patients, but the disease remission rate still remains modest, highlighting the real need for new drugs and for alternative development strategies [30]. IBD clinical trials are increasingly complex and sophisticated, involving new outcomes (e.g., patient-reported outcomes, biomarkers, and histological healing), central reading, and re-randomization [31].…”