Comparative efficacy and safety of vedolizumab and infliximab in ulcerative colitis after failure of a first subcutaneous anti‐TNF agent: a multicentre cohort study

Abstract

Background: Few data exist to help select a second biologic agent in patients with refractory ulcerative colitis (UC). Aim:To compare the efficacy of infliximab (IFX) and vedolizumab (VDZ) in UC patients who failed a first subcutaneous anti-tumor necrosing factor (TNF) agent.Methods: Consecutive UC patients from 12 French centres starting IFX or VDZ after at least one injection of adalimumab or golimumab have been included in a retrospective study. Outcomes were clinical remission at week 14, survival without treatment discontinuation and survival without UC-related event.Results: Among the 225 patients included, clinical remission at week 14 was achieved in 40/154 (26%) patients treated with IFX and in 35/71 (49%) treated with VDZ (P = 0.001). After a propensity score matching analysis, this difference remained significant (odds ratio: 1.67; 95% confidence interval: 1.08-2.56; P = 0.02). With a median follow-up of 117 weeks, survival rates without treatment discontinuation at years 1 and 3 were 50% and 29% with IFX, and 80% and 55% with VDZ, respectively (P < 0.001). Regarding survival without UC-related event, they were 49% and 27% with IFX, and 74% and 52% with VDZ (P < 0.01). Conclusion:After failure of a first subcutaneous anti-TNF agent, UC patients were more likely to achieve clinical remission with VDZ than those treated with IFX.Although due to prescription habits patients in the IFX group had a significantly more severe disease, these differences remained after adjustments and subgroup analyses. Such results have to be confirmed prospectively and warrant dedicated head-to-head trials. | 853HUPÉ et al.

Clearing of the Clouds in Inflammatory Bowel Disease Management

“…Tofacitinib is currently a second-line alternative. In patients with UC and a history of prior anti-TNF-α failures, then vedolizumab [22], ustekinumab [23], or perhaps tofacitinib may be in order. The relative benefits of these newer agents appear similar.…”

“…The data from few controlled trials provide illumination. In the management of moderate-to-severe UC, the VARSITY trial is uniquely placed on the nearly endless list of this century's clinical trials in that two mainstream biologics were directly compared, adalimumab versus vedolizumab [22]. In patients with a prior history of anti-TNF-α failure, vedolizumab offered a higher proportion of remissions than did adalimumab.…”

Drug survival of anti‐TNF agents compared with vedolizumab as a second‐line biological treatment in inflammatory bowel disease: results from nationwide Swedish registers

“…In addition, anti‐TNF treatment was restricted to adalimumab and most patients treated in clinical practice would not have been eligible for the VARSITY trial, where inclusion was restricted to patients of certain ages, degrees of disease activity, comorbidity, prior and concurrent medications. Real‐world studies comparing the effectiveness of an anti‐TNF agent vs vedolizumab show conflicting data and some include a mixture of patients with different anti‐TNF exposure, making the results difficult to interpret 29‐34 …”

Editorial: which biologic is next for ulcerative colitis patients who fail a subcutaneous anti‐TNF?

“…Hupé et al have recently presented data in Alimentary Pharmacology & Therapeutics from a multi‐centre retrospective study comparing the efficacy and safety of vedolizumab and infliximab in UC patients after failure of a first subcutaneous anti‐TNF‐agent 4 …”

“…Despite the absence of TDM data, the study by Hupé et al, 4 together with the previously mentioned studies, provides important guidance for the management of UC after subcutaneous anti‐TNF failure. It remains to be seen if these observations will be corroborated in future prospective trials, and whether the out‐of‐class superiority will also be demonstrated for other non‐anti‐TNF UC‐approved agents such as tofacitinib and ustekinumab.…”