Comparative Efficacy and Safety of Vedolizumab and Infliximab in Ulcerative Colitis After Failure of a First Subcutaneous Anti-TNF Agent

A Multicentre Cohort Study

Marianne Hupé; Pauline Rivière; Stephane Nancey; Xavier Roblin; Romain Altwegg; Jerome Filippi; Mathurin Fumery; Guillaume Bouguen; Laurent Peyrin-Biroulet; Arnaud Bourreille; Ludovic Caillo; Mireille Simon; Felix Goutorbe; David Laharie


Aliment Pharmacol Ther. 2020;51(9):852-860. 

In This Article

Abstract and Introduction


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.


Ulcerative colitis (UC) is an inflammatory bowel disease with a relapsing course that will result in chronic inflammation of the colorectal mucosa. Nowadays, therapeutic goals in UC include control of symptoms and mucosal healing.[1,2] Several drugs are able to achieve these targets in patients with moderate-to-severe UC,[3] ranging from thiopurines to biologics (three anti-tumor necrosing factor [TNF] agents: infliximab [IFX], adalimumab and golimumab; one anti-integrin: vedolizumab [VDZ]; and shortly one anti-p40 antibody targeting IL-12 and IL-23: ustekinumab)[4] and small molecules (tofacitinib).[5–9]

Management of patients with active refractory UC is based on a step-up strategy. However, evidence suggests that the chances of response decrease with the number of prior medications given.[6,7,9–13] Bearing this in mind, physicians faced with patients with moderate-to-severe UC have to choose within the panel of drugs approved with yet little proof. Currently, such a choice is mainly driven by clinician's habits, safety profiles, patient's preference and insurance reimbursement policies.

Comparative data between active UC treatments are highly anticipated. Recently, results from VARSITY, the first head-to-head randomised controlled trial conducted in UC, have shown a better remission rate at 1 year with VDZ than with adalimumab. Importantly, most of the patients recruited in the VARSITY trial were anti-TNF naïve. In the subgroup of patients with prior exposure to IFX, the difference between these drugs was not significant.[14]

Failure of a first subcutaneous anti-TNF in UC has become a common situation for physicians.[7,8,15,16] Until tofacitinib's license for UC, these patients received an intravenous second-line medical therapy that could be either IFX or VDZ. However, there are no data available comparing them directly. In the present observational study, we aimed to compare the efficacy of IFX to that of VDZ in UC patients who failed a first subcutaneous anti-TNF agent.