Clinical Effectiveness and Safety of Vedolizumab Versus Infliximab in Biologic-Naïve Ulcerative Colitis Patients: A Real-World Multicentric Observational Study

Background:
Vedolizumab (VDZ) and infliximab (IFX) are considered first-line agents in the treatment of moderate to severe ulcerative colitis (UC). However, there are no head-to-head studies comparing the relative effectiveness of the 2 agents, and real-world data on the effectiveness and safety of VDZ and IFX in UC are lacking. We compared effectiveness and safety of VDZ to IFX in Biologic-naïve UC patients.
Methods:
We conducted a multicenter retrospective cohort study, including patients with moderate to severe UC (Total Mayo score 6-12, with an endoscopic subscore of 2 or 3) who treated with VDZ or IFX. The primary endpoints were clinical remission, defined as a partial Mayo score (PMS) ≤2, endoscopic remission (endoscopic Mayo subscore 0) and steroid-free clinical remission at week 52. Secondary endpoints included clinical response at weeks 12, 26 and 52, endoscopic response (endoscopic Mayo subscore 0-1) at week 52, need for drug optimization, adverse events (AEs), need for hospitalization, loss of response and biochemical remission (C-reactive protein [CRP] ≤ 0.5 mg/dL and/or fecal calprotectin [FC] ≤ 150 µg/g) at week 52. Propensity score adjustment with inverse probability of treatment weighting (1/PS) was used to correct for bias.
Results:
A total of 297 UC biological na&#xef;ve (156 IFX and 141 VDZ) patients were included. Clinical remission and endoscopic remission at week 52 were achieved by 82.3% vs 77.4%, p&#x3d; 0.11 and 47.4% vs 33.1%, p&#x3d;0.03 of VDZ and IFX patients, respectively. Steroid-free clinical remission at week 52 was 84.8% and 83.1% in the VDZ and IFX group, respectively (<italic>P &#x3d;</italic> 0.79). Clinical response and endoscopic response at week 52 were reached in 90.7% vs 88.3% (<italic>P &#x3d;</italic> 0.80) and in 78.4% vs 62.7% (p &#x3c; 0.001) in the VDZ and IFX group, respectively. Biochemical remission at week 52 was 42.6% for VDZ, and 35.1% for IFX, respectively (p&#x3d;0.93). The need for drug optimization was higher for IFX than for VDZ (19.2% vs 36.7%, <italic>P &#x3d;</italic> 0.03). Treatment persistency was higher for VDZ than for IFX at week 52 (80.8% vs 61.8%, p &#x3c; 0.001). The incidence of AEs (46.1% vs 34.0%, p&#x3d;0.17) and need for UC-hospitalization (9.1% vs 0.71%, p &#x3c; 0.001) were higher for IFX than to VDZ patients. Secondary loss of response was similar in the 2 groups (15.0% for VDZ and 20.3% for IFX, <italic>P &#x3d;</italic> 0.24).
Conclusions:
In this real-world study VDZ and IFX had similar efficacy in inducing clinical remission, clinical response, steroid-free remission, and biochemical remission at week 52. Compared to IFX, VDZ was superior in inducing endoscopic remission, endoscopic response, treatment persistency in addition to having a better safety profile and less need for dose escalation. Regarding our results consideration should be given to use of VDZ as the first-line biologic in UC.