Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

Abstract

Background and aims: This study aimed to compare real-world clinical effectiveness and safety of vedolizumab, an α4β7-integrin inhibitor, and anti-tumour necrosis factor-α [anti-TNFα] agents in biologic-naïve ulcerative colitis [UC] and Crohn's disease [CD] patients.

Methods: This was a 24-month retrospective medical chart study in adult UC and CD patients treated with vedolizumab or anti-TNFα in Canada, Greece and the USA. Inverse probability weighting was used to account for differences between groups. Primary outcomes were cumulative rates of clinical effectiveness [clinical response, clinical remission, mucosal healing] and incidence rates of serious adverse events [SAEs] and serious infections [SIs]. Secondary outcomes included cumulative rates of treatment persistence [patients who did not discontinue index treatment during follow-up] and dose escalation and incidence rates of disease exacerbations and disease-related surgeries. Adjusted analyses were performed using inverse probability weighting.

Results: A total of 1095 patients [604 UC, 491 CD] were included. By 24 months, rates of clinical effectiveness were similar between groups, but incidence rates of SAEs (hazard ratio [HR] = 0.42 [0.28-0.62]) and SIs (HR = 0.40 [0.19-0.85]) were significantly lower in vedolizumab vs anti-TNFα patients. Rates of treatment persistence [p < 0.01] by 24 months were higher in vedolizumab patients with UC. Incidence rates of disease exacerbations were lower in vedolizumab patients with UC (HR = 0.58 [0.45-0.76]). Other outcomes did not significantly differ between groups.

Conclusion: In this real-world setting, first-line biologic therapy in biologic-naïve patients with UC and CD demonstrated that vedolizumab and anti-TNFα treatments were equally effective at controlling disease symptoms, but vedolizumab has a more favourable safety profile.

Keywords: Vedolizumab; biologic-naïve; real-world effectiveness.

Figure 1.

Patient screening and analysis flowchart.

Figure 2.

Adjusted cumulative rates of clinical remission and mucosal healing in ulcerative colitis patients.*The sum of the patient weights for each group still on treatment and at clinical outcome can still be assessed. p-values are unadjusted log-rank values. Annotated data are the rates at each time point as indicated by the dashed line.

Figure 3.

Adjusted cumulative rates of clinical remission and mucosal healing in Crohn’s disease patients.*The sum of the patient weights for each group still on treatment and at clinical outcome can still be assessed. Annotated data are the rates at each time point as indicated by the dashed line. p-values are unadjusted log-rank values.

Figure 4.

The adjusted first incidence of disease exacerbations, disease-related surgeries, serious adverse events and serious infections of patients with ulcerative colitis [A] and Crohn’s disease [B].Hazard ratios are from adjusted Cox models [number of patients experiencing an AE of interest/time in years patients were at risk, multiplied by 100]. SAE: serious adverse event, SI: serious infection. No UC-related surgeries are shown as the vedolizumab cohort had none.

Figure 5.

Adjusted cumulative rates of treatment persistence in ulcerative colitis and Crohn’s disease patients.*The sum of the patient weights for each group still on treatment and at clinical outcome can still be assessed.