COMPARATIVE EFFICACY AND SAFETY OF SUBCUTANEOUS INFLIXIMAB AND VEDOLIZUMAB MAINTENANCE THERAPY IN PATIENTS WITH CROHN’S DISEASE AND ULCERATIVE COLITIS: AN INDIRECT COMPARISON FROM RANDOMIZED CONTROLLED TRIALS

Abstract

Abstract BACKGROUND In a previous meta-analysis on randomized controlled trials (RCT) in patients with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC), infliximab (IFX) showed better efficacy in the induction phase and comparable efficacy during the maintenance phase and an overall similar safety profile as compared to vedolizumab (VDZ).1 The objective of this study is to indirectly compare the 1-year efficacy and safety results between subcutaneous IFX (SC IFX) and VDZ as maintenance therapies in moderate-to-severe CD and UC patients. This analysis incorporates data from three recently published clinical trials: LIBERTY-CD2, LIBERTY-UC3, and VISIBLE24. METHODS Separate pooled analyses were conducted for patients with CD and UC, combining data for predefined efficacy and safety outcomes. These outcomes included the proportions of patients achieving clinical remission (CD: absolute CDAI score of <150; UC: Total Mayo score ≤2 with no individual sub-score >1; or partial Mayo score of ≤1 point), clinical responses (CD: decrease in CDAI score of ≥100 from baseline; UC: a decrease in total Mayo score from baseline of ≥3 points and ≥30%; or a decrease in partial Mayo score from baseline of ≥2 points), and the proportions of patients experiencing adverse events (AEs), serious AEs, serious infections, or discontinuation due to AEs during the 1-year maintenance phase. Data were pooled using a random-effect model. The heterogeneity between studies was examined. RESULTS A total of 2,028 patients (IFX SC, n=655; VDZ, n=1,373) were included in this pooled analysis. In CD patients, a higher proportion of patients treated with SC IFX achieved clinical remission and CDAI-100 response, with non-overlapping 95% CI during the maintenance phase compared to patients treated with VDZ (Fig.1A, B). In UC, the proportion of patients achieving clinical remission and clinical response during the maintenance phase was similar between the two treatment groups, with overlapping 95% CIs (Fig.1C, D). Safety profiles were generally similar for both indications (Fig.2). CONCLUSION In this indirect comparison, patients treated with SC IFX achieved better efficacy in terms of clinical remission and response compared to those treated with VDZ during 1-year maintenance therapy in CD, and similar rates in UC. Subcutaneous IFX showed a similar safety profile to VDZ, with limitations in duration of follow-up and number of patients. These findings align with the results of a network meta-analysis5 showing that SC IFX ranks highest among biologics for achieving clinical remission during maintenance therapy. REFERENCES 1. Peyrin-Biroulet et al., BMC Gastroenterol 2022;22(1):291 2. Colombel J F et al., JCC 2023;17(S1):i161-i162 3. Sands B E et al., JCC 2023;17(S1):i623-i624 4. Severine Vermeire et al., JCC 2022;16(1):27-38 5. Peyrin-Biroulet L et al., JCC 2023:17(S1):i574–i576