Subcutaneous vedolizumab maintenance therapy in CD

The first phase 3 study results of subcutaneous vedolizumab maintenance treatment in moderate-to-severe Crohn’s disease (CD) showed that among vedolizumab induction responders, significantly more patients on vedolizumab achieved clinical remission after 1 year than on placebo [1].

Prof. Séverine Vermeire (University Hospital Leuven, Belgium) presented the results of the VISIBLE 2 study of subcutaneous vedolizumab as maintenance treatment CD. The 644 participants received intravenous vedolizumab 300 mg at weeks 0 and 2 as induction therapy. At week 6, the 412 clinical responders were then randomised to receive 108 mg subcutaneous vedolizumab (n=275) or placebo (n=134) every 2 weeks for up to 52 weeks. The primary endpoint was clinical remission at week 52, defined as a Crohn’s disease Activity Index (CDAI) score ≤150.

The primary endpoint was achieved by 48.0% of patients on subcutaneous vedolizumab versus 34.3% on placebo (P=0.008). Enhanced clinical response (decrease of ≥100 in CDAI score) was not significantly different: 52.0% versus 44.8% (P=0.167; see Figure). Prof. Vermeire stated that “the high placebo response may be explained by the carry-over effect of induction therapy”. Among patients on concomitant corticosteroids at baseline (n=95 and n=44 in the respective treatment groups), 45.3% versus 18.2% achieved corticosteroid-free clinical remission. Of anti-TNF-naïve patients, 48.6% and 42.9% achieved clinical remission.

Figure. Primary and secondary endpoints of VISIBLE 2 (full analysis set) [1]



SC, subcutaneous; CS, corticosteroid

Less than 3% of patients treated with subcutaneous vedolizumab reported injection-site reactions. Serious infections, malignancy, and liver injury were seen in ≤5% in both arms. Numerically, serious infections were lower in the treatment group (n=4) versus placebo (n=6). Anti-vedolizumab antibodies were detected in 7 (2.5%) treated patients; 4 of 7 developed neutralising antibodies. There were no new safety signals.

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   1. Vermeire S, et al. ECCO-IBD 2020, OP23.

Posted on 14 April, 20208 April, 2024