SC vedolizumab improves outcomes in patients with Crohn’s disease

Maintenance therapy with a new subcutaneous (SC) formulation of the monoclonal antibody vedolizumab led to improvements in patient-reported outcomes (PROs) in patients with moderate-to-severe active Crohn’s disease (CD) compared with placebo, interim results of the phase III VISIBLE 2 study has shown.

“CD … can lead to structural bowel damage, thereby negatively affecting quality of life (QoL) and productivity … [Our findings show that] a numerically higher proportion of patients achieved clinical remission based on PROs [and] improved QoL and work productivity with vedolizumab SC … maintenance therapy,” said the researchers.

At week 52, clinical remission was achieved by more participants treated with vedolizumab vs placebo, as reflected by the Crohn’s Disease Activity Index (CDAI) PRO2* (40 percent vs 29 percent; p=0.026) and PRO3** scores (40 percent vs 31 percent; p=0.053), as well as the mean daily stool frequency subscore ≤1.5 with abdominal pain subscore ≤1 (29 percent vs 24 percent; p=0.263). [DDW 2020, abstract Sa1816]

Clinically meaningful improvements in Inflammatory Bowel Disease Questionnaire (IBDQ) scores were also observed in both arms at week 52, with a trend favouring vedolizumab over placebo (mean, +63.3 vs +55.1).

Euro QoL-5D (EQ-5D) index and EQ-5D visual analogue scale (EQ-5D-VAS) score were similarly improved in both vedolizumab and placebo arms (mean, +0.21 vs +0.16 [EQ-5D] and +27.7 vs +26.2 [EQ-5D-VAS]).

Reductions in mean WPAI-CD*** overall work productivity loss scores from baseline to week 52 were also seen in both arms, but more so in the vedolizumab vs the placebo arm (mean, –32.5 percent vs –28.1 percent).

Maintenance alternative

Following vedolizumab 300 mg IV induction (weeks 0 and 2), 412 participants (median age 34.8 years, 53 percent male) who had a clinical response at week 6 entered the maintenance phase and were randomized 2:1 to receive vedolizumab SC 108 mg Q2W or placebo for 52 weeks.

The current findings correlate with the primary results of this trial, showing that nearly half of vedolizumab recipients (48 percent) achieved clinical remission as per CDAI score ≤150. [J Crohns Colitis 2020;14:S020-S021] Taken together, the results underpin the clinical benefit of vedolizumab SC in this setting, they added.

The initially approved route of administration for vedolizumab was via IV, noted the researchers. Given the similar improvements in IBDQ and EQ-5D parameters between the current study and another trial evaluating vedolizumab IV, [N Engl J Med 2013;369:711-721] the new SC formulation may offer CD patients an alternative route of administration for maintenance treatment, they said.