Subcutaneous Vedolizumab Safe and Effective for Crohn Disease Maintenance

Crohn illness and intestine disease or crohns medical concept as human digestive colon with inflammation symptoms causing obstruction as a 3D illustration.
Investigators evaluated the safety and efficacy of subcutaneous delivery of vedolizumab as maintenance therapy for patients with moderate to severely active Crohn disease.

Subcutaneous (SC) administration of vedolizumab is a safe and effective option for the maintenance of moderate to severely active Crohn disease, according to a phase 3 trial published in Journal of Crohn’s and Colitis.

The double-blind, placebo-controlled trial initiated all patients on vedolizumab 300 mg, via intravenous (IV) administration, at weeks 0, 2, and 6. Clinical responders, defined as those with at least a 70-point decrease in the Crohn Disease Activity Index (CDAI) score, were then randomly assigned 2:1 to receive vedolizumab 108 mg or placebo via SC administration every 2 weeks until week 50. Of the 644 enrolled patients, 275 were assigned to vedolizumab SC while 135 patients received placebo (ClinicalTrials.gov Identifier: NCT02611817).

The primary outcome was a CDAI score of ≤150, indicating clinical remission. Secondary outcomes included an enhanced clinical response, defined as a CDAI score decrease ≥100, corticosteroid-free remission, and patient-reported symptom remission.

Baseline patient demographics were generally similar between the vedolizumab SC and placebo groups; mean age in the vedolizumab SC group was 38.2 years (57.1% men) vs 36.1 years (49.3% men) in the placebo group. Most patients had CDAI scores ≤330 at baseline.

Clinical remission was achieved in 48% of patients receiving vedolizumab SC compared with only 34.3% of patients on placebo. While statistical significance cannot be claimed, 45.3% of patients on vedolizumab were corticosteroid-free at 52 weeks, while only 18.2% of patients assigned to the placebo group achieved that secondary outcome. The only notable side effect, compared with previous studies involving IV-administered vedolizumab, were injection site reactions.

Despite the lack of a study directly comparing vedolizumab IV with vedolizumab SC in patients with Crohn disease, the results of this trial indicate that vedolizumab SC may be a reasonable alternative for maintenance therapy in patients who respond to initial vedolizumab IV treatment.

Disclosure: The authors declared affiliations with biotech, pharmaceutical, and/or device companies. Pleases see the original reference for a full list of author disclosures.

Reference

Vermeire S, D’Haens G, Baert F, et. al. Efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active Crohn’s disease: results from the VISIBLE 2 randomised trial. J Crohns Colitis. Published online August 17, 2021. doi: 10.1093/ecco-jcc/jjab/33