Clinical Practice Experience With Subcutaneous Vedolizumab for the Treatment of Patients With Ulcerative Colitis and Crohn’s Disease
Background:
Vedolizumab is a humanized monoclonal antibody that inhibits α4β7 integrin. Intravenous (IV) vedolizumab is approved for the treatment of moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC) in over 60 countries. An additional subcutaneous (SC) formulation has been approved as a maintenance therapy in Australia, Canada, and Europe. We conducted a literature review to identify publications reporting use of SC vedolizumab in patients with inflammatory bowel disease (IBD) in clinical practice.
Methods:
Literature searches were conducted on September 4, 2023, to identify articles (PubMed) and congress abstracts (Embase) on SC vedolizumab published from 2019 to present.
Results:
Results were screened for relevant publications containing data on patients treated in clinical practice. Data were extracted on baseline characteristics, effectiveness, safety, and treatment patterns, including SC dose escalation and switching back from SC to IV vedolizumab. Results In total, 95 publications were identified. After screening, data were extracted from 21 eligible publications (9 congress abstracts; 12 articles). Overall, the publications included 2,730 patients who met the study eligibility criteria, of whom 2,047 patients with IBD (CD, 726; UC, 1,009; IBD – unspecified, 312) received SC vedolizumab in clinical practice. Previous exposure to other biologics ranged from 42.9% to 100% of patients at baseline in 9 publications. In five studies, a proportion of patients (14–43.7%) initiated SC vedolizumab after IV induction, whereas in ten studies, patients who switched to SC vedolizumab did so during maintenance. Regarding the dose of SC vedolizumab, three publications reported the use of vedolizumab 108 mg SC every 2 weeks regardless of the previous IV dosing schedule, while in one study, the SC dosing interval used depended on the IV dosing interval. The SC dosing interval was reduced in two studies from 2 to 1.5 weeks in two patients (1.5%) and from 2 weeks to weekly in nine patients (10.1%), of whom three received an escalated dose of vedolizumab IV prior to switching. After switching from IV to SC vedolizumab: four publications reported improvements or no differences in disease activity scores compared with baseline scores; five reported clinical remission in 58–92% of patients or that clinical remission remained stable from baseline; two publications reported corticosteroid-free remission in 39.4–68.2% of patients; two reported biochemical remission in 42.0–59.3% of patients. Six publications reported that patients were satisfied with SC vedolizumab treatment after switching. Five publications specified that injection-site reactions were the most common adverse event. The proportion of patients who switched back from SC to IV vedolizumab was 3.2–10% in six studies and 37.5% in one study. Reported reasons for switching back included adverse events, fear of needles, and patient preference. Two publications reported that 10 patients experienced an adverse event after switching back to IV, of whom five discontinued vedolizumab.
Conclusions:
SC vedolizumab is a well-tolerated, effective treatment for the maintenance of clinical remission in patients with CD and UC treated in clinical practice. Only a small proportion of patients underwent SC dose escalation or switched back to IV administration, although data are limited for these outcomes.
