Persistence, Safety and Pharmacokinetics of Vedolizumab After Switching to the Subcutaneous Route in a Prospective French National Cohort Study
Marianne Hupé, Nicolas Mathieu, Aurélien Amiot, Philippe Seksik, Maeva Charkaoui, Cyrielle Gilletta‐de‐Saint‐Joseph, Arnaud Bourreille, Mélanie Serrero, Yoram Bouhnik, Maria Nachury, Xavier Roblin, Stéphane Nancey, Vered Abitbol, Jean‐Marc Gornet, Céline Montuclard, Xavier Hébuterne, Thierry Paupard, Cléa Rouillon, Mehdi Kaassis, Pierre Andrau, Morgane Amil, Magalie Baudrant, Laurent Peyrin‐Biroulet, Stéphane Paul, Eric Vicaut, David LaharieABSTRACT
Background and Aim
We conducted a prospective study to evaluate the persistence, efficacy, pharmacokinetics, and safety of subcutaneous VDZ (SC‐VDZ) after switching from the intravenous (IV) route.
Methods
All patients with ulcerative colitis (UC) or Crohn's disease (CD) in clinical remission who switched from IV‐VDZ to SC‐VDZ between 2022 and 2024 were included in this multicentric prospective French national cohort study. Primary endpoint was SC‐VDZ persistence at Week 52. Patients who had a disease‐related surgery, repeated or prolonged (> 14 days) steroid courses, and those who were lost to follow‐up were considered non‐persistent.
Results
Among the 337 patients analysed, 246 (73%) had UC and 91 (27%) CD; 214 (64%) were on a standard IV‐VDZ regimen. At Week 52, SC‐VDZ persistence was 84% [95% confidence interval: 80–88], with no significant difference between diseases ( p = 0.36). During the study period, 32 patients (10%) had a dose increase of SC‐VDZ (either to 216 mg weekly or to 108 mg 2‐weekly), including 17 (53%) who had been on a standard IV‐VDZ regimen, and five (16%) eventually stopped VDZ due to persistent loss‐of‐response despite dose increase. Twelve out of 16 patients were successfully switched back to IV‐VDZ. Vedolizumab drug levels were similar between persistent and non‐persistent patients throughout the study period. A total of 183 patients (54%) reported at least one AE, most frequently injection‐site reactions (20%) and infections (17%), leading to SC‐VDZ discontinuation in 25 patients (7%).
Conclusion
In this multicentric cohort, the persistence at 1 year from switch to SC‐VDZ in IBD patients was 84%.