Introduction
Recently, subcutaneous vedolizumab formulation has been approved for the treatment of Inflammatory Bowel Disease. Data from randomized controlled trials on Crohn disease and ulcerative colitis report that subcutaneous vedolizumab formulation efficacy and safety were comparable to intravenous one.
Aims & Methods
The aim of our study was thus to evaluate the safety and the effectiveness of switching from intravenous to subcutaneous vedolizumab in inflammatory bowel disease patients in clinical remission.
In this prospective cohort study, we collected data on patients afferent to our center from September 2021 to April 2022. Baseline demographic characteristics, 12- and 24-weeks follow-up clinical activity and C-reactive protein levels, and adverse events were recorded. The primary endpoint was to assess combined steroid-free clinical remission plus biochemical remission at week 24.
Results
93 patients (43 Crohn disease, 50 ulcerative colitis) switched from intravenous to subcutaneous vedolizumab therapy after a median duration of intravenous treatment of 36 months [IQR 16-52]. Of note, 53.7% were previously anti-TNFα exposed and 41.9% were naive to biologics and immunosuppressors. Most of patients (94.6%) were on every 8-weeks maintenance therapy. At baseline, 80 patients (86%) were in combined remission; 93.5% of patients and 91,4% of patients reached the 12-weeks and 24-weeks follow up visit respectively. At week 24, 89.2% (n=74) patients maintained combined steroid-free clinical remission plus biochemical remission from baseline. Overall, 25 adverse events out of 23 patients were reported, mostly SARS-CoV-2 infections and injection site reactions, with further 4 recurrence episodes. Twelve patients (12.9%) discontinued subcutaneous and restarted intravenous vedolizumab.
Conclusion
Switching from intravenous to subcutaneous vedolizumab can be considered a reasonably safe and effective treatment in maintaining remission in inflammatory bowel disease patients at a 24-weeks follow-up. Additionally, this might slash healthcare costs. However, larger scale real-life studies with long-term follow-ups are needed.
Disclosure
Conflicts of interest: Daniela Pugliese received speaker fees and/or advisory board fees from AbbVie, Janssen, MSD, Pfizer and Takeda. Franco Scaldaferri received speaker fees and/or advisory board fees from, Janssen, MSD, Pfizer and Takeda, Sandoz , celltrion , ferring. Alessandro Armuzzi has received consulting/advisory board fees from AbbVie, Allergan, Amgen, Arena, Biogen, Bristol-Myers Squibb, Celgene, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda; speaker's fees from AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Tigenix; research support from Biogen, MSD, Pfizer and Takeda. Antonio
Gasbarrini is an advisory board member for Actial Farmaceutica, Alfa Sigma, Zambon and Aboca.