P376 Switching from intravenous to subcutaneous vedolizumab maintenance treatment; feasibility, safety and clinical outcome
Wiken, T.(1,2);Høivik, M.L.(1,2);Buer, L.(1);Bolstad, N.(3);Moum, B.A.(1,2);Medhus, A.W.(1);
(1)Oslo University Hospital, Departement of Gastroenterology, Oslo, Norway;(2)University of Oslo, Institute of Clinical Medicine, Oslo, Norway;(3)Oslo University Hospital, Departement of Medical Biochemistry, Oslo, Norway;
Background
Vedolizumab (VDZ) has until recently been available only as intravenous (i.v.) formulation, but the drug is now available also as subcutaneous (s.c.) formulation. In the present study, we aimed to assess the feasibility, safety and clinical outcome when switching a real world cohort of patients with inflammatory bowel disease (IBD) from i.v. to s.c. VDZ treatment.
Methods
All IBD-patients receiving i.v. VDZ at the department were identified using the medical records. Patients in the induction period or with planned change of medical treatment or surgery within 3 months were not routinely switched. The dosage of s.c. VDZ was calculated based on current i.v. dose and interval. Patients were assessed at first and fourth injection and after 3 months. The primary endpoint was percentage of patients still on s.c. treatment after 3 months. Secondary endpoints were adverse events, clinical disease activity scores (Harvey Bradshaw index and Partial Mayo Score), C-reactive protein (CRP), fecal calprotectin (FC), VDZ treatment interval, plasma-VDZ, and patients’ preferred route of administration.
Results
In total, 108 patients were switched, 51 with ulcerative colitis (UC) and 57 with Crohn’s disease (CD). After 3 months, 95.3% (103/108) remained on s.c. treatment. Four patients had switched back to i.v. and one changed treatment to ustekinumab. Nineteen patients (17.6%) experienced injection site reactions (ISR), and twelve of these (63.2%) had repeated reactions. In three cases, patients were switched back to i.v. treatment due to ISR. No serious adverse events related to the switch were observed. The median interval between injections was 12 (IQR: 7-18) days. The median p-VDZ at three months was 44.4 (IQR: 28.9-64.7) mg/L. In the UC and CD patients, 92% (47/51) and 72% (41/57) were in clinical remission at first injection, whereas the corresponding numbers after three months were 88% (p=0.18) and 83% (p=0.11), respectively. No significant change in CRP and FC was observed. Before switching, 25% of the patients reported that they would prefer i.v. treatment, 28% s.c. treatment and 47% were indifferent. Three months after switching, the corresponding numbers were 18%, 53% and 29%, respectively (p<0.001).
Conclusion
Switching from i.v. to s.c. VDZ was feasible and safe. Approximately one out of six experienced an ISR but only 3% were switched back to i.v. administration. At 3 months follow-up there was no change in clinical remission rates, CRP and FC. Furthermore, patients’ attitude towards route of administration changed after switching. The present real world data demonstrate that s.c. maintenance VDZ treatment represents an attractive alternative to i.v. treatment.