Open AccessP038 Ozanimod First-Dose Cardiac Effects in Patients with Moderately to Severely Active Ulcerative Colitis and Relapsing Multiple Sclerosis
Author(s) -
Long Millie,
Cross Raymond,
Calkwood Jonathan,
Marc Pondel,
Pai Ashwini,
Ahmad Harris,
L Charles,
Ayanbola Elegbe,
AnnKatrin Petersen,
Sheffield James,
Adil Javed,
W Douglas
Publication year - 2021
Publication title -
the american journal of gastroenterology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.907
H-Index - 252
eISSN - 1572-0241
pISSN - 0002-9270
DOI - 10.14309/01.ajg.0000798752.72296.f3
Subject(s) - medicine , dosing , ulcerative colitis , adverse effect , disease
Ozanimod, an oral sphingosine 1-phosphate (S1P) receptor modulator that selectively targets S1P1 and S1P5, is approved in the US for treating moderately to severely active ulcerative colitis (UC) and in multiple countries for treating relapsing forms of multiple sclerosis (MS). In a Phase 1 study of ozanimod in healthy participants, first-dose cardiac effects were mitigated with gradual dose escalation. Based on these results, an initial 7-day ozanimod dose escalation regimen was implemented in all Phase 2 and 3 UC and MS trials. The objective of this analysis was to evaluate the number of patients who were excluded from ozanimod treatment due to contraindications of pre-existing cardiac disorders and to evaluate the incidence of cardiac-related treatment-emergent adverse events (TEAEs) following first-dose ozanimod administration in all patients and patients with a history of non-exclusionary cardiac disorders in the UC and MS clinical trials.