Safety, feasibility and tolerability of intranodal and intradermal administration of tolerogenic dendritic cell therapy in active multiple sclerosis

Abstract

Results: Mean (standard deviation [SD]) ozanimod exposure among 185 enroled patients was 13.7 (8.6) mos (210.9 person-years [PY] total exposure); 1 patient had completed and 155 (83.8%) were on treatment at data cutoff. Baseline characteristics (N=185) included mean (SD) age 39.5 (10.7) y; 78.4% female; 85.9% White; 10.8% Black; 72.4% DMT naïve; mean 4.1 (5.5) y since MS symptom onset; mean 0.8 (0.8) relapses in prior 12 mos; and median EDSS score 2.0 (range 0㎕4). At baseline, mean (SD) SDMT score was 53.9 (11.4); after 1 y of ozanimod, 55/116 (47.4%) had ⩾4-pt or 10% improvement, 30 (25.9%) remained stable, and 31 (26.7%) had a ⩾4-pt or 10% worsening. Mean (SD) T2 lesion count at baseline (n=184) was 22.4 (16.9); mean (SD) new/enlarging T2 lesion count at 1 y (n=101) was 0.4 (0.8). Also, 91/100 (91.0%) patients with MRI data were GdE lesion-free at 1 y vs 123/185 (66.5%) at baseline. TEAEs occurred in 122 (65.9%) patients (EAIR 161.8/100 PY); TEAEs present in ⩾5% were (%;