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http://hdl.handle.net/1942/42108
Title: | Safety, feasibility and tolerability of intranodal and intradermal administration of tolerogenic dendritic cell therapy in active multiple sclerosis | Authors: | Cools, Nathalie Willekens, Barbara Presas-Rodriguez, Silvia Ten Brinke, Anja Gross, Catharina C. Mansilla, Maria Jose Teniente-Sera, Aina WENS, Inez Billiet, Thibo Schulte-Mecklenbeck, Andreas Derdelinckx, Judith Di Blasi, Daniela Cabeza, Virginia Palomares Ribbens, Annemie Van Hecke, Wim Barriocanal, Anna Maria Quirant-Sanchez, Bibiana Verheij, Herman Peelen, Sjaak Cras, Patrick Snoeckx, Annemiek Massuet-Vilamajo, Anna Reverter, Jorge Dams, Amber Nijs, Griet Sampedro, Cristina Calvino De Cerio, Ascension Lopez Diaz Inoges, Susana Prosper, Felipe HENS, Niel Wiendl, Heinz Van Ham, S. Marieke Berneman, Zwi Tello, Cristina Ramo Martinez-Caceres, Eva |
Issue Date: | 2023 | Publisher: | SAGE PUBLICATIONS LTD | Source: | Multiple Sclerosis Journal, 29 , p. 598 -600 | 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 (%; | Keywords: | ADB: has received speaker bureau;advisory board;steering com- mittee;and/or consulting fees for Alexion;Biogen;Bristol Myers Squibb;EMD Serono;Horizon Therapeutics;Mallinckrodt;Novartis;Roche-Genentech;Sanofi-Genzyme;and TG Therapeutics; clinical trials for Bristol Myers Squibb;and TG Therapeutics AZO: speaker bureau;advisory boards;steering committees;and/ or consulting fees for Alexion Pharmaceuticals;Banner Life Sciences;BD Biosciences;Biologix;Celgene;Genentech;GW Pharma;Jazz Pharmaceuticals;Novartis (local and global);Sandoz Pharmaceuticals;Sanofi/Genzyme;TG Therapeutics;and | Document URI: | http://hdl.handle.net/1942/42108 | ISSN: | 1352-4585 | e-ISSN: | 1477-0970 | ISI #: | 001091311304065 | Category: | M | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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