Temporal profile of lymphocyte counts and relationship with infections with fingolimod therapy in paediatric patients with multiple sclerosis: Results from the PARADIG MS study

• Published in: Multiple sclerosis 2021-05, Vol.27 (6), p.922-932
• Main Authors: Chitnis, Tanuja, Banwell, Brenda, Krupp, Lauren, Arnold, Douglas L, Bar-Or, Amit, Brück, Wolfgang, Giovannoni, Gavin, Greenberg, Benjamin, Ghezzi, Angelo, Waubant, Emmanuelle, Rostasy, Kevin, Deiva, Kumaran, Huppke, Peter, Wolinsky, Jerry S, Zhang, Ying, Azmon, Amin, K-Laflamme, Annik, Karan, Rajesh, Gärtner, Jutta
• Format: Article
• Language: English
• ISSN: 1352-4585; 1477-0970
• DOI: 10.1177/1352458520936934

Reduction in absolute lymphocyte count (ALC) is expected with fingolimod treatment. To evaluate the effect of fingolimod 0.5 mg versus intramuscular interferon β-1a (30 μg) on ALC and its relationship with infections in paediatric-onset multiple sclerosis (POMS) up to 4 years. We assessed ALC at baseline, monthly till 3 months, and every 3 months (core phase) and with variable periodicity (extension phase) of Phase 3 PARADIG study (  = 215). Incidence rates (IRs) of infection-related adverse events ( AEs)/100 patient-years were analysed by on-study nadir ALC. With fingolimod, ALC rapidly reduced to 29.9%-34.4% of baseline values within 2 weeks and remained stable thereafter; no relevant changes observed with interferon. IRs of AEs were 67.6 with fingolimod and 61.8 with interferon; IR ratios with respect to interferon, overall: 1.09, by nadir ALC 0.2-0.4 × 10 /L: 1.13 and >0.4 × 10 /L: 0.91. Three patients had a single episode of ALC