Natalizumab, approved for 300mg intravenous every-4-weeks dosing, is associated with PML risk.
To determine whether natalizumab EID is associated with reduced PML risk compared with SID.
Patients and methods
Average dosing intervals (ADIs) were≥3 to<5 weeks for SID and>5 to≤12 weeks for EID. The primary analysis assessed ADI in the last 18 months of infusion history. The secondary analysis identified any prolonged period of EID at any time in the infusion history. The tertiary analysis assessed ADI over the full infusion history.
In primary analyses, median exposure (months) was 44 for SID and 59 for EID. The PML HR (95% confidence interval) was 0.06 (0.01–0.22; P<0.001) for primary and 0.12 (0.05–0.29; P<0.001) for secondary analyses; no EID PML cases were observed in tertiary analyses (Kaplan–Meier log-rank test P=0.02).
In JCV Ab+patients, natalizumab EID is associated with a clinically and statistically significant reduction in PML risk as compared with SID.Le texte complet de cet article est disponible en PDF.
Keywords : PML, EID, Natalizumab