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Extended Interval Dosing of Natalizumab in Multiple Sclerosis

Extended Interval Dosing of Natalizumab in Multiple Sclerosis

L Zhovtis Ryerson, T C Frohman, J Foley, I Kister, B Weinstock-Guttman, C Tornatore, K Pandey, S Donnelly, S Pawate, R Bomprezzi, D Smith, C Kolb, S Qureshi, D Okuda, J Kalina, Z Rimler, R Green, N Monson, etc.

J Neurol Neurosurg Psychiatry. 2016 Aug;87(8):885-9.

PMID: 26917698

Abstract:

Background:
Natalizumab (NTZ), a monoclonal antibody to human α4β1/β7 integrin, is an effective therapy for multiple sclerosis (MS), albeit associated with progressive multifocal leukoencephalopathy (PML). Clinicians have been extending the dose of infusions with a hypothesis of reducing PML risk. The aim of the study is to evaluate the clinical consequences of reducing NTZ frequency of infusion up to 8 weeks 5 days.
Methods:
A retrospective chart review in 9 MS centres was performed in order to identify patients treated with extended interval dosing (EID) regimens of NTZ. Patients were stratified into 3 groups based on EID NTZ treatment schedule in individual centres: early extended dosing (EED; n=249) every 4 weeks 3 days to 6 weeks 6 days; late extended dosing (LED; n=274) every 7 weeks to 8 weeks 5 days; variable extended dosing (n=382) alternating between EED and LED. These groups were compared with patients on standard interval dosing (SID; n=1093) every 4 weeks.
Results:
17% of patients on SID had new T2 lesions compared with 14% in EID (p=0.02); 7% of patients had enhancing T1 lesions in SID compared with 9% in EID (p=0.08); annualised relapse rate was 0.14 in the SID group, and 0.09 in the EID group. No evidence of clinical or radiographic disease activity was observed in 62% of SID and 61% of EID patients (p=0.83). No cases of PML were observed in EID group compared with 4 cases in SID cohort.
Conclusions:
Dosing intervals up to 8 weeks 5 days did not diminish effectiveness of NTZ therapy. Further monitoring is ongoing to evaluate if the risk of PML is reduced in patients on EID.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP522606673	SID 3712249		522606-67-3	Price
IAR42416061	EED human			Price

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