Journal
JOURNAL OF NEUROLOGY NEUROSURGERY AND PSYCHIATRY
Volume 87, Issue 8, Pages 885-889Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/jnnp-2015-312940
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Funding
- Biogen Idec
- Novartis
- Genzyme
- Acorda
- Guthy-Jackson Charitable Foundation
- National Multiple Sclerosis Society
- Serono
- Navartis
- Questcor Pharmaceuticals, Inc
- Shire
- TEVA
- Biogen
- EMD Serono
- Acorda Therapeutics
- TEVA Neuroscience
- Genzyme Corp
- Consortium of Multiple Sclerosis Centers
- Cerespir Inc
- Consortium of MS Centers
- D3 (Drug Discovery and Development)
- Genentech
- Innate Therapeutics
- Jannsen Pharmaceuticals
- Klein-Buendel Incorporated
- Medimmune
- Opexa Therapeutics
- Receptos
- Roche
- Savara Inc
- Spiniflex Pharmaceuticals
- Somahlution
- Teva pharmaceuticals
- Transparency Life Sciences
- PML Consortium
- Takeda/Millennium Pharma
- Glaxo Smith Klein
- Genentech Roche
- Sanofi Genzyme
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Background Natalizumab (NTZ), a monoclonal antibody to human alpha(4)beta(1)/beta(7) 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.
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