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The Toronto Observational Study of Natalizumab in Multiple Sclerosis

Published online by Cambridge University Press:  02 December 2014

Kristen M. Krysko  and
Paul W. O'Connor
Kristen M. Krysko
Affiliation:
Division of Neurology, St. Michael's Hospital, Toronto, Ontario, Canada
Paul W. O'Connor*
Affiliation:
Division of Neurology, St. Michael's Hospital, Toronto, Ontario, Canada
*
MS Clinic and MS Research, St. Michael’s Hospital, 30 Bond St #3007S, Toronto, Ontario, M5B 1W8, Canada
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Abstract

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Background:

Natalizumab is indicated for the treatment of relapsing multiple sclerosis (MS) with insufficient response to first-line disease-modifying therapy (DMT). We studied the efficacy of natalizumab for treatment of MS in a single centre observational design.

Methods:

A retrospective observational study of 146 patients [66% female; mean age 37.4; 72% relapsing remitting MS (RRMS), 28% secondary progressive MS (SPMS)] referred for natalizumab treatment at St. Michael's Hospital MS Clinic between 2007 and August 2009. Data included demographic, clinical (Expanded Disability Status Scale (EDSS) and annualized relapse rate (ARR)) and patient self-report measures.

Results:

The mean duration of treatment was 20 months in those treated with natalizumab and 97% had received prior DMTs. Eighty-three patients (57%) received at least 12 months of natalizumab treatment. In those who received at least 12 months of treatment, baseline ARR and EDSS were 1.6 and 2.7 in RRMS patients versus 1.0 and 5.4 in SPMS with relapses. The ARR decreased with natalizumab treatment to 0.38 (76% reduction, p<0.001) in RRMS versus 0.32 in SPMS patients (68% reduction, p=0.01). There was a treatment associated 11% reduction in EDSS to 2.4 (p=0.04) in RRMS, but no significant change in SPMS. Eighty-five percent of patients reported improved overall quality of life (QOL) and 62% indicated improved energy.

Conclusions:

There was a major reduction in relapse rate, stabilization in EDSS and improvement in QOL and energy in some patients on natalizumab, all similar to treatment effects in the pivotal trial.

Résumé:

Résumé:Contexte:

Le natalizumab est indique dans le traitement de la sclerose en plaques (SP) remittente qui ne repond pas suffisamment au traitement de fond (TF) de premiere ligne. Nous avons utilise un plan d’etude d’observation dans un seul centre pour etudier l’efficacite du natalizumab pour traiter la SP.

Méthode:

Il s’agit d’une etude d’observation retrospective portant sur 146 patients atteints de SP [72% de SP remittente (SPR) et 28% de SP secondairement progressive (SPSP)], dont 66% etaient des femmes et dont l’age moyen etait de 37,4 ans. Ils avaient ete referes a la clinique de SP de St. Michael's Hospital pour traitement par le natalizumab entre 2007 et aout 2009. Nous avons recueilli les donnees demographiques, le score a l’Expanded Disability Status Scale (EDSS) et le taux annualise de rechute (TAR) et les mesures rapportees par les patients.

Résultats:

La duree moyenne de traitement etait de 20 mois chez les patients traites par le natalizumab et 97% ont recu d’autres TF. Quatre-vingt-trois patients (57%) ont recu le natalizumab pendant au moins 12 mois. Chez ces patients, le TAR et l’EDSS avant traitement etaient de 1,6 et 2,7 respectivement chez les patients atteints de SPR et de 1,0 et 5,4 chez ceux atteints de SPSP qui ont eu des recidives. Le TAR a diminue sous traitement par le natalizumab a 0,38 (diminution de 76%, p < 0,001) chez les patients atteints de SPR et a 0,32 chez ceux atteints de SPSP (diminution de 68%, p = 0,01). Nous avons observe une diminution de 11% du score a l’EDSS associee au traitement, soit 2,4 chez les patients atteints de SPR (p = 0,04). Il n’y a eu aucun changement significatif du score a l’EDS chez ceux atteints de SPSP. Quatre-vingtcinq pour cent des patients ont note une amelioration globale de leur qualite de vie (QV) et 62% ont note un niveau d’energie plus eleve.

Conclusions:

Sous natalizumab, certains patients ont note une diminution importante du taux de recidive, une stabilisation du score a l’EDSS et une amelioration de leur QV et de leur niveau d’energie, ce qui est similaire aux effets observes dans l’etude pivot.

Type
Original Article
Information
Canadian Journal of Neurological Sciences , Volume 38 , Issue 3 , May 2011 , pp. 422 - 428
Copyright
Copyright © The Canadian Journal of Neurological 2011

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