BACKGROUND AND OBJECTIVE: Observational studies may provide additional information about the behaviour of different drugs in the post-marketing period. We present the data from a cohort of secondary progressive multiple sclerosis (SPMS) patients treated with interferon beta (IFNbeta-1b) at our MS clinic. METHODS: This was an independent, open-label, non-randomised, observational study. Within the period 1998 to 2005, all patients with SPMS who started therapy with IFNbeta-1b at our centre were studied. Each patient was included in a follow-up protocol collecting demographic and baseline clinical data. RESULTS: We studied 146 SPMS patients with a median follow-up of 60 months. Over the total study period, 62.2% of patients had confirmed progression. The analysis of the time to con- firmed progression showed that patients with two or more relapses in the 2 years before IFNbeta initiation, had a higher risk of disability increase than those patients with less than two relapses (p = 0.002). Multiple regression analysis showed disease activity in terms of relapses as the only factor to predict increase of disability during the follow-up period. A significant proportion of patients (36%) stopped treatment during the follow-up period. IFNbeta was safe, although some unexpected adverse events were observed. CONCLUSIONS: A higher disease activity before the beginning of treatment with IFNbeta in SPMS patients with a given EDSS rank could identify those with faster disability progression after treatment initiation.
BACKGROUND AND OBJECTIVE: Observational studies may provide additional information about the behaviour of different drugs in the post-marketing period. We present the data from a cohort of secondary progressive multiple sclerosis (SPMS) patients treated with interferon beta (IFNbeta-1b) at our MS clinic. METHODS: This was an independent, open-label, non-randomised, observational study. Within the period 1998 to 2005, all patients with SPMS who started therapy with IFNbeta-1b at our centre were studied. Each patient was included in a follow-up protocol collecting demographic and baseline clinical data. RESULTS: We studied 146 SPMS patients with a median follow-up of 60 months. Over the total study period, 62.2% of patients had confirmed progression. The analysis of the time to con- firmed progression showed that patients with two or more relapses in the 2 years before IFNbeta initiation, had a higher risk of disability increase than those patients with less than two relapses (p = 0.002). Multiple regression analysis showed disease activity in terms of relapses as the only factor to predict increase of disability during the follow-up period. A significant proportion of patients (36%) stopped treatment during the follow-up period. IFNbeta was safe, although some unexpected adverse events were observed. CONCLUSIONS: A higher disease activity before the beginning of treatment with IFNbeta in SPMS patients with a given EDSS rank could identify those with faster disability progression after treatment initiation.
Authors: J W Prineas; E E Kwon; E S Cho; L R Sharer; M H Barnett; E L Oleszak; B Hoffman; B P Morgan Journal: Ann Neurol Date: 2001-11 Impact factor: 10.422
Authors: J-C Lambert; L Araria-Goumidi; L Myllykangas; C Ellis; J C Wang; M J Bullido; J M Harris; M J Artiga; D Hernandez; J M Kwon; B Frigard; R C Petersen; A M Cumming; F Pasquier; I Sastre; P J Tienari; A Frank; R Sulkava; J C Morris; D St Clair; D M Mann; F Wavrant-DeVrièze; M Ezquerra-Trabalon; P Amouyel; J Hardy; M Haltia; F Valdivieso; A M Goate; J Pérez-Tur; C L Lendon; M-C Chartier-Harlin Journal: Neurology Date: 2002-07-09 Impact factor: 9.910