Contributions
Abstract: EP1508
Type: ePoster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background and objectives: Interferon (IFN) beta-1b was the first drug approved for the treatment of multiple sclerosis (MS) in 1993, yet so far there are no post-marketing studies evaluating the long-term efficacy.
The aim of this study was to address the long-term efficacy of IFN beta-1b in a cohort of relapsing-remitting MS (RR-MS) patients.
Methods: All RR-MS patients referred to our Center and starting IFN beta-1b treatment between June 1996 and October 2014 were retrospectively included. Patients were diagnosed according to Poser and later to McDonald criteria. IFN Beta-1b was prescribed in accordance to Italian Drug Agency (AIFA) eligibility criteria for reimbursement of the drug. Neurological examination, EDSS assessment and magnetic resonance imaging (MRI) were performed at baseline and during follow-up visits according to the routine clinical practice. Clinical and MRI follow-up was also performed whether treatment discontinuation occurred as per intention-to-treat analysis. The primary end point of the study was the proportion of patients with no evidence of disease activity during the follow-up (NEDA-3). The definition of disease activity entailed at least one of the following: clinical relapse, 24 weeks confirmed disability progression based on increases in EDSS, MRI evidence of new and/or enlarging T2 hyperintense lesions and/or gadolinium enhancing lesions. Secondary end point was the proportion of patients with no evidence of disability progression.
Results: Out of 105 MS-RR patients starting IFN Beta-1b treatment during the study period twenty-five were men (23.8%) and 80 were women (76,2%). Mean age at the start of the treatment was 42.3±8.9 years. Mean follow-up duration was 10.7±5,3 (range, 1-18 years). Cumulative proportion of patients still on treatment was 90% at 2-year follow-up, 77% at 5-year, 68% at 10-year, and 34% at the end of follow-up. Mean duration of IFN Beta-1b treatment was 5.9±4.2 years (range, 1-18 years). Cumulative proportion of patients free from any disease activity was 46.1% at 2-years follow-up, 21.6% at 5 years, and 5.3% at the end of 18-year follow-up. Cumulative proportion of patients free from disability progression was 77.4% at 2-years follow-up, 55.8% at 5 years, and 34.8% at the end of 18-year follow-up.
Conclusions: Our post-marketing experience provides further evidence of sustained IFN beta-1b efficacy in modifying the natural course of MS.
Disclosure: RT received funding for travel or speaker honoraria from Almirall, Bayer, Biogen, Merck Serono, Novartis, Sanofi-Aventis, and TEVA.
Abstract: EP1508
Type: ePoster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background and objectives: Interferon (IFN) beta-1b was the first drug approved for the treatment of multiple sclerosis (MS) in 1993, yet so far there are no post-marketing studies evaluating the long-term efficacy.
The aim of this study was to address the long-term efficacy of IFN beta-1b in a cohort of relapsing-remitting MS (RR-MS) patients.
Methods: All RR-MS patients referred to our Center and starting IFN beta-1b treatment between June 1996 and October 2014 were retrospectively included. Patients were diagnosed according to Poser and later to McDonald criteria. IFN Beta-1b was prescribed in accordance to Italian Drug Agency (AIFA) eligibility criteria for reimbursement of the drug. Neurological examination, EDSS assessment and magnetic resonance imaging (MRI) were performed at baseline and during follow-up visits according to the routine clinical practice. Clinical and MRI follow-up was also performed whether treatment discontinuation occurred as per intention-to-treat analysis. The primary end point of the study was the proportion of patients with no evidence of disease activity during the follow-up (NEDA-3). The definition of disease activity entailed at least one of the following: clinical relapse, 24 weeks confirmed disability progression based on increases in EDSS, MRI evidence of new and/or enlarging T2 hyperintense lesions and/or gadolinium enhancing lesions. Secondary end point was the proportion of patients with no evidence of disability progression.
Results: Out of 105 MS-RR patients starting IFN Beta-1b treatment during the study period twenty-five were men (23.8%) and 80 were women (76,2%). Mean age at the start of the treatment was 42.3±8.9 years. Mean follow-up duration was 10.7±5,3 (range, 1-18 years). Cumulative proportion of patients still on treatment was 90% at 2-year follow-up, 77% at 5-year, 68% at 10-year, and 34% at the end of follow-up. Mean duration of IFN Beta-1b treatment was 5.9±4.2 years (range, 1-18 years). Cumulative proportion of patients free from any disease activity was 46.1% at 2-years follow-up, 21.6% at 5 years, and 5.3% at the end of 18-year follow-up. Cumulative proportion of patients free from disability progression was 77.4% at 2-years follow-up, 55.8% at 5 years, and 34.8% at the end of 18-year follow-up.
Conclusions: Our post-marketing experience provides further evidence of sustained IFN beta-1b efficacy in modifying the natural course of MS.
Disclosure: RT received funding for travel or speaker honoraria from Almirall, Bayer, Biogen, Merck Serono, Novartis, Sanofi-Aventis, and TEVA.