Contributions
Abstract: P770
Type: Poster
Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response
Background: Subcutaneous interferon β-1a (scIFNβ-1a) has been commercially available since 1998, with approximately 1.44 million patient-years of exposure. scIFNβ-1a reduces relapse rates and delays disability progression in patients with multiple sclerosis (MS). This post-hoc analysis examined the association of the Magnetic Resonance Imaging in MS (MAGNIMS) score at Year 1 (Y1) with long-term clinical disease activity free (CDAF) status and disability progression in patients treated with scIFNβ-1a using data from 15 years of PRISMS.
Methods: In PRISMS-2 relapsing-remitting MS patients were randomised to scIFNβ-1a 22 µg (n=189) or 44 µg (n=184), or placebo (n=187), three times weekly for 2 years. At the start of Year 3 placebo patients were randomised to scIFNβ-1a 22/44 µg; scIFNβ-1a patients continued their initial regimen. Patients were followed to 15 years post-randomisation (scIFNβ-1a 22 µg n=95; 44 µg n=95; placebo n=100). We classified scIFNβ-1a patients by MAGNIMS score at Y1: 0 (0-2 new T2 lesions+0 relapses), 1 (0-2 new T2 lesions+1 relapse or >3 new T2 lesions+0 relapses) or 2 (0-2 new T2 lesions+≥2 relapses or ≥3 new T2 lesions+≥1 relapse). CDAF was defined as no relapses or disability progression (an increase of 1 point vs baseline in the Expanded Disability Status Scale [EDSS] score, or 1.5 points in patients with EDSS 0). Kaplan-Meier curves and median times to first clinical disease activity (CDA) event and EDSS progression from Y1 (95% confidence interval [CI]) are presented. Hazard ratios (HR) and 95% CIs are calculated.
Results: At Y1, 129, 108 and 130 scIFNβ-1a patients had a MAGNIMS score of 0, 1 and 2, respectively. Median time to CDA event was significantly longer in patients with Y1 MAGNIMS score of 0 (2.6 [2.1-3.5] years) vs 1 (1.7 [1.5-2.0] years) and 2 (1.3 [1.2-1.4] years). Median time to EDSS progression was longer in patients with Y1 MAGNIMS score of 0 (7.5 [6.9-13.5] years) vs 1 (4.0 [3.5-7.5] years) and 2 (2.5 [1.9-3.5] years). Using MAGNIMS score of 0 as a reference, HRs for having a CDA event and EDSS progression were 1.8 (1.4-2.4) and 1.6 (1.1-2.2), respectively, in patients with MAGNIMS score of 1, and 1.5 (1.3-1.8) and 1.5 (1.3-1.7), respectively, in patients with MAGNIMS score of 2.
Conclusions: In the PRISMS study population, the MAGNIMS score at Year 1 was able to predict the risk of a CDA event or disability progression in patients treated with scIFNβ-1a.
Disclosure: Supported by Merck KGaA, Darmstadt, Germany.
MPS: has received consulting fees from Biogen Idec, Merck Serono, Teva, Genzyme, Roche, Novartis, GeNeuro and Medday.
MSF: has received honoraria or consultation fees from Actelion, Bayer HealthCare, Biogen Idec, Chugai, EMD Canada, Genzyme, Hoffman La Roche, Novartis, Sanofi, Teva.
JA: is an employee of EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany.
KM: is an employee of Merck Gesellschaft mbH Austria, a business of Merck KGaA, Darmstadt, Germany.
NDS: has received honoraria and consultation fees from Merck Serono S.A., Teva Pharmaceutical Industries, Novartis Pharma AG, BayerSchering AG, Sanofi-Aventis and Serono Symposia International Foundation.
Abstract: P770
Type: Poster
Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response
Background: Subcutaneous interferon β-1a (scIFNβ-1a) has been commercially available since 1998, with approximately 1.44 million patient-years of exposure. scIFNβ-1a reduces relapse rates and delays disability progression in patients with multiple sclerosis (MS). This post-hoc analysis examined the association of the Magnetic Resonance Imaging in MS (MAGNIMS) score at Year 1 (Y1) with long-term clinical disease activity free (CDAF) status and disability progression in patients treated with scIFNβ-1a using data from 15 years of PRISMS.
Methods: In PRISMS-2 relapsing-remitting MS patients were randomised to scIFNβ-1a 22 µg (n=189) or 44 µg (n=184), or placebo (n=187), three times weekly for 2 years. At the start of Year 3 placebo patients were randomised to scIFNβ-1a 22/44 µg; scIFNβ-1a patients continued their initial regimen. Patients were followed to 15 years post-randomisation (scIFNβ-1a 22 µg n=95; 44 µg n=95; placebo n=100). We classified scIFNβ-1a patients by MAGNIMS score at Y1: 0 (0-2 new T2 lesions+0 relapses), 1 (0-2 new T2 lesions+1 relapse or >3 new T2 lesions+0 relapses) or 2 (0-2 new T2 lesions+≥2 relapses or ≥3 new T2 lesions+≥1 relapse). CDAF was defined as no relapses or disability progression (an increase of 1 point vs baseline in the Expanded Disability Status Scale [EDSS] score, or 1.5 points in patients with EDSS 0). Kaplan-Meier curves and median times to first clinical disease activity (CDA) event and EDSS progression from Y1 (95% confidence interval [CI]) are presented. Hazard ratios (HR) and 95% CIs are calculated.
Results: At Y1, 129, 108 and 130 scIFNβ-1a patients had a MAGNIMS score of 0, 1 and 2, respectively. Median time to CDA event was significantly longer in patients with Y1 MAGNIMS score of 0 (2.6 [2.1-3.5] years) vs 1 (1.7 [1.5-2.0] years) and 2 (1.3 [1.2-1.4] years). Median time to EDSS progression was longer in patients with Y1 MAGNIMS score of 0 (7.5 [6.9-13.5] years) vs 1 (4.0 [3.5-7.5] years) and 2 (2.5 [1.9-3.5] years). Using MAGNIMS score of 0 as a reference, HRs for having a CDA event and EDSS progression were 1.8 (1.4-2.4) and 1.6 (1.1-2.2), respectively, in patients with MAGNIMS score of 1, and 1.5 (1.3-1.8) and 1.5 (1.3-1.7), respectively, in patients with MAGNIMS score of 2.
Conclusions: In the PRISMS study population, the MAGNIMS score at Year 1 was able to predict the risk of a CDA event or disability progression in patients treated with scIFNβ-1a.
Disclosure: Supported by Merck KGaA, Darmstadt, Germany.
MPS: has received consulting fees from Biogen Idec, Merck Serono, Teva, Genzyme, Roche, Novartis, GeNeuro and Medday.
MSF: has received honoraria or consultation fees from Actelion, Bayer HealthCare, Biogen Idec, Chugai, EMD Canada, Genzyme, Hoffman La Roche, Novartis, Sanofi, Teva.
JA: is an employee of EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany.
KM: is an employee of Merck Gesellschaft mbH Austria, a business of Merck KGaA, Darmstadt, Germany.
NDS: has received honoraria and consultation fees from Merck Serono S.A., Teva Pharmaceutical Industries, Novartis Pharma AG, BayerSchering AG, Sanofi-Aventis and Serono Symposia International Foundation.