Contributions
Abstract: P340
Type: Poster
Abstract Category: Clinical aspects of MS - 5 Epidemiology
Background: While there is no consensus on definition, patients with relatively high disease activity (HDA) relapsing-remitting multiple sclerosis (RRMS) present with periods of frequent relapses and/or brain lesions. To determine the adequacy of current treatment, it is essential to understand the clinical characteristics of HDA-RRMS patients and treatment patterns.
Objectives: Describe the clinical characteristics of patients with RRMS and their treatment patterns, and compare these across categories of disease activity sourced from a real-world multiple sclerosis (MS) outcomes registry.
Methods: A cohort of 6,647 adult RRMS patients enrolled in the Swedish population-based MS register between 1996-2015 (inclusive) was followed from the date of disease modifying drug (DMD) initiation until discontinuation or last recorded visit. Time to first DMD switch was analysed with a Cox proportional hazards model, where switch was defined as the initiation of a new DMD within 6 months of discontinuing the initial DMD. All other patients were censored with no event at the end of follow-up. Estimates were adjusted for age, sex, initiation year, and type of DMD. Patients were classified into three subgroups at DMD initiation: active disease, defined as the presence of a relapse or T2 lesion, HDA-R defined as 2 relapses observed within 1 year of each other, or Highly Active RRMS (HA-RRMS) defined as 9 or more T2 lesions or at least 1 gadolinium-enhanced T1 lesion. Patients not fulfilling any subgroup criteria were classified as the low activity (LA) comparator group.
Results: Across the four disease activity groups, mean (standard deviation) age ranged from 34 (10) to 38 (10) years and percentage of females ranged from 69% to 75%. Median Kurtzke Expanded Disability Status Scale at DMD initiation was 1.5 for all groups except HA-RRMS, where the median was 2.0. Interferon was the most commonly initiated DMD but was considerably less common in the HA-RRMS group. Relative to the LA group, the adjusted hazard ratio (95% confidence interval) of DMD switch was 0.88 (0.81, 0.94), 0.87 (0.79, 0.96), and 1.17 (1.04, 1.32) for patients with active disease, HDA-R, and HA-RRMS, respectively.
Conclusions: These analyses suggest clinically relevant differences across the different definitions of disease activity studied here. Those with HA-RRMS appear to have a higher risk of DMD switch, indicating that satisfactory treatment options may not be available for these patients.
Disclosure: This study was sponsored by EMD Serono Inc, a business of Merck KGaA, Darmstadt, Germany.
TS received honoraria for consultancy, funding for travel and compensation for serving on scientific advisory boards from Biogen Idec Inc; speaker honoraria from Novartis.
KG provided consulting services to Merck as an employee of PAREXEL.
BA provided consulting services to Merck as an employee of PAREXEL.
JH has received honoraria for serving on advisory boards for Biogen, Sanofi-Genzyme and Novartis and speaker's fees from Biogen, Novartis, Merck-Serono, Bayer-Schering, Teva and Sanofi-Genzyme. He has served as P.I. for projects, or received unrestricted research support from, BiogenIdec, Merck-Serono, TEVA, Sanofi-Genzyme and Bayer-Schering. His MS research is funded by the Swedish Research Council and the Swedish Brain foundation.
SW is an employee of EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany
Abstract: P340
Type: Poster
Abstract Category: Clinical aspects of MS - 5 Epidemiology
Background: While there is no consensus on definition, patients with relatively high disease activity (HDA) relapsing-remitting multiple sclerosis (RRMS) present with periods of frequent relapses and/or brain lesions. To determine the adequacy of current treatment, it is essential to understand the clinical characteristics of HDA-RRMS patients and treatment patterns.
Objectives: Describe the clinical characteristics of patients with RRMS and their treatment patterns, and compare these across categories of disease activity sourced from a real-world multiple sclerosis (MS) outcomes registry.
Methods: A cohort of 6,647 adult RRMS patients enrolled in the Swedish population-based MS register between 1996-2015 (inclusive) was followed from the date of disease modifying drug (DMD) initiation until discontinuation or last recorded visit. Time to first DMD switch was analysed with a Cox proportional hazards model, where switch was defined as the initiation of a new DMD within 6 months of discontinuing the initial DMD. All other patients were censored with no event at the end of follow-up. Estimates were adjusted for age, sex, initiation year, and type of DMD. Patients were classified into three subgroups at DMD initiation: active disease, defined as the presence of a relapse or T2 lesion, HDA-R defined as 2 relapses observed within 1 year of each other, or Highly Active RRMS (HA-RRMS) defined as 9 or more T2 lesions or at least 1 gadolinium-enhanced T1 lesion. Patients not fulfilling any subgroup criteria were classified as the low activity (LA) comparator group.
Results: Across the four disease activity groups, mean (standard deviation) age ranged from 34 (10) to 38 (10) years and percentage of females ranged from 69% to 75%. Median Kurtzke Expanded Disability Status Scale at DMD initiation was 1.5 for all groups except HA-RRMS, where the median was 2.0. Interferon was the most commonly initiated DMD but was considerably less common in the HA-RRMS group. Relative to the LA group, the adjusted hazard ratio (95% confidence interval) of DMD switch was 0.88 (0.81, 0.94), 0.87 (0.79, 0.96), and 1.17 (1.04, 1.32) for patients with active disease, HDA-R, and HA-RRMS, respectively.
Conclusions: These analyses suggest clinically relevant differences across the different definitions of disease activity studied here. Those with HA-RRMS appear to have a higher risk of DMD switch, indicating that satisfactory treatment options may not be available for these patients.
Disclosure: This study was sponsored by EMD Serono Inc, a business of Merck KGaA, Darmstadt, Germany.
TS received honoraria for consultancy, funding for travel and compensation for serving on scientific advisory boards from Biogen Idec Inc; speaker honoraria from Novartis.
KG provided consulting services to Merck as an employee of PAREXEL.
BA provided consulting services to Merck as an employee of PAREXEL.
JH has received honoraria for serving on advisory boards for Biogen, Sanofi-Genzyme and Novartis and speaker's fees from Biogen, Novartis, Merck-Serono, Bayer-Schering, Teva and Sanofi-Genzyme. He has served as P.I. for projects, or received unrestricted research support from, BiogenIdec, Merck-Serono, TEVA, Sanofi-Genzyme and Bayer-Schering. His MS research is funded by the Swedish Research Council and the Swedish Brain foundation.
SW is an employee of EMD Serono, Inc., a business of Merck KGaA, Darmstadt, Germany