Contributions
Abstract: 263
Type: Scientific Session
Abstract Category: Clinical aspects of MS - Epidemiology
Introduction: Patients with relapsing-remitting multiple sclerosis (RRMS) who experience relapses often switch disease-modifying therapy (DMT). Treatment guidelines recommend switching to a highly effective DMT (HeDMT) when a patient experiences clinical disease breakthrough. Nevertheless, patients may switch between moderately effective DMTs (MeDMT) due to breakthrough disease or adverse effects.
Objective: To compare treatment effectiveness of HeDMT with MeDMT in patients with RRMS who switch therapy due to relapse activity.
Methods: In this registry-based cohort study we retrieved data from The Danish Multiple Sclerosis Registry (DMSR) on all adults with RRMS, with Expanded Disability Status Scale (EDSS) below level 6, who experienced a relapse while treated with an MeDMT, and, consequently, switched to either an HeDMT or an MeDMT. The groups were compared from treatment start and until outcome or censoring. Censoring was defined as post-baseline switch between HeDMT and MeDMT, cessation of therapy, relocation or death, whichever occurred first. Outcomes were annualized relapse rate (ARR), relapse rate ratio, time to first relapse and time to first 1-point confirmed EDSS worsening. We used propensity score matching approach to balance groups, Cox proportional hazards model to obtain hazard ratios (HR) when modeling time to first relapse and time to first worsening, and negative binomial regression to obtain ARR and relapse rate ratios.
Results: The matched cohort consisted of 814 patients (407 in each group). Median follow-up time was 3.2 years (Interquartile range (IR) 1.7-6.0). The group of patients who switched to an HeDMT had a 39% lower hazard rate of reaching first relapse (HR 0.61; 95% CI 0.50-0.74). ARRs were 0.21 (0.18-0.24) for patients who switched to an HeDMT and 0.34 (0.30-0.39) for patients who switched to an MeDMT. Relapse rate ratio for HeDMT compared with MeDMT was 0.62 (0.50-0.76). The group who switched to an HeDMT had 13% lower hazard rate of 1-point EDSS worsening (HR 0.87: 95% CI 0.66-1.16).
Conclusion: Based on virtually complete nationwide data from patients with MS in Denmark, relapse-induced escalation to an HeDMT was associated with reduced risk of relapses. We found a statistically non-significant trend towards reduced time to first 1-point EDSS worsening over the short-to-medium term. Escalation of therapy to an HeDMT when patients experience relapses on an MeDMT is recommended to improve control of relapse activity.
Disclosure:
Chalmer T. has received support for congress participation from Merck, Novartis, Biogen and Roche.
Kalincik T served on scientific advisory boards for Roche, Genzyme-Sanofi, Novartis, Merck and Biogen, steering committee for Brain Atrophy Initiative by Genzyme, received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Genzyme-Sanofi, Teva, BioCSL and Merck and received research support from Biogen.
Sorensen P.S. has received personal compensation for serving on advisory boards for Biogen, Merck, Novartis, Teva, MedDay Pharmaceuticals and GSK; on steering committees or independent data monitoring boards in trials sponsored by Merck, Teva, GSK, and Novartis; and has received speaker honoraria from Biogen, Merck Serono, Teva, Sanofi-Aventis, Genzyme, and Novartis.
Magyari M. has served on scientific advisory board for Biogen Idec, Novartis, Merck, Sanofi and Teva; has received honoraria for lecturing from Biogen Idec, Merck, Novartis and Genzyme; has received support for congress participation from Biogen Idec, Novartis, Genzyme and Teva.
Abstract: 263
Type: Scientific Session
Abstract Category: Clinical aspects of MS - Epidemiology
Introduction: Patients with relapsing-remitting multiple sclerosis (RRMS) who experience relapses often switch disease-modifying therapy (DMT). Treatment guidelines recommend switching to a highly effective DMT (HeDMT) when a patient experiences clinical disease breakthrough. Nevertheless, patients may switch between moderately effective DMTs (MeDMT) due to breakthrough disease or adverse effects.
Objective: To compare treatment effectiveness of HeDMT with MeDMT in patients with RRMS who switch therapy due to relapse activity.
Methods: In this registry-based cohort study we retrieved data from The Danish Multiple Sclerosis Registry (DMSR) on all adults with RRMS, with Expanded Disability Status Scale (EDSS) below level 6, who experienced a relapse while treated with an MeDMT, and, consequently, switched to either an HeDMT or an MeDMT. The groups were compared from treatment start and until outcome or censoring. Censoring was defined as post-baseline switch between HeDMT and MeDMT, cessation of therapy, relocation or death, whichever occurred first. Outcomes were annualized relapse rate (ARR), relapse rate ratio, time to first relapse and time to first 1-point confirmed EDSS worsening. We used propensity score matching approach to balance groups, Cox proportional hazards model to obtain hazard ratios (HR) when modeling time to first relapse and time to first worsening, and negative binomial regression to obtain ARR and relapse rate ratios.
Results: The matched cohort consisted of 814 patients (407 in each group). Median follow-up time was 3.2 years (Interquartile range (IR) 1.7-6.0). The group of patients who switched to an HeDMT had a 39% lower hazard rate of reaching first relapse (HR 0.61; 95% CI 0.50-0.74). ARRs were 0.21 (0.18-0.24) for patients who switched to an HeDMT and 0.34 (0.30-0.39) for patients who switched to an MeDMT. Relapse rate ratio for HeDMT compared with MeDMT was 0.62 (0.50-0.76). The group who switched to an HeDMT had 13% lower hazard rate of 1-point EDSS worsening (HR 0.87: 95% CI 0.66-1.16).
Conclusion: Based on virtually complete nationwide data from patients with MS in Denmark, relapse-induced escalation to an HeDMT was associated with reduced risk of relapses. We found a statistically non-significant trend towards reduced time to first 1-point EDSS worsening over the short-to-medium term. Escalation of therapy to an HeDMT when patients experience relapses on an MeDMT is recommended to improve control of relapse activity.
Disclosure:
Chalmer T. has received support for congress participation from Merck, Novartis, Biogen and Roche.
Kalincik T served on scientific advisory boards for Roche, Genzyme-Sanofi, Novartis, Merck and Biogen, steering committee for Brain Atrophy Initiative by Genzyme, received conference travel support and/or speaker honoraria from WebMD Global, Novartis, Biogen, Genzyme-Sanofi, Teva, BioCSL and Merck and received research support from Biogen.
Sorensen P.S. has received personal compensation for serving on advisory boards for Biogen, Merck, Novartis, Teva, MedDay Pharmaceuticals and GSK; on steering committees or independent data monitoring boards in trials sponsored by Merck, Teva, GSK, and Novartis; and has received speaker honoraria from Biogen, Merck Serono, Teva, Sanofi-Aventis, Genzyme, and Novartis.
Magyari M. has served on scientific advisory board for Biogen Idec, Novartis, Merck, Sanofi and Teva; has received honoraria for lecturing from Biogen Idec, Merck, Novartis and Genzyme; has received support for congress participation from Biogen Idec, Novartis, Genzyme and Teva.