Contributions
Abstract: P1196
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Early start of disease modifying treatment (DMT) is widely considered best practice in the treatment of multiple sclerosis (MS). The beneficial effects of early treatment start have mainly been found in extensions of randomised controlled trials, while the few observational studies on this topic have varying results.
Objective: The aim of the study was to assess the effect of DMT initiation early in the disease course compared to late treatment start. We defined confirmed EDSS 6 and the hazard of death as study outcomes.
Methods: Information about all Danish MS patients (n=3,795) treated with DMT was retrieved from nationwide population based MS registries, The Danish Multiple Sclerosis Treatment Register and The Danish Multiple Sclerosis Registry. We defined a cohort consisting of early treated, defined as treatment start within 2 years after first MS symptom (n=2,395) and one of late treated patients, defined as treatment start between 2 and 8 years from clinical onset (n=1,550). Differences between cohorts were adjusted for using propensity score-based inverse probability of treatment weights. Follow-up time was 6 months to 20 years, with an average of 10.9 years for the mortality outcome and 8.7 years for the EDSS 6 outcome. A Cox proportional hazards model was used for both outcomes. A range of sensitivity analyses were conducted.
Results: Patients with late treatment start had a higher hazard of reaching EDSS 6 (HR 1.28; 95% CI 1.12-1.45; p< 0.001). When stratified by gender the increased hazard among late treated women (n=2,601) persisted (HR 1.39; 95% CI 1.10-1.76; p=0.005), but among men (n=1193) no difference in the study endpoints between early and late treatment start was seen (HR 1.09; 95% CI 0.89-1.34; p=0.41). No difference in hazard of mortality was seen between early and late treatment start (HR 1.02; 95% CI 0.71-1.47 p=0.90).
Conclusion: The delay between clinical onset of MS and DMT initiation seems to have an effect on long-term hazard of reaching EDSS 6, but did not influence the mortality during the observation period. Moreover, the treatment benefit was only found statistically significant in women. Analyses of real-world data can contribute with important post-marketing knowledge about treatment effectiveness, and especially when the study is based on nationwide data. Our results support the scheme of early treatment, but based on Danish data treatment benefits are limited.
Disclosure:
Thor A Ameri has received support for congress participation from Biogen Idec, Novartis, Merck. Melinda Magyari has served on scientific advisory board for Biogen Idec and Novartis, Merck, Sanofi, Teva, has received honoraria for lecturing from Biogen Idec, Merck, Novartis, Genzyme, has received support for congress participation from Biogen Idec, Novartis, Genzyme, Teva.
Mette Nørgaard: Nothing to disclose
Lisbeth M. Baggesen: Nothing to disclose
P. Soelberg-Sorensen 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.
Abstract: P1196
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Early start of disease modifying treatment (DMT) is widely considered best practice in the treatment of multiple sclerosis (MS). The beneficial effects of early treatment start have mainly been found in extensions of randomised controlled trials, while the few observational studies on this topic have varying results.
Objective: The aim of the study was to assess the effect of DMT initiation early in the disease course compared to late treatment start. We defined confirmed EDSS 6 and the hazard of death as study outcomes.
Methods: Information about all Danish MS patients (n=3,795) treated with DMT was retrieved from nationwide population based MS registries, The Danish Multiple Sclerosis Treatment Register and The Danish Multiple Sclerosis Registry. We defined a cohort consisting of early treated, defined as treatment start within 2 years after first MS symptom (n=2,395) and one of late treated patients, defined as treatment start between 2 and 8 years from clinical onset (n=1,550). Differences between cohorts were adjusted for using propensity score-based inverse probability of treatment weights. Follow-up time was 6 months to 20 years, with an average of 10.9 years for the mortality outcome and 8.7 years for the EDSS 6 outcome. A Cox proportional hazards model was used for both outcomes. A range of sensitivity analyses were conducted.
Results: Patients with late treatment start had a higher hazard of reaching EDSS 6 (HR 1.28; 95% CI 1.12-1.45; p< 0.001). When stratified by gender the increased hazard among late treated women (n=2,601) persisted (HR 1.39; 95% CI 1.10-1.76; p=0.005), but among men (n=1193) no difference in the study endpoints between early and late treatment start was seen (HR 1.09; 95% CI 0.89-1.34; p=0.41). No difference in hazard of mortality was seen between early and late treatment start (HR 1.02; 95% CI 0.71-1.47 p=0.90).
Conclusion: The delay between clinical onset of MS and DMT initiation seems to have an effect on long-term hazard of reaching EDSS 6, but did not influence the mortality during the observation period. Moreover, the treatment benefit was only found statistically significant in women. Analyses of real-world data can contribute with important post-marketing knowledge about treatment effectiveness, and especially when the study is based on nationwide data. Our results support the scheme of early treatment, but based on Danish data treatment benefits are limited.
Disclosure:
Thor A Ameri has received support for congress participation from Biogen Idec, Novartis, Merck. Melinda Magyari has served on scientific advisory board for Biogen Idec and Novartis, Merck, Sanofi, Teva, has received honoraria for lecturing from Biogen Idec, Merck, Novartis, Genzyme, has received support for congress participation from Biogen Idec, Novartis, Genzyme, Teva.
Mette Nørgaard: Nothing to disclose
Lisbeth M. Baggesen: Nothing to disclose
P. Soelberg-Sorensen 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.