Contributions
Abstract: P876
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: The treatment landscape for multiple sclerosis (MS) has dramatically changed, but there is currently not a universally accepted treatment paradigm. There are two ongoing PCORI funded trials (DELIVER-MS and TREAT-MS) that aim to directly compare escalation (ESC) and early highly effective treatment (EHT) strategies.
Objectives/Aims:To determine if there is equipoise in the randomization of relapsing remitting MS (RRMS) patients to ESC vs. EHT algorithms based on a large clinical cohort.
Methods: Demographics, MS disease history, and iPad based neuroperformance tests were collected from 10 academic MS centers in the US and Europe utilizing the MSPATHS database. Demographics and pairwise comparisons between the EHT (monoclonal antibodies) and ESC (all other therapies) treated patients were performed for the entire RRMS population and treatment naïve patients. Group differences were examined using T-tests and chi-squared tests for normally distributed variables and Kruskal-Wallis test for non-parametric variables.
Results: 4317 RRMS patients on treatment were identified in MS PATHS (age 46± 11.5 years, female 75.3%, white 67.4%, education >12 years 74.2%, disease duration 11±8 years, PDDS 1.1±1.6, full time employment 54.6%, private insurance 67.4%, treatment naïve 37.1%). In the entire population the treatment groups did not differ on sex, education, walking speed, processing speed, or number of relapses in prior 12 months. The high efficacy group was overall younger, had been on their current DMT less time, had a higher proportion of Medicare/Medicaid, and higher proportion of patients with vocational disability (p < 0.05 for all). In the treatment naïve population the treatment groups were similar except EHT patients were younger (38 vs 47 years), had a shorter disease duration (3 vs 6 years), better processing speed (55 vs 52 correct), and a lower rate of full time employment (55% vs 59% full time). The groups did not differ in the number Gd enhancing lesions or new T2 lesions with available radiology data. Significant variability was observed in the proportion of patients treated with ESC vs EHT across different sites.
Conclusions: Treatment naïve patients placed on EHT have similar disease and demographic characteristics to those started on ESC. Treatment strategies vary across sites. This suggests that there is equipoise for randomizing patients between treatment strategies to generate evidence that will inform standardized best practices.
Disclosure: Marisa McGinley has served on scientific advisory boards for Genzyme and Genentech, and receives funding via a Sylvia Lawry Physician Fellowship Grant through the National Multiple Sclerosis Society (#FP-1506-04742)
Nicolas Thompson has received salary support paid to CCF by Novartis Pharmaceuticals for research outside this project.
Malory Weber has nothing to disclose
Robert Bermel has served as a consultant for Biogen, Genzyme, Genentech, and Novartis. He receives research support from Biogen and Genentech.
Daniel Ontaneda has received research support from National Multiple Sclerosis Society, National Institutes of Health, Patient Centered Research Institute, Race to Erase MS Foundation, Genentech, and Genzyme. He has also received consulting fees from Biogen Idec, Genentech/Roche, Genzyme, and Merck.
MS PATHS is sponsored by Biogen.
Abstract: P876
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: The treatment landscape for multiple sclerosis (MS) has dramatically changed, but there is currently not a universally accepted treatment paradigm. There are two ongoing PCORI funded trials (DELIVER-MS and TREAT-MS) that aim to directly compare escalation (ESC) and early highly effective treatment (EHT) strategies.
Objectives/Aims:To determine if there is equipoise in the randomization of relapsing remitting MS (RRMS) patients to ESC vs. EHT algorithms based on a large clinical cohort.
Methods: Demographics, MS disease history, and iPad based neuroperformance tests were collected from 10 academic MS centers in the US and Europe utilizing the MSPATHS database. Demographics and pairwise comparisons between the EHT (monoclonal antibodies) and ESC (all other therapies) treated patients were performed for the entire RRMS population and treatment naïve patients. Group differences were examined using T-tests and chi-squared tests for normally distributed variables and Kruskal-Wallis test for non-parametric variables.
Results: 4317 RRMS patients on treatment were identified in MS PATHS (age 46± 11.5 years, female 75.3%, white 67.4%, education >12 years 74.2%, disease duration 11±8 years, PDDS 1.1±1.6, full time employment 54.6%, private insurance 67.4%, treatment naïve 37.1%). In the entire population the treatment groups did not differ on sex, education, walking speed, processing speed, or number of relapses in prior 12 months. The high efficacy group was overall younger, had been on their current DMT less time, had a higher proportion of Medicare/Medicaid, and higher proportion of patients with vocational disability (p < 0.05 for all). In the treatment naïve population the treatment groups were similar except EHT patients were younger (38 vs 47 years), had a shorter disease duration (3 vs 6 years), better processing speed (55 vs 52 correct), and a lower rate of full time employment (55% vs 59% full time). The groups did not differ in the number Gd enhancing lesions or new T2 lesions with available radiology data. Significant variability was observed in the proportion of patients treated with ESC vs EHT across different sites.
Conclusions: Treatment naïve patients placed on EHT have similar disease and demographic characteristics to those started on ESC. Treatment strategies vary across sites. This suggests that there is equipoise for randomizing patients between treatment strategies to generate evidence that will inform standardized best practices.
Disclosure: Marisa McGinley has served on scientific advisory boards for Genzyme and Genentech, and receives funding via a Sylvia Lawry Physician Fellowship Grant through the National Multiple Sclerosis Society (#FP-1506-04742)
Nicolas Thompson has received salary support paid to CCF by Novartis Pharmaceuticals for research outside this project.
Malory Weber has nothing to disclose
Robert Bermel has served as a consultant for Biogen, Genzyme, Genentech, and Novartis. He receives research support from Biogen and Genentech.
Daniel Ontaneda has received research support from National Multiple Sclerosis Society, National Institutes of Health, Patient Centered Research Institute, Race to Erase MS Foundation, Genentech, and Genzyme. He has also received consulting fees from Biogen Idec, Genentech/Roche, Genzyme, and Merck.
MS PATHS is sponsored by Biogen.