Contributions
Abstract: EP1620
Type: Poster Sessions
Abstract Category: Therapy - Neuroprotection and Repair
Background: MD1003, prescribed in France under a temporary authorization for the treatment of progressive multiple sclerosis (PMS), achieved sustained reversal of MS-related disability in some patients (pts) with a non-active form of the disease in the MS-SPI study (Tourbah et al., 2016).
Objective: To assess in a real-world setting the effectiveness of a 12-month treatment with MD1003 on dexterity, cognition, and quality of life (QOL) measures, as well as in more traditional measures (expanded disability status scale [EDSS], timed 25-foot walk test [T25FWT], in a cohort of pts with non-active PMS from one clinical Centre.
Methods: A cohort of 103 pts with non-active PMS (mean age 56 +/-9.5 yrs; median EDSS 6.5 (4-7.5); disease duration 18.8 +/- 9yrs) treated with MD1003 300 mg/day were followed at Baseline, 3, 6 and 12 months. The cohort was divided into 3 groups according to baseline EDSS: group A (EDSS 4-5.5; n=16), B (EDSS 6-6.5; n=60), and C (EDSS 7-7.5; n=27). All groups were assessed for EDSS, T25FWT, 9-hole peg test (9NHPT), symbol digit modality Test (SDMT) and QOL using physical score of Multiple Sclerosis Impact Scale-29 (MSIS-29PHYS). Repeated measures analysis of variance (ANOVA) was used to analyze data. T- tests for paired samples was used for comparison 2 to 2.
Results: After 12 months of treatment, cohort showed significant improvement of dexterity, cognition and QOL (p< 0.05). Group A showed significant improvement in 9-HPT from Baseline to 6 (p< 0.01) and Baseline to 12 Months (p< 0.001). Group B showed significant improvement in MSIS-29PHYS and SDMT from Baseline to 3 (respectively: p< 0.001; p< 0.05), Baseline to 6 (respectively: p< 0.001; p< 0.05) and Baseline to 12 Months (respectively: p< 0.001; p< 0.05). Only the MSIS-29PHYS improved significantly from baseline to 6 Months in Group C (p< 0.01). After 12 months, 7/102 pts discontinued treatment because of lack of efficacy (n=6) and adverse event (n=1).
Conclusion: A 12-month MD1003 treatment for non-active PMS was well-tolerated in most pts in our cohort. At M12, improvement from baseline in cognition, QOL, and dexterity was significant in the cohort. Improvement tended to be greater for patient groups with Baseline EDSS 6-6.5. Clinical therapeutic evaluations could be adapted to disability score to detect improvement in PMS. Further research are needed to precise what kind of clinical measures could be proposed for pts with PMS.
Disclosure: C Donze: "nothing to disclose"
P Hautecoeur:
A Kwiatkowski:
B Lenne:"nothing to disclose"
MA Guyot: "nothing to disclose"
B Lenne: "nothing to disclose"
Abstract: EP1620
Type: Poster Sessions
Abstract Category: Therapy - Neuroprotection and Repair
Background: MD1003, prescribed in France under a temporary authorization for the treatment of progressive multiple sclerosis (PMS), achieved sustained reversal of MS-related disability in some patients (pts) with a non-active form of the disease in the MS-SPI study (Tourbah et al., 2016).
Objective: To assess in a real-world setting the effectiveness of a 12-month treatment with MD1003 on dexterity, cognition, and quality of life (QOL) measures, as well as in more traditional measures (expanded disability status scale [EDSS], timed 25-foot walk test [T25FWT], in a cohort of pts with non-active PMS from one clinical Centre.
Methods: A cohort of 103 pts with non-active PMS (mean age 56 +/-9.5 yrs; median EDSS 6.5 (4-7.5); disease duration 18.8 +/- 9yrs) treated with MD1003 300 mg/day were followed at Baseline, 3, 6 and 12 months. The cohort was divided into 3 groups according to baseline EDSS: group A (EDSS 4-5.5; n=16), B (EDSS 6-6.5; n=60), and C (EDSS 7-7.5; n=27). All groups were assessed for EDSS, T25FWT, 9-hole peg test (9NHPT), symbol digit modality Test (SDMT) and QOL using physical score of Multiple Sclerosis Impact Scale-29 (MSIS-29PHYS). Repeated measures analysis of variance (ANOVA) was used to analyze data. T- tests for paired samples was used for comparison 2 to 2.
Results: After 12 months of treatment, cohort showed significant improvement of dexterity, cognition and QOL (p< 0.05). Group A showed significant improvement in 9-HPT from Baseline to 6 (p< 0.01) and Baseline to 12 Months (p< 0.001). Group B showed significant improvement in MSIS-29PHYS and SDMT from Baseline to 3 (respectively: p< 0.001; p< 0.05), Baseline to 6 (respectively: p< 0.001; p< 0.05) and Baseline to 12 Months (respectively: p< 0.001; p< 0.05). Only the MSIS-29PHYS improved significantly from baseline to 6 Months in Group C (p< 0.01). After 12 months, 7/102 pts discontinued treatment because of lack of efficacy (n=6) and adverse event (n=1).
Conclusion: A 12-month MD1003 treatment for non-active PMS was well-tolerated in most pts in our cohort. At M12, improvement from baseline in cognition, QOL, and dexterity was significant in the cohort. Improvement tended to be greater for patient groups with Baseline EDSS 6-6.5. Clinical therapeutic evaluations could be adapted to disability score to detect improvement in PMS. Further research are needed to precise what kind of clinical measures could be proposed for pts with PMS.
Disclosure: C Donze: "nothing to disclose"
P Hautecoeur:
A Kwiatkowski:
B Lenne:"nothing to disclose"
MA Guyot: "nothing to disclose"
B Lenne: "nothing to disclose"