Contributions
Abstract: P592
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: MS-SPI was a 12-month (M) double-blind study where 154 patients (pts) with nonactive progressive multiple sclerosis (PMS) were randomised to MD1003 (n=103) or placebo (n=51). As reported previously, expanded disability status scale (EDSS) or timed 25-foot walk (TW25) improvement, mean EDSS (mEDSS) score, and clinical global impression (CGI) score were all significantly (P< 0.05) in favour of MD1003 relative to placebo (Tourbah et al., 2016). In the open-label extension phase, all pts received MD1003 after M12. Here, we present the 48M results (shown as MD1003>MD1003 [MM] vs placebo>MD1003 [PM]).
Objective: To evaluate the effects of MD1003 in pts with PMS during the open-label extension phase of the pivotal MS-SPI study.
Methods: A total of 133 pts (MM: 91; PM: 42) entered the extension phase. At M18, M24, M30, M36, M42 and M48 we assessed EDSS or TW25 improvement, mEDSS change from baseline, CGI, and adverse events (AEs).
Results: In the extension phase, where both groups received MD1003, EDSS or TW25 improvement remained higher for MM vs PM pts at M18 (13% vs 7%), M24 (8% vs 5%), M30 (10% vs 2%), M36 (13% vs 0%), and M42 (13% vs 3%) (each confirmed after 6M). The difference in mEDSS score between the MM and PM groups was significant at M30 (0.10 vs 0.23, P=0.041) but not at M24 (0.04 vs 0.15, P=0.13), M36 (0.09 vs 0.18, P=0.35), and M48 (0.16 vs 0.4, P=0.17). The 2 mEDSS evolution curves remained parallel, suggesting that earlier treatment leads to a lower disability at M48. CGI scores remained stable for MM pts and improved for PM pts upon switching to MD1003; the CGI scores were no longer significantly different at M24 (4.17 vs 4.24, P=0.75), M36 (4.11 vs 4.09, P=0.88), or M48 (4.40 vs 4.35, P=0.80). Between M42 and M48, AEs were experienced by 38% vs 34% of pts in MM and PM groups, respectively. The main reasons for treatment withdrawal throughout the study (n=86 pts) were consent withdrawal (30 pts), lack of efficacy (30 pts), and AEs (14 pts).
Conclusions: Results from the long-term extension phase of MS-SPI at 4 years of follow-up indicate that 1) the effects of MD1003 observed in the 12-month double-blind phase are sustained over time, 2) pts show improvement when switching from placebo to MD1003, 3) delayed treatment in PM pts results in higher disability over time, and 4) MD1003 is well tolerated over 48M. These data confirm previous observations made after 3 years of follow up.
Disclosure: Jérôme De Sèze: nothing to disclose.
Gilles Edan: received personal fees from Bayer, and grants and personal fees from Merck Serono, Teva, Biogen, Novartis and Sanofi.
Thibault Moreau: received consultancy fees, speaker fees, research supports or honoraria from Novartis, Biogen Idec, Merck, Roche, MedDay, Teva and Sanofi Genzyme.
Bruno Brochet: received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Novartis, Biogen Idec, Merck, Roche, MedDay, Bayer, Actelion, Teva and Sanofi Genzyme
Frédéric Sedel: employee of MedDay Pharmaceuticals.
Ayman Tourbah: in the last year, received consulting and lecturing fees, travel grants and research support from MedDay, Biogen Idec, Sanofi Genzyme, Novartis, Merck Serono, Teva and Roche.
This study was sponsored by MedDay Pharmaceuticals.
Abstract: P592
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: MS-SPI was a 12-month (M) double-blind study where 154 patients (pts) with nonactive progressive multiple sclerosis (PMS) were randomised to MD1003 (n=103) or placebo (n=51). As reported previously, expanded disability status scale (EDSS) or timed 25-foot walk (TW25) improvement, mean EDSS (mEDSS) score, and clinical global impression (CGI) score were all significantly (P< 0.05) in favour of MD1003 relative to placebo (Tourbah et al., 2016). In the open-label extension phase, all pts received MD1003 after M12. Here, we present the 48M results (shown as MD1003>MD1003 [MM] vs placebo>MD1003 [PM]).
Objective: To evaluate the effects of MD1003 in pts with PMS during the open-label extension phase of the pivotal MS-SPI study.
Methods: A total of 133 pts (MM: 91; PM: 42) entered the extension phase. At M18, M24, M30, M36, M42 and M48 we assessed EDSS or TW25 improvement, mEDSS change from baseline, CGI, and adverse events (AEs).
Results: In the extension phase, where both groups received MD1003, EDSS or TW25 improvement remained higher for MM vs PM pts at M18 (13% vs 7%), M24 (8% vs 5%), M30 (10% vs 2%), M36 (13% vs 0%), and M42 (13% vs 3%) (each confirmed after 6M). The difference in mEDSS score between the MM and PM groups was significant at M30 (0.10 vs 0.23, P=0.041) but not at M24 (0.04 vs 0.15, P=0.13), M36 (0.09 vs 0.18, P=0.35), and M48 (0.16 vs 0.4, P=0.17). The 2 mEDSS evolution curves remained parallel, suggesting that earlier treatment leads to a lower disability at M48. CGI scores remained stable for MM pts and improved for PM pts upon switching to MD1003; the CGI scores were no longer significantly different at M24 (4.17 vs 4.24, P=0.75), M36 (4.11 vs 4.09, P=0.88), or M48 (4.40 vs 4.35, P=0.80). Between M42 and M48, AEs were experienced by 38% vs 34% of pts in MM and PM groups, respectively. The main reasons for treatment withdrawal throughout the study (n=86 pts) were consent withdrawal (30 pts), lack of efficacy (30 pts), and AEs (14 pts).
Conclusions: Results from the long-term extension phase of MS-SPI at 4 years of follow-up indicate that 1) the effects of MD1003 observed in the 12-month double-blind phase are sustained over time, 2) pts show improvement when switching from placebo to MD1003, 3) delayed treatment in PM pts results in higher disability over time, and 4) MD1003 is well tolerated over 48M. These data confirm previous observations made after 3 years of follow up.
Disclosure: Jérôme De Sèze: nothing to disclose.
Gilles Edan: received personal fees from Bayer, and grants and personal fees from Merck Serono, Teva, Biogen, Novartis and Sanofi.
Thibault Moreau: received consultancy fees, speaker fees, research supports or honoraria from Novartis, Biogen Idec, Merck, Roche, MedDay, Teva and Sanofi Genzyme.
Bruno Brochet: received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Novartis, Biogen Idec, Merck, Roche, MedDay, Bayer, Actelion, Teva and Sanofi Genzyme
Frédéric Sedel: employee of MedDay Pharmaceuticals.
Ayman Tourbah: in the last year, received consulting and lecturing fees, travel grants and research support from MedDay, Biogen Idec, Sanofi Genzyme, Novartis, Merck Serono, Teva and Roche.
This study was sponsored by MedDay Pharmaceuticals.