Contributions
Abstract: EP1780
Type: ePoster
Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS
Objectives: The MS-SPI study is a double-blind, randomised, placebo-controlled trial of MD1003 in progressive, not clinically active multiple sclerosis patients (pts) with evidence of spastic paraparesis. It showed a reversal of Expanded Disability Status Scale (EDSS) and/or timed 25-foot walk (TW25) in 12.6% of MD1003 pts vs 0 placebo pts (p=0.005) at 12 months (M). Here, we present the main study EDSS sub-score results.
Methods: In each of the 154 pts included in the study, EDSS sub-scores were recorded for each functional system (FS): pyramidal (P), sensory (S), cerebellar (C11), visual (V), brainstem (BS), bowel and bladder (BB), and cerebral (Cb). Change in sub-score from baseline at each visit was used to define pts as responders (improved) or worsened, depending on whether the score was lower or higher than baseline.
Results: Disability was well balanced in each arm and only a small proportion had major disability (score ≥3), other than for P FS. The most common baseline sub-scores (% of pts affected) were: P: 3-4 (~90%); S: 2-3 (~70%); C11: 2-3 (~70%); V: 0-2 (~60%); BS: 0-2 (~50%); BB: 1-2 (~70%) and Cb: 0-2 (~50%).
P scores were ≥4 in 36% of MD1003 pts at baseline and 35% at M12, and in 43% of placebo pts at baseline and 53% at M12. Between M9 and M12, 10% of MD1003 pts and 2% of placebo pts were responders, while 6% of MD1003 pts and 13% of placebo pts worsened.
S scores were ≥4 in 3% of MD1003 pts at baseline and 2% at M12, and in 4% of placebo pts at baseline and 11% at M12. Between M9 and M12, 18% of MD1003 pts and 16% of placebo pts were responders, while 9% of MD1003 pts and 31% of placebo pts worsened.
For other FS, the percentage of pts defined as responders/worsened was similar in each arm. For Cb, BS and V, the majority of pts had no impairment or had mild to moderate disability. For C11 and BB, the majority of pts had symptoms but only mild to moderate impairment. However, BB scores between M9 and M12 showed that 10% of MD1003 pts and 13% of placebo pts were responders and 18% of MD1003 pts vs 27% of placebo pts worsened.
Discussion: For P and S scores, these results show an improvement in the MD1003 group and worsening in the placebo group. Improvement in the active arm fits with the positive effect on EDSS and TW25. Pts included in the study exhibited high baseline P and S scores while those of other FS were mild to moderate, and thus had less scope to improve.
Disclosure:
Caroline Papeix has received compensation as a consultant, advisory board member or speaker for Roche, Novartis, Biogen, Teva-Aventis, Sanofi Genzyme and MedDay.
Christine Lebrun-Frenay has participated in scientific boards for Biogen, Merck, Teva, MedDay, Roche and Novartis.
Gilles Defer has received personal compensation for serving on scientific advisory boards for Biogen Idec, Merck Serono, Novartis, Sanofi Aventis, Genzyme and Teva. He has received funding for travel and/or speaker honoraria from Merck Serono, Biogen, Guerbet, Sanofi Aventis, Novartis, Genzyme and Teva. His institution received grants supporting research in his department from Merck Serono, Biogen, Sanofi Aventis and Novartis.
Pierre Labauge has nothing to disclose.
Marta Ruiz has nothing to disclose.
Olivier Simon is an employee of MedDay.
Ayman Tourbah has received, in the last year, consulting and lecturing fees, travel grants and research support from Biogen Idec, Novartis, MedDay, Merck Serono, Roche, Sanofi Genzyme and Teva
Abstract: EP1780
Type: ePoster
Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS
Objectives: The MS-SPI study is a double-blind, randomised, placebo-controlled trial of MD1003 in progressive, not clinically active multiple sclerosis patients (pts) with evidence of spastic paraparesis. It showed a reversal of Expanded Disability Status Scale (EDSS) and/or timed 25-foot walk (TW25) in 12.6% of MD1003 pts vs 0 placebo pts (p=0.005) at 12 months (M). Here, we present the main study EDSS sub-score results.
Methods: In each of the 154 pts included in the study, EDSS sub-scores were recorded for each functional system (FS): pyramidal (P), sensory (S), cerebellar (C11), visual (V), brainstem (BS), bowel and bladder (BB), and cerebral (Cb). Change in sub-score from baseline at each visit was used to define pts as responders (improved) or worsened, depending on whether the score was lower or higher than baseline.
Results: Disability was well balanced in each arm and only a small proportion had major disability (score ≥3), other than for P FS. The most common baseline sub-scores (% of pts affected) were: P: 3-4 (~90%); S: 2-3 (~70%); C11: 2-3 (~70%); V: 0-2 (~60%); BS: 0-2 (~50%); BB: 1-2 (~70%) and Cb: 0-2 (~50%).
P scores were ≥4 in 36% of MD1003 pts at baseline and 35% at M12, and in 43% of placebo pts at baseline and 53% at M12. Between M9 and M12, 10% of MD1003 pts and 2% of placebo pts were responders, while 6% of MD1003 pts and 13% of placebo pts worsened.
S scores were ≥4 in 3% of MD1003 pts at baseline and 2% at M12, and in 4% of placebo pts at baseline and 11% at M12. Between M9 and M12, 18% of MD1003 pts and 16% of placebo pts were responders, while 9% of MD1003 pts and 31% of placebo pts worsened.
For other FS, the percentage of pts defined as responders/worsened was similar in each arm. For Cb, BS and V, the majority of pts had no impairment or had mild to moderate disability. For C11 and BB, the majority of pts had symptoms but only mild to moderate impairment. However, BB scores between M9 and M12 showed that 10% of MD1003 pts and 13% of placebo pts were responders and 18% of MD1003 pts vs 27% of placebo pts worsened.
Discussion: For P and S scores, these results show an improvement in the MD1003 group and worsening in the placebo group. Improvement in the active arm fits with the positive effect on EDSS and TW25. Pts included in the study exhibited high baseline P and S scores while those of other FS were mild to moderate, and thus had less scope to improve.
Disclosure:
Caroline Papeix has received compensation as a consultant, advisory board member or speaker for Roche, Novartis, Biogen, Teva-Aventis, Sanofi Genzyme and MedDay.
Christine Lebrun-Frenay has participated in scientific boards for Biogen, Merck, Teva, MedDay, Roche and Novartis.
Gilles Defer has received personal compensation for serving on scientific advisory boards for Biogen Idec, Merck Serono, Novartis, Sanofi Aventis, Genzyme and Teva. He has received funding for travel and/or speaker honoraria from Merck Serono, Biogen, Guerbet, Sanofi Aventis, Novartis, Genzyme and Teva. His institution received grants supporting research in his department from Merck Serono, Biogen, Sanofi Aventis and Novartis.
Pierre Labauge has nothing to disclose.
Marta Ruiz has nothing to disclose.
Olivier Simon is an employee of MedDay.
Ayman Tourbah has received, in the last year, consulting and lecturing fees, travel grants and research support from Biogen Idec, Novartis, MedDay, Merck Serono, Roche, Sanofi Genzyme and Teva