Contributions
Abstract: P768
Type: Poster
Abstract Category: Therapy - symptomatic - Quality of life
Background: Disability significantly contributes to the impact of MS on patients" quality of life (QoL). Patients with active RRMS and an inadequate response (≥1 relapse) to prior therapy at baseline (BL) had improved clinical outcomes with alemtuzumab versus SC IFNB-1a over 2 years in CARE-MS II (NCT00548405). A significantly higher proportion of alemtuzumab patients achieved confirmed disability improvement (CDI). An extension study (NCT00930553) demonstrated durable efficacy of alemtuzumab through 5 years in the absence of continuous treatment.
Goal: To evaluate the relationship between CDI and QoL in alemtuzumab-treated patients over 5 years.
Methods: In CARE-MS II, patients received 2 courses of alemtuzumab 12 mg (5 days at Month 0; 3 days at Month 12). Patients who completed CARE-MS II could enter the extension, with as-needed alemtuzumab for relapse or MRI activity. Another DMT could be provided per investigator discretion. CDI was defined as ≥1.0-point EDSS score decrease sustained over 6 months. QoL assessments included FAMS, EQ-5D VAS, SF-36 PCS and MCS.
Results: 393 of 423 (93%) alemtuzumab patients who completed CARE MS II entered the extension; 357/393 (91%) remained on study at Year 5. Patients with CDI (n=61 [18%]) or without (n=269 [82%]) had stable/improved QoL. In Years 1-5, mean improvements from BL in FAMS, EQ-5D VAS, and SF-36 PCS scores were significantly greater in patients who achieved CDI versus those who did not (FAMS: 14.3, 12.7, 11.7, 10.0, and 9.7 versus 6.2, 3.5, 0.9, -0.4, and -0.9, respectively; EQ-5D VAS: 11.1, 11.2, 7.9, 8.3, 7.7 versus 4.4, 3.4, 1.2, 0.8, and 0.2; SF-36 PCS: 5.5, 5.1, 4.1, 3.8, and 3.6 versus 2.2, 1.9, 0.6, -0.2, and -0.1; all P< 0.05). SF-36 MCS improvements were also greater for patients with CDI (4.2, 3.2, 3.2, 3.1, and 3.5) than without (3.0, 1.6, 1.1, 1.1, and 0.1, respectively; Year 5 P< 0.05). Proportions with improved (≥5-point increase) or stable (< 5.0-point change) scores were higher for patients with CDI than without on the SF-36 PCS (Years 1-5: 90.2%, 83.3%, 84.6%, 86.4%, and 88.5% vs 85.8%, 81.3%, 79.9%, 72.4%, and 78.5%; all P< 0.05) and MCS (83.6%, 76.0%, 74.0%, 77.1%, and 78.8% vs 76.6%, 73.5%, 69.8%, 67.3%, and 68.7%; Years 4 and 5: P< 0.05).
Conclusion: In alemtuzumab-treated patients with or without CDI, QoL measurements are improved or stable over 5 years. Improvements are greater in patients achieving CDI, demonstrating that this outcome measure is clinically meaningful.
Disclosure:
Study support: Sanofi Genzyme and Bayer Healthcare Pharmaceuticals.
RAG: Advisory board participant and speaker (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, Teva).
DD: Honoraria for advisory boards and participations and travel grants from Bayer, Merck-Serono, Novartis, Sanofi Genzyme, and Teva.
MD: Consultant, advisory board participant, and research support from Sanofi Genzyme. RH: Research grants, speaking fees and honoraria for advisory boards from Biogen, Merck, Novartis, Sanofi Genzyme, and Teva.
CL: Compensation for consulting (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB).
JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi Genzyme, and Teva); serving on scientific advisory boards (Almirall, Biogen, Novartis, Sanofi Genzyme, and Teva); serves on the editorial board of the Acta Neurologica Scandinavica; unconditional research grants (Biogen, Novartis, and Teva).
TM: Consulting fees and speaking fees (Almirall, Bayer Schering, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva).
BS: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Genentech, Novartis, Pfizer, Sanofi Genzyme, and Teva); research support (Acorda, Biogen, MedImmune, Novartis, Roche, and Sanofi Genzyme).
DM and KT: Employees of Sanofi Genzyme.
GG: Personal compensation for participating on advisory boards in relation to clinical trial design, trial steering committees, and data and safety monitoring committees (Bayer Healthcare Pharmaceuticals, Biogen, Canbex, Eisai, Elan, Five Prime Therapeutics, Genentech, GlaxoSmithKline, Ironwood, Merck Serono, Novartis, Pfizer, Roche, Sanofi Genzyme, Synthon BV, Teva, UCB Pharma, and Vertex Pharmaceuticals).
Abstract: P768
Type: Poster
Abstract Category: Therapy - symptomatic - Quality of life
Background: Disability significantly contributes to the impact of MS on patients" quality of life (QoL). Patients with active RRMS and an inadequate response (≥1 relapse) to prior therapy at baseline (BL) had improved clinical outcomes with alemtuzumab versus SC IFNB-1a over 2 years in CARE-MS II (NCT00548405). A significantly higher proportion of alemtuzumab patients achieved confirmed disability improvement (CDI). An extension study (NCT00930553) demonstrated durable efficacy of alemtuzumab through 5 years in the absence of continuous treatment.
Goal: To evaluate the relationship between CDI and QoL in alemtuzumab-treated patients over 5 years.
Methods: In CARE-MS II, patients received 2 courses of alemtuzumab 12 mg (5 days at Month 0; 3 days at Month 12). Patients who completed CARE-MS II could enter the extension, with as-needed alemtuzumab for relapse or MRI activity. Another DMT could be provided per investigator discretion. CDI was defined as ≥1.0-point EDSS score decrease sustained over 6 months. QoL assessments included FAMS, EQ-5D VAS, SF-36 PCS and MCS.
Results: 393 of 423 (93%) alemtuzumab patients who completed CARE MS II entered the extension; 357/393 (91%) remained on study at Year 5. Patients with CDI (n=61 [18%]) or without (n=269 [82%]) had stable/improved QoL. In Years 1-5, mean improvements from BL in FAMS, EQ-5D VAS, and SF-36 PCS scores were significantly greater in patients who achieved CDI versus those who did not (FAMS: 14.3, 12.7, 11.7, 10.0, and 9.7 versus 6.2, 3.5, 0.9, -0.4, and -0.9, respectively; EQ-5D VAS: 11.1, 11.2, 7.9, 8.3, 7.7 versus 4.4, 3.4, 1.2, 0.8, and 0.2; SF-36 PCS: 5.5, 5.1, 4.1, 3.8, and 3.6 versus 2.2, 1.9, 0.6, -0.2, and -0.1; all P< 0.05). SF-36 MCS improvements were also greater for patients with CDI (4.2, 3.2, 3.2, 3.1, and 3.5) than without (3.0, 1.6, 1.1, 1.1, and 0.1, respectively; Year 5 P< 0.05). Proportions with improved (≥5-point increase) or stable (< 5.0-point change) scores were higher for patients with CDI than without on the SF-36 PCS (Years 1-5: 90.2%, 83.3%, 84.6%, 86.4%, and 88.5% vs 85.8%, 81.3%, 79.9%, 72.4%, and 78.5%; all P< 0.05) and MCS (83.6%, 76.0%, 74.0%, 77.1%, and 78.8% vs 76.6%, 73.5%, 69.8%, 67.3%, and 68.7%; Years 4 and 5: P< 0.05).
Conclusion: In alemtuzumab-treated patients with or without CDI, QoL measurements are improved or stable over 5 years. Improvements are greater in patients achieving CDI, demonstrating that this outcome measure is clinically meaningful.
Disclosure:
Study support: Sanofi Genzyme and Bayer Healthcare Pharmaceuticals.
RAG: Advisory board participant and speaker (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, Teva).
DD: Honoraria for advisory boards and participations and travel grants from Bayer, Merck-Serono, Novartis, Sanofi Genzyme, and Teva.
MD: Consultant, advisory board participant, and research support from Sanofi Genzyme. RH: Research grants, speaking fees and honoraria for advisory boards from Biogen, Merck, Novartis, Sanofi Genzyme, and Teva.
CL: Compensation for consulting (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB).
JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi Genzyme, and Teva); serving on scientific advisory boards (Almirall, Biogen, Novartis, Sanofi Genzyme, and Teva); serves on the editorial board of the Acta Neurologica Scandinavica; unconditional research grants (Biogen, Novartis, and Teva).
TM: Consulting fees and speaking fees (Almirall, Bayer Schering, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva).
BS: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Genentech, Novartis, Pfizer, Sanofi Genzyme, and Teva); research support (Acorda, Biogen, MedImmune, Novartis, Roche, and Sanofi Genzyme).
DM and KT: Employees of Sanofi Genzyme.
GG: Personal compensation for participating on advisory boards in relation to clinical trial design, trial steering committees, and data and safety monitoring committees (Bayer Healthcare Pharmaceuticals, Biogen, Canbex, Eisai, Elan, Five Prime Therapeutics, Genentech, GlaxoSmithKline, Ironwood, Merck Serono, Novartis, Pfizer, Roche, Sanofi Genzyme, Synthon BV, Teva, UCB Pharma, and Vertex Pharmaceuticals).