Contributions
Abstract: P682
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In the phase 3, CARE-MS I clinical trial (NCT00530348), alemtuzumab significantly reduced the annualised relapse rate and the rate of brain volume loss versus subcutaneous interferon beta-1a over 2 years in patients with active relapsing-remitting multiple sclerosis (RRMS) who were treatment-naive. Significantly higher proportions of alemtuzumab-treated patients also had no evidence of disease activity (NEDA) after 2 years. An extension study (NCT00930553) has shown that efficacy is durable through 5 years in the absence of continuous treatment.
Goal: To evaluate disease activity over 6 years in alemtuzumab patients who were treatment-naive.
Methods: In CARE-MS I, patients received 2 courses of alemtuzumab 12 mg (5 days at Month 0; 3 days at Month 12). At Month 24, patients who completed the core study could enter the extension study, with as-needed alemtuzumab for relapse or MRI activity. An alternative disease-modifying therapy could be provided per investigator discretion. Assessments included the proportion of patients with NEDA and its individual components, including absence of relapse, clinical disease activity (CDA: ≥1 relapse or 6-month confirmed disability worsening), and new MRI disease activity (gadolinium-enhancing T1 or new/enlarging T2 hyperintense lesions).
Results: Of the 367 alemtuzumab patients who completed CARE-MS I, 349 (95%) enrolled in the extension; of these, 325 (93%) remained in the study at 6 years. The proportion of patients with no evidence of relapse remained high in each year of the extension (Year 3: 84%; Year 4: 87%; Year 5: 88%; Year 6: 89%). In Years 3, 4, 5, and 6, high proportions of patients had no evidence of CDA (82%, 84%, 85%, and 86%) and no evidence of new MRI disease activity (72%, 70%, 70%, and 66%). The majority of patients achieved NEDA annually in the extension (Year 3: 62%; Year 4: 60%; Year 5: 62%; Year 6: 57%). These results were achieved with 63% of patients receiving no additional treatment after their initial 2 courses of alemtuzumab.
Conclusions: Alemtuzumab durably suppressed disease activity in patients who were treatment-naive. The majority of patients achieved NEDA in each year through Year 6, despite most receiving no additional treatment since the initial 2 courses of alemtuzumab. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continuous treatment for RRMS patients.
Disclosure:
Study support: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals.
HW: Consulting and/or speaking fees (Bayer, Biogen, Elan Corporation, Lilly, Lundbeck, Merck Serono, Novartis, Sanofi Genzyme, and Teva); grant/research support (Bayer, Biogen, Elan Corporation, Merck Serono, Novartis, Novo Nordisk, and Sanofi Genzyme).
DD: Institutional honoraria for advisory boards and participations and travel grants (Bayer, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
MD: Consultant/ advisory board participant and research support (Sanofi Genzyme).
CL: Compensation for consulting (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB).
OF: Consulting and/or speaking fees (Allergan, Almirall, Bayer, Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva). Compensation for serving as a journal editor, associate editor, or member of an editorial advisory board (Revista Española de Esclerosis Múltiple). Grant/Research Support (Hospital Foundation FIMABIS).
BSh: Nothing to disclose.
BSi: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Novartis, Pfizer, Roche-Genentech, Sanofi Genzyme and Teva); research support (Acorda, Biogen, MedImmune, Novartis, Roche, and Sanofi Genyzme).
PV: Consulting and/or speaking fees/Research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Novartis, Merck Serono, Sanofi Genzyme, and Teva).
DHM and KT: Employees of Sanofi Genzyme.
EH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi Genzyme, and Teva) and is supported by The Ministry of Education of Czech Republic (project PRVOUK -P26/LF1/4).
Abstract: P682
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In the phase 3, CARE-MS I clinical trial (NCT00530348), alemtuzumab significantly reduced the annualised relapse rate and the rate of brain volume loss versus subcutaneous interferon beta-1a over 2 years in patients with active relapsing-remitting multiple sclerosis (RRMS) who were treatment-naive. Significantly higher proportions of alemtuzumab-treated patients also had no evidence of disease activity (NEDA) after 2 years. An extension study (NCT00930553) has shown that efficacy is durable through 5 years in the absence of continuous treatment.
Goal: To evaluate disease activity over 6 years in alemtuzumab patients who were treatment-naive.
Methods: In CARE-MS I, patients received 2 courses of alemtuzumab 12 mg (5 days at Month 0; 3 days at Month 12). At Month 24, patients who completed the core study could enter the extension study, with as-needed alemtuzumab for relapse or MRI activity. An alternative disease-modifying therapy could be provided per investigator discretion. Assessments included the proportion of patients with NEDA and its individual components, including absence of relapse, clinical disease activity (CDA: ≥1 relapse or 6-month confirmed disability worsening), and new MRI disease activity (gadolinium-enhancing T1 or new/enlarging T2 hyperintense lesions).
Results: Of the 367 alemtuzumab patients who completed CARE-MS I, 349 (95%) enrolled in the extension; of these, 325 (93%) remained in the study at 6 years. The proportion of patients with no evidence of relapse remained high in each year of the extension (Year 3: 84%; Year 4: 87%; Year 5: 88%; Year 6: 89%). In Years 3, 4, 5, and 6, high proportions of patients had no evidence of CDA (82%, 84%, 85%, and 86%) and no evidence of new MRI disease activity (72%, 70%, 70%, and 66%). The majority of patients achieved NEDA annually in the extension (Year 3: 62%; Year 4: 60%; Year 5: 62%; Year 6: 57%). These results were achieved with 63% of patients receiving no additional treatment after their initial 2 courses of alemtuzumab.
Conclusions: Alemtuzumab durably suppressed disease activity in patients who were treatment-naive. The majority of patients achieved NEDA in each year through Year 6, despite most receiving no additional treatment since the initial 2 courses of alemtuzumab. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continuous treatment for RRMS patients.
Disclosure:
Study support: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals.
HW: Consulting and/or speaking fees (Bayer, Biogen, Elan Corporation, Lilly, Lundbeck, Merck Serono, Novartis, Sanofi Genzyme, and Teva); grant/research support (Bayer, Biogen, Elan Corporation, Merck Serono, Novartis, Novo Nordisk, and Sanofi Genzyme).
DD: Institutional honoraria for advisory boards and participations and travel grants (Bayer, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
MD: Consultant/ advisory board participant and research support (Sanofi Genzyme).
CL: Compensation for consulting (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB).
OF: Consulting and/or speaking fees (Allergan, Almirall, Bayer, Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva). Compensation for serving as a journal editor, associate editor, or member of an editorial advisory board (Revista Española de Esclerosis Múltiple). Grant/Research Support (Hospital Foundation FIMABIS).
BSh: Nothing to disclose.
BSi: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Novartis, Pfizer, Roche-Genentech, Sanofi Genzyme and Teva); research support (Acorda, Biogen, MedImmune, Novartis, Roche, and Sanofi Genyzme).
PV: Consulting and/or speaking fees/Research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Novartis, Merck Serono, Sanofi Genzyme, and Teva).
DHM and KT: Employees of Sanofi Genzyme.
EH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi Genzyme, and Teva) and is supported by The Ministry of Education of Czech Republic (project PRVOUK -P26/LF1/4).