Abstract: P683
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In the 2-year, phase 3 CARE-MS I clinical trial (NCT00530348), alemtuzumab significantly reduced the annualised relapse rate (ARR) and increased the proportion of patients with no evidence of MRI disease activity versus subcutaneous interferon beta-1a in patients with active relapsing-remitting multiple sclerosis (RRMS) who were treatment-naive at baseline (BL). Efficacy was durable through 5 years in the absence of continuous treatment in an extension study (NCT00930553).
Goal: To evaluate the effect of alemtuzumab on MRI lesion outcomes over 6 years in patients who were treatment-naive at BL.
Methods: In CARE-MS I, patients received two courses of alemtuzumab 12 mg (Month 0: 5 days; Month 12: 3 days). At the end of Year 2, patients who completed the study could enter the extension, with as-needed alemtuzumab treatment for relapse or MRI activity. Another disease-modifying therapy could be provided per investigator discretion. Baseline and annual MRI scans were assessed for gadolinium (Gd)-enhancing T1, new/enlarging T2 hyperintense, and new T1 hypointense lesions. Assessments included the proportions of patients who had no evidence of MRI disease activity (defined as no new Gd-enhancing T1 and no new/enlarging T2 lesions) and no evidence of disease activity (NEDA).
Results: Of the 367 alemtuzumab patients who completed CARE-MS I, 349 (95%) entered the extension; of these, 325 (93%) remained on study through 6 years. Throughout the extension, most patients remained free of new Gd-enhancing T1, new/enlarging T2, and new T1 lesions (87%, 67%, and 82%, respectively, were lesion-free in Year 6). In each year through Year 6, most patients showed no evidence of MRI disease activity (66% had no evidence of MRI activity in Year 6) and the majority achieved NEDA (Year 3: 62%; Year 4: 60%; Year 5: 62%, and Year 6: 57%). These efficacy results were achieved with 63% of patients receiving no additional treatment after their initial two courses of alemtuzumab.
Conclusion: The efficacy of alemtuzumab, as measured with MRI disease activity, was durable over 6 years in patients who were treatment-naive, despite most patients receiving no additional treatment since the initial two 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.
DLA: Compensation for serving as a speaker, consulting, and advisory board participant, and receiving research support (Acorda, Bayer, Biogen, Canadian Institutes of Health Research, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, MedImmune, Merck Serono, MS Society of Canada, NeuroRx Research, Novartis, Opexa Therapeutics, Receptos, Roche, Sanofi, Sanofi Genzyme, and Teva).
MB: Institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme); research consultant (Medical Safety Systems).
GC: Consulting fees (Actelion, Bayer, Merck Serono, Novartis, Sanofi Genzyme, and Teva); lecture fees (Bayer, Biogen Dompé, Merck Serono, Novartis, Sanofi Genzyme, Serono Symposia International Foundation, and Teva).
GG: Consulting and/or grant/research support (Abbvie, Bayer, Biogen, Canbex Therapeutics, Five Prime Therapeutics, GlaxoSmithKline, GW Pharma, Merck, Merck Serono, Novartis, Oxford Pharmagenesis, Protein Discovery Laboratories, Roche, Sanofi Genzyme, Synthon, Teva Neuroscience, and UCB).
DP: Consulting and/or speaking fees, and grant/research support (Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Vertex).
AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal).
SS: Consulting and/or speaking fees, and grant/research support (Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
BVW: Research and travel grants, honoraria for MS expert advice and speaker"s fees (Bayer-Schering, Biogen, Merck-Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
DHM and KT: Employees of Sanofi Genzyme.
AT: Consulting and/or speaking fees, and grant/research support (Biogen, Chugai, Roche, Sanofi Genzyme, and Teva).
Abstract: P683
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In the 2-year, phase 3 CARE-MS I clinical trial (NCT00530348), alemtuzumab significantly reduced the annualised relapse rate (ARR) and increased the proportion of patients with no evidence of MRI disease activity versus subcutaneous interferon beta-1a in patients with active relapsing-remitting multiple sclerosis (RRMS) who were treatment-naive at baseline (BL). Efficacy was durable through 5 years in the absence of continuous treatment in an extension study (NCT00930553).
Goal: To evaluate the effect of alemtuzumab on MRI lesion outcomes over 6 years in patients who were treatment-naive at BL.
Methods: In CARE-MS I, patients received two courses of alemtuzumab 12 mg (Month 0: 5 days; Month 12: 3 days). At the end of Year 2, patients who completed the study could enter the extension, with as-needed alemtuzumab treatment for relapse or MRI activity. Another disease-modifying therapy could be provided per investigator discretion. Baseline and annual MRI scans were assessed for gadolinium (Gd)-enhancing T1, new/enlarging T2 hyperintense, and new T1 hypointense lesions. Assessments included the proportions of patients who had no evidence of MRI disease activity (defined as no new Gd-enhancing T1 and no new/enlarging T2 lesions) and no evidence of disease activity (NEDA).
Results: Of the 367 alemtuzumab patients who completed CARE-MS I, 349 (95%) entered the extension; of these, 325 (93%) remained on study through 6 years. Throughout the extension, most patients remained free of new Gd-enhancing T1, new/enlarging T2, and new T1 lesions (87%, 67%, and 82%, respectively, were lesion-free in Year 6). In each year through Year 6, most patients showed no evidence of MRI disease activity (66% had no evidence of MRI activity in Year 6) and the majority achieved NEDA (Year 3: 62%; Year 4: 60%; Year 5: 62%, and Year 6: 57%). These efficacy results were achieved with 63% of patients receiving no additional treatment after their initial two courses of alemtuzumab.
Conclusion: The efficacy of alemtuzumab, as measured with MRI disease activity, was durable over 6 years in patients who were treatment-naive, despite most patients receiving no additional treatment since the initial two 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.
DLA: Compensation for serving as a speaker, consulting, and advisory board participant, and receiving research support (Acorda, Bayer, Biogen, Canadian Institutes of Health Research, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, MedImmune, Merck Serono, MS Society of Canada, NeuroRx Research, Novartis, Opexa Therapeutics, Receptos, Roche, Sanofi, Sanofi Genzyme, and Teva).
MB: Institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme); research consultant (Medical Safety Systems).
GC: Consulting fees (Actelion, Bayer, Merck Serono, Novartis, Sanofi Genzyme, and Teva); lecture fees (Bayer, Biogen Dompé, Merck Serono, Novartis, Sanofi Genzyme, Serono Symposia International Foundation, and Teva).
GG: Consulting and/or grant/research support (Abbvie, Bayer, Biogen, Canbex Therapeutics, Five Prime Therapeutics, GlaxoSmithKline, GW Pharma, Merck, Merck Serono, Novartis, Oxford Pharmagenesis, Protein Discovery Laboratories, Roche, Sanofi Genzyme, Synthon, Teva Neuroscience, and UCB).
DP: Consulting and/or speaking fees, and grant/research support (Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Vertex).
AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal).
SS: Consulting and/or speaking fees, and grant/research support (Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
BVW: Research and travel grants, honoraria for MS expert advice and speaker"s fees (Bayer-Schering, Biogen, Merck-Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
DHM and KT: Employees of Sanofi Genzyme.
AT: Consulting and/or speaking fees, and grant/research support (Biogen, Chugai, Roche, Sanofi Genzyme, and Teva).