Contributions
Abstract: P1221
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In the 2-year, phase 3 CARE-MS II clinical trial (NCT00548405), alemtuzumab significantly reduced the annualised relapse rate and brain volume loss, improved disability outcomes, and increased the proportion of patients with no evidence of MRI disease activity versus SC IFNB-1a in patients with active relapsing-remitting multiple sclerosis (RRMS) and an inadequate response (≥1 relapse) to prior therapy at baseline. An extension study (NCT00930553) has shown durable efficacy through 5 years in the absence of continuous treatment.
Goals: To evaluate the effect of alemtuzumab on MRI lesion outcomes over 6 years in patients who had an inadequate response to prior therapy at baseline.
Methods: In CARE-MS II, patients received 2 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 for relapse or MRI activity. Another disease-modifying therapy could be provided per investigator discretion. MRI scans (baseline and annually thereafter) were assessed for gadolinium (Gd)-enhancing T1, new/enlarging T2 hyperintense and new T1 hypointense lesions. Assessments: proportions of patients with 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 423 alemtuzumab patients who completed CARE-MS II, 393 (93%) entered the extension; of these, 344 (88%) remained on study through 6 years. In each year of the extension, high proportions of patients remained free of new Gd-enhancing T1, new/enlarging T2, and new T1 lesions (Year 6: 91%, 69%, and 89%, respectively). In each year, most patients showed no evidence of MRI disease activity (69% had no evidence of MRI activity in Year 6), and most achieved NEDA annually in the extension (Year 3: 53%; Year 4: 54%; Year 5: 58%; Year 6: 60%). These results were achieved with 50% of patients receiving no additional treatment after their initial 2 courses of alemtuzumab.
Conclusion: Efficacy on MRI outcomes with alemtuzumab was durable over 6 years in patients with an inadequate response to prior therapy at baseline, despite 50% of patients 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.
AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, 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 Schering, Merck Serono, Novartis, Sanofi, and Teva); lecture fees (Bayer Schering, Biogen Dompé, Merck Serono, Novartis, Sanofi, Serono Symposia International Foundation, and Teva).
JDS: Consulting and/or speaking fees, advisory board, and grant/research support (Sanofi Genzyme).
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 Labratories, 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).
DHM and KT: Employees of Sanofi Genzyme.
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 Pharmaceuticals).
Abstract: P1221
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In the 2-year, phase 3 CARE-MS II clinical trial (NCT00548405), alemtuzumab significantly reduced the annualised relapse rate and brain volume loss, improved disability outcomes, and increased the proportion of patients with no evidence of MRI disease activity versus SC IFNB-1a in patients with active relapsing-remitting multiple sclerosis (RRMS) and an inadequate response (≥1 relapse) to prior therapy at baseline. An extension study (NCT00930553) has shown durable efficacy through 5 years in the absence of continuous treatment.
Goals: To evaluate the effect of alemtuzumab on MRI lesion outcomes over 6 years in patients who had an inadequate response to prior therapy at baseline.
Methods: In CARE-MS II, patients received 2 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 for relapse or MRI activity. Another disease-modifying therapy could be provided per investigator discretion. MRI scans (baseline and annually thereafter) were assessed for gadolinium (Gd)-enhancing T1, new/enlarging T2 hyperintense and new T1 hypointense lesions. Assessments: proportions of patients with 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 423 alemtuzumab patients who completed CARE-MS II, 393 (93%) entered the extension; of these, 344 (88%) remained on study through 6 years. In each year of the extension, high proportions of patients remained free of new Gd-enhancing T1, new/enlarging T2, and new T1 lesions (Year 6: 91%, 69%, and 89%, respectively). In each year, most patients showed no evidence of MRI disease activity (69% had no evidence of MRI activity in Year 6), and most achieved NEDA annually in the extension (Year 3: 53%; Year 4: 54%; Year 5: 58%; Year 6: 60%). These results were achieved with 50% of patients receiving no additional treatment after their initial 2 courses of alemtuzumab.
Conclusion: Efficacy on MRI outcomes with alemtuzumab was durable over 6 years in patients with an inadequate response to prior therapy at baseline, despite 50% of patients 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.
AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, 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 Schering, Merck Serono, Novartis, Sanofi, and Teva); lecture fees (Bayer Schering, Biogen Dompé, Merck Serono, Novartis, Sanofi, Serono Symposia International Foundation, and Teva).
JDS: Consulting and/or speaking fees, advisory board, and grant/research support (Sanofi Genzyme).
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 Labratories, 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).
DHM and KT: Employees of Sanofi Genzyme.
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 Pharmaceuticals).