Contributions
Abstract: P681
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In patients with active relapsing-remitting multiple sclerosis (RRMS) and an inadequate response (≥1 relapse) to prior therapy at baseline, alemtuzumab treatment significantly reduced the annualised relapse rate and the rate of brain volume loss versus subcutaneous interferon beta-1a over 2 years (CARE-MS II; NCT00548405). Significantly higher proportions of alemtuzumab-treated patients also had no evidence of disease activity (NEDA) over 2 years. An extension study (NCT00930553) has shown durable efficacy through 5 years in the absence of continuous treatment.
Goal: To evaluate disease activity over 6 years in alemtuzumab patients with an inadequate response to prior therapy.
Methods: In CARE-MS II, patients received 2 treatment 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 study, with as-needed alemtuzumab retreatment for relapse or MRI activity. An alternate 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 423 alemtuzumab patients who completed CARE-MS II, 393 (93%) enrolled in the extension study; 344 (88%) remained on study through 6 years. The proportion of patients with no evidence of relapse remained high in each year of the extension (Year 3: 81%; Year 4: 80%; Year 5: 84%; Year 6: 88%). In Years 3, 4, 5, and 6, high proportions of patients had no evidence of CDA (76%, 75%, 80%, and 85%) and no evidence of new MRI disease activity (68%, 70%, 68%, and 69%). The majority of patients achieved NEDA annually (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.
Conclusions: Alemtuzumab durably suppressed disease activity in patients who had an inadequate response to prior therapy. The majority of patients achieved NEDA in each year through Year 6, despite 50% 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.
CL: Compensation for consulting (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB).
JDS: Consulting and/or speaking fees, advisory board, and grant/research support (Sanofi Genzyme).
MSF: Honoraria or consulting fees (Actelion, Bayer Healthcare, Biogen, Canada Innovation, Chugai, EMD Canada, Hoffman-La Roche, Merck Serono, Novartis, Sanofi Aventis, Sanofi Genzyme, and Teva); serving on advisory boards, board of directors or other similar group (Actelion, Bayer Healthcare, Biogen, Hoffman-La Roche, Merck Serono, Novartis, Opexa, and Sanofi Aventis); and participation in speaker"s bureau (Sanofi Genzyme).
MH: Nothing to disclose.
RMMH: Research grants, speaker´s fees and honoraria for advisory boards (Biogen, Merck, Novartis, Sanofi Genzyme, and Teva).
VL: Honoraria for consulting and speaking at symposia (Bayer Healthcare, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi, and Teva, with approval by the HR-Department, Cologne General Hospital, University of Cologne).
RALM: Honoraria and travel support (Biogen Idec, Merck Serono, Genzyme, Bayer, and Novartis). Honoraria for speaking engagements and advisory boards are directed to N-CRESS at Austin Heath. N-CRESS also receives sponsorship from Biogen Idec, Merck Serono, Genzyme, CSL, Bayer, and Novartis.
KS: Consulting and/or speaking fees (Biogen Idec, Merck, Novartis, Roche, Sanofi Genzyme, and Synthon).
DHM and KT: Employees of Sanofi Genzyme.
EH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi Genzyme, and Teva), and support from Ministry of Education of Czech Republic, project PRVOUK -P26/LF1/4).
Abstract: P681
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In patients with active relapsing-remitting multiple sclerosis (RRMS) and an inadequate response (≥1 relapse) to prior therapy at baseline, alemtuzumab treatment significantly reduced the annualised relapse rate and the rate of brain volume loss versus subcutaneous interferon beta-1a over 2 years (CARE-MS II; NCT00548405). Significantly higher proportions of alemtuzumab-treated patients also had no evidence of disease activity (NEDA) over 2 years. An extension study (NCT00930553) has shown durable efficacy through 5 years in the absence of continuous treatment.
Goal: To evaluate disease activity over 6 years in alemtuzumab patients with an inadequate response to prior therapy.
Methods: In CARE-MS II, patients received 2 treatment 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 study, with as-needed alemtuzumab retreatment for relapse or MRI activity. An alternate 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 423 alemtuzumab patients who completed CARE-MS II, 393 (93%) enrolled in the extension study; 344 (88%) remained on study through 6 years. The proportion of patients with no evidence of relapse remained high in each year of the extension (Year 3: 81%; Year 4: 80%; Year 5: 84%; Year 6: 88%). In Years 3, 4, 5, and 6, high proportions of patients had no evidence of CDA (76%, 75%, 80%, and 85%) and no evidence of new MRI disease activity (68%, 70%, 68%, and 69%). The majority of patients achieved NEDA annually (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.
Conclusions: Alemtuzumab durably suppressed disease activity in patients who had an inadequate response to prior therapy. The majority of patients achieved NEDA in each year through Year 6, despite 50% 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.
CL: Compensation for consulting (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB).
JDS: Consulting and/or speaking fees, advisory board, and grant/research support (Sanofi Genzyme).
MSF: Honoraria or consulting fees (Actelion, Bayer Healthcare, Biogen, Canada Innovation, Chugai, EMD Canada, Hoffman-La Roche, Merck Serono, Novartis, Sanofi Aventis, Sanofi Genzyme, and Teva); serving on advisory boards, board of directors or other similar group (Actelion, Bayer Healthcare, Biogen, Hoffman-La Roche, Merck Serono, Novartis, Opexa, and Sanofi Aventis); and participation in speaker"s bureau (Sanofi Genzyme).
MH: Nothing to disclose.
RMMH: Research grants, speaker´s fees and honoraria for advisory boards (Biogen, Merck, Novartis, Sanofi Genzyme, and Teva).
VL: Honoraria for consulting and speaking at symposia (Bayer Healthcare, Biogen, Genzyme, Merck Serono, Novartis, Roche, Sanofi, and Teva, with approval by the HR-Department, Cologne General Hospital, University of Cologne).
RALM: Honoraria and travel support (Biogen Idec, Merck Serono, Genzyme, Bayer, and Novartis). Honoraria for speaking engagements and advisory boards are directed to N-CRESS at Austin Heath. N-CRESS also receives sponsorship from Biogen Idec, Merck Serono, Genzyme, CSL, Bayer, and Novartis.
KS: Consulting and/or speaking fees (Biogen Idec, Merck, Novartis, Roche, Sanofi Genzyme, and Synthon).
DHM and KT: Employees of Sanofi Genzyme.
EH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi Genzyme, and Teva), and support from Ministry of Education of Czech Republic, project PRVOUK -P26/LF1/4).