Contributions
Abstract: P628
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Introduction: Over 2 years (y) in the CARE-MS studies, 2 courses of alemtuzumab (12 mg/day; baseline: 5 days; 12 months [M] later: 3 days) significantly improved outcomes vs SC IFNB-1a in treatment-naive RRMS patients (CARE-MS I; NCT00530348) or those who had an inadequate response to prior therapy (CARE-MS II; NCT00548405). Alemtuzumab remained efficacious in a 4-y extension (NCT00930553), wherein patients could receive additional courses of alemtuzumab (12 mg/day on 3 days; ≥12M apart) as needed for disease activity, or receive another disease-modifying therapy (DMT; investigator discretion). After the 4-y extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension study, in which patients can receive additional as-needed alemtuzumab (≥12M apart; no criteria), or receive another DMT (any time).
Aims: To evaluate efficacy and safety in pooled CARE-MS patients who received Course 4 (C4) of alemtuzumab over 7 y.
Methods: Inclusion criteria for this analysis: ≥4 courses by M72, to allow ≥12M follow-up post-C4; no other DMT. Data were censored at C5.
Results: 742/811 (91%) pooled CARE-MS patients entered the extension, with 129 (17%) receiving ≥4 courses. C4 was given in Y4 (6.0%), Y5 (4.6%), Y6 (3.5%), or Y7 (3.2%); mean time was 1.9 y after C3. 103 (14%) patients met the analysis inclusion criteria. Annualised relapse rate was 1.59 12M pre-study, 0.77 12M pre-C4, 0.24 12M post-C4 (P< 0.0001), and 0.27 36M post-C4. At 36M post-C4, mean EDSS score change was -0.37 from the time of C4 administration, 95% of patients were free of 6-M confirmed disability worsening, and 31% of patients had 6-M confirmed disability improvement. At 12M pre-C4, 12M post-C4, and 36M post-C4, patients were free of MRI disease activity (50%, 65% [P< 0.01], and 74%, respectively), new gadolinium-enhancing lesions (64%, 81% [P< 0.01], 88%), new/enlarging T2 hyperintense lesions (50%, 65% [P< 0.01], 74%), and new T1 hypointense lesions (66%, 75% [P< 0.05], 87%). Incidence of adverse events (AEs), including infections and autoimmune AEs, in patients receiving additional courses was similar to the overall CARE-MS population and those receiving 2 courses over 7 y.
Conclusion: In the small percentage of patients with disease activity after C3, a fourth course of alemtuzumab, given on average 1.9 years after C3, improved clinical and MRI outcomes up to 36M. Safety was similar to the overall CARE-MS population and those receiving 2 courses over 7 y.
Disclosure: SS: Consulting and/or speaking fees (Biogen, Merck Serono, Novartis, Sanofi, and Teva); grant/research support (Novartis and Sanofi). ADB: Consulting fees/fees for non-CME services from commercial interest or their agents/grant and research support (Biogen, Mallinckrodt, Novartis, Roche-Genentech, Sanofi, Teva Neuroscience, and TG Therapeutics). AB: Consulting fees and/or fees for non-CME services (Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi, and Teva). RB: Advisory boards and consulting (Acorda, Avanir, Bayer, Biogen, Novartis, Questcor, Sanofi, and Teva). GC: Consulting fees (Actelion, Bayer, Merck Serono, Novartis, Sanofi, and Teva); lecture fees (Bayer, Biogen Dompé, Merck Serono, Novartis, Sanofi, Serono Symposia International Foundation, and Teva). OF: Speaking and/or consulting (Allergan, Almirall, Bayer-Schering, Biogen, Merck Serono, Novartis, Sanofi, and Teva); compensation for serving as a journal editor, associate editor, or member of an editorial advisory board (Revista Española de Esclerosis Múltiple); and research support (Hospital Foundation FIMABIS). HJK: Consulting and/or speaking fees (Bayer, Biogen, Celltrion, Eisai, Genzyme, HanAll BioPharma, MedImmune, Merck Serono, Novartis, Teva-Handok, and UCB); research support (Genzyme, Merck Serono, Ministry of Science & ICT, Teva-Handok, and UCB); steering committee member (MedImmune); co-editor (Multiple Sclerosis Journal - Experimental, Translational, and Clinical); and associate editor (Journal of Clinical Neurology). VL: Honoraria for consulting and speaking at symposia (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva, with approval by the HR Department, Cologne General Hospital, and University of Cologne). JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi, and Teva); scientific advisory boards (Almirall, Biogen, Novartis, Sanofi, and Teva); unconditional research grants (Biogen, Novartis, and Teva); and editorial board (Acta Neurologica Scandinavica). RALM: Compensation for advisory board and/or speaking fees (Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) and research support (Biogen, Merck, Novartis, Sanofi, and Teva). BAS: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Genentech, Novartis, Sanofi, and Teva), and research support (Acorda, Alkermes, Biogen, MedImmune, Novartis, Roche, and Sanofi). PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, Celgene, Merck Serono, Novartis, Sanofi, Servier, and Teva). HW: Consulting and/or speaking fees (Bayer, Biogen, Behring, EMD Serono, Fresenius Medical Care, Merck Serono, Novartis, Roche, Sanofi, and Teva); license fee payments (Huber-Verlag); and grant/research support (Neotope Bioscience, Novartis, and PML Consortium). TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) and grant/research support (Biogen, Novartis, Sanofi, and Teva). LC, ND, and CER: Employees of Sanofi. AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, Sanofi, and Teva).STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.
Abstract: P628
Type: Poster Sessions
Abstract Category: Therapy - Symptomatic treatment
Introduction: Over 2 years (y) in the CARE-MS studies, 2 courses of alemtuzumab (12 mg/day; baseline: 5 days; 12 months [M] later: 3 days) significantly improved outcomes vs SC IFNB-1a in treatment-naive RRMS patients (CARE-MS I; NCT00530348) or those who had an inadequate response to prior therapy (CARE-MS II; NCT00548405). Alemtuzumab remained efficacious in a 4-y extension (NCT00930553), wherein patients could receive additional courses of alemtuzumab (12 mg/day on 3 days; ≥12M apart) as needed for disease activity, or receive another disease-modifying therapy (DMT; investigator discretion). After the 4-y extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension study, in which patients can receive additional as-needed alemtuzumab (≥12M apart; no criteria), or receive another DMT (any time).
Aims: To evaluate efficacy and safety in pooled CARE-MS patients who received Course 4 (C4) of alemtuzumab over 7 y.
Methods: Inclusion criteria for this analysis: ≥4 courses by M72, to allow ≥12M follow-up post-C4; no other DMT. Data were censored at C5.
Results: 742/811 (91%) pooled CARE-MS patients entered the extension, with 129 (17%) receiving ≥4 courses. C4 was given in Y4 (6.0%), Y5 (4.6%), Y6 (3.5%), or Y7 (3.2%); mean time was 1.9 y after C3. 103 (14%) patients met the analysis inclusion criteria. Annualised relapse rate was 1.59 12M pre-study, 0.77 12M pre-C4, 0.24 12M post-C4 (P< 0.0001), and 0.27 36M post-C4. At 36M post-C4, mean EDSS score change was -0.37 from the time of C4 administration, 95% of patients were free of 6-M confirmed disability worsening, and 31% of patients had 6-M confirmed disability improvement. At 12M pre-C4, 12M post-C4, and 36M post-C4, patients were free of MRI disease activity (50%, 65% [P< 0.01], and 74%, respectively), new gadolinium-enhancing lesions (64%, 81% [P< 0.01], 88%), new/enlarging T2 hyperintense lesions (50%, 65% [P< 0.01], 74%), and new T1 hypointense lesions (66%, 75% [P< 0.05], 87%). Incidence of adverse events (AEs), including infections and autoimmune AEs, in patients receiving additional courses was similar to the overall CARE-MS population and those receiving 2 courses over 7 y.
Conclusion: In the small percentage of patients with disease activity after C3, a fourth course of alemtuzumab, given on average 1.9 years after C3, improved clinical and MRI outcomes up to 36M. Safety was similar to the overall CARE-MS population and those receiving 2 courses over 7 y.
Disclosure: SS: Consulting and/or speaking fees (Biogen, Merck Serono, Novartis, Sanofi, and Teva); grant/research support (Novartis and Sanofi). ADB: Consulting fees/fees for non-CME services from commercial interest or their agents/grant and research support (Biogen, Mallinckrodt, Novartis, Roche-Genentech, Sanofi, Teva Neuroscience, and TG Therapeutics). AB: Consulting fees and/or fees for non-CME services (Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi, and Teva). RB: Advisory boards and consulting (Acorda, Avanir, Bayer, Biogen, Novartis, Questcor, Sanofi, and Teva). GC: Consulting fees (Actelion, Bayer, Merck Serono, Novartis, Sanofi, and Teva); lecture fees (Bayer, Biogen Dompé, Merck Serono, Novartis, Sanofi, Serono Symposia International Foundation, and Teva). OF: Speaking and/or consulting (Allergan, Almirall, Bayer-Schering, Biogen, Merck Serono, Novartis, Sanofi, and Teva); compensation for serving as a journal editor, associate editor, or member of an editorial advisory board (Revista Española de Esclerosis Múltiple); and research support (Hospital Foundation FIMABIS). HJK: Consulting and/or speaking fees (Bayer, Biogen, Celltrion, Eisai, Genzyme, HanAll BioPharma, MedImmune, Merck Serono, Novartis, Teva-Handok, and UCB); research support (Genzyme, Merck Serono, Ministry of Science & ICT, Teva-Handok, and UCB); steering committee member (MedImmune); co-editor (Multiple Sclerosis Journal - Experimental, Translational, and Clinical); and associate editor (Journal of Clinical Neurology). VL: Honoraria for consulting and speaking at symposia (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva, with approval by the HR Department, Cologne General Hospital, and University of Cologne). JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi, and Teva); scientific advisory boards (Almirall, Biogen, Novartis, Sanofi, and Teva); unconditional research grants (Biogen, Novartis, and Teva); and editorial board (Acta Neurologica Scandinavica). RALM: Compensation for advisory board and/or speaking fees (Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) and research support (Biogen, Merck, Novartis, Sanofi, and Teva). BAS: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Genentech, Novartis, Sanofi, and Teva), and research support (Acorda, Alkermes, Biogen, MedImmune, Novartis, Roche, and Sanofi). PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, Celgene, Merck Serono, Novartis, Sanofi, Servier, and Teva). HW: Consulting and/or speaking fees (Bayer, Biogen, Behring, EMD Serono, Fresenius Medical Care, Merck Serono, Novartis, Roche, Sanofi, and Teva); license fee payments (Huber-Verlag); and grant/research support (Neotope Bioscience, Novartis, and PML Consortium). TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) and grant/research support (Biogen, Novartis, Sanofi, and Teva). LC, ND, and CER: Employees of Sanofi. AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, Sanofi, and Teva).STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.