Contributions
Abstract: EP1598
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: Alemtuzumab (ALZ) belongs to the pulsed immune reconstitution therapies for relapsing-remitting multiple sclerosis (RRMS). In clinical practice ALZ is used as a second or third line treatment of RRMS and thus the real-world population treated with ALZ is different from the populations participated in the pivotal studies of ALZ.
Objective/Aim: We aimed to assess basic characteristics and therapeutic effects on clinical and imaging parameters of disease activity for RRMS patients selected for ALZ.
Methods: RRMS patients were consecutively included. Patients were clinically assessed with Expanded Disability Status Scale (EDSS), occurrence of clinical relapses and with cerebral MRI at baseline and at month 6, 12, 18 and 24.
Results: 51(30 females) RRMS patients, mean age 38±7.2 years and mean disease duration at baseline 7.4±5.6 years, were included. Prior to baseline 6(12%) patients had first line treatment, 38(74%) had second line and 7(14%) were treatment naive. Reasons to switch to ALZ were breakthrough disease activity despite disease modifying therapy (DMT) in 23(45%) patients, side effects in 3(4%), positive JC virus test during natalizumab in 18(35%) and highly active disease from disease onset in 7(14%). All patients received the first course of ALZ, 50(98%) the second, 9(18%) a third and 1(2%) a fourth course. Median EDSS at baseline was 2(range 0-7.5), at month 12, 1.5(range 0-7) and at month 24, 1.5(range 0-7,n=42). In total 40/51(78%) patients had no relapse. Baseline MRI revealed high lesion load; 36(71%) had T2 lesions >20, 12(23%) had T2 lesions 10-20 and 3(6%) had T2 lesions 1-9. 36(71%) had no contrast enhancement. Upon follow-up at 6, 12, 18 and 24 months, 42(82%) patients, 39(76%), 39(89%,n=44) and 39(93%,n=42) had no new or enlarged T2 lesions. Corresponding number with no contrast enhancement was 48(94%), 41(80%), 44(100%) and 38(90%). Between baseline and 12 months of follow-up 8(16%) patients had Clinical Disability Worsening (CDW), 8(16%) had Clinical Disability Improvement (CDI) and 28(55%) met No Evidence of Disease Activity (NEDA), between 12 and 24 months of follow-up, corresponding number was 2(5%,n=42), 3(7%) and 29(70%).
Conclusion: This real word population confirms that ALZ as second or third line treatment effectively reduced disease activity with CDI or stability in 92%, and NEDA in 51% at 24 months of follow-up. The study population is currently followed to collect long-term efficacy and safety data of ALZ.
Disclosure: SS and LN has nothing to disclose. MA has received compensation for lectures and/ or advisory boards from Biogen, Genzyme, and Novartis. JL has received travel support and/ or lecture honoraria from Biogen, Novartis, Teva and Genzyme/ SanofiAventis; has served on scientific advisory boards for Almirall, Teva, Biogen, Novartis and Genzyme/ SanofiAventis; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva. CM has received honoraria for lectures and advisory boards from Biogen, Merck, Novartis and SanofiAventis.
Abstract: EP1598
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: Alemtuzumab (ALZ) belongs to the pulsed immune reconstitution therapies for relapsing-remitting multiple sclerosis (RRMS). In clinical practice ALZ is used as a second or third line treatment of RRMS and thus the real-world population treated with ALZ is different from the populations participated in the pivotal studies of ALZ.
Objective/Aim: We aimed to assess basic characteristics and therapeutic effects on clinical and imaging parameters of disease activity for RRMS patients selected for ALZ.
Methods: RRMS patients were consecutively included. Patients were clinically assessed with Expanded Disability Status Scale (EDSS), occurrence of clinical relapses and with cerebral MRI at baseline and at month 6, 12, 18 and 24.
Results: 51(30 females) RRMS patients, mean age 38±7.2 years and mean disease duration at baseline 7.4±5.6 years, were included. Prior to baseline 6(12%) patients had first line treatment, 38(74%) had second line and 7(14%) were treatment naive. Reasons to switch to ALZ were breakthrough disease activity despite disease modifying therapy (DMT) in 23(45%) patients, side effects in 3(4%), positive JC virus test during natalizumab in 18(35%) and highly active disease from disease onset in 7(14%). All patients received the first course of ALZ, 50(98%) the second, 9(18%) a third and 1(2%) a fourth course. Median EDSS at baseline was 2(range 0-7.5), at month 12, 1.5(range 0-7) and at month 24, 1.5(range 0-7,n=42). In total 40/51(78%) patients had no relapse. Baseline MRI revealed high lesion load; 36(71%) had T2 lesions >20, 12(23%) had T2 lesions 10-20 and 3(6%) had T2 lesions 1-9. 36(71%) had no contrast enhancement. Upon follow-up at 6, 12, 18 and 24 months, 42(82%) patients, 39(76%), 39(89%,n=44) and 39(93%,n=42) had no new or enlarged T2 lesions. Corresponding number with no contrast enhancement was 48(94%), 41(80%), 44(100%) and 38(90%). Between baseline and 12 months of follow-up 8(16%) patients had Clinical Disability Worsening (CDW), 8(16%) had Clinical Disability Improvement (CDI) and 28(55%) met No Evidence of Disease Activity (NEDA), between 12 and 24 months of follow-up, corresponding number was 2(5%,n=42), 3(7%) and 29(70%).
Conclusion: This real word population confirms that ALZ as second or third line treatment effectively reduced disease activity with CDI or stability in 92%, and NEDA in 51% at 24 months of follow-up. The study population is currently followed to collect long-term efficacy and safety data of ALZ.
Disclosure: SS and LN has nothing to disclose. MA has received compensation for lectures and/ or advisory boards from Biogen, Genzyme, and Novartis. JL has received travel support and/ or lecture honoraria from Biogen, Novartis, Teva and Genzyme/ SanofiAventis; has served on scientific advisory boards for Almirall, Teva, Biogen, Novartis and Genzyme/ SanofiAventis; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva. CM has received honoraria for lectures and advisory boards from Biogen, Merck, Novartis and SanofiAventis.