Contributions
Abstract: EP1618
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Alemtuzumab has been approved by the European Medicines Agency as a treatment of relapsing-remitting multiple sclerosis (RRMS). However, with regards to its safety profile, French regulators have limited its use to radiologically and clinically active and severe cases only.
Objectives: To describe the efficacy and safety profile of alemtuzumab in a monocentric cohort of patients.
Methods: We prospectively collected clinical and radiological data of RRMS patients treated with alemtuzumab since January 2015.
Results: 19 RRMS patients (16 women/3 men) received alemtuzumab (mean age at treatment: 34.5 years). Mean disease duration was 11.5 years (range: 2.5-26) and mean EDSS was 4.8 (range 0-8) at treatment onset. In the year before, mean number of relapses was 1.6 (range 1-5). Pre-treatment MRI showed new T2 lesions in 91% and Gadolinium-enhancing lesions in 82% of patients. Mean number of previous disease modifying treatments (DMT) before alemtuzumab was 4 (2-7). Among 18 patients followed for at least one year, 15 did not relapse and mean EDSS decreased by 0.5. New T2 lesions and new Gadolinium-enhancing lesions were found in 40 % (from 1 to 30 G + lesions / patient). At two years, 9/11 patients had no relapse and mean EDSS decreased by 0.7. New T2 lesions and new Gadolinium-enhancing lesions were found in respectively 36 % and 18 % of the patients (from 8 to 14 G + lesions/patient). Infusion-related reactions were found in 85% of the patients (mainly rash and headache/pyrexia). Noteworthy, 8 patients presented short-term moderate to severe adverse events: 4 episodes of bradycardia (25-45 pulses/mn), 1 pleural and pericardial effusion associated to hepatic cytolysis, 1 pericarditis, 1 spontaneous multiple cervical artery dissection complicated by ischemic stroke and 1 intra alveolar haemorrhage. After 2 years, 1 patient had severe immune thrombocytopenia and neutropenia and 2 patients developped thyroid disorders.
Conclusion: Our experience emphasizes the possible modified efficacy and safety profile of alemtuzumab when used as a rescue therapy, rather than in its original early indication, in patients previously exposed to many other DMTs. Further evaluations are warranted to support this assumption.
Disclosure:
Françoise Durand-Dubief has received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.
Romain Marignier serves on scientific advisory board for MedImmune and has received funding for travel and honoraria from Biogen Idec, Merck Serono, Novartis, Sanofi- Genzyme, Roche and Teva.
Iuliana Ionescu, Julie Pique and Caroline Lavie received funding for travel from Biogen Idec, Merck Serono, Novartis, Sanofi- Genzyme, Roche and Teva.
Sandra Vukusic has received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.
Abstract: EP1618
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Alemtuzumab has been approved by the European Medicines Agency as a treatment of relapsing-remitting multiple sclerosis (RRMS). However, with regards to its safety profile, French regulators have limited its use to radiologically and clinically active and severe cases only.
Objectives: To describe the efficacy and safety profile of alemtuzumab in a monocentric cohort of patients.
Methods: We prospectively collected clinical and radiological data of RRMS patients treated with alemtuzumab since January 2015.
Results: 19 RRMS patients (16 women/3 men) received alemtuzumab (mean age at treatment: 34.5 years). Mean disease duration was 11.5 years (range: 2.5-26) and mean EDSS was 4.8 (range 0-8) at treatment onset. In the year before, mean number of relapses was 1.6 (range 1-5). Pre-treatment MRI showed new T2 lesions in 91% and Gadolinium-enhancing lesions in 82% of patients. Mean number of previous disease modifying treatments (DMT) before alemtuzumab was 4 (2-7). Among 18 patients followed for at least one year, 15 did not relapse and mean EDSS decreased by 0.5. New T2 lesions and new Gadolinium-enhancing lesions were found in 40 % (from 1 to 30 G + lesions / patient). At two years, 9/11 patients had no relapse and mean EDSS decreased by 0.7. New T2 lesions and new Gadolinium-enhancing lesions were found in respectively 36 % and 18 % of the patients (from 8 to 14 G + lesions/patient). Infusion-related reactions were found in 85% of the patients (mainly rash and headache/pyrexia). Noteworthy, 8 patients presented short-term moderate to severe adverse events: 4 episodes of bradycardia (25-45 pulses/mn), 1 pleural and pericardial effusion associated to hepatic cytolysis, 1 pericarditis, 1 spontaneous multiple cervical artery dissection complicated by ischemic stroke and 1 intra alveolar haemorrhage. After 2 years, 1 patient had severe immune thrombocytopenia and neutropenia and 2 patients developped thyroid disorders.
Conclusion: Our experience emphasizes the possible modified efficacy and safety profile of alemtuzumab when used as a rescue therapy, rather than in its original early indication, in patients previously exposed to many other DMTs. Further evaluations are warranted to support this assumption.
Disclosure:
Françoise Durand-Dubief has received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.
Romain Marignier serves on scientific advisory board for MedImmune and has received funding for travel and honoraria from Biogen Idec, Merck Serono, Novartis, Sanofi- Genzyme, Roche and Teva.
Iuliana Ionescu, Julie Pique and Caroline Lavie received funding for travel from Biogen Idec, Merck Serono, Novartis, Sanofi- Genzyme, Roche and Teva.
Sandra Vukusic has received consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.