Contributions
Abstract: EP1626
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Alemtuzumab has shown high efficacy in decreasing relapse rates in patients with active relapsing MS in clinical trials, but data from real world clinical practice is needed to confirm these findings.
Goal: To study efficacy and safety outcomes in real world patients treated with alemtuzumab.
Methods: Patients with highly active RRMS treated with alemtuzumab since March 2015 at Virgen Macarena Hospital, Sevilla, Spain. Baseline, MS characteristics, relapses, change in disability, and adverse event data in alemtuzumab-treated patients were collected.
Results: 65 patients (43 females, 66%) were identified with a mean follow-up of 13.3 months (28-3). 31 (48%) have received their second course of treatment.
Average age was 39.4 years (range 20-60) and the mean years since MS diagnosis was 15.2 (range 3-30). Patients had been treated with a mean of 2.3 disease modifiying therapies prior to alemtuzumab treatment. Following alemtuzumab treatment, the annualized relapse rate (ARR) decreased from 1.6 to 0.09, and EDSS decreased from a mean of 4.6 to 4.0. 34 (59.6%) patients showed lower EDSS values, 22 (38.6%) patients showed stable EDSS, and 1 (1.7%) showed an increase in EDSS. 3 patients (4.6%) had relapses after receiving the first course of alemtuzumab (with active MRI), and one of them was treated with the second course 10 months after the first. This patient is currently the only candidate for re-treatment.
All patients were treated with the second course of alemtuzumab when their lymphocyte counts were normal, with a mean of 12.7 months post first course (10-16). 89% had mild to moderate infusion reactions during the first course, with 77% experiencing mild infections within the first year on treatment. One patient suffered a severe cytomegalovirus and pneumocystis jirovenci pneumonia infection, but recovered following antibiotic treatment. 13% of patients developed thyroid disorders between the two courses; 3 cases of hypothyroidism and 5 cases of hyperthyroidism, 2 of which required a thyroidectomy.
Conclusions: Our data shows that MS patients treated with alemtuzumab in a real world clinical setting show significant decreases in ARR and the majority mantain or improve their disability. Mild to moderate infusion reactions and manageable adverse events were observed.
Disclosure:
Sara Eichau received speaker honoraria and consulting fees from Genzye, Biogen, Merck Serono, Teva and Novartis
Abstract: EP1626
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Alemtuzumab has shown high efficacy in decreasing relapse rates in patients with active relapsing MS in clinical trials, but data from real world clinical practice is needed to confirm these findings.
Goal: To study efficacy and safety outcomes in real world patients treated with alemtuzumab.
Methods: Patients with highly active RRMS treated with alemtuzumab since March 2015 at Virgen Macarena Hospital, Sevilla, Spain. Baseline, MS characteristics, relapses, change in disability, and adverse event data in alemtuzumab-treated patients were collected.
Results: 65 patients (43 females, 66%) were identified with a mean follow-up of 13.3 months (28-3). 31 (48%) have received their second course of treatment.
Average age was 39.4 years (range 20-60) and the mean years since MS diagnosis was 15.2 (range 3-30). Patients had been treated with a mean of 2.3 disease modifiying therapies prior to alemtuzumab treatment. Following alemtuzumab treatment, the annualized relapse rate (ARR) decreased from 1.6 to 0.09, and EDSS decreased from a mean of 4.6 to 4.0. 34 (59.6%) patients showed lower EDSS values, 22 (38.6%) patients showed stable EDSS, and 1 (1.7%) showed an increase in EDSS. 3 patients (4.6%) had relapses after receiving the first course of alemtuzumab (with active MRI), and one of them was treated with the second course 10 months after the first. This patient is currently the only candidate for re-treatment.
All patients were treated with the second course of alemtuzumab when their lymphocyte counts were normal, with a mean of 12.7 months post first course (10-16). 89% had mild to moderate infusion reactions during the first course, with 77% experiencing mild infections within the first year on treatment. One patient suffered a severe cytomegalovirus and pneumocystis jirovenci pneumonia infection, but recovered following antibiotic treatment. 13% of patients developed thyroid disorders between the two courses; 3 cases of hypothyroidism and 5 cases of hyperthyroidism, 2 of which required a thyroidectomy.
Conclusions: Our data shows that MS patients treated with alemtuzumab in a real world clinical setting show significant decreases in ARR and the majority mantain or improve their disability. Mild to moderate infusion reactions and manageable adverse events were observed.
Disclosure:
Sara Eichau received speaker honoraria and consulting fees from Genzye, Biogen, Merck Serono, Teva and Novartis