Contributions
Abstract: P703
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background and goals: Alemtuzumab (Alem) is a monoclonal anti-CD52 antibody which rapidly depletes circulating lymphocytes followed by their reconstitution. It is approved for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS)1. The currently practiced treatment regimen with two courses one year apart, is a highly effective therapy in achieving disease control2. However, treatment with Alem is associated with significant adverse events and requires prolonged monitoring2,3. Optimizing its balance of therapeutic index, cost, and adverse event profile is imperative. We investigated the efficacy of a single course treatment with Alem in RRMS.
Methods: We performed a retrospective review of 26 patients (15:9 F:M) with a median disease duration (DD) of 53.5 months and median age of 36, treated with Alem who had at least 12 months post infusion follow up. Average follow up was 24.2 months post infusion.
Results: At 12 months ́ post infusion, one patient (1/26) had a clinical relapse and two patients had one new lesion on MRI without clinical relapse. The mean Annual Relapse Rate (ARR) was 0.04 compared to 0.68 pretreatment. 11/23 patients who were clinically and radiologic progression-free at 12 months ́ post treatment opted not to have the second course of Alem at year two. We followed these patients over a mean of 9.3 additional months, and they had no subsequent clinical or radiologic progression. 5/26 patients developed autoimmune thyroid disease, but no other autoimmune disorder. Further clinical data, including disability, will be provided at the time of presentation.
Conclusion: Given Alemtuzumab ́s mechanism of action, the ability for immunologic reconstitution, there could potentially be patients for whom induction of disease remission could be achieved with just one cycle of Alem. Additionally, the shorter treatment period could potentially decrease the risk of autoimmunity and decrease the duration of post infusion monitoring. We believe our findings warrant further study and long-term analysis.
References:
1.LEMTRADA [PI]. Cambridge, MA: Genzyme Corporation; 2016.
2.Cohen J, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 2012: 380: 1819-28.
3.Coles A, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 2012; 380: 1829-39.
Disclosure:
David E. Klein: Nothing to disclose.
Alexandra Kocsik: Nothing to disclose.
Stacey Foster: Nothing to disclose.
Jai Perumal, M.D.: Has received speaker honoraria and consultant fees from Genzyme.
Abstract: P703
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background and goals: Alemtuzumab (Alem) is a monoclonal anti-CD52 antibody which rapidly depletes circulating lymphocytes followed by their reconstitution. It is approved for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS)1. The currently practiced treatment regimen with two courses one year apart, is a highly effective therapy in achieving disease control2. However, treatment with Alem is associated with significant adverse events and requires prolonged monitoring2,3. Optimizing its balance of therapeutic index, cost, and adverse event profile is imperative. We investigated the efficacy of a single course treatment with Alem in RRMS.
Methods: We performed a retrospective review of 26 patients (15:9 F:M) with a median disease duration (DD) of 53.5 months and median age of 36, treated with Alem who had at least 12 months post infusion follow up. Average follow up was 24.2 months post infusion.
Results: At 12 months ́ post infusion, one patient (1/26) had a clinical relapse and two patients had one new lesion on MRI without clinical relapse. The mean Annual Relapse Rate (ARR) was 0.04 compared to 0.68 pretreatment. 11/23 patients who were clinically and radiologic progression-free at 12 months ́ post treatment opted not to have the second course of Alem at year two. We followed these patients over a mean of 9.3 additional months, and they had no subsequent clinical or radiologic progression. 5/26 patients developed autoimmune thyroid disease, but no other autoimmune disorder. Further clinical data, including disability, will be provided at the time of presentation.
Conclusion: Given Alemtuzumab ́s mechanism of action, the ability for immunologic reconstitution, there could potentially be patients for whom induction of disease remission could be achieved with just one cycle of Alem. Additionally, the shorter treatment period could potentially decrease the risk of autoimmunity and decrease the duration of post infusion monitoring. We believe our findings warrant further study and long-term analysis.
References:
1.LEMTRADA [PI]. Cambridge, MA: Genzyme Corporation; 2016.
2.Cohen J, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial. Lancet 2012: 380: 1819-28.
3.Coles A, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet 2012; 380: 1829-39.
Disclosure:
David E. Klein: Nothing to disclose.
Alexandra Kocsik: Nothing to disclose.
Stacey Foster: Nothing to disclose.
Jai Perumal, M.D.: Has received speaker honoraria and consultant fees from Genzyme.