Contributions
Abstract: P1166
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Rates of multiple sclerosis (MS) are generally low among African Americans, but the disease course can be aggressive in these patients. PREFERMS was the first large, randomized, prospective study of treatment retention comparing fingolimod 0.5 mg with injectable disease-modifying therapies (iDMTs) in patients with relapsing-remitting MS, and included 136 African-American patients.
Objective: To report treatment retention, key clinical, magnetic resonance imaging and patient satisfaction outcomes in the PREFERMS African-American patient subgroup.
Methods: PREFERMS was a 12-month, phase 4 open-label, active-controlled, randomized, multicentre study. At enrolment, patients were either treatment-naïve or treated with one class of iDMT (interferon or glatiramer acetate). Patients were randomized (1:1) to fingolimod 0.5 mg or to a pre-selected iDMT. One on-study treatment switch was allowed after ≥3 months of treatment, or before if related to efficacy or safety. At the end of randomized treatment (EoRT), treatment retention, annualized relapse rate (ARR), new gadolinium-enhancing (Gd+) lesion counts, new/enlarging T2 lesion counts, and treatment satisfaction (Medication Satisfaction Questionnaire data, pooled to include somewhat, very and extremely satisfied) were evaluated post hoc in the African-American subgroup.
Results: In total, 875 patients were randomized (fingolimod, n=436; iDMT, n=439). In the African-American subgroup (fingolimod, n=67; iDMT, n=69), patient retention was 80.6% on fingolimod and 30.4% on iDMTs (difference: 50.2%, 95% confidence interval [CI]: 35.8-64.6%). Respectively, in the fingolimod and iDMT groups at EoRT: ARRs were 0.13 and 0.23 (ratio, 0.57; 95% CI: 0.21-1.53); median new Gd+ lesion counts were 0 and 0; and median new/enlarging T2 lesion counts were 0 and 0. Proportionally more patients were satisfied with fingolimod (80.6%) than with iDMT (49.3%) at EoRT (difference: 31.3%, 95% CI: 16.2-46.5%).
Conclusions: African-American patients randomized to fingolimod in PREFERMS had greater treatment retention and satisfaction, and lower relapse rates at EoRT, than those randomized to iDMTs; new Gd+ and new/enlarging T2 lesion counts were similar in the two treatment groups.
Disclosure: Mark Cascione has received research support, speaker fees and/or consulting fees from Acorda, Bayer HealthCare Pharmaceuticals, Biogen, EMD Serono, Novartis, Pfizer, Roche/Genentech, Sanofi Genzyme and Teva.
Jeanette Wendt has received speaker fees from Biogen, EMD Serono, Mallinckrodt, Sanofi Genzyme and Teva Pharmaceuticals.
Bruce A C Cree has received personal compensation for consulting from Abbvie, Biogen, EMD Serono, Sanofi Genzyme, MedImmune, Novartis, Shire and Teva.
Xiangyi Meng, Lesley Schofield and Nadia Tenenbaum are employees of Novartis Pharmaceuticals Corporation.
Abstract: P1166
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Rates of multiple sclerosis (MS) are generally low among African Americans, but the disease course can be aggressive in these patients. PREFERMS was the first large, randomized, prospective study of treatment retention comparing fingolimod 0.5 mg with injectable disease-modifying therapies (iDMTs) in patients with relapsing-remitting MS, and included 136 African-American patients.
Objective: To report treatment retention, key clinical, magnetic resonance imaging and patient satisfaction outcomes in the PREFERMS African-American patient subgroup.
Methods: PREFERMS was a 12-month, phase 4 open-label, active-controlled, randomized, multicentre study. At enrolment, patients were either treatment-naïve or treated with one class of iDMT (interferon or glatiramer acetate). Patients were randomized (1:1) to fingolimod 0.5 mg or to a pre-selected iDMT. One on-study treatment switch was allowed after ≥3 months of treatment, or before if related to efficacy or safety. At the end of randomized treatment (EoRT), treatment retention, annualized relapse rate (ARR), new gadolinium-enhancing (Gd+) lesion counts, new/enlarging T2 lesion counts, and treatment satisfaction (Medication Satisfaction Questionnaire data, pooled to include somewhat, very and extremely satisfied) were evaluated post hoc in the African-American subgroup.
Results: In total, 875 patients were randomized (fingolimod, n=436; iDMT, n=439). In the African-American subgroup (fingolimod, n=67; iDMT, n=69), patient retention was 80.6% on fingolimod and 30.4% on iDMTs (difference: 50.2%, 95% confidence interval [CI]: 35.8-64.6%). Respectively, in the fingolimod and iDMT groups at EoRT: ARRs were 0.13 and 0.23 (ratio, 0.57; 95% CI: 0.21-1.53); median new Gd+ lesion counts were 0 and 0; and median new/enlarging T2 lesion counts were 0 and 0. Proportionally more patients were satisfied with fingolimod (80.6%) than with iDMT (49.3%) at EoRT (difference: 31.3%, 95% CI: 16.2-46.5%).
Conclusions: African-American patients randomized to fingolimod in PREFERMS had greater treatment retention and satisfaction, and lower relapse rates at EoRT, than those randomized to iDMTs; new Gd+ and new/enlarging T2 lesion counts were similar in the two treatment groups.
Disclosure: Mark Cascione has received research support, speaker fees and/or consulting fees from Acorda, Bayer HealthCare Pharmaceuticals, Biogen, EMD Serono, Novartis, Pfizer, Roche/Genentech, Sanofi Genzyme and Teva.
Jeanette Wendt has received speaker fees from Biogen, EMD Serono, Mallinckrodt, Sanofi Genzyme and Teva Pharmaceuticals.
Bruce A C Cree has received personal compensation for consulting from Abbvie, Biogen, EMD Serono, Sanofi Genzyme, MedImmune, Novartis, Shire and Teva.
Xiangyi Meng, Lesley Schofield and Nadia Tenenbaum are employees of Novartis Pharmaceuticals Corporation.