Abstract: EP1496
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: 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 multiple sclerosis. During PREFERMS, a substantial proportion of patients randomized to iDMTs subsequently switched to fingolimod.
Objective: To report pre-planned analyses of clinical, magnetic resonance imaging and patient satisfaction outcomes in PREFERMS at the end of randomized treatment (EoRT) and at the end of the entire study (EoS) after any treatment switch.
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 iDMTs (interferon or glatiramer acetate). Patients were randomized (1:1) to fingolimod 0.5 mg or a pre-selected iDMT. One on-study treatment switch was allowed after ≥3 months of treatment, or before if related to efficacy or safety. Pre-planned analyses of the full analysis set (FAS) evaluated annualized relapse rate (ARR), brain volume loss (BVL) and treatment satisfaction (measured using the Medication Satisfaction Questionnaire, pooled data for patients who were somewhat, very and extremely satisfied), by randomized treatment group at EoRT and at EoS (EoS population included those who switched to fingolimod).
Results: In total, 284 patients switched from their randomized treatment group; more switched from iDMT (n=257, 90.5%) than from fingolimod (n=27, 9.5%). Median exposure to randomized treatment was 337 days for fingolimod and 105 days for iDMT. At EoRT, ARR was 0.22 with fingolimod and 0.31 with iDMT (ratio, 0.70; 95% confidence interval [CI]: 0.47, 1.05); at EoS, ARR was 0.22 with fingolimod and 0.24 with iDMT (ratio, 0.92; 95% CI: 0.65, 1.31), which included patients who switched to fingolimod. There was less exposure-adjusted median BVL with fingolimod than with iDMT at EoRT (change from baseline, 0.37% vs 0.69%) and at EoS (0.40% vs 0.46%). More patients were satisfied with fingolimod (77.4%) than with iDMT (47.4%) at EoRT (difference: 30.1%; 95% CI: 23.9%, 36.2%); this between-group difference was smaller at EoS (fingolimod, 80.2%; iDMT, 78.3%; difference: 2.0%; 95% CI: −3.5%, 7.4%).
Conclusions: Switching to fingolimod from iDMT leads to reductions in ARR and BVL at EoS and increased treatment satisfaction.
Disclosure: Samuel F Hunter has received consulting fees and/or research support from and/or served on speakers" bureau for Acorda, Avanir, Bayer, Genentech-Roche, Sanofi-Genzyme, Novartis, Osmotica, and Teva.
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.
Florian P Thomas has served as a speaker and/or consultant for Acorda, Biogen Idec, Genzyme, Novartis, and Teva, and has received research support from Biogen Idec and Teva.
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: EP1496
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: 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 multiple sclerosis. During PREFERMS, a substantial proportion of patients randomized to iDMTs subsequently switched to fingolimod.
Objective: To report pre-planned analyses of clinical, magnetic resonance imaging and patient satisfaction outcomes in PREFERMS at the end of randomized treatment (EoRT) and at the end of the entire study (EoS) after any treatment switch.
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 iDMTs (interferon or glatiramer acetate). Patients were randomized (1:1) to fingolimod 0.5 mg or a pre-selected iDMT. One on-study treatment switch was allowed after ≥3 months of treatment, or before if related to efficacy or safety. Pre-planned analyses of the full analysis set (FAS) evaluated annualized relapse rate (ARR), brain volume loss (BVL) and treatment satisfaction (measured using the Medication Satisfaction Questionnaire, pooled data for patients who were somewhat, very and extremely satisfied), by randomized treatment group at EoRT and at EoS (EoS population included those who switched to fingolimod).
Results: In total, 284 patients switched from their randomized treatment group; more switched from iDMT (n=257, 90.5%) than from fingolimod (n=27, 9.5%). Median exposure to randomized treatment was 337 days for fingolimod and 105 days for iDMT. At EoRT, ARR was 0.22 with fingolimod and 0.31 with iDMT (ratio, 0.70; 95% confidence interval [CI]: 0.47, 1.05); at EoS, ARR was 0.22 with fingolimod and 0.24 with iDMT (ratio, 0.92; 95% CI: 0.65, 1.31), which included patients who switched to fingolimod. There was less exposure-adjusted median BVL with fingolimod than with iDMT at EoRT (change from baseline, 0.37% vs 0.69%) and at EoS (0.40% vs 0.46%). More patients were satisfied with fingolimod (77.4%) than with iDMT (47.4%) at EoRT (difference: 30.1%; 95% CI: 23.9%, 36.2%); this between-group difference was smaller at EoS (fingolimod, 80.2%; iDMT, 78.3%; difference: 2.0%; 95% CI: −3.5%, 7.4%).
Conclusions: Switching to fingolimod from iDMT leads to reductions in ARR and BVL at EoS and increased treatment satisfaction.
Disclosure: Samuel F Hunter has received consulting fees and/or research support from and/or served on speakers" bureau for Acorda, Avanir, Bayer, Genentech-Roche, Sanofi-Genzyme, Novartis, Osmotica, and Teva.
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.
Florian P Thomas has served as a speaker and/or consultant for Acorda, Biogen Idec, Genzyme, Novartis, and Teva, and has received research support from Biogen Idec and Teva.
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.