Abstract: P1165
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: PREFERMS was a 12-month, phase 4, active-controlled, open-label, multicentre study that compared treatment retention on fingolimod with that on injectable disease-modifying therapy (iDMT) in 875 patients with relapsing multiple sclerosis. Patients could switch treatment once. At end of randomized treatment (EoRT), patients had received only fingolimod or iDMT. At end of study (EoS) randomized groups were a mix of patients exposed only to randomized treatment and of those who had switched. The majority of patients in the iDMT group (58.1%) switched to fingolimod, but few in the fingolimod group (6.2%) switched to iDMT.
Objectives: To examine the impact of treatment switch on MRI and cognitive parameters by comparing effects at EoRT and EoS.
Methods: In PREFERMS, patients who were treatment-naïve or had previously been treated with either interferon beta or glatiramer acetate were randomized 1:1 to fingolimod or a preselected iDMT. One treatment switch was allowed after ≥3 months for any reason, or before for efficacy or safety reasons. Exposure-adjusted percent brain volume loss (BVL) and percent cortical grey-matter volume loss (cGMVL) and change in oral Symbol Digit Modalities Test (SDMT) scores were analysed post hoc at EoRT and at EoS by treatment assignment at randomization (fingolimod, n=433; iDMT, n=428). Analyses were for hypothesis generation only.
Results: Median exposure to randomized treatment was: fingolimod, 337 days; iDMT, 105 days. At EoRT, median BVL from baseline was numerically lower in the fingolimod group than in the iDMT group (0.37% [n=370] vs 0.69% [n=246]); at EoS, rates were similar (0.40% [n=382] vs 0.46% [n=361]). At EoRT, median cGMVL from baseline was numerically lower in the fingolimod than in the iDMT group (0.02% [n=327] vs 0.27% [n=109]); at EoS, the difference was smaller (0.03% [n=348] vs 0.21% [n=297]). At EoRT, least-squares (LS) mean oral SDMT scores (95% confidence interval [CI]) increased from baseline in the fingolimod group (3.4 [1.4, 5.4], n=73) but not in the iDMT group (0.3 [−1.8, 2.4], n=65). At EoS, LS mean (95% CI) score increases were similar in the treatment groups (fingolimod, 3.2 [1.1, 5.3], n=73; iDMT, 2.6 [0.4, 4.8], n=67).
Conclusions: In PREFERMS, improvements in BVL, cGMVL and cognition in the iDMT group at EoS were associated with a high proportion of switches to fingolimod. This benefit from switching manifested within 9 months.
Disclosure: Samuel F Hunter has received consulting fees and/or research support from and/or served on speakers' bureau for Acorda Therapeutics, Avanir, Bayer, Genentech-Roche, Sanofi Genzyme, Novartis, Osmotica and Teva Neuroscience.
Florian P Thomas has served as a speaker and/or consultant for Acorda Therapeutics, Biogen, Genzyme, Novartis and Teva Neuroscience, and has received research support from Biogen and Teva Neuroscience.
Bruce AC Cree has received personal compensation for consulting from Abbvie, Biogen, EMD Serono, and Novartis.
Xiangyi Meng, Lesley Schofield, Fernanda Boulos and Nadia Tenenbaum are employees of Novartis Pharmaceuticals Corporation.
Abstract: P1165
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: PREFERMS was a 12-month, phase 4, active-controlled, open-label, multicentre study that compared treatment retention on fingolimod with that on injectable disease-modifying therapy (iDMT) in 875 patients with relapsing multiple sclerosis. Patients could switch treatment once. At end of randomized treatment (EoRT), patients had received only fingolimod or iDMT. At end of study (EoS) randomized groups were a mix of patients exposed only to randomized treatment and of those who had switched. The majority of patients in the iDMT group (58.1%) switched to fingolimod, but few in the fingolimod group (6.2%) switched to iDMT.
Objectives: To examine the impact of treatment switch on MRI and cognitive parameters by comparing effects at EoRT and EoS.
Methods: In PREFERMS, patients who were treatment-naïve or had previously been treated with either interferon beta or glatiramer acetate were randomized 1:1 to fingolimod or a preselected iDMT. One treatment switch was allowed after ≥3 months for any reason, or before for efficacy or safety reasons. Exposure-adjusted percent brain volume loss (BVL) and percent cortical grey-matter volume loss (cGMVL) and change in oral Symbol Digit Modalities Test (SDMT) scores were analysed post hoc at EoRT and at EoS by treatment assignment at randomization (fingolimod, n=433; iDMT, n=428). Analyses were for hypothesis generation only.
Results: Median exposure to randomized treatment was: fingolimod, 337 days; iDMT, 105 days. At EoRT, median BVL from baseline was numerically lower in the fingolimod group than in the iDMT group (0.37% [n=370] vs 0.69% [n=246]); at EoS, rates were similar (0.40% [n=382] vs 0.46% [n=361]). At EoRT, median cGMVL from baseline was numerically lower in the fingolimod than in the iDMT group (0.02% [n=327] vs 0.27% [n=109]); at EoS, the difference was smaller (0.03% [n=348] vs 0.21% [n=297]). At EoRT, least-squares (LS) mean oral SDMT scores (95% confidence interval [CI]) increased from baseline in the fingolimod group (3.4 [1.4, 5.4], n=73) but not in the iDMT group (0.3 [−1.8, 2.4], n=65). At EoS, LS mean (95% CI) score increases were similar in the treatment groups (fingolimod, 3.2 [1.1, 5.3], n=73; iDMT, 2.6 [0.4, 4.8], n=67).
Conclusions: In PREFERMS, improvements in BVL, cGMVL and cognition in the iDMT group at EoS were associated with a high proportion of switches to fingolimod. This benefit from switching manifested within 9 months.
Disclosure: Samuel F Hunter has received consulting fees and/or research support from and/or served on speakers' bureau for Acorda Therapeutics, Avanir, Bayer, Genentech-Roche, Sanofi Genzyme, Novartis, Osmotica and Teva Neuroscience.
Florian P Thomas has served as a speaker and/or consultant for Acorda Therapeutics, Biogen, Genzyme, Novartis and Teva Neuroscience, and has received research support from Biogen and Teva Neuroscience.
Bruce AC Cree has received personal compensation for consulting from Abbvie, Biogen, EMD Serono, and Novartis.
Xiangyi Meng, Lesley Schofield, Fernanda Boulos and Nadia Tenenbaum are employees of Novartis Pharmaceuticals Corporation.