Abstract: EP1663
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: PREFERMS was a 12-month, phase 4, open-label study comparing treatment retention on fingolimod and on injectable disease-modifying therapy (iDMT: interferon [IFN] beta or glatiramer acetate [GA]) in patients with relapsing multiple sclerosis. One treatment switch was allowed for any reason after ≥3 months, or before for efficacy or safety. At end of randomized treatment (EoRT), patients had received only randomized therapy. At end of study (EoS), randomized groups were a mix of patients exposed only to randomized treatment and those who had switched. In total, 58.1% of patients switched to fingolimod from IFN or GA and 6.2% switched to iDMT from fingolimod.
Objective: To compare patient outcomes on fingolimod and on different iDMT classes before (EoRT) and after (EoS) any treatment switches.
Methods: In PREFERMS (N=875), patients who were treatment-naïve or previously treated with iDMT were randomized 1:1 to fingolimod or to preselected IFN or GA. 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; GA, n=231; IFN, n=197). Analyses were for hypothesis generation only.
Results: At EoRT, median BVL from baseline in the fingolimod and GA groups was 0.37% (n=370) and 0.46% (n=127), and at EoS was 0.40% (n=382) and 0.40% (n=194). Greatest BVL was in the IFN group at EoRT (0.85% [n=119]) but had reduced by EoS (0.59% [n=167]). At EoRT, median cGMVL from baseline in the fingolimod and GA groups was 0.02% (n=327) and 0.12% (n=53), and at EoS was 0.03% (n=348) and 0.12% (n=160). Greatest cGMVL was in the IFN group at EoRT (0.48% [n=56]) but had reduced by EoS (0.28% [n=137]). At EoRT, least-squares (LS) mean oral SDMT scores (95% confidence interval [CI]) had increased more in the fingolimod than in the GA group (3.5 [1.7, 5.2; n=73] vs 1.0 [−1.6, 3.6; n=35]) but were closer by EoS (3.2 [1.3, 5.1; n=73] vs 2.7 [0.0, 5.4; n=37]). At EoRT, LS mean score (95% CI) had decreased in the IFN group (−0.7 [−4.0, 2.6; n=30]) but had increased by EoS (2.5 [−1.0, 6.1; n=30]).
Conclusions: In PREFERMS, patients on fingolimod tended to have less BVL and cGMVL, and better cognitive scores than those on iDMT. At EoS, improved BVL and cGMVL in the IFN group, and cognition in the IFN and GA groups, might be due to the high proportion of switches to fingolimod.
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, Scott Kolodny and Nadia Tenenbaum are employees of Novartis Pharmaceuticals Corporation.
Abstract: EP1663
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: PREFERMS was a 12-month, phase 4, open-label study comparing treatment retention on fingolimod and on injectable disease-modifying therapy (iDMT: interferon [IFN] beta or glatiramer acetate [GA]) in patients with relapsing multiple sclerosis. One treatment switch was allowed for any reason after ≥3 months, or before for efficacy or safety. At end of randomized treatment (EoRT), patients had received only randomized therapy. At end of study (EoS), randomized groups were a mix of patients exposed only to randomized treatment and those who had switched. In total, 58.1% of patients switched to fingolimod from IFN or GA and 6.2% switched to iDMT from fingolimod.
Objective: To compare patient outcomes on fingolimod and on different iDMT classes before (EoRT) and after (EoS) any treatment switches.
Methods: In PREFERMS (N=875), patients who were treatment-naïve or previously treated with iDMT were randomized 1:1 to fingolimod or to preselected IFN or GA. 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; GA, n=231; IFN, n=197). Analyses were for hypothesis generation only.
Results: At EoRT, median BVL from baseline in the fingolimod and GA groups was 0.37% (n=370) and 0.46% (n=127), and at EoS was 0.40% (n=382) and 0.40% (n=194). Greatest BVL was in the IFN group at EoRT (0.85% [n=119]) but had reduced by EoS (0.59% [n=167]). At EoRT, median cGMVL from baseline in the fingolimod and GA groups was 0.02% (n=327) and 0.12% (n=53), and at EoS was 0.03% (n=348) and 0.12% (n=160). Greatest cGMVL was in the IFN group at EoRT (0.48% [n=56]) but had reduced by EoS (0.28% [n=137]). At EoRT, least-squares (LS) mean oral SDMT scores (95% confidence interval [CI]) had increased more in the fingolimod than in the GA group (3.5 [1.7, 5.2; n=73] vs 1.0 [−1.6, 3.6; n=35]) but were closer by EoS (3.2 [1.3, 5.1; n=73] vs 2.7 [0.0, 5.4; n=37]). At EoRT, LS mean score (95% CI) had decreased in the IFN group (−0.7 [−4.0, 2.6; n=30]) but had increased by EoS (2.5 [−1.0, 6.1; n=30]).
Conclusions: In PREFERMS, patients on fingolimod tended to have less BVL and cGMVL, and better cognitive scores than those on iDMT. At EoS, improved BVL and cGMVL in the IFN group, and cognition in the IFN and GA groups, might be due to the high proportion of switches to fingolimod.
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, Scott Kolodny and Nadia Tenenbaum are employees of Novartis Pharmaceuticals Corporation.