Abstract: EP1493
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: For patients with relapsing-remitting multiple sclerosis, oral disease-modifying therapies (DMTs) such as fingolimod 0.5 mg can be an alternative to injectable DMTs (iDMTs), which cause some patients discomfort. Objective: To report post hoc analyses of treatment satisfaction in patient subgroups from PREFERMS, a large, randomized, prospective study, measured using the Medication Satisfaction Questionnaire (MSQ).
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 a pre-selected iDMT. One on-study treatment switch was allowed after ≥3 months of treatment, or earlier if related to efficacy or safety. In the full analysis set (FAS), post hoc analyses of treatment satisfaction (MSQ data were pooled to combine response options: somewhat, very and extremely satisfied) were conducted in patient subgroups, defined by baseline demographic and clinical characteristics, at the end of randomized treatment (EoRT) and at the end of the entire study (EoS) after any treatment switch.
Results: A total of 875 patients were randomized (fingolimod, n=436; iDMT, n=439), with 861 patients in the FAS (fingolimod, n=433; iDMT, n=428). Overall and across subgroups, there were no between-group differences in treatment satisfaction at baseline. At EoRT, treatment satisfaction was greater with fingolimod than with iDMTs both overall (p< 0.0001) and across subgroups (see below). At EoS (after any treatment switch), satisfaction among those randomized to iDMT had increased to a level similar to that among individuals randomized to fingolimod. Between-group differences (fingolimod minus iDMT [95% confidence interval]) by patient subgroup at EoRT and EoS, respectively, were: treatment-naïve, 25.9% (16.7-35.1%) and 3.3% (−5.0-11.6%); previously treated: 33.7% (25.4-42.0%) and 1.1% (−6.0-8.3%); age ≤40 years, 32.4% (23.6-41.3%) and 4.6% (−3.2-12.4%); age >40 years, 27.9% (19.3-36.5%) and −0.4% (−7.9-7.2%); unemployed, 28.7% (18.0-39.3%) and 2.1% (−7.8-12.0%); employed, 30.2% (22.4-38.1%) and 1.1% (−5.5-7.6%).
Conclusions: In PREFERMS, treatment satisfaction with fingolimod was greater than with iDMTs across patient subgroups. Among those randomized to iDMT, increased treatment satisfaction at EoS may be attributable to patients switching to fingolimod.
Disclosure: 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.
Heidi Crayton has received research support from Avanir, Biogen Idec, Genzyme, Novartis and Teva, and has served as a consultant/speaker for Acorda, Genzyme, Novartis and Questcor.
Brian Steingo has served as a speaker and/or consultant for Acorda, Biogen Idec, EMD Serono, Genzyme, Novartis, Pfizer, Questcor and Teva, and has received research support from Acorda, Avanir, Biogen Idec, EMD Serono, Novartis and Teva.
Xiangyi Meng, Kristen Johnson, Lesley Schofield and Nadia Tenenbaum are employees of Novartis Pharmaceuticals Corporation.
Abstract: EP1493
Type: ePoster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: For patients with relapsing-remitting multiple sclerosis, oral disease-modifying therapies (DMTs) such as fingolimod 0.5 mg can be an alternative to injectable DMTs (iDMTs), which cause some patients discomfort. Objective: To report post hoc analyses of treatment satisfaction in patient subgroups from PREFERMS, a large, randomized, prospective study, measured using the Medication Satisfaction Questionnaire (MSQ).
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 a pre-selected iDMT. One on-study treatment switch was allowed after ≥3 months of treatment, or earlier if related to efficacy or safety. In the full analysis set (FAS), post hoc analyses of treatment satisfaction (MSQ data were pooled to combine response options: somewhat, very and extremely satisfied) were conducted in patient subgroups, defined by baseline demographic and clinical characteristics, at the end of randomized treatment (EoRT) and at the end of the entire study (EoS) after any treatment switch.
Results: A total of 875 patients were randomized (fingolimod, n=436; iDMT, n=439), with 861 patients in the FAS (fingolimod, n=433; iDMT, n=428). Overall and across subgroups, there were no between-group differences in treatment satisfaction at baseline. At EoRT, treatment satisfaction was greater with fingolimod than with iDMTs both overall (p< 0.0001) and across subgroups (see below). At EoS (after any treatment switch), satisfaction among those randomized to iDMT had increased to a level similar to that among individuals randomized to fingolimod. Between-group differences (fingolimod minus iDMT [95% confidence interval]) by patient subgroup at EoRT and EoS, respectively, were: treatment-naïve, 25.9% (16.7-35.1%) and 3.3% (−5.0-11.6%); previously treated: 33.7% (25.4-42.0%) and 1.1% (−6.0-8.3%); age ≤40 years, 32.4% (23.6-41.3%) and 4.6% (−3.2-12.4%); age >40 years, 27.9% (19.3-36.5%) and −0.4% (−7.9-7.2%); unemployed, 28.7% (18.0-39.3%) and 2.1% (−7.8-12.0%); employed, 30.2% (22.4-38.1%) and 1.1% (−5.5-7.6%).
Conclusions: In PREFERMS, treatment satisfaction with fingolimod was greater than with iDMTs across patient subgroups. Among those randomized to iDMT, increased treatment satisfaction at EoS may be attributable to patients switching to fingolimod.
Disclosure: 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.
Heidi Crayton has received research support from Avanir, Biogen Idec, Genzyme, Novartis and Teva, and has served as a consultant/speaker for Acorda, Genzyme, Novartis and Questcor.
Brian Steingo has served as a speaker and/or consultant for Acorda, Biogen Idec, EMD Serono, Genzyme, Novartis, Pfizer, Questcor and Teva, and has received research support from Acorda, Avanir, Biogen Idec, EMD Serono, Novartis and Teva.
Xiangyi Meng, Kristen Johnson, Lesley Schofield and Nadia Tenenbaum are employees of Novartis Pharmaceuticals Corporation.