Quality of Life in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Delayed-Release Dimethyl Fumarate: A Three-Year Interim Analysis of ENDORSE (P7.236)

doi:https://doi.org/10.1212/wnl.84.14_supplement.p7.236

Article10.1212/wnl.84.14_supplement.p7.236

Quality of Life in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Delayed-Release Dimethyl Fumarate: A Three-Year Interim Analysis of ENDORSE (P7.236)

Mariko Kita,Ludwig Kappos,Robert J. Fox,Ralf Gold,Gavin Giovannoni,J. Theodore Phillips+4 more-2015-04-06-Neurology

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TL;DRAbstract

OBJECTIVE: Present an interim analysis of health-related quality of life (HRQoL) in relapsing-remitting multiple sclerosis (RRMS) patients treated with delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) in ENDORSE, an 8-year extension of Phase 3 DEFINE and CONFIRM studies. BACKGROUND: In DEFINE/CONFIRM, patients receiving DMF showed better HRQoL compared to placebo (PBO), as assessed by the 36-item Short Form health survey version 1 (SF-36v1). DESIGN/METHODS: Patients randomized to DMF 240mg twice (BID) or three times daily (TID) in DEFINE/CONFIRM continued the same dosage. Patients receiving PBO or glatiramer acetate (GA) were re-randomized 1:1 to DMF BID or TID. SF-36v1 was administered at baseline and every 48 weeks thereafter: a positive change indicates improved HRQoL. Data (as of May 14, 2014) for approved dosage (BID) are reported and analyzed by parent/extension study arm; GA/BID results are not shown due to small sample size. Changes relative to DEFINE

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OBJECTIVE: Present an interim analysis of health-related quality of life (HRQoL) in relapsing-remitting multiple sclerosis (RRMS) patients treated with delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF) in ENDORSE, an 8-year extension of Phase 3 DEFINE and CONFIRM studies. BACKGROUND: In DEFINE/CONFIRM, patients receiving DMF showed better HRQoL compared to placebo (PBO), as assessed by the 36-item Short Form health survey version 1 (SF-36v1). DESIGN/METHODS: Patients randomized to DMF 240mg twice (BID) or three times daily (TID) in DEFINE/CONFIRM continued the same dosage. Patients receiving PBO or glatiramer acetate (GA) were re-randomized 1:1 to DMF BID or TID. SF-36v1 was administered at baseline and every 48 weeks thereafter: a positive change indicates improved HRQoL. Data (as of May 14, 2014) for approved dosage (BID) are reported and analyzed by parent/extension study arm; GA/BID results are not shown due to small sample size. Changes relative to DEFINE

Keywords

Relapsing remittingDimethyl fumarateInterimMedicineInterim analysisMultiple sclerosisQuality of life (healthcare)Internal medicine

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