Table 3.

Existing PRO Studies and Dimethyl Fumarate

Study	N Patients	Disease Type	Study Design	Time Frame	PROs Used	Outcome
DEFINE1	1234 DMF BID (n=410) DMF TID (n=416) Placebo (n=408)	RRMS	Double Blind, Placebo controlled	24 months	SF-36 EQ-5D Global well-being-VAS	The scores from all measures showed significant improvement in the treatment group compared to the placebo
CONFIRM2	1417 DMF BID (n=359) DMF TID (n=345) Placebo (n=363) GA (n=350)	RRMS	Double Blind, Placebo controlled and active comparator	24 months	SF-36 EQ-5D Global well-being-VAS	The scores from all measures showed significant improvement in the treatment group compared to the placebo There was no significant difference between DMF and GA group
DEFINE/CONFIRM Integrated Analysis31	2301 DMF BID (n=769) DMF TID (n=761) Placebo (n=771)	RRMS	Double Blind, Placebo controlled	24 months	SF-36 EQ-5D Global well-being-VAS	The scores from all measures showed significant improvement in the treatment group compared to the placebo
Work Productivity Outcomes42	31(DMF) 229(Beta-INFs and GA)	RRMS	Cross-Sectional Study	Cross Sectional	HAQUAMS EQ-5D WPAI-MS	The scores from all measures was significantly better in the DMF group compared to the Beta interferon and GA’s.
RESPOND34	318(received ≥1 dose of DMF)	RRMS	Observational Study	12 months	SF-36 MFIS-5 TSQM-14 WPAI-MS BDI-7 PR-EDSS	PR-EDSS and WPAI-MS scores remained stable and others showed significant improvement compared to the baseline
Interim Analysis of ESTEEM45,46	2025 (received ≥1 dose of DMF)	RRMS	Observational Study	12 months	MSIS-29 MFIS-5 EQ-5D-5L VAS WPAI-MS	The scores from all measures remained stable compared to the baseline
PROTEC47	1105 (received ≥1 dose of DMF)	RRMS	Observational Study	12 months	MSIS-29 MFIS-5 TSQM-14 EQ-5D-5L VAS PRIMUS WPAI-MS BDI-7	The scores from all measures showed significant improvement except for PRIMUS which stayed stable compared to the baseline