%0 Journal Article
%T Impact of sex on clinical outcome in early Multiple Sclerosis.
%A Gottwald NS
%A Asseyer S
%A Chien C
%A Brasanac J
%A Nauman AT
%A Rust R
%A Schmitz-Hübsch T
%A Strobl JB
%A Ruprecht K
%A Paul F
%A Regitz-Zagrosek V
%A Gold SM
%A Sperber PS
%J Mult Scler Relat Disord
%V 88
%N 0
%D 2024 Jun 29
%M 38959589
%F 4.808
%R 10.1016/j.msard.2024.105749
%X <B>BACKGROUND: </B>Previous evidence suggests sex differences in the clinical course of relapsing remitting multiple sclerosis (RRMS), but comprehensive early-stage prospective studies are lacking. We aim to quantify the impact of sex on clinical outcomes in early-stage RRMS.<BR><B>METHODS: </B>Utilizing prospective cohort data, we assessed the impact of biological sex on time-to-relapse, disability progression (Expanded Disability Status Scale [EDSS]), extremity function (Nine-Hole Peg Test, Timed-25-food walk test), cognition (Paced Auditory Serial Addition Test, Symbol Digit Modalities Test), quality-of-life (Hamburg Quality of Life Questionnaire in Multiple Sclerosis, Short-Form-36), fatigue (Fatigue Severity Scale, Fatigue Scale for Motor and Cognitive functions), and depression (Beck Depression Inventory-II) in clinically isolated syndrome (CIS) or RRMS patients. Inclusion was within 12 months of symptom onset. Linear, negative binomial, mixed, and Cox models estimated male vs. female effects at the four-year follow-up including baseline-to-follow-up course.<BR><B>RESULTS: </B>We included 149 patients (65.1 % female). Eighty-five completed four-year follow-up. No sex differences in time-to-relapse emerged (HR = 0.91;95 %CI = 0.53-1.58). Males had no increased risk of EDSS worsening (OR = 0.75;95 %CI = 0.21-2.35) compared to females. Similarly, minor/no sex differences emerged in other outcomes.<BR><B>CONCLUSIONS: </B>Four years after first manifestation, neither disease activity (disability progression and relapse rate) nor patient-reported outcomes showed sex-related disparities in this early-MS-cohort.<BR><B>RESULTS: </B><BR><B>UNASSIGNED: </B>NCT01371071.