Background Clinicians frequently rely on relapse counts, T2 MRI lesion load (T2L) and Expanded Disability Status Scale (EDSS) scores to guide treatment decisions for individuals diagnosed with multiple sclerosis (MS). This study evaluates how these factors, along with age and sex, influence prognosis during treatment with teriflunomide (TFL). Methods We conducted a nationwide cohort study using data from the Danish Multiple Sclerosis Registry. Eligible participants had relapsing-remitting MS or clinically isolated syndrome and initiated TFL as their first treatment between 2013 and 2019. The effect of age, pretreatment relapses, T2L and EDSS scores on the risk of disease activity on TFL were stratified by sex. Results In total, 784 individuals were included (57.4% females). A high number of pretreatment relapses (≥2) was associated with an increased risk of disease activity in females only (OR and (95% CI): 1.76 (1.11 to 2.81)). Age group 50+ was associated with a lower risk of disease activity in both sexes (OR females=0.28 (0.14 to 0.56); OR males=0.22 (0.09 to 0.55)), while age 35–49 showed a different impact in males and females (OR females=0.79 (0.50 to 1.23); OR males=0.42 (0.24 to 0.72)). EDSS scores and T2L did not show any consistent associations. Conclusion A high number of pretreatment relapses was only associated with an increased risk of disease activity in females, while age had a differential impact on the risk of disease activity according to sex. Clinicians may consider age, sex and relapses when deciding on TFL treatment. Data are available upon reasonable request. Access to data is possible through a qualified request approved by the Capital Region of Denmark.

中文翻译：

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新诊断的接受特立氟胺治疗的多发性硬化症患者疾病活动的预后因素：丹麦全国性研究

背景 临床医生经常依靠复发计数、T2 MRI 病变负荷 (T2L) 和扩展残疾状态量表 (EDSS) 评分来指导诊断为多发性硬化症 (MS) 患者的治疗决策。本研究评估了这些因素以及年龄和性别如何影响特立氟胺 (TFL) 治疗期间的预后。方法 我们利用丹麦多发性硬化症登记处的数据进行了一项全国性队列研究。符合条件的参与者患有复发缓解型多发性硬化症或临床孤立综合征，并在 2013 年至 2019 年间开始将 TFL 作为首次治疗。年龄、治疗前复发、T2L 和 EDSS 评分对 TFL 疾病活动风险的影响按性别进行分层。结果 总共纳入 784 人（57.4% 为女性）。仅在女性中，大量治疗前复发（≥2）与疾病活动风险增加相关（OR 和（95% CI）：1.76（1.11 至 2.81））。 50 岁以上年龄组与两性的较低疾病活动风险相关（OR 女性=0.28（0.14 至 0.56）；OR 男性=0.22（0.09 至 0.55）），而 35-49 岁年龄组对男性和女性的影响不同。女性（或女性=0.79（0.50至1.23）；或男性=0.42（0.24至0.72））。 EDSS 分数和 T2L 没有显示出任何一致的关联。结论 治疗前大量复发仅与女性疾病活动风险增加相关，而年龄对疾病活动风险的影响因性别而异。临床医生在决定 TFL 治疗时可能会考虑年龄、性别和复发情况。数据可根据合理要求提供。通过丹麦首都地区批准的合格请求可以访问数据。