Gender and ethnicity differences in patients with diffuse systemic sclerosis--analysis from three large randomized...

Area of Science:

• Rheumatology
• Clinical Immunology
• Systemic Sclerosis Research

Background:

• Diffuse cutaneous systemic sclerosis (dcSSc) disproportionately affects minority populations.
• The influence of gender and ethnicity on dcSSc disease progression remains unclear.
• Understanding these factors is crucial for personalized treatment and clinical trial design.

Purpose of the Study:

• To evaluate differences in disease course, including modified Rodnan skin score (MRSS), HAQ-disability index (HAQ-DI), and forced vital capacity (FVC%), between men and women with dcSSc.
• To compare the disease course among European Caucasian, African-American, and Hispanic patients with dcSSc.
• To identify predictors of disease course in dcSSc.

Main Methods:

• Pooled data from three randomized clinical trials (RCTs) involving 495 dcSSc patients.
• Linear mixed-effects models were employed to analyze MRSS, HAQ-DI, and FVC% changes over time.
• Models were adjusted for baseline covariates and assessed the impact of gender, ethnicity, and time-in-study.

Main Results:

• Men reported lower HAQ-DI scores than women.
• Ethnic groups differed in baseline characteristics: Caucasians were older, African-Americans had lower FVC%, and Hispanics had more tender joints.
• No significant differences in the disease course of MRSS, HAQ-DI, or FVC% were observed between genders or ethnic groups.
• Time-in-study was a significant predictor of improvement in MRSS and HAQ-DI.

Conclusions:

• Gender and ethnicity did not significantly impact the disease course of dcSSc in this pooled RCT analysis.
• Disease progression, measured by MRSS and HAQ-DI, improved over time in study.
• Findings highlight the need for careful consideration of gender and ethnicity in future dcSSc clinical trial design.