PMID- 20889574
OWN - NLM
STAT- MEDLINE
DCOM- 20110923
LR  - 20221207
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Print)
IS  - 1462-0324 (Linking)
VI  - 50
IP  - 2
DP  - 2011 Feb
TI  - Gender and ethnicity differences in patients with diffuse systemic 
      sclerosis--analysis from three large randomized clinical trials.
PG  - 335-42
LID - 10.1093/rheumatology/keq294 [doi]
AB  - OBJECTIVE: Although the incidence of dcSSc is higher in African-American and 
      Hispanic populations compared with European Caucasian patients, it is not clear 
      whether there are differences in subsequent disease course. Also, the potential 
      impact of gender on the disease course of dcSSc is not well defined. Our 
      objective was to assess the course of modified Rodnan skin score (MRSS), 
      HAQ-disability index (HAQ-DI) and forced vital capacity per cent (FVC%) predicted 
      between men vs women and three ethnic groups with dcSSc participating in three 
      randomized clinical trials (RCTs). METHOD: Data from RCTs (n = 495) were pooled 
      and analysed. Baseline characteristics were compared in men vs women and among 
      ethnic groups. A linear mixed effects model was used to assess the predictors of 
      MRSS, HAQ-DI and FVC%. The primary independent variables were time-in-study and 
      its interaction with gender and ethnicity. The models were adjusted for other 
      covariates that were significant at baseline between gender and ethnicity 
      analyses. RESULTS: Men had lower HAQI-DI scores compared with women (P < 0.05). 
      Among the three ethnic groups, Caucasians were older, African-Americans had lower 
      FVC% predicted and Hispanics had greater tender joint counts (P < 0.05). The 
      course of MRSS, HAQ-DI and FVC% predicted during the study period was not 
      significantly different between gender and three ethnicities. Time-in-study was 
      an independent predictor of improvement in MRSS and HAQ-DI. CONCLUSION: Our 
      analysis explores the influence of gender and ethnicity on disease course in 
      RCTs. These findings are relevant to issues of future trial design.
FAU - Nashid, Mahsa
AU  - Nashid M
AD  - Department of Medicine, David Geffen School of Medicine, Los Angeles, CA 90095, 
      USA.
FAU - Khanna, Puja P
AU  - Khanna PP
FAU - Furst, Daniel E
AU  - Furst DE
FAU - Clements, Philip J
AU  - Clements PJ
FAU - Maranian, Paul
AU  - Maranian P
FAU - Seibold, James
AU  - Seibold J
FAU - Postlethwaite, Arnold E
AU  - Postlethwaite AE
FAU - Louie, James S
AU  - Louie JS
FAU - Mayes, Maureen D
AU  - Mayes MD
FAU - Agrawal, Harsh
AU  - Agrawal H
FAU - Khanna, Dinesh
AU  - Khanna D
CN  - investigators of the D-penicillamine, human recombinant relaxin and oral bovine 
      type I collagen clinical trials
LA  - eng
GR  - K23 AR053858/AR/NIAMS NIH HHS/United States
GR  - K23 AR053858-04/AR/NIAMS NIH HHS/United States
GR  - 1 T32 AR053463/AR/NIAMS NIH HHS/United States
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20101001
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
SB  - IM
MH  - Adult
MH  - Black or African American/ethnology
MH  - Disability Evaluation
MH  - Disease Progression
MH  - Female
MH  - Hispanic or Latino/ethnology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
MH  - Scleroderma, Diffuse/*ethnology/pathology
MH  - *Severity of Illness Index
MH  - Sex Factors
MH  - Statistics as Topic
MH  - White People/ethnology
PMC - PMC3107588
EDAT- 2010/10/05 06:00
MHDA- 2011/09/29 06:00
PMCR- 2012/02/01
CRDT- 2010/10/05 06:00
PHST- 2010/10/05 06:00 [entrez]
PHST- 2010/10/05 06:00 [pubmed]
PHST- 2011/09/29 06:00 [medline]
PHST- 2012/02/01 00:00 [pmc-release]
AID - keq294 [pii]
AID - 10.1093/rheumatology/keq294 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2011 Feb;50(2):335-42. doi: 10.1093/rheumatology/keq294. 
      Epub 2010 Oct 1.