Differences in presentation of younger and older systemic sclerosis patients in clinical trials.
OBJECTIVE
To compare the characteristics of younger and older subjects with diffuse cutaneous systemic sclerosis (SSc) entering clinical trials.


METHODS
Subjects were participants in three randomised interventional trials that shared relative uniformity of demographics and disease characteristics. Only subjects with diffuse cutaneous systemic sclerosis were evaluated. To maximise possible differences, the lowest (age<38 years) and highest quartiles (age>53 years) were used, and a total of 264 diffuse cutaneous SSc (dcSSc) subjects were identified. For the comparison between the two age groups, generalised linear mixed or linear models with adjustment for population norms, demographics and medications were employed to assess differences attributable to subject age.


RESULTS
After adjustment for population norms and study effects, differences in diastolic blood pressure, alkaline phosphatase, AST, and creatinine phosphokinase (CK) were found between the two age groups. After further adjustment for demographics, disease duration and medications, older SSc patients still had significantly higher alkaline phosphatase (11 U/L higher), and lower CK (76 U/L lower) than younger patients (p<0.003 for all). All other variables were not significantly different in the two age groups.


CONCLUSIONS
Clinical baseline differences exist between younger and older patients with SSc. However, after adjustment for population norms and potential confounders, including medications, only differences in alkaline phosphatise (only 11U/L) and CK (76 U/L) remain. Overall, older patients with SSc in clinical trials seem to be more similar to younger patients than was previously thought.
Amgen Inc, Thousand Oaks, CA, USA. hollyweng@yahoo.com
H H
HH
Weng
V K
VK
Ranganath
M
M
Oh
G S
GS
Park
D
D
Khanna
P J
PJ
Clements
J R
JR
Seibold
D A
DA
Elashoff
D E
DE
Furst
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000469:Alkaline Phosphatase / Q000097:blood; D001794:Blood Pressure; D019963:Clinical Chemistry Tests; D003402:Creatine Kinase / Q000097:blood; D005260:Female; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D045743:Scleroderma, Diffuse / Q000097:blood / Q000175:diagnosis* / Q000503:physiopathology; D012720:Severity of Illness Index; D012867:Skin / Q000473:pathology; D055815:Young Adult
D003402:Creatine Kinase; D000469:Alkaline Phosphatase