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Table 2 Safety and efficacya outcomes

From: Gene expression changes reflect clinical response in a placebo-controlled randomized trial of abatacept in patients with diffuse cutaneous systemic sclerosis

Variable Abatacept Placebo p-value
n = 7 n = 3
Adverse events 7 7 1
 Serious adverse events 1 0  
 Infectionsb 2 4  
 Pruritus 2 0  
 Lower extremity edema 0 1  
 Headache 1 0  
 Dry mouth 0 1  
 Nausea 0 1  
 Fever 1 0  
Absolute change in mRSS, abatacept −8.6 ± 7.5 0.0625
Absolute change in mRSS, placebo −2.3 ± 15 0.75
Change in HAQ-DI −0.04 ± 0.24 0.25 ± 0.25 0.16
Change in physician global VAS −11.9 ± 18.1 −17.3 ± 23.2 0.048
Change in patient global VAS −8 ± 7.6 −2.7 ± 6.7 0.023
Change in patient pain VAS −11.4 ± 8.3 −15 ± 25.1 0.18
Change in ESR −6 ± 7.0 1.7 ± 7.6 0.37
Change in FVC % predicted 1.3 ± 8.5 0.3 ± 8.5 0.72
Change in DLCO % predicted 2.0 ± 6.3 −7.4 ± 10.7 0.84
  1. Values are mean ± SD. aEfficacy outcomes are based on comparing week 24 to baseline. bInfections in the abatacept group included two upper respiratory tract infections, and in the placebo group one of each of the following: upper respiratory tract infection, urinary tract infection, hordeolum, and infected toe digital ulcer. DLCO diffusing capacity of the lung for carbon monoxide, ESR erythrocyte sedimentation rate, FVC forced vital capacity, HAQ-DI Health Assessment Questionnaire Disability Index, mRSS modified Rodnan skin score, VAS visual analogue scale