Table 2.

Summary of clinical results


Clinical parameter

Study Entry

1 Year

P
Overall response rate, no./no. total (%)   NA   14/20 (70)   
Complete response rate, no./no. total (%)   NA   2/20 (10)   
Prednisone dose, median mg/d  40   10   < .001  
    Discontinued prednisone, no./no total (%)   NA   4/19 (21)*  
    Prednisone reduction of at least 50%, no./no. total (%)   NA   13/19 (68)   
    No change, or higher dose, no./no. total (%)   NA   6/19 (32)   
Cutaneous involvement, median %    
    Total body surface area   42   20   .02  
    Sclerodermatous involvement   35   20   .19  
    Lichenoid involvement   19.5   3   .17  
Rheumatologic involvement    
    VAS pain score, median   4   1.5   .02  
    VAS fatigue score, median   5   2   .50  
    Preston dynamometer, average left and right hand, lb   62.5   71.5   .13  
Oral involvement    
    Pathology score   11.75   12.5   .63  
Ocular involvement    
    Schirmer test, average left and right eye, mm
 
1
 
3.75
 
< .99
 

Clinical parameter

Study Entry

1 Year

P
Overall response rate, no./no. total (%)   NA   14/20 (70)   
Complete response rate, no./no. total (%)   NA   2/20 (10)   
Prednisone dose, median mg/d  40   10   < .001  
    Discontinued prednisone, no./no total (%)   NA   4/19 (21)*  
    Prednisone reduction of at least 50%, no./no. total (%)   NA   13/19 (68)   
    No change, or higher dose, no./no. total (%)   NA   6/19 (32)   
Cutaneous involvement, median %    
    Total body surface area   42   20   .02  
    Sclerodermatous involvement   35   20   .19  
    Lichenoid involvement   19.5   3   .17  
Rheumatologic involvement    
    VAS pain score, median   4   1.5   .02  
    VAS fatigue score, median   5   2   .50  
    Preston dynamometer, average left and right hand, lb   62.5   71.5   .13  
Oral involvement    
    Pathology score   11.75   12.5   .63  
Ocular involvement    
    Schirmer test, average left and right eye, mm
 
1
 
3.75
 
< .99
 

VAS indicates visual analog scale.

*

One patient not using prednisone at study initiation and one patient with disease relapse are excluded.

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