Table 2

Chronic GVHD characteristics

CharacteristicECP, n = 48Control, n = 47
Corticosteroid status, n (%)*   
    Corticosteroid-dependent 28 (58) 25 (53) 
    Corticosteroid-refractory 7 (15) 5 (11) 
    Corticosteroid-intolerant 13 (27) 17 (36) 
Median days from transplantation to cGVHD (range) 140 (69-637) 129 (70-1389) 
Median days from cGVHD to randomization (range) 569 (35-2743) 630 (1-2253) 
Onset type of cGVHD, n (%)   
    Progressive 28 (58) 25 (53) 
    Quiescent 5 (10) 6 (13) 
    de novo 15 (32) 16 (34) 
Severity of cGVHD, n (%)   
    Limited 3 (6) 3 (6) 
    Extensive 45 (94) 44 (94) 
Total Skin Score (TSS) at baseline, median (range) 9.4 (0.6-23.6) 9.2 (1.0-20.7) 
Extracutaneous GVHD involvement, n (%)   
    Ocular 27 (56.3) 28 (59.6) 
    Gastrointestinal 2 (4.2) 9 (19.1) 
    Liver 14 (29.2) 14 (29.8) 
    Lung 9 (18.8) 7 (14.9) 
    Oral mucosa 30 (62.5) 30 (63.8) 
    Joints 18 (37.5) 16 (34) 
Median duration (wks) of corticosteroid usage for cGVHD before study entry (range) 50 (2.7-426) 55 (1.9-319) 
Median daily total oral corticosteroid dose (mg) at baseline (range) 16 (4-64) 20 (3.3-60) 
Concurrent immunosuppressive medication at baseline, n (%)   
    Mycophenolate mofetil 26 (54) 26 (55) 
    Cyclosporin A 24 (50) 28 (60) 
    FK-506 11 (23) 6 (13) 
Baseline platelet count < 100 000/μL, n (%) 5 (10.4) 6 (12.8) 
CharacteristicECP, n = 48Control, n = 47
Corticosteroid status, n (%)*   
    Corticosteroid-dependent 28 (58) 25 (53) 
    Corticosteroid-refractory 7 (15) 5 (11) 
    Corticosteroid-intolerant 13 (27) 17 (36) 
Median days from transplantation to cGVHD (range) 140 (69-637) 129 (70-1389) 
Median days from cGVHD to randomization (range) 569 (35-2743) 630 (1-2253) 
Onset type of cGVHD, n (%)   
    Progressive 28 (58) 25 (53) 
    Quiescent 5 (10) 6 (13) 
    de novo 15 (32) 16 (34) 
Severity of cGVHD, n (%)   
    Limited 3 (6) 3 (6) 
    Extensive 45 (94) 44 (94) 
Total Skin Score (TSS) at baseline, median (range) 9.4 (0.6-23.6) 9.2 (1.0-20.7) 
Extracutaneous GVHD involvement, n (%)   
    Ocular 27 (56.3) 28 (59.6) 
    Gastrointestinal 2 (4.2) 9 (19.1) 
    Liver 14 (29.2) 14 (29.8) 
    Lung 9 (18.8) 7 (14.9) 
    Oral mucosa 30 (62.5) 30 (63.8) 
    Joints 18 (37.5) 16 (34) 
Median duration (wks) of corticosteroid usage for cGVHD before study entry (range) 50 (2.7-426) 55 (1.9-319) 
Median daily total oral corticosteroid dose (mg) at baseline (range) 16 (4-64) 20 (3.3-60) 
Concurrent immunosuppressive medication at baseline, n (%)   
    Mycophenolate mofetil 26 (54) 26 (55) 
    Cyclosporin A 24 (50) 28 (60) 
    FK-506 11 (23) 6 (13) 
Baseline platelet count < 100 000/μL, n (%) 5 (10.4) 6 (12.8) 
*

One patient in the ECP arm and 3 in the control arm were corticosteroid-dependent and -intolerant; these 4 patients are categorized as corticosteroid-intolerant.

Subjects were allowed to enter the study if they had a history of severe steroid intolerance before the onset of cGVHD.

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