Table 4.

Incidence of acute graft-versus-host disease, severity, and organ distribution

	No. of patients (%)
Acute GVHD	Twice-daily MMF, n = 38	3-times-daily MMF, n = 47
Grades II-IV	26 (68)	32 (68)
Grades III-IV	4 (11)	8 (17)
Stages 2+ to 4+
Skin	21 (55)	27 (57)
Gut*	3 (8)	8 (17)
Liver	1 (3)	3 (6)

Additionally, there were 11 and 20 patients in the twice-daily and 3-times-daily MMF group, respectively, with stage 1+ gut GVHD. Considering all patients with stage 1+ to 4+ gut GVHD, there was a suggestion of an increased incidence of gut GVHD in the 3-times-daily MMF group, P = .05. Twenty-eight patients (33%) underwent gut biopsy to evaluate symptoms consistent with acute GVHD between 14 to 126 (median, 39) days after transplantation. Twenty-five of 28 gut biopsies (89%) had histologic evidence diagnostic for acute GVHD. The 3 patients with gut biopsies that showed nonspecific changes subsequently developed and were treated for histologically confirmed acute GVHD of the skin at 3, 9, and 24 days after gut biopsy. There was no endoscopic evidence of MMF toxicity documented in any of the 85 patients in the study.

^*P = .33