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Progressive Improvement In Steroid-Refractory/Dependent/Intolerant Cutaneous Chronic Graft-Versus-Host Disease (Cgvhd) Following A 24-Week Course Of Extracorporeal Photopheresis (Ecp)

Year: 2010

Type: article

Abstract: In a previously reported multicenter randomized standard-therapy controlled trial, a 12-week course of ECP resulted in several beneficial outcomes in patients (pts) with steroid-refractory/intolerant/dependent cGVHD. (Flowers et al, Blood 112:2667-74. 2008). We conducted an open-label cross-over extension study to provide access to ECP for participants in the standard of care arm of this randomized study and enrolled 29 pts. ECP was administered 3 times during week 1, 2 treatments weekly until week 12 then 2 treatments until week 24. The median age of the study cohort was 43 (20-67) years and 26 pts (90%) had extensive cGVHD. Onset was de novo in 11 (37.9%), progressive in 15 (51.7%) and quiescent in 3 (10.3%). Twenty-five of 29 pts (86%) completed the 24 week course of ECP open-label treatment. Causes for not completing the 24-weeks were GVHD progression (n=2), 1 suicide, and 1 withdrawal of consent. Mean daily steroid dose was 18.4 mg at the first ECP visit in this extension study (baseline). The median total skin score (TSS) was 7.8 (1.0-18.5) at the start of this cross-over extension study. The median percent change in TSS from baseline to week 12 and week 24 was -8.0 and -22.7, respectively. Four pts (14%) and 7 pts (24%) achieved a ≥50% reduction in steroid dose at weeks 12 and 24, respectively. In 4 pts (14%) and 8 pts (28%) a ≥50% reduction in steroid dose and a final steroid dose of <10 mg/day at weeks 12 and 24 was obtained respectively. Complete or partial skin response at week 24 was observed in 4 pts (14%) by investigator assessment. Progressive improvement in cutaneous manifestations of cGVHD was observed following a 24-week course of ECP in pts who previously had exhibited no clinical response or worsening of cGVHD while receiving standard immunosuppressive therapy with corticosteroids. ECP improved skin GVHD and allowed for tapering of corticosteroid doses to “low risk” levels of <10 mg prednisone-equivalents/day.

Source: Transplantation and Cellular Therapy

DOI: 10.1016/j.bbmt.2009.12.450