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- Titel:
Progressive improvement in cutaneous and extracutaneous chronic graft-versus-host disease after a 24-week course of extracorporeal photopheresis--results of a crossover randomized study.
- Dokumenttyp:
- journal article
- Autor(en):
- Greinix, HT; van Besien, K; Elmaagacli, AH; Hillen, U; Grigg, A; Knobler, R; Parenti, D; Reddy, V; Theunissen, K; Michallet, M; Flowers, ME; UVADEX Chronic GVHD Study Group; Mistrik, M; Durrant, S; van Besien, K; Dodds, T; Elmaagacli, AH; Hillen, U; Reddy, V; Theunissen, K; Machado, AM; Michallet, M; Kolb, HJ; Grigg, A; Bouzas, L; Taylor, P; Flowers, ME; Greinix, HT; Knobler, R
- Abstract:
- In a prior multicenter randomized controlled trial, we found that a 12-week course of extracorporeal photopheresis (ECP) plus standard immunosuppressive therapy resulted in several beneficial outcomes in patients with corticosteroid-refractory/intolerant/dependent chronic graft-versus-host disease (GVHD). Here, we report the results of an open-label crossover ECP study in 29 eligible participants randomized initially to the standard of care non-ECP (control) arm. Eligible for the crossover ECP study were control arm patients who either (1) had progression of cutaneous chronic GVHD (cGVHD), defined as>25% worsening from baseline as measured by the percent change in the total skin score (TSS) at any time, or (2) had less than 15% improvement in the TSS, or had a<=25% reduction in corticosteroid dose at week 12 of the initial study. ECP was administered 3 times during week 1, then twice weekly until week 12, followed by 2 treatments monthly until week 24. The median age of the study cohort was 43 (20-67) years and 90% had extensive cGVHD. The median months from onset of cGVHD to start of ECP were 26 (range: 4-79). Twenty-five of 29 patients (86%) completed the 24-week course of ECP. Complete or partial skin response at week 24 was noted in 9 patients (31%). The median percent of decrease in TSS from baseline to weeks 12 and 24 was -7.9 and -25.8, respectively. In 4 (17%) and 8 (33%) patients, a>=50% reduction in corticosteroid dose at weeks 12 and 24 was observed. Extracutaneous cGVHD response was highest in oral mucosa with 70% complete and partial resolution after week 24. In conclusion, progressive improvement in cutaneous and extracutaneous cGVHD was observed after a 24-week course of ECP in patients who previously had no clinical improvement or exhibited worsening of cGVHD while receiving standard immunosuppressive therapy alone in a randomized study. These results confirm previous findings and support the notion that prolonged ECP appears to be necessary for optimal therapeutic effects in corticosteroid-refractory cGVHD patients.
- Zeitschriftentitel:
- Biol Blood Marrow Transplant
- Jahr:
- 2011
- Band / Volume:
- 17
- Heft / Issue:
- 12
- Seitenangaben Beitrag:
- 1775-82
- Sprache:
- eng
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/21621629
- Print-ISSN:
- 1083-8791
- TUM Einrichtung:
- III. Medizinische Klinik und Poliklinik
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