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 Article

International Collaboration

cited authors

  • Greinix, Hildegard T., van Besien, Koen, Elmaagacli, Ahmet H., Hillen, Uwe, Grigg, Andrew, Knobler, Robert, Parenti, Dennis, Reddy, Vijay, Theunissen, Koen, Michallet, Mauricette, Flowers, Mary E. D., UVADEX Chronic GVHD Study Grp

funding text

  • Financial disclosure: This study was sponsored by Therakos, a division of Johnson & Johnson, Raritan, NJ. D.P. is a full-time employee of Johnson & Johnson. H.T.G.,.U.W., and R.K. served as consultants to Therakos and participated as lecturers in the speakers bureau for Therakos. K.v.B. was a member of the advisory board of Therakos and received study support from Therakos. A.H.E. received a research fund from Novartis. M.M. was a member of the advisory board of Therakos.

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 <= 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. Biol Blood Man-ow Transplant 17: 1775-1782 (2011) (C) 2011 American Society fir Blood and Marrow Transplantation

Publication Date

  • December 1, 2011

webpage

published in

category

start page

  • 1775

end page

  • 1782

volume

  • 17

issue

  • 12

WoS Citations

  • 58

WoS References

  • 30