Response to Daily Systemic Steroids
STEROID-REFRACTORY PATIENTS CAN BE IDENTIFIED AS EARLY AS 3 DAYS AFTER STARTING TREATMENT
Additional Therapy May Be Required
Approximately half of patients with acute GVHD (aGVHD) will not achieve an adequate response to steroids.2-6
Patients Can Be Identified As Early As 3 Days
Patients with steroid-refractory aGVHD can be identified as early as 3 days after starting treatment with steroids.6
CIBMTR, Center for International Blood and Marrow Transplant Research; EBMT, European Society for Blood and Marrow Transplantation; NIH, National Institutes of Health.
Disease Progression in Steroid-Refractory aGHVD: Real-World Data
An Incyte-sponsored retrospective chart review of 168 patients with Grade II to IV Steroid-Refractory aGVHD9*
- Median time from diagnosis to maximum grade was 6 days in the steroid-refractory population
- 40% of the 134 patients with Grade II or III steroid-refractory aGVHD advanced to a higher maximum grade
- 54% of patients with steroid-refractory aGVHD had new organ involvement or an increase in grade
- Among the 66 patients with steroid-refractory aGVHD in skin alone at diagnosis, 36% developed symptoms in a new organ
*A multicenter, retrospective chart review conducted at 11 large US academic and community transplant centers in patients with Grade II–IV steroid-refractory aGVHD who had their first hematopoietic cell transplantation between January 2014 and June 2016.
FDA approval for Jakafi for the treatment of steroid-refractory aGVHD was based on the data from the REACH1 study. REACH2 data are not included in the Jakafi Prescribing Information. Although the adverse event data reported in REACH2 is informative, the risk information as described in the Full Prescribing Information for Jakafi should be considered when making prescribing decisions.
- Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.
- Dignan FL, Clark A, Amrolia P, et al. Diagnosis and management of acute graft-versus-host disease. Br J Haematol. 2012;158(1):30-45.
- Martin PJ, Rizzo JD, Wingard JR, et al. First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the American Society of Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2012;18(8):1150-1163.
- Hill L, Alousi A, Kebriaei P, et al. New and emerging therapies for acute and chronic graft versus host disease. Ther Adv Hematol. 2018;9(1):21-46.
- MacMillan ML, Weisdorf DJ, Wagner JE, et al. Response of 443 patients to steroids as primary therapy for acute graft-versus-host disease: comparison of grading systems. Biol Blood Marrow Transplant. 2002;8(7):387-394.
- Schoemans HM, Lee SJ, Ferrara JL, et al. EBMT—NIH—CIBMTR Task Force position statement on standardized terminology & guidance for graft-versus-host disease assessment. Bone Marrow Transplant. 2018;53(11):1401-1415.
- Mendoza KA, Chen H, Englehardt BG, et al. Similar outcomes in early failure steroid dependent acute GvHD and upfront steroid refractory acute GvHD. Presented at: 59th American Society of Hematology (ASH) Annual Meeting and Exposition; December 9-12, 2017; Atlanta, GA; Abstract 1975.
- Das-Gupta E, Greinix H, Jacobs R, et al. Extracorporeal photopheresis as second-line treatment for acute graft-versus-host disease: impact on six-month freedom from treatment failure. Haematologica. 2014;99(11):1746-1752.
- Yu J, Hanna B, Paranagama D, Tang J, Naim A, Galvin JP. Disease progression, hospital readmissions, and clinical outcomes of patients with steroid-refractory acute graft-versus-host disease: a multicenter chart review. Blood. 2019;134(suppl, abstr):1994.