Etanercept plus Topical Corticosteroids as Initial Therapy for Grade One Acute Graft- Versus-Host Disease after Allogeneic Hematopoietic Cell Transplantation

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Etanercept plus Topical Corticosteroids as Initial Therapy for Grade One Acute Graft- Versus-Host Disease after Allogeneic Hematopoietic Cell Transplantation Erin Gatza, Thomas Braun, John E. Levine, James L.M. Ferrara, Shuang Zhao, Tianyi Wang, Lawrence Chang, Andrew Harris, Attaphol Pawarode, Carrie Kitko, John M. Magenau, Gregory A. Yanik, Daniel R. Couriel, Steven Goldstein, James Connelly, Pavan Reddy, Sophie Paczesny, Sung Won Choi Biology of Blood and Marrow Transplantation Volume 20, Issue 9, Pages 1426-1434 (September 2014) DOI: 10.1016/j.bbmt.2014.05.023 Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Study schema. Thirty-four patients diagnosed with skin grade 1 to 2 acute GVHD (overall grade 1) were treated with etanercept twice weekly for 4 weeks. Patients whose GVHD progressed to grade 2 to 4 within the first 28 days were considered study failures. In these patients, etanercept therapy was stopped and treatment with systemic steroids was initiated. GVHD was formally evaluated 4 and 8 weeks after diagnosis and onset of etanercept therapy. CR indicates complete resolution of GVHD; SD, stable disease; PD, progressive disease. *One patient died of idiopathic pneumonia syndrome (IPS) before the 4 week GVHD evaluation; †Seven of 10 patients with SD at the 4-week evaluation received an additional 4-week course of etanercept treatment. Biology of Blood and Marrow Transplantation 2014 20, 1426-1434DOI: (10.1016/j.bbmt.2014.05.023) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Incidence of acute GVHD, NRM, and OS in study patients (n = 34). (A) 1-year cumulative incidence of acute GVHD. Dashed line, grade 2 to 4 acute GVHD; solid line, grade 3 to 4 acute GVHD. (B) 2-year NRM. (C) 2-year OS. Biology of Blood and Marrow Transplantation 2014 20, 1426-1434DOI: (10.1016/j.bbmt.2014.05.023) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 Incidence of GVHD in study (n = 34) and contemporaneous control (n = 26) patients. (A) Cumulative incidence of grade 2 to 4 acute GVHD. Study versus control, P = .08. (B) Cumulative incidence of grade 3 to 4 acute GVHD. Study versus control, P = .05. (C) Cumulative incidence of moderate-to-severe chronic GVHD. Study versus control, P = .40. Dashed line, contemporaneous control patients; solid line, study patients treated with etanercept. Biology of Blood and Marrow Transplantation 2014 20, 1426-1434DOI: (10.1016/j.bbmt.2014.05.023) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 Biomarkers of acute GVHD in the plasma of study and contemporaneous control patients. Red circles denote patients in the study who received etanercept treatment. Blue squares are contemporaneous control patients. Horizontal black lines show the median values on each plot. (A and B) Plasma ST2 and Reg3α concentrations at the time of grade 1 diagnosis and treatment onset (day 0), day 14, and day 28. (A) Plasma ST2. (B) Plasma Reg3α. (C) Day-28 ST2 (left) and Reg3α (right) concentrations normalized to the concentration at GVHD diagnosis (ratio of day 28 over day 0). The number (n) of patients for whom samples were available to calculate the normalized value is indicated on each plot. Values plotted using linear-scale y-axis. (D) Plasma elafin. (E) Plasma TNFR1. (A, B, D, E) Study patient samples available for analysis: day 0, n = 34; day 14, n = 21; day 28, n = 32. Control samples: day 0, n = 26; day 14, n = 21; day 28, n = 23. Biomarker concentrations were plotted using a logarithmic-scale (Log10) y-axis to allow visualization of the full range of data at each time point. Biology of Blood and Marrow Transplantation 2014 20, 1426-1434DOI: (10.1016/j.bbmt.2014.05.023) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 5 Patients whose acute GVHD progressed to grade 2 to 4 had higher plasma ST2 levels than patients whose GVHD did not progress. Plasma ST2 concentrations at the time of grade 1 diagnosis and treatment onset (day 0), day 14, and day 28 in patients whose GVHD remained grade 1 or resolved with treatment (nonprogressor) and patients whose GVHD progressed to grade 2 to 4 (progressor) at any time after diagnosis. (Left) Study patients. Nonprogressors with samples available for analysis: day 0, n = 19; day 14, n = 10; day 28, n = 19. Progressors: day 0, n = 15; day 14, n = 11; day 28, n = 13. (Right) Contemporaneous control patients. Nonprogressors with samples available for analysis: day 0, n = 9; day 14, n = 9; day 28, n = 9. Progressors: day 0, n = 17; day 14, n = 12; day 28, n = 14. Each plotted point represents a single patient. Horizontal black lines represent median ST2 concentrations plotted on a logarithmic-scale (Log10) y-axis. Biology of Blood and Marrow Transplantation 2014 20, 1426-1434DOI: (10.1016/j.bbmt.2014.05.023) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions