Chronic GVHD Consortium CATCH Study: Incidence, initial presentation and risk factors for chronic GVHD development

The incidence of chronic graft-versus-host disease (GVHD) is declining but up to 30% of survivors are still diagnosed with chronic GVHD. We conducted a prospective, multi-center, observational study to understand the incidence and earliest presenting signs and symptoms of chronic graft vs. host disease (GVHD) in the current era to inform trials testing early therapy. Patients were enrolled and assessed prior to allogeneic transplantation (HCT), and approximately every 2 months through the first year post-HCT, and at time of chronic GVHD diagnosis. Clinician assessments, patient-reported measures (Lee Symptom Score (LSS), PROMIS), and biologic samples were collected at each time point. A total of 208 subjects were enrolled across 7 HCT centers. The cumulative incidence of any chronic GVHD was 54% by 24 months post-HCT, while chronic GVHD requiring systemic immune suppressive therapy (IST) was 38%. At onset, organ involvement included skin (32%), eye (41%), mouth (42%), liver (17%), GI (9%), lung (11%), and joint/fascia (5%) with overall severity of mild (or less) in 55%, moderate in 37%, or severe in 8%. Management practices were heterogeneous. Subsequent chronic GVHD requiring IST was significantly associated with baseline donor/recipient CMV positivity and non-PTCY-based acute GVHD prophylaxis, as well as serial changes in skin/mouth/joint (PROM) organ scores and LSS summary score. These data provide current estimates of chronic GVHD incidence and presenting features, new data on risk predictors, and a data resource for future overall and organ-specific biomarker studies.