Chronic GVHD consortium CATCH study: incidence, initial presentation, and risk factors for chronic GVHD development.

abstractThe incidence of chronic graft-versus-host disease (GVHD) is declining, but up to 30% of GVHD survivors are still diagnosed with chronic GVHD. We conducted a prospective, multicenter, and observational study to understand the incidence and earliest presenting signs and symptoms of chronic GVHD in the current era to inform trials testing early therapies. Patients were enrolled and assessed before allogeneic hematopoietic cell transplantation (HCT), approximately every 2 months through the first year after HCT, and at the time of chronic GVHD diagnosis. Clinician assessments, patient-reported measures (Lee Symptom Scale [LSS], Patient-Reported Outcomes Measurement Information System), 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 after HCT, whereas chronic GVHD requiring systemic immunosuppressive therapy (IST) was 38%. At onset, organ involvement included skin (32%), eyes (41%), mouth (42%), liver (17%), gastrointestinal tract (9%), lungs (11%), and joint/fascia (5%), with an overall severity of mild (or less) in 55%, moderate in 37%, or severe in 8% of patients. Management practices were heterogeneous. Subsequent chronic GVHD requiring IST was significantly associated with baseline donor/recipient cytomegalovirus positivity and nonposttransplant cyclophosphamide-based acute GVHD prophylaxis, as well as serial changes in skin/mouth/joint (photographic range of motion) organ scores and the 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. This trial was registered at www.clinicaltrials.gov as NCT04188912.