OBJECTIVES:

Chronic graft-versus-host disease (cGVHD) is a major complication following allogeneic hematopoietic stem cell transplantation (HSCT). This study aimed to estimate the number of HSCT patients with incident cGVHD per year in France, Germany, Italy, Spain and the UK, and across the EU28.

METHODS:

A model was developed to estimate the annual number of incident cGVHD patients, and cases by disease severity and organ involvement in the top 5 European countries and across the EU28 from 2019 to 2023. cGVHD was defined according to the National Institutes of Health Consensus Guidelines. The number of HSCT patients was estimated based on country-specific data derived from the annual reports of the European Society for Blood and Marrow Transplantation Registry. A systematic literature review was conducted to obtain country/region-specific cGVHD incidence data. Scenarios estimating steroid-refractory cGVHD cases were also explored.

RESULTS:

The analysis indicated that the estimated number of incident cGVHD patients in the EU28 will range from 3218 (mild: 908; moderate: 1375; severe: 935) to 3465 (mild: 977; moderate: 1481; severe: 1007) between 2019 and 2023. Our model indicated that the most frequently involved organs are mouth, eyes, skin and liver. These results were also consistent for the EU5 group. Exploratory analysis predicted that due to the higher number of transplantations performed, the number of steroid-refractory patients in the EU28 will likely increase from 1609 to 1732 during the model period.

CONCLUSIONS:

With steady growth in allogeneic HSCTs performed in Europe, it can be expected that the number of cGVHD patients will increase by around 7.5% in the next 5 years. Our findings suggest the majority of diagnosed patients will be moderate or severe. Considering the high morbidity and impaired quality of life of moderate and severe cGVHD, there is a need for effective and tolerable new treatments.