A large real-world study in Japan has confirmed the long-term safety and effectiveness of Darbepoetin Alfa for treating anemia in patients with myelodysplastic syndromes (MDS). The 5-year post-marketing surveillance study followed 1,834 patients across 460 medical centers, providing much broader evidence than the original 2014 approval trial, which included only 52 patients.
Researchers found that hemoglobin levels steadily improved over time, rising from an average of 7.6 g/dL at baseline to as high as 9.6 g/dL during long-term treatment. Among patients who required regular red blood cell transfusions at the start of the study, more than 40% achieved transfusion independence after four to five years. Patients with lower baseline erythropoietin levels showed the strongest treatment responses.
The study also linked better hemoglobin responses to improved survival outcomes. Patients who reached hemoglobin levels above 10 g/dL had significantly higher five-year survival rates than those who remained severely anemic. No new safety concerns were identified, and researchers concluded that darbepoetin alfa remains a reliable long-term treatment option for MDS-related anemia in real-world clinical practice.