Alexion’s Soliris Therapy Found to Improve Fatigue in Hemoglobinuria Study
Alexion Pharmaceuticals has announced that Soliris therapy improved the often disabling fatigue experienced by patients with the rare blood disorder paroxysmal nocturnal hemoglobinuria, independent of improvements in anemia.
In clinical trials with Soliris, paroxysmal nocturnal hemoglobinuria (PNH) patients experienced a substantial improvement in PNH-related fatigue independent of changes in their anemia. This improvement was larger than the improvement in fatigue reported in a separate study of anemic cancer patients treated with erythropoietin (EPO).
Data on 164 patients with PNH were derived from two Phase III studies of Soliris as a treatment for PNH: Triumph, a six-month, double-blind, placebo-controlled study, and Shepherd, a 12-month, open-label study. The study results show that while intravascular hemolysis reduction (decreased LDH) and anemia improvement (increased hemoglobin) were both significantly associated with fatigue improvement (odds ratio 1.11, P<0.001 and 1.29, P=0.005,respectively) hemolysis reduction was predictive of an improvement in fatigue independent of an improvement in anemia in patients with PNH (1.07, P=0.028).
The improvement in fatigue was greater (P=0.002) in Soliris-treated PNH patients compared to EPO-treated anemic cancer patients. These data suggest that fatigue experienced by patients with PNH is related directly to hemolysis – the red blood cell destruction that defines the disease – and can be improved independent of correction of anemia.
Leonard Bell, CEO of Alexion, said: “This study indicates that patients can experience life-changing improvements in fatigue with long-term Soliris therapy regardless of changes in their anemia.”