A Prospective Analysis of Breakthrough Hemolysis in 2 Phase 3 Randomized Studies of Ravulizumab (ALXN1210) Versus Eculizumab in Adults with Paroxysmal Nocturnal Hemoglobinuria

Background/Objective: Breakthrough hemolysis (BTH) is the return of hemolytic disease activity during treatment with complement C5 inhibitors for paroxysmal nocturnal hemoglobinuria (PNH). BTH may be associated with inadequate C5 inhibition or complement activating conditions (eg, infection). Despit...

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Published in:Blood 2018-11, Vol.132 (Supplement 1), p.2330-2330
Main Authors: Brodsky, Robert A., Peffault De Latour, Regis, Rottinghaus, Scott T., Röth, Alexander, Risitano, Antonio M., Weitz, Ilene C., Hillmen, Peter, Maciejewski, Jaroslaw P., Szer, Jeffrey, Lee, Jong-Wook, Kulasekararaj, Austin G., Volles, Lori, Damokosh, Andrew I., Ortiz, Stephan, Shafner, Lori, Hill, Anita, Schrezenmeier, Hubert
Format: Article
Language:English
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Summary:Background/Objective: Breakthrough hemolysis (BTH) is the return of hemolytic disease activity during treatment with complement C5 inhibitors for paroxysmal nocturnal hemoglobinuria (PNH). BTH may be associated with inadequate C5 inhibition or complement activating conditions (eg, infection). Despite reports that up to 19% of patients (pts) receiving eculizumab may experience BTH, there is no commonly accepted definition of BTH. The definition of BTH was derived from literature review and expert consensus. BTH was defined as ≥1 new or worsening symptom/sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, dyspnea, anemia [hemoglobin
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2018-99-110874