Assessment of human antihuman antibodies to eculizumab after long-term treatment in patients with paroxysmal nocturnal hemoglobinuria

American Journal of Hematology

Volumn 91, Issue 3, 2016, Pages E16-E17

  Hillmen, Peter ^a   Muus, Petra ^b   Szer, Jeffrey ^c   Hill, Anita ^d   Höchsmann, Britta ^e   Kulasekararaj, Austin ^f   Risitano, Antonio M ^g   Van Den Neste, Eric ^h   Liljeholm, Maria ⁱ   Ebrahim, Kurt S ^j   Bedrosian, Camille L ^k   Gao, Xiang ^k   Ames, Donna ^k   Socié, Gérard ^l  

^a ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

^b RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^c ROYAL MELBOURNE HOSPITAL   (Australia)

^d LEEDS TEACHING HOSPITALS NHS TRUST   (United Kingdom)

^e UNIVERSITY OF ULM   (Germany)

^f KING S COLLEGE HOSPITAL   (United Kingdom)

^g UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^h CLINIQUES UNIVERSITAIRES SAINT LUC   (Belgium)

ⁱ UMEÅ UNIVERSITY HOSPITAL   (Sweden)

^j New England Cancer Specialists   (United States)

^k ALEXION PHARMACEUTICALS   (United States)

^l SAINT LOUIS HOSPITAL   (France)

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Author keywords

[No Author keywords available]

Indexed keywords

ECULIZUMAB; NEUTRALIZING ANTIBODY; COMPLEMENT COMPONENT C5; COMPLEMENT INHIBITOR; MONOCLONAL ANTIBODY;

ANTIBODY PRODUCTION; ANTIBODY RESPONSE; ARTHRALGIA; BLEEDING; BLOOD SAMPLING; DRUG PROTEIN BINDING; DRUG SAFETY; EPISTAXIS; FATIGUE; GAMMOPATHY; HEADACHE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; LETTER; LONG TERM CARE; OPEN STUDY; PAROXYSMAL NOCTURNAL HEMOGLOBINURIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; SKIN DEFECT; TREATMENT RESPONSE; WOUND INFECTION; ANTAGONISTS AND INHIBITORS; BLOOD; DOSE RESPONSE; DRUG EFFECTS; FEMALE; HEMOGLOBINURIA, PAROXYSMAL; HEMOLYSIS; IMMUNOLOGY; MALE; MIDDLE AGED; TIME FACTOR;

ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIBODIES, NEUTRALIZING; COMPLEMENT C5; COMPLEMENT INACTIVATING AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEMOGLOBINURIA, PAROXYSMAL; HEMOLYSIS; HUMANS; MALE; MIDDLE AGED; TIME FACTORS;

EID: 84959167612     PISSN: 03618609     EISSN: 10968652     Source Type: Journal    
DOI: 10.1002/ajh.24280     Document Type: Letter

References (10)

1. Koren E, Zuckerman LA, Mire-Sluis AR. Immune responses to therapeutic proteins in humans-clinical significance, assessment and prediction. Curr Pharm Biotechnol 2002;3:349-360.
2. Hwang WY, Foote J. Immunogenicity of engineered antibodies. Methods 2005;36:3-10.
3. Nechansky A. HAHA-nothing to laugh about. Measuring the immunogenicity (human anti-human antibody response) induced by humanized monoclonal antibodies applying ELISA and SPR technology. J Pharm Biomed Anal 2010;51:252-254.
4. Brodsky RA, Young NS, Antonioli E, et al. Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria. Blood 2008;111:1840-1847.
5. Hillmen P, Hall C, Marsh JC, et al. Effect of eculizumab on hemolysis and transfusion requirements in patients with paroxysmal nocturnal hemoglobinuria. N Engl J Med 2004;350:552-559.
6. Hillmen P, Young NS, Schubert J, et al. The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med 2006;355:1233-1243.
7. Hillmen P, Muus P, Roth A, et al. Long-term safety and efficacy of sustained eculizumab treatment in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol 2013;162:62-73.
8. Shankar G, Arkin S, Cocea L, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J 2014;16:658-673.
9. Soliris (eculizumab) [prescribing information]. Cheshire, CT: Alexion Pharmaceuticals, Inc; April 2014.
10. Baker MP, Reynolds HM, Lumicisi B, Bryson CJ. Immunogenicity of protein therapeutics: The key causes, consequences and challenges. Self Nonself 2010;1:314-322.