Immunogenicity assessment of recombinant human C1-inhibitor: An integrated analysis of clinical studies

BioDrugs

Volumn 26, Issue 5, 2012, Pages 303-313

  Hack, C Erik ^a   Mannesse, Maurice ^b   Baboeram, Aartie ^c   Oortwijn, Beatrijs ^c   Relan, Anurag ^c  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b Xendo BV   (Netherlands)

^c Pharming Group NV   (Netherlands)

Author keywords

Conestat alfa; Hereditary angioedema; Immunoassay

Indexed keywords

COMPLEMENT COMPONENT C1S INHIBITOR; NEUTRALIZING ANTIBODY;

ABSENCE OF SIDE EFFECTS; ADOLESCENT; ADULT; AGED; ANGIONEUROTIC EDEMA; ANTIBODY RESPONSE; ARTICLE; BLOOD ANALYSIS; BLOOD SAMPLING; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; IMMUNOASSAY; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL;

ADOLESCENT; ADULT; AGED; ANGIOEDEMAS, HEREDITARY; ANTIBODIES; ANTIBODIES, NEUTRALIZING; CLINICAL TRIALS AS TOPIC; COMPLEMENT C1 INHIBITOR PROTEIN; COMPLEMENT INACTIVATING AGENTS; FEMALE; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; RECOMBINANT PROTEINS; TIME FACTORS; YOUNG ADULT;

EID: 84866100966     PISSN: 11738804     EISSN: 1179190X     Source Type: Journal    
DOI: 10.2165/11634370-000000000-00000     Document Type: Article

References (18)

1. Donaldson VH, Evans RR. A biochemical abnormality in hereditary angioneurotic edema: Absence of serum inhibitor of C1-esterase. Am J Med 1963; 35: 37-44
2. Zuraw BL. Clinical practice: Hereditary angioedema. N Engl J Med 2008; 359: 1027-36
3. Rosen FS, Pensky J, Donaldson VH, et al. Hereditary angioneurotic edema: Two genetic variants. Science 1965; 148: 957-8
4. Agostoni A, Aygoren-Pursun E, Binkley KE, et al. Hereditary and acquired angioedema: Eroblems and progress. Proceedings of the third C1 esterase inhibitor deficiency workshop and beyond. J Allergy Clin Immunol 2004; 114 (Suppl.): S51-131
5. Cicardi M, Zanichelli A. Replacement therapy with C1 esterase inhibitors for hereditary angioedema. Drugs Today (Barc) 2010; 46: 867-74
6. Jahn EM, Schneider CK. How to systematically evaluate immunogenicity of therapeutic proteins: Regulatory considerations. N Biotechnol 2009; 25: 280-6
7. Schellekens H. The immunogenicity of therapeutic proteins. Discov Med 2010; 9: 560-4
8. Koren E, Smith HW, Shores E, et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. J Immunol Methods 2008; 333: 1-9
9. European Medicines Agency. Guideline on immunogenicity assessment of biotechnology- derived therapeutic proteins. EMEA/CHMP/BMWP/14327/ 2006 [online]. Available from URL: Http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2009/09/WC500003946.pdf [Accessed 2011 Sep 5]
10. Choi G, Soeters MR, Farkas H, et al. Recombinant human C1-inhibitor in the treatment of acute angioedema attacks. Transfusion. 2007 47 1028-1032.
11. Zuraw B, Cicardi M, Levy RJ, et al. Recombinant human C1-inhibitor for the treatment of acute angioedema attacks in patients with hereditary angioedema. J Allergy Clin Immunol 2010; 126: 821-7
12. Mire-Sluis AR, Barrett YC, Devanarayan V, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods 2004; 289: 1-16
13. Deisenhammer F. Neutralizing antibodies to interferon-beta and other immunological treatments for multiple sclerosis: Erevalence and impact on outcomes. CNS Drugs 2009; 23: 379-96
14. Varga L, Fust G, Csuka D, et al. Treatment with C1-inhibitor concentrate does not induce IgM type anti-C1 inhibitor antibodies in patients with hereditary angioedema. Mol Immunol 2011; 48: 572-6
15. Craig TJ, Bewtra AK, Bahna SL, et al. C1 esterase inhibitor concentrate in 1085
16. hereditary angioedema attacks: Final results of the IMPACT2 study. Allergy 2011; 66: 1604-11
17. Koles K, van Berkel PH, Pieper FR, et al. N- and O-glycans of recombinant human C1 inhibitor expressed in the milk of transgenic rabbits. Glycobiology 2004; 14: 51-64
18. Hack CE, Baboeram A, Relan A, et al. IgE against rabbit allergens and the therapeutic use of recombinant human C1 inhibitor (rhC1INH) in hereditary angioedema (HAE), Poster Sessions. Allergy 2010; 65: 209-682