Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

AAPS Journal

Volumn 18, Issue 2, 2016, Pages 395-403

  Wang, Yow Ming C ^a   Wang, Jie ^a   Hon, Yuen Yi ^a   Zhou, Lin ^a   Fang, Lanyan ^a   Ahn, Hae Young ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

clinical pharmacology assessment; immunogenicity data for approved biological products; impact on clinical pharmacokinetics and efficacy; incidence of anti drug antibodies and neutralizing antibodies

Indexed keywords

ADALIMUMAB; BIOLOGICAL PRODUCT; CYANOCOBALAMIN; DRUG ANTIBODY; GROWTH FACTOR; INTRINSIC FACTOR; MONOCLONAL ANTIBODY; NEUTRALIZING ANTIBODY;

ARTICLE; CLINICAL PHARMACOLOGY; DRUG CLEARANCE; DRUG EFFICACY; DRUG SAFETY; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INCIDENCE; PHARMACOKINETICS; PRESCRIPTION; RELIABILITY; ANIMAL; EVALUATION STUDY; FOOD AND DRUG ADMINISTRATION; IMMUNOGENETICS; IMMUNOLOGY; METABOLISM; PROCEDURES; STANDARDS; UNITED STATES;

ANIMALS; BIOLOGICAL PRODUCTS; EVALUATION STUDIES AS TOPIC; HUMANS; IMMUNOGENETIC PHENOMENA; PHARMACOLOGY, CLINICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84959481932     PISSN: None     EISSN: 15507416     Source Type: Journal    
DOI: 10.1208/s12248-015-9857-y     Document Type: Article

References (24)

1. Mckoy JM, Stonecash RE, Cournoyer D, Rossert J, Nissenson AR, Raisch D, et al. Epoetin-associated pure red cell aplasia: past, present, and future considerations. Transfusion. 2008;48(8):1754–62.
2. Nanda KS, Cheifetz AS, Moss AC. Impact of antibodies to Infliximab on clinical outcomes and serum Infliximab levels in patients with inflammatory bowel disease (IBD): a meta-analysis. Am J Gastroenterol. 2013;108(1):40–7. quiz 8.
3. Shankar G, Arkin S, Cocea L, Devanarayan V, Kirshner S, Kromminga A, et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-harmonized terminology and tactical recommendations. AAPS J. 2014;16(4):658–73.
4. FDA Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products (2014).
5. Moss AC, Brinks V, Carpenter JF. Review article: immunogenicity of anti-TNF biologics in IBD—the role of patient, product and prescriber factors. Aliment Pharmacol Ther. 2013;38(10):1188–97.
6. Shankar G, Shores E, Wagner C, Mire-Sluis A. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol. 2006;24(6):274–80.
7. Garces S, Demengeot J, Benito-Garcia E. The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis. Ann Rheum Dis. 2013;72(12):1947–55.
8. Keiserman M, Codreanu C, Handa R, Xibille-Friedmann D, Mysler E, Briceno F, et al. The effect of antidrug antibodies on the sustainable efficacy of biologic therapies in rheumatoid arthritis: practical consequences. Expert Rev Clin Immunol. 2014;10(8):1049–57.
9. Wang YM, Fang L, Zhou L, Wang J, Ahn HY. A survey of applications of biological products for drug interference of immunogenicity assays. Pharm Res. 2012;29(12):3384–92.
10. Bartelds GM, Krieckaert CL, Nurmohamed MT, van Schouwenburg PA, Lems WF, Twisk JW, et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA. 2011;305(14):1460–8.
11. FDA Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins (2009).
12. Drucker DJ, Buse JB, Taylor K, Kendall DM, Trautmann M, Zhuang D, et al. Exenatide once weekly versus twice daily for the treatment of type 2 diabetes: a randomised, open-label, non-inferiority study. Lancet. 2008;372(9645):1240–50.
13. US Prescribing information of Myozyme (alglucosidase alfa). May 20, 2014.
14. US Prescribing Information of Elaprase (idursulfase). June 24, 2013.
15. Eser A, Primas C, Reinisch W. Drug monitoring of biologics in inflammatory bowel disease. Curr Opin Gastroenterol. 2013;29(4):391–6.
16. Khanna R, Sattin BD, Afif W, Benchimol EI, Bernard EJ, Bitton A, et al. Review article: a clinician’s guide for therapeutic drug monitoring of Infliximab in inflammatory bowel disease. Aliment Pharmacol Ther. 2013;38(5):447–59.
17. Bendtzen K. Critical review: assessment of interferon-beta immunogenicity in multiple sclerosis. J Interferon Cytokine Res. 2010;30(10):759–66.
18. Patton A, Mullenix MC, Swanson SJ, Koren E. An acid dissociation bridging ELISA for detection of antibodies directed against therapeutic proteins in the presence of antigen. J Immunol Methods. 2005;304(1–2):189–95.
19. Wang SL, Ohrmund L, Hauenstein S, Salbato J, Reddy R, Monk P, et al. Development and validation of a homogeneous mobility shift assay for the measurement of Infliximab and antibodies-to-Infliximab levels in patient serum. J Immunol Methods. 2012;382(1–2):177–88.
20. Li J, Schantz A, Schwegler M, Shankar G. Detection of low-affinity anti-drug antibodies and improved drug tolerance in immunogenicity testing by Octet((R)) biolayer interferometry. J Pharm Biomed Anal. 2011;54(2):286–94.
21. Swann PG, Shapiro MA. Regulatory considerations for development of bioanalytical assays for biotechnology products. Bioanalysis. 2011;3(6):597–603.
22. Lee JW, Kelley M, King LE, Yang J, Salimi-Moosavi H, Tang MT, et al. Bioanalytical approaches to quantify “total” and “free” therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J. 2011;13(1):99–110.
23. Bashaw ED, DeSilva B, Rose MJ, Wang YM, Shukla C. Bioanalytical method validation: concepts, expectations and challenges in small molecule and macromolecule—a report of PITTCON 2013 symposium. AAPS J. 2014;16(3):586–91.
24. Wang YM, Jawa V, Ma M. Immunogenicity and PK/PD evaluation in biotherapeutic drug development: scientific considerations for bioanalytical methods and data analysis. Bioanalysis. 2014;6(1):79–87.