Evaluation of the immunogenicity of the synthetic α-melanocyte-stimulating hormone (α-MSH) analogue afamelanotide ([Nle4-D-Phe7]-α-MSH, Scenesse(r)) in erythropoietic protoporphyria patients by elisa detecting both anti-afamelanotide and anti-α-MSH antibodies

Skin Pharmacology and Physiology

Volumn 28, Issue 2, 2015, Pages 103-113

  Lengweiler, Stephan ^a   Kreim, Saskia ^b   Barman Aksözen, Jasmin ^b   Maurer, Marcus ^c   Minder, Elisabeth I ^b  

^a Unilabs   (France)

^b TRIEMLI HOSPITAL   (Switzerland)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

Afamelanotide; Anti drug antibodies; Biological; ELISA; Erythropoietic protoporphyria; Immunogenicity; Photodermatoses; Melanocyte stimulating hormone analogues

Indexed keywords

AFAMELANOTIDE; AFAMELANOTIDE ANTIBODY; ALPHA INTERMEDIN ANTIBODY; DRUG ANTIBODY; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; IMMUNOGLOBULIN M; UNCLASSIFIED DRUG; ALPHA INTERMEDIN; ANTIBODY; DRUG IMPLANT;

ABSORPTION; ADOLESCENT; ADULT; ANTIBODY BLOOD LEVEL; ANTIBODY RESPONSE; ANTIGEN ANTIBODY REACTION; ANTIGEN SPECIFICITY; ARTICLE; CLINICAL ARTICLE; COMPASSIONATE USE; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; COVALENT BOND; DRUG EFFICACY; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHROPOIETIC PROTOPORPHYRIA; FEMALE; FOLLOW UP; HUMAN; IMMUNOGENICITY; IMMUNOREACTIVITY; MALE; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; TREATMENT DURATION; ANALOGS AND DERIVATIVES; BLOOD; CLINICAL TRIAL; DRUG IMPLANT; IMMUNOLOGY; PORPHYRIA, ERYTHROPOIETIC; PREDICTIVE VALUE; TIME; TREATMENT OUTCOME;

ALPHA-MSH; ANTIBODIES; COMPASSIONATE USE TRIALS; DRUG IMPLANTS; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; PORPHYRIA, ERYTHROPOIETIC; PREDICTIVE VALUE OF TESTS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84923540154     PISSN: 16605527     EISSN: 16605535     Source Type: Journal    
DOI: 10.1159/000362174     Document Type: Article

References (27)

1. Haylett AK, Nie Z, Brownrigg M, Taylor R, Rhodes LE: Systemic photoprotection in solar urticaria with alpha-melanocyte-stimulating hormone analogue [Nle4-D-Phe7]-alpha-MSH. Br J Dermatol 2011; 164: 407-414.
2. Harms J, Lautenschlager S, Minder CE, Minder EI: An alpha-melanocyte-stimulating hormone analogue in erythropoietic protoporphyria. N Engl J Med 2009; 360: 306-307.
3. Sawyer TK, Sanfilippo PJ, Hruby VJ, Engel MH, Heward CB, Burnett JB, Hadley ME: 4-Norleucine, 7-D-phenylalanine-alpha-melanocyte-stimulating hormone: a highly potent alpha-melanotropin with ultralong biological activity. Proc Natl Acad Sci USA 1980; 77: 5754-5758.
4. Dorr RT, Dawson BV, al-Obeidi F, Hadley ME, Levine N, Hruby VJ: Toxicologic studies of a superpotent alpha-melanotropin, [Nle4, D-Phe7]alpha-MSH. Invest New Drugs 1988; 6: 251-258.
5. Sela M: Antigenicity: some molecular aspects. Science 1969; 166: 1365-1374.
6. Mariani M, Bracci L, Presentini R, Nucci D, Neri P, Antoni G: Immunogenicity of a free synthetic peptide: carrier-conjugation enhances antibody affinity for the native protein. Mol Immunol 1987; 24: 297-303.
7. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, Michaud P, Papo T, Ugo V, Teyssandier I, Varet B, Mayeux P: Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002; 346: 469-475.
8. Bhardwaj R, Blanchard J: In vitro characterization and in vivo release profile of a poly (D , L-lactide-co-glycolide)-based implant delivery system for the alpha-MSH analog, melanotan-I. Int J Pharm 1998; 170: 109-117.
9. Mire-Sluis AR, Barrett YC, Devanarayan V, Koren E, Liu H, Maia M, Parish T, Scott G, Shankar G, Shores E, Swanson SJ, Taniguchi G, Wierda D, Zuckerman LA: 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.
10. Dwyer T, Blizzard L, Ashbolt R, Plumb J, Berwick M, Stankovich JM: Cutaneous melanin density of Caucasians measured by spectrophotometry and risk of malignant melanoma, basal cell carcinoma, and squamous cell carcinoma of the skin. Am J Epidemiol 2002; 155: 614-621.
11. Jensen SP, Rasmussen SE, Jakobson MH: Photochemical coupling of peptides to polystyrene microwell plates; in Epton R (ed): Innovation and Perspectives in Solid Phase Synthesis and Combinatorial Libraries. Proc 4th Int Symp on Solid Phase Synthesis. Paris, Intercept, 1996.
12. Harlow E, Lane D: Antibodies. A Laboratory Manual. New York, Cold Spring Harbor Laboratory, 1988.
13. Shankar G, Devanarayan V, Amaravadi L, Barrett YC, Bowsher R, Finco-Kent D, Fiscella M, Gorovits B, Kirschner S, Moxness M, Parish T, Quarmby V, Smith H, Smith W, Zuckerman LA, Koren E: Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J Pharm Biomed Anal 2008; 48: 1267-1281.
14. Baker MP, Reynolds HM, Lumicisi B, Bryson CJ: Immunogenicity of protein therapeutics: the key causes, consequences and challenges. Self Nonself 2010; 1: 314-322.
15. Geng D, Shankar G, Schantz A, Rajadhyaksha M, Davis H, Wagner C: Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies. J Pharm Biomed Anal 2005; 39: 364-375.
16. Fetissov SO, Harro J, Jaanisk M, Jarv A, Podar I, Allik J, Nilsson I, Sakthivel P, Lefvert AK, Hokfelt T: Autoantibodies against neuropeptides are associated with psychological traits in eating disorders. Proc Natl Acad Sci USA 2005; 102: 14865-14870.
17. Philip R, Carrington L, Chan M: US FDA perspective on challenges in co-developing in vitro companion diagnostics and targeted cancer therapeutics. Bioanalysis 2011; 3: 383-389.
18. Aebischer I, Stampfli MR, Zurcher A, Miescher S, Urwyler A, Frey B, Luger T, White RR, Stadler BM: Neuropeptides are potent modulators of human in vitro immunoglobulin E synthesis. Eur J Immunol 1994; 24: 1908-1913.
19. Rheins LA, Cotleur AL, Kleier RS, Hoppenjans WB, Saunder DN, Nordlund JJ: Alphamelanocyte stimulating hormone modulates contact hypersensitivity responsiveness in C57/BL6 mice. J Invest Dermatol 1989; 93: 511-517.
20. Lipton JM, Macaluso A, Hiltz ME, Catania A: Central administration of the peptide alpha-MSH inhibits inflammation in the skin. Peptides 1991; 12: 795-798.
21. Grabbe S, Bhardwaj RS, Mahnke K, Simon MM, Schwarz T, Luger TA: Alpha-melanocyte-stimulating hormone induces haptenspecific tolerance in mice. J Immunol 1996; 156: 473-478.
22. Raap U, Brzoska T, Sohl S, Path G, Emmel J, Herz U, Braun A, Luger T, Renz H: Alphamelanocyte-stimulating hormone inhibits allergic airway inflammation. J Immunol 2003; 171: 353-359.
23. Cooper A, Robinson SJ, Pickard C, Jackson CL, Friedmann PS, Healy E: Alpha-melanocyte-stimulating hormone suppresses antigen-induced lymphocyte proliferation in humans independently of melanocortin 1 receptor gene status. J Immunol 2005; 175: 4806-4813.
24. Jahn EM, Schneider CK: How to systematically evaluate immunogenicity of therapeutic proteins-regulatory considerations. N Biotechnol 2009; 25: 280-286.
25. Fetissov SO, Hallman J, Oreland L, Af KB, Grenback E, Hulting AL, Hokfelt T: Autoantibodies against alpha-MSH, ACTH, and LHRH in anorexia and bulimia nervosa patients. Proc Natl Acad Sci USA 2002; 99: 17155-17160.
26. Sinno MH, do Rego JC, Coeffier M, Bole-Feysot C, Ducrotte P, Gilbert D, Tron F, Costentin J, Hokfelt T, Dechelotte P, Fetissov SO: Regulation of feeding and anxiety by alpha-MSH reactive autoantibodies. Psychoneuroendocrinology 2009; 34: 140-149.
27. Spichty R, Balimann M, Barman J, Minder EI: A bioassay for detection of neutralizing antibodies against the alpha-melanocyte stimulating hormone analogue afamelanotide in patients with erythropoietic protoporphyria. J Pharm Biomed Anal 2012; 75: 192-198.