Anti-drug antibodies of IL-17 inhibitors for psoriasis: a systematic review

References

• Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin. Br J Dermatol. 2009;160(2):319–324.
   PubMed Web of Science ®Google Scholar
• Fletcher JM, Moran B, Petrasca A, et al. IL-17 in inflammatory skin diseases psoriasis and hidradenitis suppurativa. Clin Exp Immunol. 2020;201(2):121–134.
   PubMed Web of Science ®Google Scholar
• Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther. 2002;24(11):1720–1740.
   PubMed Web of Science ®Google Scholar
• Gunn GR 3rd, Sealey DC, Jamali F, et al. From the bench to clinical practice: understanding the challenges and uncertainties in immunogenicity testing for biopharmaceuticals. Clin Exp Immunol. 2016;184(2):137–146.
   PubMed Web of Science ®Google Scholar
• Norden A, Moon JY, Javadi SS, et al. Anti-drug antibodies of IL-23 inhibitors for psoriasis: a systematic review. J Eur Acad Dermatol Venereol. 2022;36(8):1171–1177. Epub ahead of print. PMID: 35246887.
   PubMed Web of Science ®Google Scholar
• Strand V, Balsa A, Al-Saleh J, et al. Immunogenicity of biologics in chronic inflammatory diseases: a systematic review. BioDrugs. 2017;31(4):299–316.
   PubMed Web of Science ®Google Scholar
• De Simone C, Amerio P, Amoruso G, et al. Immunogenicity of anti-TNFα therapy in psoriasis: a clinical issue? Expert Opin Biol Ther. 2013;13(12):1673–1682.
   PubMed Web of Science ®Google Scholar
• Bartelds GM, Krieckaert CL, Nurmohamed MT, 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):1460–1468.
   PubMed Web of Science ®Google Scholar
• Jahn EM, Schneider CK. How to systematically evaluate immunogenicity of therapeutic proteins—regulatory considerations. N Biotechnol. 2009;25(5):280–286.
   PubMed Web of Science ®Google Scholar
• Tsakok T, Rispens T, Spuls P, et al. Immunogenicity of biologic therapies in psoriasis: myths, facts and a suggested approach. J Eur Acad Dermatol Venereol. 2021;35(2):329–337.
   PubMed Web of Science ®Google Scholar
• Reich K, Blauvelt A, Armstrong A, et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits minimal immunogenicity in patients with moderate-to-severe plaque psoriasis. Br J Dermatol. 2017;176(3):752–758.
   PubMed Web of Science ®Google Scholar
• Reich K, Blauvelt A, Armstrong A, et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years. J Eur Acad Dermatol Venereol. 2019;33(9):1733–1741.
   PubMed Web of Science ®Google Scholar
• Lacour JP, Paul C, Jazayeri S, et al. Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial. J Eur Acad Dermatol Venereol. 2017;31(5):847–856.
   PubMed Web of Science ®Google Scholar
• Gottlieb AB, Kubanov A, van Doorn M, et al. Sustained efficacy of secukinumab in patients with moderate-to-severe palmoplantar psoriasis: 2·5-year results from GESTURE, a randomized, double-blind, placebo-controlled trial. Br J Dermatol. 2020;182(4):889–899.
   PubMed Web of Science ®Google Scholar
• Blauvelt A, Reich K, Warren RB, et al. Secukinumab re-initiation achieves regain of high response levels in patients who interrupt treatment for moderate to severe plaque psoriasis. Br J Dermatol. 2017;177(3):879–881.
   PubMed Web of Science ®Google Scholar
• Bissonnette R, Luger T, Thaçi D, et al. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017;177(4):1033–1042.
   PubMed Web of Science ®Google Scholar
• Cai L, Zhang JZ, Yao X, et al. Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis. Chin Med J. 2020;133(22):2665–2673.
   PubMed Web of Science ®Google Scholar
• Wu NL, Hsu CJ, Sun FJ, et al. Efficacy and safety of secukinumab in Taiwanese patients with moderate to severe plaque psoriasis: subanalysis from ERASURE phase III study. J Dermatol. 2017;44(10):1129–1137.
   PubMed Web of Science ®Google Scholar
• Reich K, Jackson K, Ball S, et al. Ixekizumab pharmacokinetics, anti-drug antibodies, and efficacy through 60 weeks of treatment of moderate to severe plaque psoriasis. J Invest Dermatol. 2018;138(10):2168–2173.
   PubMed Web of Science ®Google Scholar
• Blauvelt A, Papp KA, Sofen H, et al. Continuous dosing versus interrupted therapy with ixekizumab: an integrated analysis of two phase 3 trials in psoriasis. J Eur Acad Dermatol Venereol. 2017;31(6):1004–1013.
   PubMed Web of Science ®Google Scholar
• Umezawa Y, Torisu-Itakura H, Morisaki Y, Japanese Ixekizumab Study Group, et al. Long-term efficacy and safety results from an open-label phase III study (UNCOVER-J) in Japanese plaque psoriasis patients: impact of treatment withdrawal and retreatment of ixekizumab. J Eur Acad Dermatol Venereol. 2019;33(3):568–576.
   PubMed Web of Science ®Google Scholar
• Saeki H, Nakagawa H, Nakajo K, Japanese Ixekizumab Study Group, et al. Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: results from a 52-week, open-label, phase 3 study (UNCOVER-J). J Dermatol. 2017;44(4):355–362.
   PubMed Web of Science ®Google Scholar
• Bagel J, Lebwohl M, Israel RJ, et al. Immunogenicity and skin clearance recapture in clinical studies of brodalumab. J Am Acad Dermatol. 2020;82(2):344–351.
   PubMed Web of Science ®Google Scholar
• Yamaguchi Y, Takatsu N, Ootaki K, et al. Long-term safety of brodalumab in Japanese patients with plaque psoriasis: an open-label extension study. J Dermatol. 2020;47(6):569–577.
   PubMed Web of Science ®Google Scholar
• Seo SJ, Shin BS, Lee JH, et al. Efficacy and safety of brodalumab in the Korean population for the treatment of moderate to severe plaque psoriasis: a randomized, phase III, double-blind, placebo-controlled study. J Dermatol. 2021;48(6):807–817.
   PubMed Web of Science ®Google Scholar
• Yamasaki K, Nakagawa H, Kubo Y, Japanese Brodalumab Study Group, et al. Efficacy and safety of brodalumab in patients with generalized pustular psoriasis and psoriatic erythroderma: results from a 52-week, open-label study. Br J Dermatol. 2017;176(3):741–751.
   PubMed Web of Science ®Google Scholar
• Papp K, Menter A, Leonardi C, et al. Long-term efficacy and safety of brodalumab in psoriasis through 120 weeks and after withdrawal and retreatment: subgroup analysis of a randomized phase III trial (AMAGINE-1). Br J Dermatol. 2020;183(6):1037–1048.
   PubMed Web of Science ®Google Scholar
• Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991–1001.
   PubMed Web of Science ®Google Scholar
• Oliver R, Krueger JG, Glatt S, et al. Bimekizumab for the treatment of moderate-to-severe plaque psoriasis: efficacy, safety, pharmacokinetics, pharmacodynamics and transcriptomics from a phase IIa, randomized, double-blind multicentre study. Br J Dermatol. 2022;186(4):652–663.
   PubMed Web of Science ®Google Scholar
• Mok CC, van der Kleij D, Wolbink GJ. Drug levels, anti-drug antibodies, and clinical efficacy of the anti-TNFα biologics in rheumatic diseases. Clin Rheumatol. 2013;32(10):1429–1435.
   PubMed Web of Science ®Google Scholar
• Adişen E, Aral A, Aybay C, et al. Anti-infliximab antibody status and its relation to clinical response in psoriatic patients: a pilot study. J Dermatol. 2010;37(8):708–713.
   PubMed Web of Science ®Google Scholar
• Jullien D. Anti-drug antibodies, auto-antibodies and biotherapy in psoriasis. Ann Dermatol Venereol. 2012;139:S58–S67.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration. Immunogenicity assessment for therapeutic protein products. MD,USA: FDA; 2013.
   Google Scholar
• European Medicines Agency. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. London: EMEA; 2007.
   Google Scholar