Risk factor analysis for the immunogenicity of adalimumab associated with decreased clinical response in Chinese patients with psoriasis

Acta Dermato-Venereologica

Volumn 95, Issue 6, 2015, Pages 711-716

  Chiu, Hsien Yi ^a,b   Wang, Ting Shun ^b   Chan, Chih Chieh ^a,b   Lin, Sung Jan ^a,b,c   Tsai, Tsen Fang ^b  

^a NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^b NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^c NATIONAL TAIWAN UNIVERSITY   (Taiwan)

Author keywords

Adalimumab; Anti adalimumab antibody; Anti drug antibody; Anti etanercept antibody; Etanercept; Immunogenicity; Methotrexate; Psoriasis; Tumour necrosis factor inhibitor

Indexed keywords

ADALIMUMAB; BIOLOGICAL PRODUCT; DRUG ANTIBODY; METHOTREXATE; TUMOR NECROSIS FACTOR ALPHA INHIBITOR; ANTIBODY; IMMUNOSUPPRESSIVE AGENT; NONSTEROID ANTIINFLAMMATORY AGENT;

ADULT; ANTIBODY PRODUCTION; ANTIBODY TITER; ARTICLE; CHINESE; DRUG BLOOD LEVEL; DRUG EFFICACY; FEMALE; HUMAN; IMMUNOGENICITY; LOADING DRUG DOSE; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MINIMUM PLASMA CONCENTRATION; MONOTHERAPY; PRIORITY JOURNAL; PSORIASIS AREA AND SEVERITY INDEX; PSORIASIS VULGARIS; PSORIATIC ARTHRITIS; RISK FACTOR; STATISTICAL SIGNIFICANCE; TREATMENT RESPONSE; BLOOD; CHINA; DRUG COMBINATION; DRUG RESISTANCE; DRUG SUBSTITUTION; IMMUNOLOGY; PSORIASIS; RETROSPECTIVE STUDY; SEVERITY OF ILLNESS INDEX;

ADALIMUMAB; ADULT; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIBODIES; CHINA; DRUG RESISTANCE; DRUG SUBSTITUTION; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; METHOTREXATE; MIDDLE AGED; PSORIASIS; RETROSPECTIVE STUDIES; RISK FACTORS; SEVERITY OF ILLNESS INDEX;

EID: 84932095819     PISSN: 00015555     EISSN: 16512057     Source Type: Journal    
DOI: 10.2340/00015555-2069     Document Type: Article

References (51)

1. Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009; 361: 496-509.
2. Chiu HY, Cheng YP, Tsai TF. T helper type 17 in psoriasis: from basic immunology to clinical practice. Dermatologica Sinica 2012; 30: 136-141.
3. 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: 1460-1468.
4. Baert F, Noman M, Vermeire S, Van Assche G, D'Haens G, Carbonez A, et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med 2003; 348: 601-608.
5. de Vries MK, Wolbink GJ, Stapel SO, de Vrieze H, van Denderen JC, Dijkmans BA, et al. Decreased clinical response to infliximab in ankylosing spondylitis is correlated with anti-infliximab formation. Ann Rheum Dis 2007; 66: 1252-1254.
6. de Vries MK, Brouwer E, van der Horst-Bruinsma IE, Spoorenberg A, van Denderen JC, Jamnitski A, et al. Decreased clinical response to adalimumab in ankylosing spondylitis is associated with antibody formation. Ann Rheum Dis 2009; 68: 1787-1788.
7. Menting SP, van Lumig PP, de Vries AC, van den Reek JM, van der Kleij D, de Jong EM, et al. Extent and consequences of antibody formation against adalimumab in patients with psoriasis: one-year follow-up. JAMA Dermatol 2013; 150: 130-136.
8. Lecluse LL, Driessen RJ, Spuls PI, de Jong EM, Stapel SO, van Doorn MB, et al. Extent and clinical consequences of antibody formation against adalimumab in patients with plaque psoriasis. Arch Dermatol 2010; 146: 127-132.
9. Hsu L, Snodgrass BT, Armstrong AW. Anti-drug antibodies in psoriasis: a systematic review. Br J Dermatol 2013; 170: 261-273.
10. Asahina A, Nakagawa H, Etoh T, Ohtsuki M. Adalimumab in Japanese patients with moderate to severe chronic plaque psoriasis: efficacy and safety results from a Phase II/III randomized controlled study. J Dermatol 2010; 37: 299-310.
11. Takahashi H, Tsuji H, Ishida-Yamamoto A, Iizuka H. Plasma trough levels of adalimumab and infliximab in terms of clinical efficacy during the treatment of psoriasis. J Dermatol 2013; 40: 39-42.
12. Mahil SK, Arkir Z, Richards G, Lewis CM, Barker JN, Smith CH. Predicting treatment response in psoriasis using serum levels of adalimumab and etanercept: a single-centre, cohort study. Br J Dermatol 2013; 169: 306-313.
13. Chiu HY, Hsueh PR, Tsai TF. Clinical experience of QuantiFERON((R)) -TB Gold testing in patients with psoriasis treated with tumour necrosis factor blockers in Taiwan. Br J Dermatol 2011; 164: 553-559.
14. Cho YT, Chen CH, Chiu HY, Tsai TF. Use of anti-tumor necrosis factor-alpha therapy in hepatitis B virus carriers with psoriasis or psoriatic arthritis: a case series in Taiwan. J Dermatol 2012; 39: 269-373.
15. Chiu HY, Chen CH, Wu MS, Cheng YP, Tsai TF. The safety profile of ustekinumab in the treatment of patients with psoriasis and concurrent hepatitis B or C. Br J Dermatol 2013; 169: 1295-1303.
16. He GY, Tsai TF. Concomitant occurrence of acneiform eruption, alopecia areata, and urticaria during adalimumab treatment in a patient with pustulosis palmoplantaris: case report and literature review. Dermatologica Sinica 2012; 30: 51-56.
17. Chiu HY, Wang TS, Chang CY, Tsai TF. The effectiveness and safety of adalimumab in the treatment of non-reimbursed patients with mild-to-moderate psoriasis. J Eur Acad Dermatol Venereol 2012; 26: 991-998.
18. Hart MH, de Vrieze H, Wouters D, Wolbink GJ, Killestein J, de Groot ER, et al. Differential effect of drug interference in immunogenicity assays. J Immunol Methods 2011; 372: 196-203.
19. Rispens T, de Vrieze H, de Groot E, Wouters D, Stapel S, Wolbink GJ, et al. Antibodies to constant domains of therapeutic monoclonal antibodies: anti-hinge antibodies in immunogenicity testing. J Immunol Methods 2012; 375: 93-99.
20. van Schouwenburg PA, Bartelds GM, Hart MH, Aarden L, Wolbink GJ, Wouters D. A novel method for the detection of antibodies to adalimumab in the presence of drug reveals "hidden" immunogenicity in rheumatoid arthritis patients. J Immunol Methods 2010; 362: 82-88.
21. Jamnitski A, Krieckaert CL, Nurmohamed MT, Hart MH, Dijkmans BA, Aarden L, et al. Patients non-responding to etanercept obtain lower etanercept concentrations compared with responding patients. Ann Rheum Dis 2012; 71: 88-91.
22. Kneepkens EL, Wei JC, Nurmohamed MT, Yeo KJ, Chen CY, van der Horst-Bruinsma IE, et al. Immunogenicity, adalimumab levels and clinical response in ankylosing spondylitis patients during 24 weeks of follow-up. Ann Rheum Dis 2015; 74: 396-401.
23. Wang TS, Tsai TF. Safety and effectiveness of adalimumab in patients with moderate-to-severe psoriasis who had inadequate therapeutic response to prior etanercept. Dermatologica Sinica 2013; 31: 11-18.
24. Strober BE, Poulin Y, Kerdel FA, Langley RG, Gu Y, Gupta SR, et al. Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: efficacy and safety results from an open-label study. J Am Acad Dermatol 2011; 64: 671-681.
25. van der Laken CJ, Voskuyl AE, Roos JC, Stigter van Walsum M, de Groot ER, Wolbink G, et al. Imaging and serum analysis of immune complex formation of radiolabelled infliximab and anti-infliximab in responders and nonresponders to therapy for rheumatoid arthritis. Ann Rheum Dis 2007; 66: 253-266.
26. Krieckaert CL, Bartelds GM, Lems WF, Wolbink GJ. The effect of immunomodulators on the immunogenicity of TNF-blocking therapeutic monoclonal antibodies: a review. Arthritis Res Ther 2010; 12: 217.
27. Ordas I, Mould DR, Feagan BG, Sandborn WJ. Anti-TNF monoclonal antibodies in inflammatory bowel disease: pharmacokinetics-based dosing paradigms. Clin Pharmacol Ther 2012; 91: 635-646.
28. Chiu HY, Huang PY, Jee SH, Hu CY, Chou CT, Chang YT, et al. HLA polymorphism among Chinese patients with chronic plaque psoriasis: Subgroup analysis. Br J Dermatol 2012; 166: 288-297.
29. van den Reek JM, Tummers M, Zweegers J, Seyger MM, van Lumig PP, Driessen RJ, et al. Predictors of adalimumab drug survival in psoriasis differ by reason for discontinuation: long-term results from the Bio-CAPTURE registry. J Eur Acad Dermatol Venereol 2015; 29: 560-565.
30. Tsai TF, Liu MT, Liao YH, Licu D. Clinical effectiveness and safety experience with efalizumab in the treatment of patients with moderate-to-severe plaque psoriasis in Taiwan: results of an open-label, single-arm pilot study. J Eur Acad Dermatol Venereol 2008; 22: 345-352.
31. Leonardi CL, Papp KA, Gordon KB, Menter A, Feldman SR, Caro I, et al. Extended efalizumab therapy improves chronic plaque psoriasis: results from a randomized phase III trial. J Am Acad Dermatol 2005; 52: 425-433.
32. Krieckaert CL, Nurmohamed MT, Wolbink GJ. Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose dependent manner. Ann Rheum Dis 2012; 71: 1914-1915.
33. Garman RD, Munroe K, Richards SM. Methotrexate reduces antibody responses to recombinant human alphagalactosidase A therapy in a mouse model of Fabry disease. Clin Exp Immunol 2004; 137: 496-502.
34. Menter A, Feldman SR, Weinstein GD, Papp K, Evans R, Guzzo C, et al. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis. J Am Acad Dermatol 2007; 56: 31 e1-15.
35. Moore A, Gordon KB, Kang S, Gottlieb A, Freundlich B, Xia HA, et al. A randomized, open-label trial of continuous versus interrupted etanercept therapy in the treatment of psoriasis. J Am Acad Dermatol 2007; 56: 598-603.
36. Brezinski EA, Armstrong AW. Off-label biologic regimens in psoriasis: a systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy. PLoS One 2012; 7: e33486.
37. Papp K, Crowley J, Ortonne JP, Leu J, Okun M, Gupta SR, et al. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol 2011; 164: 434-441.
38. Chiu HY, Wang TS, Cho YT, Tsai TF. Etanercept use for psoriasis in Taiwan: a case series study. Int J Dermatol 2013; 52: 673-680.
39. Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003; 349: 2014-2022.
40. Ortonne JP. Clinical response to alefacept: results of a phase 3 study of intramuscular administration of alefacept in patients with chronic plaque psoriasis. J Eur Acad Dermatol Venereol 2003; 17 Suppl 2: 12-16.
41. Lebwohl M, Christophers E, Langley R, Ortonne JP, Roberts J, Griffiths CE. An international, randomized, doubleblind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis. Arch Dermatol 2003; 139: 719-727.
42. Maini RN, Breedveld FC, Kalden JR, Smolen JS, Davis D, Macfarlane JD, et al. Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis. Arthritis Rheum 1998; 41: 1552-1563.
43. Bartelds GM, Wijbrandts CA, Nurmohamed MT, Stapel S, Lems WF, Aarden L, et al. Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study. Ann Rheum Dis 2010; 69: 817-821.
44. Wolbink GJ, Vis M, Lems W, Voskuyl AE, de Groot E, Nurmohamed MT, et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 2006; 54: 711-715.
45. Leonardi C, Sobell JM, Crowley JJ, Mrowietz U, Bao Y, Mulani PM, et al. Efficacy, safety and medication cost implications of adalimumab 40 mg weekly dosing in patients with psoriasis with suboptimal response to 40 mg every other week dosing: results from an open-label study. Br J Dermatol 2012; 167: 658-667.
46. Martyn-Simmons CL, Green L, Ash G, Groves RW, Smith CH, Barker JN. Adalimumab for psoriasis patients who are non-responders to etanercept: open-label prospective evaluation. J Eur Acad Dermatol Venereol 2009; 23: 1394-1397.
47. Woolf RT, Smith CH, Robertson K, Barker JN. Switching to adalimumab in patients with moderate to severe psoriasis who have failed on etanercept: a retrospective case cohort study. Br J Dermatol 2010; 163: 889-892.
48. West RL, Zelinkova Z, Wolbink GJ, Kuipers EJ, Stokkers PC, van der Woude CJ. Immunogenicity negatively influences the outcome of adalimumab treatment in Crohn's disease. Aliment Pharmacol Ther 2008; 28: 1122-1126.
49. Jamnitski A, Bartelds GM, Nurmohamed MT, van Schouwenburg PA, van Schaardenburg D, Stapel SO, et al. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis 2011; 70: 284-288.
50. Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol 2013; 149: 1180-1185.
51. Menter A, Gordon KB, Leonardi CL, Gu Y, Goldblum OM. Efficacy and safety of adalimumab across subgroups of patients with moderate to severe psoriasis. J Am Acad Dermatol 2010; 63: 448-456