High frequency of antidrug antibodies and association of random drug levels with efficacy in certolizumab pegol-treated patients with rheumatoid arthritis: Results from the BRAGGSS cohort

Annals of the Rheumatic Diseases

Volumn 76, Issue 1, 2017, Pages 208-213

  Jani, Meghna ^a   Isaacs, J D ^f   Morgan, Ann W ^c   Wilson, Anthony G ^d   Plant, Darren ^e   Hyrich, K L ^f   Chinoy, H ^f   Barton, A ^f   Prouse, P J ^f   Moitra, R K ^f   Shawe, D J ^f   Nisar, M ^f   Fairburn, K ^f   Nixon, J ^f   Barnes, T ^f   Hui, M ^f   Coady, D ^f   Wright, D ^f   Morley, C ^f   Raftery, G ^f   Bracewell, C ^f   Bridges, M ^f   Armstrong, D ^f   Chuck, A J ^f   Hailwood, S ^f   Kumar, N ^f   Ashok, D ^f   Reece, R ^f   O'Reilly, S C ^f   Ding, T ^f   Badcock, L J ^f   Deighton, C M ^f   Raj, N ^f   Regan, M R ^f   Summers, G D ^f   Williams, R A ^f   Lambert, J R ^f   Stevens, R ^f   Wilkinson, C ^f   Kelly, C A ^f   Hamilton, J ^f   Heycock, C R ^f   Saravanan, V ^f   Cope, A ^f   Garrood, T ^f   Ng, N ^f   Kirkham, B ^f   Green, M ^f   Gough, A ^f   Lawson, C ^f   Das, D ^f   Borbas, E ^f   Wazir, T ^f   Emery, P ^f   Bingham, S ^f   Bird, H A ^f   Conaghan, P G ^f   Pease, C T ^f   Wakefield, R J ^f   Buch, M ^f   Bruce, I ^f   Gorodkin, R ^f   Ho, P ^f   Parker, B ^f   Smith, W ^f   Jenkins, E ^f   Mukhtyar, C ^f   Gaffney, K ^f   Macgregor, A J ^f   Marshall, T ^f   Merry, P ^f   DeSilva, C ^f   Birrell, F N ^f   Crook, P R ^f   Szebenyi, B ^f   Bates, D ^f   James, D ^f   Gillott, T ^f   Alvi, A ^f   Grey, C ^f   Browning, J ^f   McHale, J F ^f   Gaywood, I C ^f   Jones, A C ^f   Lanyon, P ^f   Pande, I ^f   Doherty, M ^f   Gupta, A ^f   Courtney, P A ^f   Srikanth, A ^f   Abhishek, A ^f   Das, L ^f   Pattrick, M ^f   Snowden, H N ^f   Bowden, A P ^f   Smith, E E ^f   Klimiuk, P ^f   Speden, D J ^f   Naz, S ^f   Ledingham, J M ^f   Hull, R G ^f   McCrae, F ^f   Cooper, A ^f   Young Min, S A ^f   Wong, E ^f   Shaban, R ^f   Woolf, A D ^f   Davis, M ^f   Hutchinson, D ^f   Endean, A ^f   Mewar, D ^f   Tunn, E J ^f   Nelson, K ^f   Kennedy, T D ^f   Dubois, C ^f   Pauling, J ^f   Korendowych, E ^f   Jenkinson, T ^f   Sengupta, R ^f   Bhalla, A ^f   McHugh, N ^f   O'Neill, T ^f   Herrick, A L ^f   Jones, A K ^f   Cooper, R G ^f   Dixon, W G ^f   Harrison, B ^f   Buckley, C D ^f   Carruthers, D C ^f   Elamanchi, R ^f   Gordon, P C ^f   Grindulis, K A ^f   Khattak, F ^f   Raza, K ^f   Situnayake, K ^f   Akil, M ^f   Till, S ^f   Dunkley, L ^f   Tattersall, R ^f   Kilding, R ^f   Tait, T ^f   Maxwell, J ^f   Kuet, K P ^f   Plant, M J ^f   Clarke, F ^f   Fordham, J N ^f   Tuck, S ^f   Pathare, S K ^f   Paul, A ^f   Marguerie, C P ^f   Rigby, S P ^f   Dunn, N ^f   Abbas, I ^f   Filer, C ^f   Abernethy, V E ^f   Clewes, A R ^f   Dawson, J K ^f   Kitas, G ^f   Erb, N ^f   Klocke, R ^f   Whallett, A J ^f   Douglas, K ^f   Pace, A ^f   Sandhu, R ^f   John, H ^f   Shand, L ^f   Lane, S ^f   Foster, H ^f   Griffiths, B ^f   Griffiths, I ^f   Kay, L ^f   Ng, W F ^f   Platt, P N ^f   Walker, D J ^f   Peterson, P ^f   Lorenzi, A ^f   Friswell, M ^f   Thompson, B ^f   Lee, M ^f   Pratt, A ^f   Hopkinson, N D ^f   Dunne, C A ^f   Quilty, B ^f   Marks, J ^f   Mukherjee, S ^f   Mulherin, D ^f   Chalam, S V ^f   Price, T ^f   Sheeran, T ^f   Venkatachalam, S ^f   Baskar, S ^f   Al Allaf, W ^f   McKenna, F ^f   Shah, P ^f   Filer, A ^f   Bowman, S J ^f   Jobanputra, P ^f   Rankin, E C ^f   Allen, M ^f   Chaudhuri, K ^f   Price Forbes, A ^f   Ravindran, J ^f   Samanta, A ^f   Sheldon, P ^f   Hassan, W ^f   Francis, J ^f   Kinder, A ^f   Neame, R ^f   Moorthy, A ^f   Bukhari, M ^f   Ottewell, L ^f   Palkonyai, E ^f   Hider, S ^f   Hassell, A ^f   Menon, A ^f   Dowson, C ^f   Kamath, S ^f   Packham, J ^f   Dutta, S ^f   Price, S ^f   Roddy, E ^f   Paskins, Z ^f   O'Reilly, D T ^f   Rajagopal, V ^f   Bhagat, S ^f   Chattopadhyay, C B ^f   Quinn, D ^f   Isdale, A ^f   Brown, A ^f   Saleem, B ^f   Foo, B ^f   Al Saffar, Z ^f   Koduri, G ^f   more..

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b NEWCASTLE UNIVERSITY   (United Kingdom)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d UNIVERSITY COLLEGE DUBLIN   (Ireland)

^e MANCHESTER UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

^f Manchester Academic Health Science ^*

Author keywords

[No Author keywords available]

Indexed keywords

CERTOLIZUMAB PEGOL; DRUG ANTIBODY; ANTIBODY; ANTIRHEUMATIC AGENT;

ADULT; ANTIBODY DETECTION; ARTICLE; BILATERAL PITTING EDEMA; C REACTIVE PROTEIN TEST KIT; CHEST INFECTION; CHRONIC OBSTRUCTIVE LUNG DISEASE; CLINICAL TRIAL; COHORT ANALYSIS; DAS28; DISEASE EXACERBATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG WITHDRAWAL; EDEMA; ENZYME LINKED IMMUNOSORBENT ASSAY; FATIGUE; FEMALE; HUMAN; LOGISTIC REGRESSION ANALYSIS; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PATIENT COMPLIANCE; PROSPECTIVE STUDY; RADIOIMMUNOASSAY; RHEUMATOID ARTHRITIS; SELF REPORT; TREATMENT RESPONSE; AGED; ARTHRITIS, RHEUMATOID; BLOOD; IMMUNOLOGY; MULTICENTER STUDY; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CERTOLIZUMAB PEGOL; COHORT STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 85009723388     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2015-208849     Document Type: Article

References (15)

1. Keystone E, Heijde Dv, Mason D, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 2008; 58: 3319-29.
2. Smolen J, Landewé RB, Mease P, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis 2009; 68: 797-804.
3. Garcês 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: 1947-55.
4. Vincent FB, Morand EF, Murphy K, et al. Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective. Ann Rheum Dis 2013; 72: 165-78.
5. Kneepkens EL, Plasencia C, Krieckaert CL, et al. Golimumab trough levels, antidrug antibodies and clinical response in patients with rheumatoid arthritis treated in daily clinical practice. Ann Rheum Dis 2014; 73: 2217-9.
6. He XH, Shaw PC, Tam SC. Reducing the immunogenicity and improving the in vivo activity of trichosanthin by site-directed pegylation. Life Sci 1999; 65: 355-68.
7. Ganson NJ, Kelly SJ, Scarlett E, et al. Control of hyperuricemia in subjects with refractory gout, and induction of antibody against poly(ethylene glycol) (PEG), in a phase I trial of subcutaneous PEGylated urate oxidase. Arthritis Res Ther 2006; 8: R12.
8. Colombel JF, Sandborn WJ, Allez M, et al. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol 2014; 12: 423-31.e1.
9. Jani M, Chinoy H, Warren RB, et al. Clinical utility of random anti-TNF drug level testing and measurement of anti-drug antibodies on long-term treatment response in rheumatoid arthritis. Arthritis Rheumatol 2015; 67: 2011-19.
10. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315-24.
11. Bluett J, Morgan C, Thurston L, et al. Impact of inadequate adherence on response to subcutaneously administered anti-tumour necrosis factor drugs: results from the Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate cohort. Rheumatology (Oxford) 2015; 54: 494-9.
12. van Gestel AM, Prevoo ML, van't Hof MA, et al. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/International League Against Rheumatism Criteria. Arthritis Rheum 1996; 39: 34-40.
13. Pouw MF, Krieckaert CL, Nurmohamed MT, et al. Key findings towards optimising adalimumab treatment: the concentration-effect curve. Ann Rheum Dis 2015; 74: 513-8.
14. Rispens T, de Vrieze H, de Groot E, et al. Antibodies to constant domains of therapeutic monoclonal antibodies: anti-hinge antibodies in immunogenicity testing. J Immunol Methods 2012; 375: 93-9.
15. 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: 1460-8.