Drug safety and immunogenicity of tumour necrosis factor inhibitors: the story so far
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Bartelds, 2011, Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up, JAMA, 305, 1460, 10.1001/jama.2011.406
Vincent, 2013, Antidrug antibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective, Ann Rheum Dis, 72, 165, 10.1136/annrheumdis-2012-202545
Garcês, 2013, The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis, Ann Rheum Dis, 72, 1947, 10.1136/annrheumdis-2012-202220
Jani, 2015, Clinical utility of random anti–tumor necrosis factor drug–level testing and measurement of antidrug antibodies on the long-term treatment response in rheumatoid arthritis, Arthritis Rheumatol, 67, 2011, 10.1002/art.39169
Jani, 2017, 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, Ann Rheum Dis, 76, 208, 10.1136/annrheumdis-2015-208849
Bandyopadhyay, 2015, Complexities of protein therapeutics and immunogenicity, J Bioanal Biomed, 7, 70, 10.4172/1948-593X.1000126
FDA
European Medicines Agency, 2017
Schernthaner, 1993, Immunogenicity and allergenic potential of animal and human insulins, Diabetes Care, 16 (Suppl 3), 155, 10.2337/diacare.16.3.155
Schellekens, 2003, Immunogenicity of therapeutic proteins, Nephrol Dial Transplant, 18, 1257, 10.1093/ndt/gfg164
Arrue, 2007, Lupus-like reaction to interferon at the injection site: report of five cases, J Cutan Pathol, 34, 18, 10.1111/j.1600-0560.2007.00715.x
Szilasiová, 2009, Cutaneous vasculitis associated with interferon β-1b treatment for multiple sclerosis, Clin Neuropharmacol, 32, 301, 10.1097/WNF.0b013e3181a2b5fd
Casadevall, 2002, Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin, N Engl J Med, 346, 469, 10.1056/NEJMoa011931
Schellekens, 2002, Bioequivalence and the immunogenicity of biopharmaceuticals, Nat Rev Drug Discov, 1, 457, 10.1038/nrd818
Jani, 2014, The role of DMARDs in reducing the immunogenicity of TNF inhibitors in chronic inflammatory diseases, Rheumatology, 53, 213, 10.1093/rheumatology/ket260
Jani, 2016, Detection of anti-drug antibodies using a bridging ELISA compared with radioimmunoassay in adalimumab-treated rheumatoid arthritis patients with random drug levels, Rheumatology, 55, 2050, 10.1093/rheumatology/kew299
Weir, 2006, A new generation of high-affinity humanized PEGylated Fab’ fragment anti-tumor necrosis factor-α monoclonal antibodies, Therapy, 3, 535
Brinks, 2013, Immunogenicity of biosimilar monoclonal antibodies, Generics Biosimilars Initiat J, 2, 188, 10.5639/gabij.2013.0204.052
Dörner, 2013, The role of biosimilars in the treatment of rheumatic diseases, Ann Rheum Dis, 72, 322, 10.1136/annrheumdis-2012-202715
Bendtzen, 2011, Is there a need for immunopharmacologic guidance of anti-tumor necrosis factor therapies?, Arthritis Rheum, 63, 867, 10.1002/art.30207
Krintel, 2013, The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure, Rheumatology, 52, 1245, 10.1093/rheumatology/ket017
Plasencia, 2013, The timing of serum infliximab loss, or the appearance of antibodies to infliximab (ATI), is related with the clinical activity in ATI-positive patients with rheumatoid arthritis treated with infliximab, Ann Rheum Dis, 72, 1888, 10.1136/annrheumdis-2013-203353
Arstikyte, 2015, Influence of immunogenicity on the efficacy of long-term treatment with TNF α blockers in rheumatoid arthritis and spondyloarthritis patients, Biomed Res Int, 2015, 604872, 10.1155/2015/604872
Pascual-Salcedo, 2011, Influence of immunogenicity on the efficacy of long-term treatment with infliximab in rheumatoid arthritis, Rheumatology, 50, 1445, 10.1093/rheumatology/ker124
Ducourau, 2011, Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases, Arthritis Res Ther, 13, R105, 10.1186/ar3386
Maini, 1998, 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, 41, 1552, 10.1002/1529-0131(199809)41:9<1552::AID-ART5>3.0.CO;2-W
Hoshino, 2012, Influence of antibodies against infliximab and etanercept on the treatment effectiveness of these agents in Japanese patients with rheumatoid arthritis, Mod Rheumatol, 22, 532, 10.3109/s10165-011-0567-8
Vultaggio, 2010, Anti-infliximab IgE and non-IgE antibodies and induction of infusion-related severe anaphylactic reactions, Allergy, 65, 657, 10.1111/j.1398-9995.2009.02280.x
van Schie, 2017, Infusion reactions during infliximab treatment are not associated with IgE anti-infliximab antibodies, Ann Rheum Dis, 76, 1285, 10.1136/annrheumdis-2016-211035
Lipsky, 2000, Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group, N Engl J Med, 343, 1594, 10.1056/NEJM200011303432202
Yoo, 2013, A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study, Ann Rheum Dis, 72, 1613, 10.1136/annrheumdis-2012-203090
Park, 2013, A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study, Ann Rheum Dis, 72, 1605, 10.1136/annrheumdis-2012-203091
Benucci, 2008, Anti-nucleosome antibodies as prediction factor of development of autoantibodies during therapy with three different TNFα blocking agents in rheumatoid arthritis, Clin Rheumatol, 27, 91, 10.1007/s10067-007-0728-5
Takase, 2014, What is the utility of routine ANA testing in predicting development of biological DMARD-induced lupus and vasculitis in patients with rheumatoid arthritis? Data from a single-centre cohort, Ann Rheum Dis, 73, 1695, 10.1136/annrheumdis-2014-205318
Pink, 2010, Antinuclear antibodies associate with loss of response to antitumour necrosis factor-alpha therapy in psoriasis: a retrospective, observational study, Br J Dermatol, 162, 780, 10.1111/j.1365-2133.2009.09563.x
Hoffmann, 2011, Autoantibodies in psoriasis as predictors for loss of response and anti-infliximab antibody induction, Br J Dermatol, 165, 1355, 10.1111/j.1365-2133.2011.10555.x
Yukawa, 2011, Correlation of antinuclear antibody and anti-double-stranded DNA antibody with clinical response to infliximab in patients with rheumatoid arthritis: a retrospective clinical study, Arthritis Res Ther, 13, R213, 10.1186/ar3546
Nguyen, 2015, pANCA positivity predicts lower clinical response to infliximab therapy among patients with IBD, South Med J, 108, 139, 10.14423/SMJ.0000000000000253
Ramos-Casals, 2007, Autoimmune diseases induced by TNF-targeted therapies: analysis of 233 cases, Medicine, 86, 242, 10.1097/MD.0b013e3181441a68
Elliott, 1994, Randomised double-blind comparison of chimeric monoclonal antibody to tumour necrosis factor alpha (cA2) versus placebo in rheumatoid arthritis, Lancet, 344, 1105, 10.1016/S0140-6736(94)90628-9
Maini, 1999, Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial, Lancet, 354, 1932, 10.1016/S0140-6736(99)05246-0
Breedveld, 2006, The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment, Arthritis Rheum, 54, 26, 10.1002/art.21519
Smolen, 2009, Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial, Ann Rheum Dis, 68, 797, 10.1136/ard.2008.101659
Moreland, 1997, Treatment of rheumatoid arthritis with a recombinant human tumour necrosis factor receptor (p75)-Fc fusion protein, N Engl J Med, 337, 141, 10.1056/NEJM199707173370301
Keystone, 2004, Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis: results of a multicenter, randomized, double-blind, placebo-controlled trial, Arthritis Rheum, 50, 353, 10.1002/art.20019
Kavanaugh, 2007, Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial, Ann Rheum Dis, 66, 498, 10.1136/ard.2006.058339
van de Putte, 2003, Efficacy and safety of the fully human anti-tumour necrosis factor alpha monoclonal antibody adalimumab (D2E7) in DMARD refractory patients with rheumatoid arthritis: a 12 week, phase II study, Ann Rheum Dis, 62, 1168, 10.1136/ard.2003.009563
Emery, 2009, Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis, Arthritis Rheum, 60, 2272, 10.1002/art.24638
Shakoor, 2002, Drug-induced systemic lupus erythematosus associated with etanercept therapy, Lancet, 359, 579, 10.1016/S0140-6736(02)07714-0
De Bandt, 2005, Systemic lupus erythematosus induced by anti-tumour necrosis factor alpha therapy: a French national survey, Arthritis Res Ther, 7, R545, 10.1186/ar1715
Costa, 2008, Drug-induced lupus due to anti-tumor necrosis factor alpha agents, Semin Arthritis Rheum, 37, 381, 10.1016/j.semarthrit.2007.08.003
Moulis, 2014, Is the risk of tumour necrosis factor inhibitor-induced lupus or lupus-like syndrome the same with monoclonal antibodies and soluble receptor? A case/non-case study in a nationwide pharmacovigilance database, Rheumatology, 53, 1864, 10.1093/rheumatology/keu214
de Boissieu, 2014, Notoriety bias in a database of spontaneous reports: the example of osteonecrosis of the jaw under bisphosphonate therapy in the French national pharmacovigilance database, Pharmacoepidemiol Drug Saf, 23, 989, 10.1002/pds.3622
Jani, 2017, Drug-specific risk and characteristics of lupus and vasculitis-like events in patients with rheumatoid arthritis treated with TNFi: results from BSRBR-RA, RMD Open, 3, e000314, 10.1136/rmdopen-2016-000314
Wallace, 2012
Bartelds, 2010, 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, 69, 817, 10.1136/ard.2009.112847
De Bandt, 2005, Systemic lupus erythematosus induced by anti-tumour necrosis factor alpha therapy: a French national survey, Arthritis Res Ther, 7, R545, 10.1186/ar1715
Flendrie, 2005, Dermatological conditions during TNF-alpha-blocking therapy in patients with rheumatoid arthritis: a prospective study, Arthritis Res Ther, 7, R666, 10.1186/ar1724
Lee, 2007, Cutaneous side-effects in patients with rheumatic diseases during application of tumour necrosis factor-alpha antagonists, Br J Dermatol, 156, 486, 10.1111/j.1365-2133.2007.07682.x
Grönhagen, 2012, Subacute cutaneous lupus erythematosus and its association with drugs: a population-based matched case–control study of 234 patients in Sweden, Br J Dermatol, 167, 296, 10.1111/j.1365-2133.2012.10969.x
Ortiz-Sanjuán, 2014, Drug-associated cutaneous vasculitis: study of 239 patients from a single referral center, J Rheumatol, 41, 2201, 10.3899/jrheum.140390
Cestelli, 2014, Large vessel vasculitis occurring in rheumatoid arthritis patient under anti-TNF therapy, Case Rep Med, 2014, 624184, 10.1155/2014/624184
Osman, 2011, Takayasu’s arteritis progression on anti-TNF biologics: a case series, Clin Rheumatol, 30, 703, 10.1007/s10067-010-1658-1
Parekh, 2010, Onset of Wegener’s granulomatosis during therapy with golimumab for rheumatoid arthritis: a rare adverse event?, Rheumatology, 49, 1785, 10.1093/rheumatology/keq101
Ortiz-sierra, 2014, Case report developing of Granulomatosis with Polyangiitis during etanercept therapy, 2
Jarrett, 2003, Anti-tumor necrosis factor-α therapy–induced vasculitis: case series, J Rheumatol, 30, 2287
Toussirot, 2016, Paradoxical reactions under TNF-alpha blocking agents and other biological agents given for chronic immune-mediated diseases: an analytical and comprehensive overview, RMD Open, 2, e000239, 10.1136/rmdopen-2015-000239
Saint Marcoux, 2006, Vasculitides induced by TNFalpha antagonists: a study in 39 patients in France, Joint Bone Spine, 73, 710, 10.1016/j.jbspin.2006.02.010
Bathon, 2000, A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis, N Engl J Med, 343, 1586, 10.1056/NEJM200011303432201
Fleischmann, 2009, Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study, Ann Rheum Dis, 68, 805, 10.1136/ard.2008.099291
Krieckaert, 2012, Methotrexate reduces immunogenicity in adalimumab treated rheumatoid arthritis patients in a dose dependent manner, Ann Rheum Dis, 71, 1914, 10.1136/annrheumdis-2012-201544
Makol, 2010, Etanercept and venous thromboembolism: a case series, J Med Case Rep, 4, 12, 10.1186/1752-1947-4-12
Petitpain, 2009, Arterial and venous thromboembolic events during anti-TNF therapy: a study of 85 spontaneous reports in the period 2000–2006, Biomed Mater Eng, 19, 355
Masson, 2012, Thromboembolic events and anti-tumor necrosis factor therapies, Int Immunopharmacol, 14, 444, 10.1016/j.intimp.2012.08.018
Korswagen, 2011, Venous and arterial thromboembolic events in adalimumab-treated patients with antiadalimumab antibodies: a case series and cohort study, Arthritis Rheum, 63, 877, 10.1002/art.30209
Low, 2017, Relationship between exposure to tumour necrosis factor inhibitor therapy and incidence and severity of myocardial infarction in patients with rheumatoid arthritis, Ann Rheum Dis, 76, 654, 10.1136/annrheumdis-2016-209784
Kim, 2015, Risk of venous thromboembolism in patients with rheumatoid arthritis: initiating disease-modifying antirheumatic drugs, Am J Med, 128, 539.e7, 10.1016/j.amjmed.2014.11.025
Davies, 2011, Venous thrombotic events are not increased in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register, Ann Rheum Dis, 70, 1831, 10.1136/ard.2011.153536
Chung, 2014, Rheumatoid arthritis increases the risk of deep vein thrombosis and pulmonary thromboembolism: a nationwide cohort study, Ann Rheum Dis, 73, 1774, 10.1136/annrheumdis-2013-203380
Smolen, 2017, EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update, Ann Rheum Dis, 76, 960, 10.1136/annrheumdis-2016-210715
van den Bemt, 2008, Sustained effect after lowering high-dose infliximab in patients with rheumatoid arthritis: a prospective dose titration study, Ann Rheum Dis, 67, 1697, 10.1136/ard.2007.083683
Smolen, 2013, Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial, Lancet, 381, 918, 10.1016/S0140-6736(12)61811-X
Fautrel, 2016, Step-down strategy of spacing TNF-blocker injections for established rheumatoid arthritis in remission: results of the multicentre non-inferiority randomised open-label controlled trial (STRASS: Spacing of TNF-blocker injections in Rheumatoid ArthritiS), Ann Rheum Dis, 75, 59, 10.1136/annrheumdis-2014-206696
van Herwaarden, 2015, Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial, BMJ, 350, h1389, 10.1136/bmj.h1389
Park, 2017, Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study, Ann Rheum Dis, 76, 346, 10.1136/annrheumdis-2015-208783
Jørgensen, 2017, Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial, Lancet, 6736, 30068
Glintborg, 2017, A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry, Ann Rheum Dis, 76, 1426, 10.1136/annrheumdis-2016-210742
Scherlinger, 2017, Serum sickness-like disease after switching to biosimilar infliximab, Rheumatology, 56, 2032
Gottenberg, 2016, Non–TNF-targeted biologic vs a second anti-TNF drug to treat rheumatoid arthritis in patients with insufficient response to a first anti-TNF drug, JAMA, 316, 1172, 10.1001/jama.2016.13512
Jamnitski, 2011, The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept, Ann Rheum Dis, 70, 284, 10.1136/ard.2010.135111
Jamnitski, 2012, Patients non-responding to etanercept obtain lower etanercept concentrations compared with responding patients, Ann Rheum Dis, 71, 88, 10.1136/annrheumdis-2011-200184