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Review

Clinical utility of therapeutic drug monitoring in biological disease modifying anti-rheumatic drug treatment of rheumatic disorders: a systematic narrative review

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Pages 843-857 | Received 09 May 2017, Accepted 06 Jul 2017, Published online: 17 Jul 2017

References

  • Nam JL, Takase-Minegishi K, Ramiro S, et al. Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2017;76(6):1113–1136
  • Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960–977.
  • Ramiro S, Smolen JS, Landewé R, et al. Pharmacological treatment of psoriatic arthritis: a systematic literature review for the 2015 update of the EULAR recommendations for the management of psoriatic arthritis. Ann Rheum Dis. 2016;75:490–498.
  • Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016;75:499–510.
  • Sepriano A, Regel A, Van Der Heijde D, et al. Efficacy and safety of biological and targeted-synthetic DMARDs: a systematic literature review informing the 2016 update of the ASAS/EULAR recommendations for the management of axial spondyloarthritis. RMD Open. 2017;3:e000396.
  • van der Heijde D, Ramiro S, Landewé R, et al. Update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76(6):978–991.
  • Ternant D, Bejan-Angoulvant T, Passot C, et al. Clinical pharmacokinetics and pharmacodynamics of monoclonal antibodies approved to treat rheumatoid arthritis. Clin Pharmacokinet. 2015;54(11):1107–1123.
  • van den Bemt BJF, Den Broeder AA, Wolbink GJ, et al. Anti-infliximab antibodies are already detectable in most patients with rheumatoid arthritis halfway through an infusion cycle: an open-label pharmacokinetic cohort study. BMC Musculoskelet Disord. 2011;12:12.
  • Bartelds GM, Wijbrandts CA, Nurmohamed MT, et al. Clinical response to adalimumab: relationship to anti-adalimumab antibodies and serum adalimumab concentrations in rheumatoid arthritis. Ann Rheum Dis. 2007;66:921–926.
  • Fautrel B, den Broeder AA. De-intensifying treatment in established rheumatoid arthritis (RA): why, how, when and in whom can DMARDs be tapered? Best Pract Res Clin Rheumatol. 2015 Aug–Dec;29(4–5):550–565.
  • Singh JA, Cameron C, Noorbaloochi S, et al. Risk of serious infection in biological treatment of patients with rheumatoid arthritis: a systematic review and meta-analysis. Lancet. 2015 Jul 18;386(9990):258–265.
  • Bouman C, Van Herwaarden N, van den Hoogen F, et al. Prediction of successful dose reduction or discontinuation of adalimumab, etanercept or infliximab in rheumatoid arthritis patients using serum drug levels and antidrug antibody measurement. Expert Opin Drug Metab Toxicol. 2017;13:597–604. [Epub ahead of print].
  • Cuppen BV, Welsing PM, Sprengers JJ, et al. Personalized biological treatment for rheumatoid arthritis: a systematic review with a focus on clinical applicability. Rheumatology (Oxford). 2016;55(5):826–839.
  • Tweehuysen L, van Den Ende CH, Beeren FM, et al. Little evidence for usefulness of biomarkers for predicting successful dose reduction or discontinuation of a biologic agent in rheumatoid arthritis: a systematic review. Arthritis Rheumatol. 2017 Feb;69(2):301–308.
  • Coates LC, Moverley AR, McParland L, et al. Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial. Lancet. 2015;386(10012):2489–2498.
  • Iatdmct.org [Internet]. Rochester (NY): IATDMCT; [ cited 2017 June 30]. Available from: https://www.iatdmct.org/about-us/about-association/about-definitions-tdm-ct.html
  • Bossuyt P, Reitsma JB, Bruns DE, et al. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. Bmj. 2015;28(351):h5527.
  • Whiting PF, Rutjes ANW, Westwood ME, et al. QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies. Ann Intern Med. 2011;155:529–536.
  • Mallett S, Halligan S, Thompson M, et al. Interpreting diagnostic accuracy studies for patient care. Bmj. 2012;345:e3999.
  • Aarnoutse RE, Schapiro JM, Boucher CAB, et al. Therapeutic drug monitoring: an aid to optimising response to antiretroviral drugs? Drugs. 2003;63(8):741–753.
  • Moons KG, Altman DG, Reitsma JB, et al. New guideline for the reporting of studies developing, validating, or updating a multivariable clinical prediction model: the TRIPOD statement. Adv Anat Pathol. 2015 Sep;22(5):303–305.
  • Schulz KF, Altman DG, Moher D. for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med. 2010;152(11):726–732.
  • Hazlewood GS, Barnabe C, Tomlinson G, et al. Methotrexate monotherapy and methotrexate combination therapy with traditional and biologic disease modifying anti-rheumatic drugs for rheumatoid arthritis: a network meta-analysis. Cochrane Database Syst Rev. 2016;8:CD010227.
  • Maxwell LJ, Zochling J, Boonen A, et al. TNF-alpha inhibitors for ankylosing spondylitis. Cochrane Database Syst Rev. 2015;4:CD005468.
  • 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 Apr 13;305(14):1460–1468.
  • Jamnitski A, Krieckaert CL, Nurmohamed MT, et al. Patients non-responding to etanercept obtain lower etanercept concentrations compared with responding patients. Ann Rheum Dis. 2012 Jan;71(1):88–91.
  • Kneepkens EL, Krieckaert CL, van Der Kleij D, et al. Lower etanercept levels are associated with high disease activity in ankylosing spondylitis patients at 24 weeks of follow-up. Ann Rheum Dis. 2015;74(10):1825–1829.
  • Kneepkens EL, Wei JC, Nurmohamed MT, et al. Immunogenicity, adalimumab levels and clinical response in ankylosing spondylitis patients during 24 weeks of follow-up. Ann Rheum Dis. 2015;74(2):396–401.
  • Arends S, Lebbink HR, Spoorenberg A, et al. The formation of autoantibodies and antibodies to TNF-α blocking agents in relation to clinical response in patients with ankylosing spondylitis. Clin Exp Rheumatol. 2010;28(5):661–668.
  • van Herwaarden N, Den Broeder AA, Jacobs W, et al. Down-titration and discontinuation strategies of tumor necrosis factor-blocking agents for rheumatoid arthritis in patients with low disease activity. Cochrane Database Syst Rev. 2014;29(9):CD010455.
  • Edwards CJ, Fautrel B, Schulze-Koops H, et al. Dosing down with biologic therapies: a systematic review and clinicians’ perspective. Rheumatology (Oxford). 2017. [Epub ahead of print].
  • Verhoef LM, Tweehuysen L, Hulscher ME, et al. bDMARD dose reduction in rheumatoid arthritis: a narrative review with systematic literature search. Rheumatol Ther. 2017;4:1–24. [Epub ahead of print].
  • Bouman CA, Den Broeder AA, van Der Maas A, et al. What causes a small increase in radiographic progression in rheumatoid arthritis patients tapering TNF inhibitors? RMD Open. 2017;3(1):e000327.
  • Bendtzen K. Is there a need for immunopharmacologic guidance of anti-tumor necrosis factor therapies?. Arthritis Rheum. 2011;63(4):867–870.
  • Krieckaert CL, Nair SC, Nurmohamed MT, et al. Personalised treatment using serum drug levels of adalimumab in patients with rheumatoid arthritis: an evaluation of costs and effects. Ann Rheum Dis. 2015 Feb;74(2):361–368.
  • 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(2):165–178.
  • Hetland ML, Christensen IJTarp IJ, Tarp U, et al. Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum. 2010;62(1):22–32.
  • van Vollenhoven RF, Brannemark S, Klareskog L. Dose escalation of infliximab in clinical practice: improvements seen may be explained by a regression-like effect. Ann Rheum Dis. 2004;63(4):426–430.
  • van Den Bemt BJF, Den Broeder AA, Wolbink GJ, et al. The combined use of disease activity and infliximab serum trough concentrations for early prediction of (non-)response to infliximab in rheumatoid arthritis. Br J Clin Pharmacol. 2013;76(6):939–945.
  • Jani M, Chinoy H, Warren RB, et al. 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. 2015;67(8):2011–2019.
  • Hoxha A, Calligaro A, Tonello M, et al. The clinical relevance of early anti-adalimumab antibodies detection in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis: a prospective multicentre study. Joint Bone Spine. 2016;83(2):167–171.
  • Bartelds GM, Wijbrandts CA, Nurmohamed MT, 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(5):817–821.
  • Jamnitski A, Bartelds GM, Nurmohamed MT, et al. The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept. Ann Rheum Dis. 2011;70(2):284–288.
  • Plasencia C, Pascual-Salcedo D, García-Carazo S, et al. The immunogenicity to the first anti-TNF therapy determines the outcome of switching to a second anti-TNF therapy in spondyloarthritis patients. Arthritis Res Ther. 2013;15(4):R79.
  • van Herwaarden N, Bouman CAM, van Der Maas A, et al. Adalimumab and etanercept serum (anti)drug levels are not predictive for successful dose reduction or discontinuation in rheumatoid arthritis. Ann Rheum Dis. 2015 Dec;74(12):2260–2261.
  • Marotte H, Rinaudo M, Paul S, et al. FRI0180 No prediction of relapse by TNF blocker concentrations or detection of antibodies against anti-TNF: data from strass study. Ann Rheum Dis. 2016;75:495.1-495. EULAR ABSTRACT.
  • Chen DY, Chen YM, Hsieh TY, et al. Drug trough levels predict therapeutic responses to dose reduction of adalimumab for rheumatoid arthritis patients during 24 weeks of follow-up. Rheumatology (Oxford). 2016 Jan;55(1):143–148.
  • Bouman CAM, Den Broeder AA. Response to: “Drug trough levels predict therapeutic responses to dose reduction of adalimumab for rheumatoid arthritis patients during 24 weeks of follow-up” by Chen et al. Rheumatology. 2016 Jan 21.
  • Paramarta JE, Baeten DL. Adalimumab serum levels and antidrug antibodies towards adalimumab in peripheral spondyloarthritis: no association with clinical response to treatment or with disease relapse upon treatment discontinuation. Arthritis Res Ther. 2014;16(4):R160.
  • Plasencia C, Jurado T, Villalba A, et al. Effect of infliximab dose increase in rheumatoid arthritis at different trough concentrations: a cohort study in clinical practice conditions. Front Med (Lausanne). 2015;8(2):71.
  • Inman RD, Davis JC Jr, van Der Heijde D, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis results of a randomized, double-blind, placebo-controlled, Phase III trial. Arthritis Rheum. 2008;58(11):3402–3412.
  • Mazilu D, Opris D, Gainaru C, et al. Monitoring drug and antidrug levels: a rational approach in rheumatoid arthritis patients treated with biologic agents who experience inadequate response while being on a stable biologic treatment. Biomed Res Int. 2014;702701.
  • Pouw MF, Krieckaert CL, Nurmohamed MT, et al. Key findings towards optimising adalimumab treatment: the concentration-effect curve. Ann Rheum Dis. 2015;74(3):513–518.
  • Pavelka K, Jarosová K, Suchý D, et al. Increasing the infliximab dose in rheumatoid arthritis patients: a randomised, double blind study failed to confirm its efficacy. Ann Rheum Dis. 2009;68(8):1285–1289.
  • den Broeder AA, Van Der Maas A, van den Bemt BJ. Antidrug antibodies to tumour necrosis factor specific neutralising agents in chronic inflammatory diseases: a real issue, a clinical perspective; comment on the article by Vincent et al. Ann Rheum Dis. 2013;72(7):e14.
  • van Herwaarden N, van der Maas A, Minten MJ, et al. 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. 2015;350:h1389.
  • Kredo T, van der Walt JS, Siegfried N, et al. Therapeutic drug monitoring of antiretrovirals for people with HIV. Cochrane Database Syst Rev. 2009;3:CD007268.
  • Tomson T, Dahl ML, Kimland E. Therapeutic monitoring of antiepileptic drugs for epilepsy. Cochrane Database Syst Rev. 2007;1:CD002216.
  • Saquib N, Saquib J, Ioannidis JP. Does screening for disease save lives in asymptomatic adults? Systematic review of meta-analyses and randomized trials. Int J Epidemiol. 2015 Feb;44(1):264–277.

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