International Association of
Therapeutic Drug Monitoring and Clinical Toxicology
Fostering education, research and practice in TDM and CT

TDM of Biologics

Núria Padullés-Zamora

Chair

Núria Padullés-Zamora
Universitat de Barcelona, Spain

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Scientific Committees
TDM of Biologics Committee

Murray Barclay

Vice-Chair

Murray Barclay
University of Otago, New Zealand

Purpose of the Committee

  • To develop guidelines for the use of TDM of biologics.
  • To encourage the use of TDM of biologics with the aim of optimizing clinical drug use and outcomes.
  • To promote development of PK and PKPD models that can be used for dose adjustment in clinical practice.
  • To provide knowledge of PK and the PK-response interactions.
  • To promote best practice in relation to laboratory analysis of biologics.
  • To enhance collaboration between groups working in the field and disseminate research in this area.
  • To provide information on the measurement and clinical relevance of antibodies to biologics.
  • To focus on harmonization and standardization of assays for TDM.

Committee Initiatives Currently in Progress (2021)

  • To perform an international comparative study across assays every 5 years.
  • To continue contributions for Compass.
    • 2021: José Germán Sánchez Hernández (Pharmacokinetic Unit. Pharmacy Department. Complejo Asistencial Universitario de Salamanca). Early Personalized vedolizumab treatment in ulcerative colitis
  • To suggest some names of new members (TDM of Biologics in Oncology) or propose a collaboration with the TDM in Oncology Scientific Committee and the Pharmacometrics Committee.
  • To update website.
  • To submit proposals for workshops and symposia for the next IATDMCT Congresses.
  • To seek opportunities for affiliation with other societies.
  • To re-organize educational activities (workshops) cancelled in 2020:
    • University of Barcelona and Hospital Universitari de Bellvitge. IDIBELL: two workshops were organized but cancelled due to the pandemic in 2020:
      • I Jornada de Actualización Práctica en Monitorizacion Farmacocinética. Situacion actual y perspectivas de futuro (cancelled twice-March and Nov 2020). Location: Hospital Universitari de Bellvitge.
      • Population modeling with Pmetrics and dose optimization with BestDose web-based tool. Location: Bellvitge Health Sciences Campus. School of Medicine. Barcelona (july 2020)

    Committee Initiatives & Activities

    • Publications: multiple peer reviewed papers related to TDM of Biologics during 2019, 2020 and 2021:
      • Santacana Juncosa E, Rodriguez Alonso L, Padullés Zamora A, Guardiola J, Rodriguez Moranta F, Serra Nilsson K, Bas Minguet J, Morandeira Rego F, Colom Codina H; Padullés Zamora N. Bayes-based dosing of Infliximab in inflammatory bowel diseases: short-term efficacy. British Journal of Clinical Pharmacology 2021;87(2): 494-505. doi: 10.1111/bcp.14410
      • Colls Gonzalez M, Notario Rosa J, Bas Minguet J, Padullés Zamora A, Morandeira Rego F, Valentí Medina F, Colom Codina H, Padullés Zamora N. Journal of Dermatological Treatment 2021;32(2): 180-187. doi: 10.1080/09546634.2019.1690623
      • Santacana Juncosa E, Rodriguez Alonso L, Padullés Zamora A, Guardiola Capon J, Bas Minguet J, Rodiguez Moranta F, Serra Nilssen K, Morandeira F, Colom Codina H, Padullés Zamora N. Predictors of Infliximab trough concentrations in inflammatory bowel disease patients using a repeated-mesures design. Ther Drug Monit 2020;42(1):102-110. doi: 10.1097/FTD.0000000000000669
      • Casellas M, Padullés N, Carballo N, Juanola X, Narváez FJ, Padullés A, Santacana E, Morandeira F, Colom H. Causas de falta de respuesta primaria y pérdida de respuesta secundaria a inhibidores del factor de necrosis tumoral alfa en artritis reumatoide. El Farmacético Hospitales 2021; 220: 25-34
      • Casellas Gibert M, Padullés Zamora N, Padullés Zamora A, Juanola Roura X, Santacana Juncosa E, Morandeira Rego F, Carballo Martinez N, Narvaez García FJ, Colom Codina H. Monitorización de agentes biológicos en la artritis reumatoide. El Farmacético Hospitales 2019; 216: 19-27
      • Casellas Gibert M, Padullés Zamora N, Santacana Juncosa E, Padullés Zamora A, Colom Codina H. Farmacocinética de los anticuerpos monoclonales. El Farmacético Hospitales 2019; 215: 15.21
      • McNeill RP, Barclay ML. Cost-effectiveness of therapeutic drug monitoring in inflammatory bowel disease. Current Opinion in Pharmacology 2020, 55: 41-46. https://doi.org/10.1016/j.coph.2020.09.006
      • Thomas PWA, Chin PKL, Barclay ML. A nationwide survey on therapeutic drug monitoring of anti-tumour necrosis factor agents for inflammatory bowel disease. Internal Medicine Journal 2020 Feb 11. doi: 10.1111/imj.14778
      • Khan A, Berahmana AB, Day AS, Barclay ML, Schultz M. New Zealand Society of Gastroenterology Guidelines on Therapeutic Drug Monitoring in Inflammatory Bowel Disease. New Zealand Medical Journal 2019, Mar 8; 132(1491): 46-62
      • Barclay ML, Karim S, Helms ETJ, Keating PE, Hock B, Stamp LK, Schultz M. Infliximab and adalimumab concentrations and anti-drug antibodies in inflammatory bowel disease control using New Zealand assays. Internal Medicine Journal 2019 Apr, 49(4): 513–518. doi: 10.1111/imj.14064
      • Xiong Y, Mizuno T, Colman R, Hyams J, Noe JD, Boyle B, Tsai YT, Dong M, Jackson K, Punt N, Rosen MJ, Denson LA, Vinks AA, Minar P. Real-world Infliximab Pharmacokinetic Study Informs an Electronic Health Record-Embedded Dashboard to Guide Precision Dosing in Children with Crohn's. Clin Pharmacol Ther. 2020. Online ahead of print. PMID: 33354765
      • Bauman LE*, Xiong Y*, Mizuno T, Minar P, Fukuda T, Dong M, Rosen MJ, Vinks AA (*Co-First Authors). Improved Population Pharmacokinetic Model for Predicting Optimized Infliximab Exposure in Pediatric Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Feb; 26 (3), 429-439. PMID: 31287855
      • van Kempen ZLE, Hoogervorst ELJ, Wattjes MP, Kalkers NF, Mostert JP, Lissenberg-Witte BI, de Vries A, Ten Brinke A, van Oosten BW, Barkhof F, Teunissen CE, Uitdehaag BMJ, Rispens T, Killestein J. Personalized extended interval dosing of natalizumab in MS: a prospective multicenter study. Neurology. 2020 Aug 11;95(6):e745-e754
      • Vande Casteele N, Abreu MT, Flier S, Papamichael K, Rieder F, Silverberg MS, Khanna R, Okada L, Yang L, Jain A, Cheifetz AS. Patients with low drug levels or antibodies to a prior anti-TNF are more likely to develop antibodies to a subsequent anti-TNF. Clin Gastroenterol Hepatol 2021 Jan 6:S1542-3565(21)00008-2. doi: 10.1016/j.cgh.2021.01.006. Online ahead of print. PMID: 33421628
      • Papamichael K, Vande Casteele N, Jeyarajah J, Jairath V, Osterman MT, Cheifetz AS. Higher postinduction infliximab concentrations are associated with improved clinical outcomes in fistulizing Crohn's disease. Am J Gastroenterol 2021 May 1;116(5):1007-1014 doi: 10.14309/ajg.0000000000001111. PMID: 33929379
      • Papamichael K, Cheifetz AS. Therapeutic drug monitoring in patients on biologics: lessons from gastroenterology Curr Opin Rheumatol 2020 Jul;32(4):371-379. doi: 10.1097/BOR.0000000000000713.PMID: 32412995
      • Papamichael K, Clarke WT, Casteele NV, Germansky KA, Feuerstein JD, Melmed GY, Siegel CA, Irving PM, Cheifetz AS. Comparison between assays used for therapeutic drug monitoring of infliximab and adalimumab in inflammatory bowel disease. Clin Gastroenterol Hepatol 2021 Apr;19(4):839-841. doi: 10.1016/j.cgh.2020.03.002.PMID: 32147594
      • Papamichael K, Cheifetz AS. Therapeutic drug monitoring in inflammatory bowel disease: for every patient and every drug? Curr Opin Gastroenterol 2019 Jul;35(4):302-310 doi: 10.1097/MOG.0000000000000536. PMID: 30973355
      • Papamichael K*, Juncadella A*, Wong D, Rakowsky S, Sattler LA, Campbell JP, Vaughn BP, Cheifetz AS. Proactive therapeutic drug monitoring of adalimumab is associated with better long-term outcomes compared to standard of care in patients with inflammatory bowel disease. J Crohns Colitis 2019 Aug 14;13(8):976-981. doi: 10.1093/ecco-jcc/jjz018. PMID: 30689771
      • Papamichael K, Vogelzang E, Lambert J, Wolbink G, Cheifetz AS. Therapeutic drug monitoring with biologic agents in immune mediated inflammatory diseases. Expert Rev Clin Immunol 2019 Aug;15(8):837-848. doi: 10.1080/1744666X.2019.1630273.PMID: 31180729
    • Compass submissions:
      • 2019:
        • A new scientific committee has been created within IATDMCT. The committee is dedicated to promoting the use of therapeutic drug monitoring of biologics. By Núria Padullés-Zamora, And Murray Barclay; On behalf of the TDM of Biologics Committee.
      • 2020:
        • Welcome the new members of IATDMCT committees: Z. van Kempen.
        • Personalized natalizumab treatment in multiple sclerosis. By Z. van Kempen and J. Killestein, MS, on behalf of the TDM of Biologics Committee.
        • New committee members: TDM of biologics committee: José Germán Sánchez-Hernández, and Patricio Más-Serrano.

    Minutes of Committee Meetings