Biologics

Chair

Erwin Dreesen
Leuven, Netherlands

Vice-Chair

Tomoyuki Mizuno
Cincinnati, Ohio

Committee Purpose

  • To develop guidelines and best practice recommendations for TDM of biologics
  • To promote the harmonization and standardization of TDM practices for biologics, including assay methodologies, data interpretation, and treatment optimization strategies
  • To develop, curate, and share educational material and workshops to support healthcare professionals and researchers in the field of TDM of biologicals
  • To support and advance the development, validation, and implementation of model-informed precision dosing approaches for biologics
  • To foster collaboration with other IATDMCT committees, scientific societies, and stakeholders to advance the research and practice of TDM for biologics
  • To encourage and facilitate multicenter research, data sharing, and innovation in the field of TDM of biologics

2024

 
2024: TDM of Biologics Symposium, endorsed by the IATDMCT (Amsterdam, 6 December 2024)
 

2022

 
TDM of Biologics Symposium, endorsed by the IATDMCT (Amsterdam, 9 December 2022)

2024

Alsoud D, Moes DJAR, Wang Z, Soenen R, Layegh Z, Barclay M, Mizuno T, Minichmayr IK, Keizer RJ, Wicha SG, Wolbink G, Lambert J, Vermeire S, de Vries A, Papamichael K, Padullés-Zamora N, Dreesen E. Best Practice for Therapeutic Drug Monitoring of Infliximab: Position Statement from the International Association of Therapeutic Drug Monitoring and Clinical Toxicology. Ther Drug Monit. 2024 Jun 1;46(3):291-308. doi: 10.1097/FTD.0000000000001204. Epub 2024 Apr 17. PMID: 38648666.

2022

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-Tumor Necrosis Factor Are More Likely to Develop Antibodies to a Subsequent Anti-Tumor Necrosis Factor. Clin Gastroenterol Hepatol. 2022 Feb;20(2):465-467.e2. doi: 10.1016/j.cgh.2021.01.006. Epub 2021 Jan 6. PMID: 33421628; PMCID: PMC8257758.

2021

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: An ACCENT-II Post Hoc Analysis. Am J Gastroenterol. 2021 May 1;116(5):1007-1014. doi: 10.14309/ajg.0000000000001111. PMID: 33929379; PMCID: PMC8095681.

Papamichael K, Clarke WT, Vande Casteele N, Germansky KA, Feuerstein JD, Melmed GY, Siegel CA, Irving PM, Cheifetz AS. Comparison of Assays for Therapeutic Monitoring of Infliximab and Adalimumab in Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2021 Apr;19(4):839-841.e2. doi: 10.1016/j.cgh.2020.03.002. Epub 2020 Mar 5. PMID: 32147594; PMCID: PMC7483237.

Colls-Gonzalez M, Notario-Rosa J, Bas-Minguet J, Padullés-Zamora A, Morandeira-Rego F, Valentí-Medina F, Colom-Codina H, Padullés-Zamora N. Association between infliximab concentrations and clinical response in psoriasis: a prospective cohort study. J Dermatolog Treat. 2021 Mar;32(2):180-187. doi: 10.1080/09546634.2019.1690623. Epub 2019 Nov 20. PMID: 31696747.

Santacana Juncosa E, Rodríguez-Alonso L, Padullés Zamora A, Guardiola J, Rodríguez-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. Br J Clin Pharmacol. 2021 Feb;87(2):494-505. doi: 10.1111/bcp.14410. Epub 2020 Jun 26. PMID: 32495380.

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.

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 Disease. Clin Pharmacol Ther. 2021 Jun;109(6):1639-1647. doi: 10.1002/cpt.2148. Epub 2021 Jan 7. PMID: 33354765; PMCID: PMC8159860.

Thomas PWA, Chin PKL, Barclay ML. A nationwide survey on therapeutic drug monitoring of anti-tumour necrosis factor agents for inflammatory bowel disease. Intern Med J. 2021 Mar;51(3):341-347. doi: 10.1111/imj.14778. PMID: 32043746.

Compass submissions:

  • José Germán Sánchez Hernández (Pharmacokinetic Unit. Pharmacy Department. Complejo Asistencial Universitario de Salamanca). Early Personalized vedolizumab treatment in ulcerative colitis.

2020

McNeill RP, Barclay ML. Cost-effectiveness of therapeutic drug monitoring in inflammatory bowel disease. Curr Opin Pharmacol. 2020 Dec;55:41-46. doi: 10.1016/j.coph.2020.09.006. Epub 2020 Oct 26. PMID: 33120169.

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 trial. Neurology. 2020 Aug 11;95(6):e745-e754. doi: 10.1212/WNL.0000000000009995. Epub 2020 Jul 20. PMID: 32690785.

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; PMCID: PMC8294174.

Santacana E, Rodríguez-Alonso L, Padullés A, Guardiola J, Bas J, Rodríguez-Moranta F, Serra K, Morandeira F, Colom H, Padullés N. Predictors of Infliximab Trough Concentrations in Inflammatory Bowel Disease Patients Using a Repeated-Measures Design. Ther Drug Monit. 2020 Feb;42(1):102-110. doi: 10.1097/FTD.0000000000000669. PMID: 31283556.

Bauman LE, Xiong Y, Mizuno T, Minar P, Fukuda T, Dong M, Rosen MJ, Vinks AA. Improved Population Pharmacokinetic Model for Predicting Optimized Infliximab Exposure in Pediatric Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Feb 11;26(3):429-439. doi: 10.1093/ibd/izz143. PMID: 31287855; PMCID: PMC7171445.

Compass submissions:

  • 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.

2019

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 With 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; PMCID: PMC6939875.

Papamichael K, Vogelzang EH, 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. Epub 2019 Jun 14. PMID: 31180729.

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; PMCID: PMC6785387.

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

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. Intern Med J. 2019 Apr;49(4):513-518. doi: 10.1111/imj.14064. PMID: 30091273.

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

Compass submissions:

  • 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.

D.J.A.R. Moes, J. Tol, J.R. Kroep, R. Ter Heine. Is there room for personalized dosing of trastuzumab deruxtecan? IATDMCT Compass. 2025 Sep; 24(3):8–9.
 
S. Lanooij, A. Martens, T. Rispens, A. de Vries. Small drops, big impact: Finger prick testing to personalize treatment and dosing. IATDMCT Compass. 2024 Jun; 23(2): 3–5.
 
F. de Vries, D.J.A.R. Moes. Challenges and solutions for the increasing use of immune checkpoint inhibitors in oncology: Addressing costs, indication expansion, dosing strategies, and environmental impact. IATDMCT Compass. 2023 Jun; 22(2): 3–4.
 
E. Dreesen, S. Wicha. Model-informed precision dosing to enhance therapeutic drug monitoring. IATDMCT Compass. 2023 Mar; 22(1): 7–8.
 
A. de Vries, D.J.A.R. Moes. Activities of the TDM of Biologics Committee: Consensus paper and third symposium. IATDMCT Compass. 2022 Sep; 21(3): 6.
 
A. de Vries, D.J.A.R. Moes. Meet the new leaders: Perspectives of the “TDM of Biologics Committee” activities. IATDMCT Compass. 2022 Mar; 21(1): 11–12.
 
J.G. Sánchez Hernández. Early personalized vedolizumab treatment in ulcerative colitis. IATDMCT Compass. 2021 Jun; 20(2): 5.
 
Z. van Kempen, J. Killestein. Personalized natalizumab treatment in multiple sclerosis. IATDMCT Compass. 2020 Sep; 19(3): 8–9.
 
N. Padullés–Zamora, M. Barclay. A new scientific committee has been created within IATDMCT: The committee is dedicated to promoting the use of therapeutic drug monitoring of biologics. IATDMCT Compass. 2019 Dec; 18(4): 6–7.

23rd Congress, September 21-24, 2025, Singapore
Symposium 19: Model-informed precision dosing of biologics: New modalities and pediatrics. IATDMCT 2025, Singapore. Wednesday 24 September 2025; 10:30–12:00; Waterfront Ballroom II.
Chairs: D.J.A.R. Moes, E. Dreesen, I. Minichmayr.

  • Clinical pharmacology considerations of biologics: fundamentals & principles. Donald E. Mager. University at Buffalo, SUNY, Buffalo, New York, USA
  • How (not) to dose biologics in children: what do we know? Catherijne A.J. Knibbe. St Antonius Hospital/LACDR, Leiden University, The Netherlands
  • From struggle to success: Real-world pediatric model-informed precision dosing of biological drugs in stem cell transplantation. Kana Mizuno. Cincinnati Children’s Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio, USA

22nd Congress, September 15-18, 2024, Banff, Canada
Symposium: Presented by the TDM of Biologics Committee
Chairs: D.J.A.R Moes, A. de Vries.

  • Difficulties in the TDM of Biologics of the highly dosed newer drugs. Femke Hooijberg. Amsterdam UMC, Netherlands
  • The association between serum drug concentration and a flare in rheumatoid arthritis patients tapering TNF inhibitors. Zohra Layegh. Erasmus Medical Center and Immunoloy Center Reade, Netherlands
  • Enhancing Pediatric Care: Therapeutic Drug Monitoring of Biologic Agents in Inflammatory Diseases. Ruud Verstegen. The Hospital for Sick Children, Canada

 
Symposium: Presented by the TDM of Biologics Committee & Pharmacometrics Committee
Chairs: A. Åsberg, I. Minichmayr, D.J.A.R. Moes, A. de Vries.

  • From Theory to Action: Applying MIPD Tools in Clinical Practice. Iris K. Minichmayr. Medical University of Vienna, Austria
  • Modelling based on real life data; does one model fit all biologics? Stephan van den Berg. Sanquin Diagnostic Services, Netherlands
  • Selected Abstract: Monitoring The Biotransformation of Etanercept in the Body Using LC-S/MS. Sho Masui, Keio University, Japan
  • Selected Abstract: Therapeutic drug monitoring of bevacizumab in Hereditary Hemorrhagic Telangiectasia. Olivier Le Tilly, Tours University Hospital, France

 
Symposium: Presented by the TDM of Biologics Committee & TDM in Oncology Committee
Chairs: V. Gota, D.J.A.R. Moes.

  • Model-informed (precision) dosing of Antibody Drug Conjugates in (hemato)oncology. Dirk Jan Moes. Leiden University Medical Center, Netherlands
  • Selected Abstract: The relationship between the blood trough concentrations of imatinib and the body compositions in patients with gastrointestinal stromal tumors. Yi Zhou. Chongqing Medical University, China

 
21st Congress, September 24-27, 2023, Oslo, Norway
Symposium: TDM of Biologics
Chairs: A. de Vries, J. Gehin.

  • Biologicals in oncology: is there room for personalized dosing for antibody drug conjugates? M. Kågedal. Genentech/Roche
  • TDM of biologicals -analytical pitfalls. N. Bolstad. Oslo University Hospital, Oslo, Norway
  • Value of TDM of adalimumab in Chinese patients with ankylosing spondylitis. C. Huang. Soochow University, China

COST Action CA21147: European Network on Optimising Treatment with Therapeutic Antibodies in chronic inflammatory diseases – ENOTTA [https://enotta.eu/]

Erwin Dreesen (Chair)
Tomoyuki Mizuno (Vice-Chair)
Annick de Vries
Olivier Le Tilly
Dirk Jan Moes
Núria Padullés
Rani Soenen
Zoé van Kempen
Atsushi Yonezawa

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