TDM of Biologics

Chair

D.J.A.R. Moes
Leiden, Netherlands

Vice-Chair

Erwin Dreesen
Leuven, Netherlands

Committee Purpose

  • 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.

2021

To perform an international comparative study across assays every 5 years.

To continue contributions for Compass.

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)

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.

2022 – Prague
2019 – Foz do Iguazu

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