دورية أكاديمية
Population Pharmacokinetics of Adalimumab in Juvenile Idiopathic Arthritis Patients: A Retrospective Cohort Study Using Clinical Care Data.
| العنوان: | Population Pharmacokinetics of Adalimumab in Juvenile Idiopathic Arthritis Patients: A Retrospective Cohort Study Using Clinical Care Data. |
|---|---|
| المؤلفون: | Nassar-Sheikh Rashid A; Department of Pediatric Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. a.nassar@amsterdamumc.nl.; Department of Pediatrics, Zaans Medical Center, Zaandam, The Netherlands. a.nassar@amsterdamumc.nl., Hooijberg F; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Location Reade, Dr. Jan van Breemenstraat 2, 1056 AB, Amsterdam, The Netherlands.; Department of Rheumatology, Amsterdam UMC, Location VUmc, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands., Bergkamp SC; Department of Pediatric Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands., Gruppen MP; Department of Pediatric Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands., Kuijpers TW; Department of Pediatric Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands., Nurmohamed M; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Location Reade, Dr. Jan van Breemenstraat 2, 1056 AB, Amsterdam, The Netherlands.; Department of Rheumatology, Amsterdam UMC, Location VUmc, De Boelelaan 1118, 1081 HZ, Amsterdam, The Netherlands., Rispens T; Department of Immunopathology, Sanquin Research and Landsteiner Laboratory Academic Medical Center, Plesmanlaan 125, 1066 CX, Amsterdam, The Netherlands., Wolbink G; Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Location Reade, Dr. Jan van Breemenstraat 2, 1056 AB, Amsterdam, The Netherlands., van den Berg JM; Department of Pediatric Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands., Schonenberg-Meinema D; Department of Pediatric Immunology, Rheumatology and Infectious Diseases, Emma Children's Hospital, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands., Mathôt RAA; Hospital Pharmacy, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands. |
| المصدر: | Paediatric drugs [Paediatr Drugs] 2024 Jul; Vol. 26 (4), pp. 441-450. Date of Electronic Publication: 2024 Apr 17. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer International Country of Publication: Switzerland NLM ID: 100883685 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-2019 (Electronic) Linking ISSN: 11745878 NLM ISO Abbreviation: Paediatr Drugs Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: June 2010- : Cham, Switzerland : Springer International Original Publication: Auckland ; Philadelphia : Adis International, c1999- |
| مواضيع طبية MeSH: | Arthritis, Juvenile*/drug therapy , Adalimumab*/pharmacokinetics , Adalimumab*/therapeutic use , Adalimumab*/administration & dosage , Antirheumatic Agents*/pharmacokinetics , Antirheumatic Agents*/therapeutic use , Antirheumatic Agents*/administration & dosage, Humans ; Child ; Retrospective Studies ; Male ; Female ; Adolescent ; Models, Biological ; Monte Carlo Method ; Cohort Studies |
| مستخلص: | Background and Objective: Juvenile idiopathic arthritis (JIA) is a chronic autoimmune disorder that primarily affects the joints in children. Notably, it is known to co-occur with uveitis. Adalimumab, a monoclonal anti-TNF antibody, is effective in treating both conditions. A deeper understanding of the pharmacokinetics (PK) of adalimumab in JIA is crucial to advance in more personalized treatment approaches. The objective of this study is to evaluate the population PK profile of adalimumab in JIA and to explain causes for its variability. Materials and Methods: Adalimumab and antidrug antibody concentrations were retrospectively retrieved from the charts of patients with JIA. Initially, five literature-based population PK models of adalimumab were evaluated to assess their ability to describe the observed concentration-time profiles in the JIA cohort. These models included one specifically for the pediatric Crohn's disease population and four derived from studies in adult populations in healthy subjects and rheumatoid arthritis patients. Subsequently, a novel population PK model tailored to the JIA population was developed using NONMEM software. Monte Carlo simulations were then conducted utilizing the final PK model to visualize the concentration-time profile of adalimumab in patients with JIA and the impact of covariates. Results: A cohort of 50 patients with JIA with 78 available adalimumab samples was assessed. The mean age was 11.8 ± 3.9 years, with a median body weight of 49 kg (interquartile range 29.4-59.8 kg). All literature models adequately described the concentration-time profiles in JIA. The best model, which was developed in patients with rheumatoid arthritis during the maintenance phase of treatment, served as a basis for estimating clearance in JIA, resulting in a value of 0.37 L per day per 70 kg. Patient body weight, antidrug antibodies, methotrexate use, CRP level, and comorbidity of uveitis were found to have a significant impact on adalimumab clearance, and these reduced the inter-patient variability from 58.6 to 28.0%. On steady state in the simulated patient population, the mean trough level was 7.4 ± 5.5 mg/L. The two dosing regimens of 20 and 40 mg every other week, based on patients' body weight, resulted in comparable simulated overall drug exposure. Conclusions: Five literature models effectively described adalimumab PK in this pediatric cohort, highlighting the potential for extrapolating existing models to the pediatric population. The new JIA model confirmed the effect of several known covariates and found a novel association for drug clearance with methotrexate use (lower) and uveitis (higher), which might have clinical relevance for personalized dosing in JIA. (© 2024. The Author(s).) |
| References: | Rheumatol Int. 2017 May;37(5):695-703. (PMID: 28283733) Pediatr Rheumatol Online J. 2021 Apr 29;19(1):59. (PMID: 33926495) Ann Rheum Dis. 2015 Mar;74(3):513-8. (PMID: 24326008) Clin Pharmacokinet. 1996 May;30(5):329-32. (PMID: 8743333) Ther Drug Monit. 2018 Apr;40(2):202-211. (PMID: 29529008) Clin Rheumatol. 2014;33(10):1433-41. (PMID: 24487484) Clin Rev Allergy Immunol. 2010 Apr;38(2-3):82-9. (PMID: 19565360) J Clin Rheumatol. 2022 Jan 1;28(1):e301-e304. (PMID: 33790207) Front Immunol. 2020 Feb 26;11:312. (PMID: 32174918) Ann Rheum Dis. 2013 May;72(5):721-7. (PMID: 22730374) Ophthalmology. 2020 Oct;127(10):1431-1433. (PMID: 32423769) CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576-588. (PMID: 28653357) Gastroenterology. 2015 Aug;149(2):350-5.e2. (PMID: 25917786) Lancet. 2011 Jun 18;377(9783):2138-49. (PMID: 21684384) Rheumatology (Oxford). 2014 Feb;53(2):213-22. (PMID: 23946436) J Clin Med. 2021 Jun 30;10(13):. (PMID: 34208973) Br J Ophthalmol. 2022 Oct;106(10):1380-1386. (PMID: 33875451) Clin Rheumatol. 2018 Feb;37(2):549-553. (PMID: 29103180) Clin Pharmacokinet. 2013 Jan;52(1):1-8. (PMID: 23150213) N Engl J Med. 2008 Aug 21;359(8):810-20. (PMID: 18716298) Scand J Rheumatol. 2015;44(5):359-62. (PMID: 25974288) Ophthalmology. 2013 Jan;120(1):186-92. (PMID: 23062650) Br J Clin Pharmacol. 2015 Feb;79(2):286-97. (PMID: 25223394) Br J Clin Pharmacol. 2020 Nov;86(11):2274-2285. (PMID: 32363771) J Immunol Methods. 2010 Oct 31;362(1-2):82-8. (PMID: 20833178) Ann Rheum Dis. 2015 Feb;74(2):396-401. (PMID: 24326011) Br J Pharmacol. 2024 Apr;181(8):1165-1181. (PMID: 37859583) Ther Drug Monit. 2016 Aug;38(4):432-8. (PMID: 27120178) Sci Transl Med. 2019 Jan 30;11(477):. (PMID: 30700574) Arthritis Care Res (Hoboken). 2019 Jun;71(6):703-716. (PMID: 31021540) Inflamm Bowel Dis. 2015 Apr;21(4):783-92. (PMID: 25723614) Curr Opin Rheumatol. 2019 Sep;31(5):428-435. (PMID: 31169547) Paediatr Drugs. 2020 Apr;22(2):199-216. (PMID: 32052309) Ann Rheum Dis. 2015 Jun;74(6):1037-44. (PMID: 24550168) Clin Pharmacokinet. 2017 Sep;56(9):1091-1102. (PMID: 28066879) Arthritis Res Ther. 2019 Jul 8;21(1):168. (PMID: 31287015) AAPS J. 2011 Jun;13(2):143-51. (PMID: 21302010) Clin Rheumatol. 2012 Dec;31(12):1713-21. (PMID: 23053683) Cochrane Database Syst Rev. 2022 Oct 14;10:CD013818. (PMID: 36239193) Ann Rheum Dis. 2007 Jul;66(7):921-6. (PMID: 17301106) |
| المشرفين على المادة: | FYS6T7F842 (Adalimumab) 0 (Antirheumatic Agents) |
| تواريخ الأحداث: | Date Created: 20240417 Date Completed: 20240621 Latest Revision: 20240624 |
| رمز التحديث: | 20240624 |
| مُعرف محوري في PubMed: | PMC11192828 |
| DOI: | 10.1007/s40272-024-00629-7 |
| PMID: | 38630199 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1179-2019 |
|---|---|
| DOI: | 10.1007/s40272-024-00629-7 |