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Enregistrement W4322489387 · doi:10.1182/blood.2022019343

Romiplostim drug presence in pregnancy and lactation

2023· article· en· W4322489387 sur OpenAlexaffabout
A. Labrecque, Steven Roy, Daniel Young, Si An Chen, Laurent Brechenmacher, Doan Le, Stephanie Cooper, Paul Gibson, Ann E. Clarke, Antoine Dufour, Leslie Skeith

Notice bibliographique

RevueBlood · 2023
Typearticle
Langueen
DomaineBiochemistry, Genetics and Molecular Biology
ThématiqueBlood disorders and treatments
Établissements canadiensUniversity of CalgaryUniversité de MontréalCentre Hospitalier Universitaire Sainte-Justine
Organismes subventionnairesnon disponible
Mots-clésMedicineObstetrics and gynaecologyLibrary scienceFamily medicinePregnancyBiologyGeneticsComputer science

Résumé

récupéré en direct d'OpenAlex

Letter to Blood| May 18, 2023 Romiplostim drug presence in pregnancy and lactation Clinical Trials & Observations Audrey Ann Labrecque, Audrey Ann Labrecque 1Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, CHU Sainte-Justine, University of Montreal, QC, Canada https://orcid.org/0000-0002-7220-7516 Search for other works by this author on: This Site PubMed Google Scholar Steven Roy, Steven Roy 2Department of Critical Care Medicine, Cumming School of Medicine, University of Calgary, AB, Canada Search for other works by this author on: This Site PubMed Google Scholar Daniel Young, Daniel Young 3Departments of Physiology and Pharmacology, Biochemistry and Molecular Biology, University of Calgary, AB, Canada Search for other works by this author on: This Site PubMed Google Scholar Si An Chen, Si An Chen 3Departments of Physiology and Pharmacology, Biochemistry and Molecular Biology, University of Calgary, AB, Canada Search for other works by this author on: This Site PubMed Google Scholar Laurent Brechenmacher, Laurent Brechenmacher 4Southern Alberta Mass Spectrometry Core Facility, University of Calgary, AB, Canada Search for other works by this author on: This Site PubMed Google Scholar Doan Le, Doan Le 5Department of Pediatrics, Cumming School of Medicine, University of Calgary, AB, Canada Search for other works by this author on: This Site PubMed Google Scholar Stephanie Cooper, Stephanie Cooper 6Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Cumming School of Medicine, University of Calgary, AB, Canada Search for other works by this author on: This Site PubMed Google Scholar Paul Gibson, Paul Gibson 6Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, Cumming School of Medicine, University of Calgary, AB, Canada7Department of Medicine, Cumming School of Medicine, University of Calgary, AB, Canada Search for other works by this author on: This Site PubMed Google Scholar Ann E. Clarke, Ann E. Clarke 7Department of Medicine, Cumming School of Medicine, University of Calgary, AB, Canada Search for other works by this author on: This Site PubMed Google Scholar Antoine Dufour, Antoine Dufour 3Departments of Physiology and Pharmacology, Biochemistry and Molecular Biology, University of Calgary, AB, Canada4Southern Alberta Mass Spectrometry Core Facility, University of Calgary, AB, Canada https://orcid.org/0000-0002-3429-4188 Search for other works by this author on: This Site PubMed Google Scholar Leslie Skeith Leslie Skeith 7Department of Medicine, Cumming School of Medicine, University of Calgary, AB, Canada https://orcid.org/0000-0002-5587-398X Search for other works by this author on: This Site PubMed Google Scholar Blood (2023) 141 (20): 2537–2540. https://doi.org/10.1182/blood.2022019343 Article history Submitted: December 6, 2022 Accepted: February 2, 2023 First Edition: February 27, 2023 Share Icon Share Facebook Twitter LinkedIn Email Tools Icon Tools Request Permissions Cite Icon Cite Search Site Citation Audrey Ann Labrecque, Steven Roy, Daniel Young, Si An Chen, Laurent Brechenmacher, Doan Le, Stephanie Cooper, Paul Gibson, Ann E. Clarke, Antoine Dufour, Leslie Skeith; Romiplostim drug presence in pregnancy and lactation. Blood 2023; 141 (20): 2537–2540. doi: https://doi.org/10.1182/blood.2022019343 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search Search Dropdown Menu toolbar search search input Search input auto suggest filter your search All ContentAll JournalsBlood Search Subjects: Clinical Trials and Observations, Platelets and Thrombopoiesis TO THE EDITOR: Immune thrombocytopenia (ITP) treatments during pregnancy include IV immunoglobulin (IVIg) and corticosteroids because of the reassuring safety data. There are limited safety data with respect to pregnancy and lactation for the thrombopoietin receptor agonists (TPO-RAs) romiplostim or eltrombopag. The largest retrospective study reports 15 pregnant individuals with ITP who used a TPO-RA during pregnancy with no attributable neonatal complications.1 Breastfeeding data were not systematically reported, but there was a case of thrombocytosis in a breastfed infant whose mother took eltrombopag in the postpartum period.1 Other preclinical studies and case reports have reported TPO-RA use during pregnancy2-8; 1 study recounts romiplostim use in a breastfeeding individual with no neonatal complications; however, no laboratory values were reported.9 We present a prospective case study of a 34-year-old postpartum individual who received romiplostim during her first pregnancy... References 1.Michel M, Ruggeri M, Gonzalez-Lopez TJ, et al. Use of thrombopoietin receptor agonists for immune thrombocytopenia in pregnancy: results from a multicenter study. Blood. 2020;136(26):3056-3061.Google ScholarCrossrefSearch ADS PubMed 2.Chua SJ, Morton MR, Svigos J, Ross DM, Kane S. Use of romiplostim in pregnancy for refractory idiopathic thrombocytopenic purpura: two case reports with maternal and fetal outcomes and literature review. Obstet Med. 2018;13:45-50.Google ScholarCrossrefSearch ADS PubMed 3.Chon AH, Chan R, Lee RH, Kwong K, Wertheimer FB, Weitz IC. Multidrug therapy for refractory immune thrombocytopenia in pregnancy. Obstet Gynecol. 2020;135(3):723-727.Google ScholarCrossrefSearch ADS PubMed 4.Samuelson Bannow B, Kreuziger LB. Use of romiplostim for refractory primary immune thrombocytopenia during pregnancy. Clin Obstet Gynecol Reprod Med. 2017;3(1):1-3.Google Scholar 5.Maria RNR, Laura RL, Angeles PB, Laura LB. Use of Romiplostim during pregnancy as a rescue therapy in primary immune thrombocytopenia: literature review and case description. Platelets. 2019;31(3):1-4.Google Scholar 6.Decroocq J, Marcellin L, Le Ray C, Willems L. Rescue therapy with romiplostim for refractory primary immune thrombocytopenia during pregnancy. Obstet Gynecol. 2014;124(2 Pt 2 suppl 1):481-483.Google ScholarPubMed 7.Patil AS, Dotters-Katz SK, Metjian AD, James AH, Swamy GK. Use of a thrombopoietin mimetic for chronic immune thrombocytopenic purpura in pregnancy. Obstet Gynecol. 2013;122(2 Pt 2):483-485.Google ScholarPubMed 8.Agarwal N, Mangla A. Thrombopoietin receptor agonist for treatment of immune thrombocytopenia in pregnancy: a narrative review. Ther Adv Hematol. 2021;12:20406207211001139.Google ScholarCrossrefSearch ADS PubMed 9.Patras A, Figueroa R, Singh AP, Madan I. Romiplostim for management of refractory immune thrombocytopenia in the immediate postpartum period. BMJ Case Rep. 2020;13(5):e234335.Google ScholarCrossrefSearch ADS PubMed 10.Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008;371(9610):395-403.Google ScholarCrossrefSearch ADS PubMed 11.Kuter DJ. Biology and chemistry of thrombopoietic agents. Semin Hematol. 2010;47(3):243-248.Google ScholarCrossrefSearch ADS PubMed 12.Min H, Sitney KC, Hartley C. Peptides and related compounds having thrombopoietic activity. 2003https://www.freepatentsonline.com/y2003/0176352.html.13.Syme MR, Paxton JW, Keelan J a. Drug transfer and metabolism by the human placenta. Clin Pharmacokinet. 2004;43(8):487-514.Google ScholarCrossrefSearch ADS PubMed 14.Schneider H, Miller RK. Receptor-mediated uptake and transport of macromolecules in the human placenta. Int J Dev Biol. 2010;54(2-3):367-375.Google ScholarCrossrefSearch ADS PubMed 15.Nakai K, Misugi T, Kitada K, et al. Effect of thrombopoietin receptor agonist on pregnant mice. Pharmaceutics. 2022;14(3):514.Google ScholarCrossrefSearch ADS PubMed 16.Sparger KA, Ramsey H, Lorenz V, et al. Developmental differences between newborn and adult mice in response to romiplostim. Platelets. 2018;29(4):365-372.Google ScholarCrossrefSearch ADS PubMed 17.Mahat U, Talati R, Kodish E. Comment on: use of thrombopoietin receptor agonist (romiplostim) in neonatal autoimmune thrombocytopenia due to maternal immune thrombocytopenia. Pediatr Blood Cancer. 2019;66(6):e27706.Google ScholarCrossrefSearch ADS PubMed 18.Wiedmeier SE, Henry E, Sola-Visner MC, Christensen RD. Platelet reference ranges for neonates, defined using data from over 47000 patients in a multihospital healthcare system. J Perinatol. 2009;29(2):130-136.Google ScholarCrossrefSearch ADS 19.Ishiguro A, Nakahata T, Matsubara K, et al. Age-related changes in thrombopoietin in children: reference interval for serum thrombopoietin levels. Br J Haematol. 1999;106(4):884-888.Google ScholarCrossrefSearch ADS PubMed 20.Kao Y-R, Chen J, Narayanagari S-R, et al. Thrombopoietin receptor-independent stimulation of hematopoietic stem cells by eltrombopag. Sci Transl Med. 2018;10(458):eaas9563.Google ScholarCrossrefSearch ADS PubMed 21.Sun H, Tsai Y, Nowak I, Liesveld J, Chen Y. Eltrombopag, a thrombopoietin receptor agonist, enhances human umbilical cord blood hematopoietic stem/primitive progenitor cell expansion and promotes multi-lineage hematopoiesis. Stem Cell Res. 2012;9(2):77-86.Google ScholarCrossrefSearch ADS PubMed 22.Lee JW, Lee SE, Jung CW, et al. Romiplostim in patients with refractory aplastic anaemia previously treated with immunosuppressive therapy: a dose-finding and long-term treatment phase 2 trial. Lancet Haematol. 2019;6(11):e562-e572.Google ScholarCrossrefSearch ADS PubMed 23.Jang JH, Tomiyama Y, Miyazaki K, et al. Efficacy and safety of romiplostim in refractory aplastic anaemia: a phase II/III, multicentre, open-label study. Br J Haematol. 2021;192(1):190-199.Google ScholarCrossrefSearch ADS PubMed © 2023 by The American Society of Hematology2023 © 2023 by The American Society of Hematology2023 You do not currently have access to this content. Sign in via your Institution

Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.

Comment cette classification a été obtenuedéplier

Prédiction machine sur la base complète

Imitation des enseignants

Ni prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.

score de la tête « metaresearch » (Codex)0,002
score de la tête « metaresearch » (Gemma)0,011
Version: metacan-v3-hybrid-931329e0061cStatut de validation: machine_predicted_unvalidated
Catégories candidatesaucune
Catégories consensuellesaucune
DomaineSignal candidat: aucune · Signal consensuel: aucune
Devis d'étudeSignal candidat: Observationnel · Signal consensuel: aucune
GenreSignal candidat: Empirique · Signal consensuel: aucune
Score de désaccord entre enseignants0,008
Score d'incertitude au seuil0,027

Scores du classifieur distillé par catégorie (deux têtes)

CatégorieCodexGemma
Métarecherche0,0020,011
Méta-épidémiologie (sens strict)0,0000,000
Méta-épidémiologie (sens large)0,0010,000
Bibliométrie0,0010,001
Études des sciences et des technologies0,0010,001
Communication savante0,0020,001
Science ouverte0,0010,000
Intégrité de la recherche0,0040,005
Charge utile insuffisante (le modèle a refusé de juger)0,0080,003

Scores machine (provisoires)

Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.

Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.

Tête enseignante Opus0,007
Tête enseignante GPT0,236
Écart entre enseignants0,228 · la distance entre les deux têtes enseignantes sur ce seul travail
Statut de validationscore_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle

Classification

machine, non validée

Prédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.

Les modèles n’ont appliqué aucune catégorie : rien dans la taxonomie ne correspondait à ce travail.
Devis d'étudeObservationnel
Domainenon disponible
GenreEmpirique

Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».

En bref

Citations8
Publié2023
Routes d'admission2
Résumé présentoui

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