Ustekinumab Safety in Pregnancy: A Comprehensive Review.
Journal
Arthritis care & research
ISSN: 2151-4658
Titre abrégé: Arthritis Care Res (Hoboken)
Pays: United States
ID NLM: 101518086
Informations de publication
Date de publication:
04 2023
04 2023
Historique:
revised:
13
10
2021
received:
12
05
2021
accepted:
04
11
2021
medline:
29
3
2023
pubmed:
9
11
2021
entrez:
8
11
2021
Statut:
ppublish
Résumé
Chronic inflammatory conditions, including inflammatory bowel diseases (IBD), psoriasis, and psoriatic arthritis, are prevalent among women of reproductive age; patients with active disease during pregnancy may be at an increased risk of adverse birth outcomes. For this reason, physicians are focused on approaches to controlling disease activity prior to and during pregnancy. The safety profile of many therapies used for these conditions has been relatively well established, though evidence on newer therapies is lacking. Ustekinumab is a relatively new interleukin-12/23 inhibitor approved for IBD, psoriasis, and psoriatic arthritis, whose safety in pregnancy is not yet fully understood. In this comprehensive review, we critically assess the available evidence on ustekinumab in pregnancy across animal studies and human case reports, case series, observational studies, and clinical practice guidelines. We show that, to date, studies have not identified an excess risk of adverse pregnancy outcomes among women exposed to ustekinumab in pregnancy, with few exposed pregnancies and potential for some bias. Clinical guidelines are conflicted regarding whether they recommend continuing or discontinuing ustekinumab, highlighting the paucity of data and need for more research on this issue.
Substances chimiques
Ustekinumab
FU77B4U5Z0
Types de publication
Journal Article
Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
930-935Subventions
Organisme : CIHR
ID : 419778
Pays : Canada
Informations de copyright
© 2021 American College of Rheumatology.
Références
Cornish J, Tan E, Teare J, et al. A meta-analysis on the influence of inflammatory bowel disease on pregnancy. Gut 2007;56:830-7.
Chaparro M, Ordás I, Cabré E, et al. Safety of thiopurine therapy in inflammatory bowel disease: long-term follow-up study of 3931 patients. Inflamm Bowel Dis 2013;19:1404-10.
Götestam Skorpen C, Hoeltzenbein M, Tincani A, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis 2016;75:795-810.
Mahadevan U, Long MD, Kane SV, et al. Pregnancy and neonatal outcomes after fetal exposure to biologics and thiopurines among women with inflammatory bowel disease. Gastroenterology 2021;160:1131-9.
European Medicines Agency. Abbott Laboratories Limited withdraws its marketing authorisation application for Ozespa (briakinumab). 2011. URL: https://www.ema.europa.eu/en/news/abbott-laboratories-limited-withdraws-its-marketing-authorisation-application-ozespa-briakinumab.
Martin PL, Sachs C, Imai N, et al. Development in the cynomolgus macaque following administration of ustekinumab, a human anti-IL-12/23p40 monoclonal antibody, during pregnancy and lactation. Birth Defects Res B Dev Reprod Toxicol 2010;89:351-63.
Klenske E, Osaba L, Nagore D, et al. Drug levels in the maternal serum, cord blood and breast milk of a ustekinumab-treated patient with Crohn's disease. J Crohns Colitis 2019;13:267-9.
Rowan CR, Cullen G, Mulcahy HE, et al. Ustekinumab drug levels in maternal and cord blood in a woman with Crohn's disease treated until 33 weeks of gestation. J Crohns Colitis 2018;12:376-8.
Matro R, Martin CF, Wolf D, et al. Exposure concentrations of infants breastfed by women receiving biologic therapies for inflammatory bowel diseases and effects of breastfeeding on infections and development. Gastroenterology 2018;155:696-704.
Watson N, Wu K, Farr P, et al. Ustekinumab exposure during conception and pregnancy in patients with chronic plaque psoriasis: a case series of 10 pregnancies. Br J Dermatolog 2019;180:195-6.
Mugheddu C, Atzori L, Lappi A, et al. Biologics exposure during pregnancy and breastfeeding in a psoriasis patient. Dermatol Ther 2019;32:e12895.
Rocha K, Piccinin MC, Kalache LF, et al. Pregnancy during ustekinumab treatment for severe psoriasis. Dermatology 2015;231:103-4.
Alsenaid A, Prinz JC. Inadvertent pregnancy during ustekinumab therapy in a patient with plaque psoriasis and impetigo herpetiformis. J Eur Acad Dermatol Venereol 2016;30:488-90.
Galli-Novak E, Mook SC, Büning J, et al. Successful pregnancy outcome under prolonged ustekinumab treatment in a patient with Crohn's disease and paradoxical psoriasis. J Eur Acad Dermatol Venereol 2016;30:e191-2.
Cortes X, Borrás-Blasco J, Antequera B, et al. Ustekinumab therapy for Crohn's disease during pregnancy: a case report and review of the literature. J Clin Pharm Ther 2017;42:234-6.
Cather JC, Rahawi KW, Shaufelberger BW, et al. Pregnancy outcomes in women exposed to ustekinumab in the psoriasis clinical development program [abstract]. J Am Acad Dermatol 2014;70:97.
Scherl EJ, Jacobstein D, Murphy C, et al. Pregnancy outcomes in women exposed to ustekinumab in the Crohn's disease clinical development program [abstract]. Am J Gastroenterol 2017;112:S332-3.
Geldhof A, Volger S, Lin CB, et al. P538 Pregnancy outcomes in women with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis treated with ustekinumab. J Crohns Colitis 2020;14:S460.
Wils P, Seksik P, Stefanescu C, et al. Safety of ustekinumab or vedolizumab in pregnant inflammatory bowel disease patients: a multicentre cohort study. Aliment Pharmacol Ther 2021;53:460-70.
Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol 2020;72:529-56.
Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol 2019;80:1029-72.
Mahadevan U, Robinson C, Bernasko N, et al. Inflammatory bowel disease in pregnancy clinical care pathway: a report from the American Gastroenterological Association IBD Parenthood Project Working Group. Gastroenterology 2019;156;1508-24.
Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.
Jeremy H, Iain C, Paul G. Explanation of the 2011 Oxford Centre for Evidence-Based Medicine (OCEBM) table of evidence. 2021. URL: https://www.cebm.ox.ac.uk/resources/levels-of-evidence/ocebm-levels-of-evidence.
Ebell MH, Siwek J, Weiss BD, et al. Strength of Recommendation Taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature. Am Fam Physician 2004;69:548-56.
Fotiadou C, Lazaridou E, Sotiriou E, et al. Spontaneous abortion during ustekinumab therapy. J Dermatol Case Rep 2012;6:105-7.
Andrulonis R, Ferris L. Treatment of severe psoriasis with ustekinumab during pregnancy. J Drugs Dermatol 2012;11:1240.
Sheeran C, Nicolopoulos J. Pregnancy outcomes of two patients exposed to ustekinumab in the first trimester. Australas J Dermatol 2014;55:235-6.
Lund T, Thomsen SF. Use of TNF-inhibitors and ustekinumab for psoriasis during pregnancy: a patient series. Dermatol Ther 2017;30:e12454.
Echeverría-García B, Nuño-González A, Dauden E, et al. A case series of patients with psoriasis exposed to biologic therapy during pregnancy: the BIOBADADERM Register and a review of the literature. Actas Dermosifiliogr 2017;108:168-70.
Venturin C, Nancey S, Danion P, et al. Fetal death in utero and miscarriage in a patient with Crohn's disease under therapy with ustekinumab: case-report and review of the literature. BMC Gastroenterol 2017;17:80.
Galluzzo M, D'Adamio S, Bianchi L, et al. Psoriasis in pregnancy: case series and literature review of data concerning exposure during pregnancy to ustekinumab. J Dermatolog Treat 2019;30:40-4.
Megna M, Villani A, Balato N, et al. Letter to the editor submitted in response to “psoriasis in pregnancy: case series and literature review of data concerning exposure during pregnancy to ustekinumab” [letter]. J Dermatolog Treat 2019;30:309.