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Certolizumab Pegol (Cimzia®)

Selected References

  • Anderson PO. 2021. Monoclonal antibodies during breastfeeding. Breastfeed Med, 16(8):591-593.
  • Belichón I, et al. 2022. Implementation of Recommendations for the Management of Psoriasis During Preconception, Pregnancy, Postpartum, Breastfeeding, and Perinatal Care. Actas Dermosifiliogr. 113(7):666-673.
  • Beltagy A, et al. 2021. Biologics During Pregnancy and Breastfeeding Among Women with Rheumatic Diseases: Safety Clinical Evidence on the Road. Front Pharmacol. 12:621247.
  • Cimzia Prescribing Information. Accessed January 22022.
  • Clowse ME, et al. 2018. Pregnancy Outcomes after Exposure to Certolizumab Pegol: Updated Results from a Pharmacovigilance Safety Database. Arthritis Rheumatol., 70(9):1399-1407.
  • Clowse MEB, et al. 2017. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis, 76:1890–1896.
  • Clowse M, et al. 2022. Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol. Ther Adv Musculoskelet. 14:1759720X221087650.
  • Förger F, et al. 2016. Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients. Joint Bone Spine, 83:341–343.
  • Habal FM and Huang VW. 2012. Review article: a decision-making algorithm for the management of pregnancy in the inflammatory bowel disease patient. Aliment Pharmacol Ther, 35(5):501-15.
  • Khan N, et al. 2014. Safety of anti-TNF therapy in inflammatory bowel disease during pregnancy. Expert Opin Drug Saf, 13 (12):1699-708.
  • Lambiase S, et al. 2022. Certolizumab pegol in pregnant and breastfeeding psoriatic patients. Ital J Dermatol Venerol. 157:383-34
  • Mahadevan U, et al. 2011. The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD with the European Crohn’s and Colitis Organization: pregnancy and pediatrics. Am J Gastroenterol, 106 (2):214-23.
  • Mahadevan U, et al. 2012. PIANO: A 1000 patient prospective registry of pregnancy outcomes in women with IBD exposed to immunomodulators and biologic therapy. Gastroenterology, 142(Suppl 1):S149. Abstract 865.
  • Mahadevan U, et al. 2017. Drug Safety and Risk of Adverse Outcomes for Pregnant Patients with Inflammatory Bowel Disease. Gastroenterology, 152(2):451-462.e452.
  • Mahadevan U, et al. 2021. Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women with Inflammatory Bowel Disease. Gastroenterology, 160 (4):1131-1139.
  • Mariette X, et al. 2017. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis, 0:1–6.
  • Membrive-Jiménez C, et al. 2023. Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry. Reumatol Clin (Engl Ed). 19:500-6.
  • Oussalah A, et al. 2009. Certolizumab use in pregnancy. Gut, 58 (4):608.
  • Prieto-Peña D, et al. 2021. Efficacy and safety of certolizumabpegol in pregnant women with uveitis. Recommendations on the management with immunosuppressive and biologic therapies in uveitis during pregnancy. Clin Exp Rheumatol, 39:105–14.
  • Romanowska-Próchnicka K, et al. 2021. The Role of TNF-a and Anti-TNF-a Agents during Preconception, Pregnancy, and Breastfeeding. Int J Mol Sci. 22(6):2922.
  • Russell MD, et al. 2023. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: Immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 62:e48-e88.
  • Sammaritano LR, et al. 2020. 2020 American College of Rheumatology Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases. Arthritis Rheumatol, 72:529–56.
  • Shimada H, et al. 2019. Effect of biologic disease-modifying anti-rheumatic drugs for patients with rheumatoid arthritis who hope to become mothers.  Rheumatol.38 (5):1453–1458.
  • Strain J, et al. 2021. Certolizumab Pegol in Plaque Psoriasis: Considerations for Pregnancy. Skin Therapy. 26(2):1-5.
  • Thatiparthi A, et al. 2021. Biologic treatment algorithms for moderate-to-severe psoriasis with comorbid conditions and special populations: A review. Am J Clin Dermatol. 22:425-42
  • Wakefield I, et al. 2011. The use of surrogate antibodies to evaluate the developmental and reproductive toxicity potential of an anti-TNF alpha PEGylated Fab’ monoclonal antibody. Toxicol Sci, 122(1):170-6.
  • Weber-Schoendorfer C; network of French pharmacovigilance centres, et al. 2015. Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J Clin Pharmacol, 80 (4):727-39.
  • Wolf D and Mahadevan U. 2010. Certolizumab use in pregnancy: low levels detected in cord blood. Arthritis Rheum [abstract], 62Suppl10:718.

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