Certolizumab Pegol in Plaque Psoriasis: Considerations for Pregnancy

Jeremy Strain, BSc; Maria Leis, BA; Kyle O. Lee, BMBS, MPH, CCFP; Patrick Fleming, MD, MSc, FRCPC, FCDA

Disclosures

Skin Therapy Letter. 2021;26(2):1-5. 

In This Article

Abstract and Introduction

Abstract

Psoriasis is a chronic, immune-mediated skin condition which commonly affects women of childbearing age. Certolizumab pegol (CZP) is an anti-tumor necrosis factor-alpha (anti-TNFα) agent that has demonstrated long-term safety and efficacy in treating moderate-to-severe plaque psoriasis. Previously, there has been limited safety data surrounding its use in pregnancy. The objective of this article is to review pivotal clinical trial data for CZP and explore safety considerations for this agent in pregnancy. This review demonstrates that CZP offers a safe and effective treatment option for women during childbearing years based on pharmacokinetics and available safety data. The observed occurrence of major congenital malformations and miscarriages appears to be no greater than the background occurrence of those in the general population, and risks to the mother are minimal based on its known safety profile. The use of CZP for treatment of plaque psoriasis should be considered and discussed with patients considering childbearing or whom are currently pregnant or breastfeeding.

Introduction

Plaque psoriasis is a chronic inflammatory immune-mediated skin disorder associated with genetic and environmental factors. The global prevalence of psoriasis is approximately 2% with some regional variation.[1,2] Although psoriasis primarily affects the skin, it also has widespread systemic effects including psoriatic arthritis, depression, and cardiovascular disease.[2]

Over the past two decades our understanding of the pathogenesis of psoriasis has been largely elucidated. Research has demonstrated that the disease is primarily driven through a mediated pathogenic T-cell pathway. Specifically, high levels of interleukin (IL)-23/T-helper type 17 T-cell are thought to stimulate release of IL-17.[3] IL-17 upregulation in turn leads to a "feed forward" cycle, including inflammatory responses in keratinocytes which further drive the development of psoriatic plaques by inducing characteristic changes such as epidermal hyperplasia and cell proliferation and leukocyte recruitment.[3]

TNFα is a pro-inflammatory cytokine further implicated in the immunopathogenesis of psoriasis.[3] The upregulation of TNFα leads to increased production of IL-23, further stimulating the psoriatic pathway. Additionally, TNFα works synergistically with IL-17 to upregulate transcription of many pro-inflammatory genes. Increased understanding of these inflammatory pathways has led to the advent of biologic therapies, including TNFα inhibitors, which have revolutionized the treatment of psoriasis.[3]

Although advances in our understanding of the disease pathogenesis have spawned the development of targeted biologic therapies, research is limited on the use of these medications in specific subpopulations. Considering that psoriasis often affects women of childbearing age, effective and safe treatment options during pregnancy are an important consideration.[4] The objective of this article is to review pivotal clinical trial data for certolizumab pegol (CZP), a PEGylated anti-TNFα biologic agent, and explore safety considerations for this treatment option in pregnancy.

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