Drug discontinuation in pregnant women with psoriasis: The <scp>PSO</scp>‐<scp>MOTHER</scp> cohort study

Belleudi, Valeria; Poggi, Francesca Romana; Perna, Serena; Naldi, Luigi; Bortolus, Renata; Rosa, Alessandro Cesare; Kirchmayer, Ursula; Davoli, Marina; Addis, Antonio

doi:10.1002/pds.5030

Cited by 6 publications

(10 citation statements)

References 19 publications

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“…This dearth of information often leads to the discontinuation of biologics during preconception and pregnancy, favouring disease exacerbations. 47,48 Thus, there is a strong demand for scientific evidence, which explains the recently intense research interest: not only have most included studies (58.8%) been published since 2018, they feature in highimpact scientific journals.…”

Section: Discussionmentioning

confidence: 99%

Exposure to biologic therapy before and during pregnancy in patients with psoriasis: Systematic review and meta‐analysis

Sánchez‐García,

Hernández‐Quiles,

de‐Miguel‐Balsa

et al. 2023

Acad Dermatol Venereol

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Biologicals have transformed the management of severe disease phenotypes in psoriasis and are often prescribed in women of childbearing age. However, information on safety of biologicals in pregnancy are lacking. We conducted a systematic review and meta‐analysis aimed to describe the characteristics and pregnancy outcomes in women with psoriasis exposed to biologics within 3 months before or during pregnancy, and to estimate the pooled prevalence of spontaneous, elective and total abortions, and congenital malformations in their newborns. Bibliographic searches were performed in the PubMed, Embase, Scopus and Web of Science databases up to 14 April 2022. No restrictions on sample size or publication date were applied. Review performance complied with PRISMA guidelines, and two reviewers assessed randomized controlled trials and nonrandomized studies reporting pregnancy outcomes in women exposed to biologics indicated for psoriasis during the pre‐gestational and/or gestational period. Studies focusing on rheumatologic or gastroenterological immune‐mediated inflammatory diseases were excluded. Regardless of data heterogeneity, a random‐effects model was used to pool prevalence estimates. We included 51 observational studies, involving 739 pregnancies exposed to approved biologics for psoriasis. Administration was mostly (70.4%) limited to the first trimester, and the most common drug was ustekinumab (36.0%). The estimated prevalence of miscarriage was 15.3% (95% confidence interval [CI] 12.7–18.0) and elective abortions, 10.8% (95% CI 7.7–14.3). Congenital malformations occurred in about 3.0% (95% CI 1.6–4.8) of live births exposed to biologics during pregnancy. Altogether, exposure to biologics for psoriasis during pregnancy and/or conception does not seem to be associated with an increased risk of miscarriage/abortion or congenital malformations, showing similar rates to the general population. These results suggest that biologic drugs are safe and pose an acceptable risk to the foetuses/neonates.

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Section: Discussionmentioning

confidence: 99%

Exposure to biologic therapy before and during pregnancy in patients with psoriasis: Systematic review and meta‐analysis

Sánchez‐García,

Hernández‐Quiles,

de‐Miguel‐Balsa

et al. 2023

Acad Dermatol Venereol

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“…However, only 3/6 TNFi treatments and 4/10 other biologics investigated in this study were approved by the European Medicines Agency (EMA) for use in the treatment of PSO in the European Union (EU) during the study period. The PSO-MOTHER retrospective cohort study in Italy reported a reduction in systemic drug prescriptions in patients with PSO during pregnancy and an increase in the 91 days after delivery, yet the levels after delivery did not reach pre-pregnancy prescription rates [ 31 ]. The PSO-MOTHER study also showed that prescriptions for biologics decreased during pregnancy and then increased after delivery [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

“…The PSO-MOTHER retrospective cohort study in Italy reported a reduction in systemic drug prescriptions in patients with PSO during pregnancy and an increase in the 91 days after delivery, yet the levels after delivery did not reach pre-pregnancy prescription rates [ 31 ]. The PSO-MOTHER study also showed that prescriptions for biologics decreased during pregnancy and then increased after delivery [ 31 ]. Reasons suggested by the PSO-MOTHER study for the reduction in prescriptions during pregnancy center around concerns by mothers over the impact of treatment on pregnancy outcomes [ 31 ].…”

Section: Discussionmentioning

confidence: 99%

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Treatment Patterns and Resource Utilization of Pregnant Women with Inflammatory Rheumatic Diseases or Psoriasis in Germany: A Claims Database Analysis

et al. 2021

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Background: Uncontrolled inflammatory disease activity can impact pregnancy outcomes and the health of the mother and child. This retrospective claims database analysis assessed treatment patterns before, during, and after pregnancy among women with inflammatory rheumatic disease (IRD; axial spondyloarthritis [axSpA], psoriatic arthritis [PsA], and rheumatoid arthritis [RA]) or psoriasis (PSO) in Germany. Methods: Data were extracted from the BARMER sickness fund (2013)(2014)(2015)(2016)(2017). Pregnant women (18-45 years) with documented IRD or PSO diagnoses were compared with age-matched controls from the same database for the analysis of patient characteristics, healthcare resource utilization, and pharmacological treatment during pregnancy. Reported measures included the proportion of women with pharmacological prescriptions or hospitalization/new prescription of corticosteroids or biologics in the 180 days before pregnancy, during pregnancy, and 180 days after delivery. Pre-specified prescription categories (such as disease-specific drugs [not including biologics]) were identified by anatomical therapeutic chemical classification codes. Extrapolated values to the German statutory health insurance population are reported. Results: Overall, 2702 pregnant women with IRD (axSpA: 1063; PsA: 660; RA: 979) and 6527 with PSO were identified. The proportion of women with IRD receiving prescriptions for disease-specific drugs reduced during pregnancy and remained stable after delivery (before: 15.0%; during: 9.0%; after: 9.7%). The proportion of women with PSO receiving prescriptions for disease-specific drugs was low (before: 0.6%; during: 0.3%; after: 0.1%). The proportion of women with hospitalization/new prescription of corticosteroids or biologics decreased during pregnancy, compared with pre-pregnancy, and increased after delivery in women with IRD

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“…As many therapeutic agents can be used without adverse effect during pregnancy, it is important that clinicians coproduce a management plan with their patients so that women make safe choices and do not unnecessarily discontinue all treatments because of safety concerns during pregnancy. A study of people with psoriasis found that 52% of women used topical treatment before pregnancy, but only 9% in the third trimester, and the number of women using no treatment increased from 34% before pregnancy to 88% in the third trimester 10…”

Section: Periconceptional Use Of Systemic Immunosuppression Retinoids...mentioning

confidence: 99%

Prescribing for pregnancy: chronic skin diseases

Caux

Mariappa

Perera

et al. 2023

DTB

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Chronic skin disease is common in women of reproductive age. Although skin can improve or remain stable during pregnancy, it is also common for existing conditions to flare and for new conditions to develop. A small number of medications used to control chronic skin disease can potentially have adverse effects on the outcome of the pregnancy. This article forms part of a series on prescribing for pregnancy and highlights the importance of achieving good control of the skin disease prior to conception and during pregnancy. It emphasises the need for patient-centred, open and informed discussions around medication options to achieve good control. During pregnancy and breastfeeding each patient should be treated as an individual in accordance with the medications that are appropriate for them, their preferences, and the severity of their skin disease. This should be done through collaborative working across primary care, dermatology and obstetric services.

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Drug discontinuation in pregnant women with psoriasis: The PSO‐MOTHER cohort study

Cited by 6 publications

References 19 publications

Exposure to biologic therapy before and during pregnancy in patients with psoriasis: Systematic review and meta‐analysis

Exposure to biologic therapy before and during pregnancy in patients with psoriasis: Systematic review and meta‐analysis

Treatment Patterns and Resource Utilization of Pregnant Women with Inflammatory Rheumatic Diseases or Psoriasis in Germany: A Claims Database Analysis

Prescribing for pregnancy: chronic skin diseases

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