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Meta-analysis results reassure tolerability of biologic therapies among pregnant psoriasis patients

31 Jul 2023

Psoriasis is an immune-mediated inflammatory disease which has been found to influence the hormone levels of pregnant women, with up to 23% of patients experiencing exacerbation during pregnancy and 65% experiencing worsening conditions after delivery.1 Additionally, psoriasis is associated with undesirable maternal outcomes, often resulting in elevated risk of preeclampsia, pregnancy-related hypertension, and severe post-partum hemorrhage.2 Despite the availability of biologic therapies for psoriasis, it is a challenge when it comes to treating pregnant patients due to the limited understanding of their safety.3 Hence, a meta-analysis has been conducted to address the knowledge gap and investigated the effects of biologic therapies on pregnancy outcomes in women with psoriasis.3

The meta-analysis conducted a systematic literature review on English, Spanish and Italian academic papers published as of 14 April 2022, which included randomized controlled trials, cohort studies, case-control studies, case series, case report studies, and patient registries.3 The primary endpoints of this meta-analysis were the pregnancy outcomes of patients, including live births, miscarriages, elective abortions, unspecified abortions, and congenital malformations (i.e., structural or functional abnormalities present at birth in live births).3 The secondary endpoints focused on live birth outcomes, including the frequency of small for gestational age (SGA) (i.e., birthweight <10th centile for gestation and sex), preterm birth (i.e., birth before 35 weeks of gestation), low birth weight (<2.5kg), neonatal complications [i.e., neonatal respiratory distress syndrome (RDS), neonatal interventricular hemorrhage (IVH), neonatal necrotizing enterocolitis (NEC), neonatal sepsis, admission to the neonatal intensive care unit (NICU)], information on child morbidity, and the long-term growth and development.3

The literature review yielded a total of 51 studies with 739 psoriasis patients who had been exposed to at least 3 months of biologics treatment before or during pregnancy, with plaque psoriasis being the dominant type of psoriasis among patients (96.7%).3 The mean duration of biologic exposure was 16.8 weeks, with ustekinumab (35.9%), etanercept (19.3%), and infliximab (12.7%) being the conventional biologics utilized for treating psoriasis.3 Biologic exposures were limited to the first trimester of pregnancy and suspended during pregnancy for 70.4% and 77.6% of patients, respectively.3

Overall, the pooled data estimated the prevalence of miscarriage of 15.3% (95% CI: 12.7-18.0), with low heterogeneity (I2=0%; 95% CI: 0-31.2), elective abortion of 10.8% (95% CI: 7.7-14.3; I2=23.7%; 95% CI: 0-46.9).3 The estimated prevalence for total abortions was 23.7% (95% CI: 18.8-29.0; I2=36.5%; 95% CI: 2.3-55.2).3 No associations between exposure to a specific biologic treatment and pregnancy outcomes were observed.3

As to the secondary endpoints, the reported outcomes varied among all articles in the analysis.3 Specifically, the incidence rate of SGA was reported in only 8 studies, resulting in an estimated incidence rate of 7.9%.3 The prevalence of preterm delivery was estimated to be 15%, concluding from 283 live birth outcomes of 36 studies.3 In terms of congenital malformations, 24 studies with a pooled population of 492 were included, resulting in an estimated prevalence of 3.0% (95% CI: 1.6-4.8; I2= 10.5%; 95% CI: 0-45.8).3

To sum up, the results of this meta-analysis exhibited a weak association between biologic exposure for psoriasis treatment during pregnancy and a higher risk of miscarriages or congenital malformations, regardless of the administered biologic therapies.3 These findings suggested that biologics were generally well tolerated, with manageable risk towards pregnancy and live birth outcomes.3 Nevertheless, further research is still required to address the clinical uncertainties of biologic usage in treating pregnant patients with psoriasis.3

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