Psoriasis Flare Associated with Withdrawal from Biologics Prior to Pregnancy

The discontinuation of biologic therapy prior to the end of the first trimester and not before conception could limit psoriasis flares during pregnancy, new findings suggest, given the high risk of flares observed when biologics are discontinued pre-conception.1

These conclusions represent the result of a retrospective multicentric study authored by such investigators as E. Burle, from the Toulouse University Hospital Department of Dermatology and Allergology in France. Burle and colleagues highlighted that psoriasis has previously been linked to a risk increase for preterm birth as well as low birth weight.2

They added that a balance of the potential risks that can be attributed to biologics is necessary to be evaluated alongside the possible negative consequences of psoriasis.

“The aim of this retrospective multicentric study was to assess the real-life practice of dermatologists in managing pregnant and breastfeeding women treated with biologics,” Burle and coauthors wrote.1

Design and Findings

The trial investigators conducted their research with the aim of assessing the effectiveness and safety of biologics in pregnant patients living with psoriasis, focusing on maternal and fetal outcomes. They also focused on the ways in which the skin condition progresses during pregnancy and at the time of delivery, along with the postpartum management of biologics and influences on breastfeeding decisions.

There were 71 women aged between 21 - 42 years included at the time of their pregnancies. During the initiation of biologic treatments, these womens' average Psoriasis Area and Severity Index (PASI) was noted to be 16.6 (±9). their Dermatology Life Quality Index (DLQI) scores averaged 17.6 (±5). On average, biologic therapies were noted to have been implemented for 2.5 years prior to pregnancy, by which point mean DLQI and PASI scores had risen to 1.7 and 1.2, respectively.

Once they learned of their pregnancies, 50.7% of these 71 participants ceased their use of biologics. An additional 29.6% discontinued their utilization of biologics during their pregnancies, mostly in the initial trimester. Burle and coauthors noted that 5.6% of the subjects continued biologic use throughout their pregnancy, and 14.1% discontinued their treatments prior to their children's conceptions.

Retrospective evaluations of psoriasis took place among these trial participants during their pregnancies.1 Burle et al highlighted that 52.2% of these 67 subjects reported disease flares, 41.8% reported no changes, and 4.5% noted improvement. Among those who stopped biologics during pregnancy, 66.7% of 21 noted that their skin conditions remained stable, compared to just 33.3% of the 36 who discontinued at the time of pregnancy discovery and 20% of 10 who stopped prior to conception.

Such distinctions were shown by the investigative team to be statistically significant (P < .02, Chi-square test), suggestinng a higher likelihood of disease flare in those who discontinued treatment prior to their becoming pregnant. In terms of safety analyses, there was no risk increase for congenital abnormalities, miscarriage, or infections identified in the mothers, fetuses, or infants.

Notably, however, exacerbations of participants' psoriasis were found to be common following their children's delivery. Specifically, flares impacted 73% of the cohort. Burle and colleagues added that a subset of 6.3% reported having a rebound, wherein psoriasis symptoms worsened past baseline severity. Biologic drugs were typically found to have been restarted an average of 2.2 months postpartum (±2.6 months), at which time the mean PASI score was 9.1.

When they were asked about infant feeding decisions, 59.3% were shown to have chosen not to breastfeed. Among these individuals, the investigators highlighted that 43.8% cited the need to resume biologics as the reason for forgoing breastfeeding.

Overall, these conclusions support the notion clinicians often diverge from the Summary of Product Characteristics (SmPC) without raising the risk of spontaneous miscarriage or birth defects. These data align with existing evidence suggesting the relative safety of biologics during pregnancy. Nonetheless, many women either unnecessarily avoid breastfeeding or delay treatment reinitiation due to a lack of clear, evidence-based guidelines.

Currently, European recommendations offer no direction on postpartum timing for restarting biologics. In contrast, guidance for inflammatory bowel disease suggests restarting biologics within 24 hours following a vaginal birth or within 48 hours after a cesarean section, provided there is no infection. While live vaccines are contraindicated in the first year of life for infants exposed to biologics in utero due to rare complications like fatal BCG infections post-infliximab, no such risks have been reported with IL-17 or IL-23 inhibitors.

“In conclusion, discontinuing biologic agents before the end of the first trimester and not before conception could limit psoriasis flares during pregnancy,” they concluded.1 “We recommend a multidisciplinary approach with a gynaecologist and propose a therapeutic algorithm for psoriasis management during pregnancy.”

References

1. Burle E, Tran C, Paul C, et al. Withdrawal of biologic agents before pregnancy is associated with psoriasis flare. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.20841.

2. Bröms G, Haerskjold A, et al. Effect of maternal psoriasis on pregnancy and birth outcomes: a population-based cohort study from Denmark and Sweden. Acta Derm Venereol. 2018; 98(8): 728–734.