Biological agents in pregnancy and lactation – A rational approach

Abstract

Biologicals are a rapidly evolving group of drugs derived from biological agents which target specific immune mediators. The use of biologicals in dermatology is on the rise, especially for inflammatory and immunological conditions. As pregnancy and lactation are associated with exacerbation of various inflammatory conditions necessitating administration of biologicals in certain cases, their use in these physiologically altered states has to be evaluated. This article aims at reviewing the common biologicals used in dermatology and their feasibility in pregnancy and lactation. Tumor necrosis factor-alpha inhibitors are the most experienced group of biologicals in pregnancy and lactation, the newer biologicals have only animal studies and isolated case reports to back up their use. The commonly used biologicals are tabulated and discussed herewith. The guidelines and recommendations are derived from the data of use in other conditions such as inflammatory bowel disease and rheumatoid arthritis as there is no sufficient literature evidence for the use of biologicals in pregnancy for dermatological conditions. It was extrapolated that biologicals, being large molecular weight immunoglobulins or recombinant proteins, may be used with judicious care in the first two trimesters of pregnancy and after the 1st week of lactation, if benefits to the mother outweigh the theoretical risk to the infant.

Atopic Dermatitis Treated Safely with Dupilumab during Pregnancy: A Case Report and Review of the Literature

“…Registries however can be subject to bias because adverse outcomes are more likely to be reported [8,15]. Overall, the current evidence indicates that biologic therapies appear to be safe in the first two trimesters of pregnancy, especially if the potential benefits of treatment outweigh the potential risks [8].…”

“…Pregnancy is often a trigger for AD and worsening of disease is typically reported during the second and third trimesters [4,7]. In a normal pregnancy state, the balance between the T helper cell (Th) 1 and Th2 cytokine response is altered [8]. To prevent fetal rejection and thus reduce the risk of miscarriage, there is a shift from Th1 to Th2 response [9].…”

“…There is a growing body of evidence which suggests that biologic agents can be used for the treatment of dermatological conditions such as psoriasis during pregnancy and lactation [8,15]. The majority of the data on biologic agents and pregnancy, including guidelines and recommendations, stem from gastroenterology and rheumatology literature due to the frequent use TNF-α inhibitors to treat IBD and rheumatoid arthritis [15].…”

“…Given that controlled clinical trials often exclude pregnant women from enrollment, data on newer biologic agents, such as ustekinumab (IL-12/23 inhibitor), secukinumab (IL-17 inhibitor), and ixekizumab (IL-17 inhibitor), are lacking. Evidence for the use of biologic therapies in pregnancy for dermatological conditions mostly originates from animal studies, case reports or case series, small retrospective studies, pregnancy registry studies, and surveillance programs [8]. Registries however can be subject to bias because adverse outcomes are more likely to be reported [8,15].…”

“…Evidence for the use of biologic therapies in pregnancy for dermatological conditions mostly originates from animal studies, case reports or case series, small retrospective studies, pregnancy registry studies, and surveillance programs [8]. Registries however can be subject to bias because adverse outcomes are more likely to be reported [8,15]. Overall, the current evidence indicates that biologic therapies appear to be safe in the first two trimesters of pregnancy, especially if the potential benefits of treatment outweigh the potential risks [8].…”