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Biologics and novel small molecule treatments, reproduction and psoriasis

Author: Dr Charlotte L Thomas, MBChB MA (Oxon) MRCP Dermatology Research Fellow, Skin and Cancer Foundation Australia; Dr.Monisha Gupta, MD, FACD, Dermatologist, Sydney, Australia. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, August 2015.

Introduction

Psoriasis is a common scaly skin condition. If you are pregnant or planning pregnancy and have psoriasis, seek your doctor's advice. This is particularly important if you are on systemic therapy for psoriasis. This article discusses the use of biologic and novel small molecule treatments for psoriasis such as apremilast, in women during their reproductive time of life.

Note:

How does pregnancy affect psoriasis and its treatment?

Active psoriasis is characterised by inflammation throughout the body. The risk to the unborn baby from uncontrolled inflammation must be weighed up against the risk from medication.

Other health conditions associated with psoriasis may also complicate pregnancy:

Safety of medicines in pregnancy

All medications are categorised by their safety in pregnancy and the risk of harm to the unborn baby. The Australian Drug Evaluation Committee’s categorisation of medicines in pregnancy is summarised in Table 1.

Table 1: Categorisation of medicines in pregnancy
CategoryDescription
A Drugs which have been taken by large numbers of pregnant women, without any proven increase of malformations or any other harmful effects on the fetus.
B1 Drugs that have been taken by only a limited number of pregnant women, without an increase in the frequency of malformation or harmful effects on the fetus.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
B2 Drugs which have only been taken by a limited number of pregnant women, without an increase in the frequency of malformation or other harmful effects on the human fetus.
Studies in animals are inadequate or lacking, but show no increased occurrence of fetal damage.
B3 Drugs which have only been taken by a limited number of pregnant women, without an increase in the frequency of malformation or other harmful effects on the human fetus.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
C Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing harmful effects on the human fetus or neonates without causing malformations. These effects may be reversible.
D Drugs which have caused are expected to have caused an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects
X Drugs which are so high risk for causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.

How safe are biologics and small molecule drugs in pregnancy?

Evidence regarding the use of biologic and small molecule medications in pregnancy and when planning a pregnancy is summarised in Table 2.

Table 2. Biologic and small molecules for the treatment of psoriasis
Medication (trade name)Pregnancy categoryMechanism and routeHalf life5 half lives* (days)
Biologic agents
Infliximab
(Remicade®)
C Anti-TNFα
  • Chimeric human-murine IgG monoclonal antibody
  • Intravenous
10 days 50
Adalimumab
(Humira®)
C Anti-TNFα
  • Human recombinant IgG monoclonal antibody
  • Subcutaneous
14 days 70
Etanercept
(Enbrel®)
B2 Anti-TNFα
  • Human recombinant TNF-α receptor fusion protein
  • Subcutaneous
3 days 15
Ustekinumab
(Stelara®)
B1 Anti-IL-12/IL-23
  • Human IgG monoclonal antibody
  • Subcutaneous
21 days 105
Secukinumab
(Cosentyx®)
C Anti-IL17A
  • Human IgG monoclonal antibody
  • Subcutaneous
27 days 135
Small molecule inhibitor
Apremilast
(Otezla®)
B3 Anti-PD4
  • Small molecule inhibitor of enzyme
  • Oral
9 hours 2

*In general, drugs are eliminated from the body after 5 drug half-lives.
TNF: tumour necrosis factor
IL: Interleukin
PD: phosphodiesterase

Is fertility affected by these agents?

Conclusions:

Are these medications harmful during pregnancy?

Biologics and small molecule medications are not routinely recommended in pregnancy because they have not been studied sufficiently; they should only be considered when the potential benefit outweighs the risk. Therefore, contraceptive measures are recommended during biologic and apremilast treatment and for at least 5 half-lives afterwards.

Conclusions:

Should live vaccines be avoided?

Babies whose mothers are treated with a biologic may be at higher risk of infection. It is very important that live vaccinations (live polio, chickenpox/varicella, yellow fever) are avoided in these young infants. See Immunisation in immunosuppressed dermatology patients.

Can biologics be used during breast-feeding?

It is unknown if biologics are excreted in breast milk or whether they are absorbed by the infant through their gut.

Conclusions:

Related information

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