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Psoriasis therapy for children and pregnancies

Presented by
Prof. Mark Lebwohl, Icahn School of Medicine at Mount Sinai, USA
AAD 2020
More and more biologics and small molecules enter the therapeutic arena in psoriasis, making the choice of the right drug increasingly complex. In this talk, Prof. Mark Lebwohl (Icahn School of Medicine at Mount Sinai, USA) addressed therapy for paediatric patients and for women with severe psoriasis who wish to become pregnant [1].

For women who wish to become pregnant, it is important to find an agent that does not cross the placenta. One such agent is the TNFα blocker certolizumab pegol [2]. The CRIB trial showed that there is only minimal to no placental transfer from mother to infant; only 1 infant from 14 exposed mothers had a minimal certolizumab pegol level of 0.042 µg/ml [3].

TNFα blockers seem to be relatively safe during pregnancy. A cohort study analysing the outcomes after anti-rheumatic drug use before and during pregnancy among 150,000 pregnant women and expecting fathers found no major malformations [4]. However, caution is advised in the administration of live vaccines to infants born to female patients treated with infliximab during pregnancy, since infliximab is known to cross the placenta and has been detected up to 6 months in the serum of infants. A case report of a fatal case of disseminated Bacillus Calmette-Guérin (BCG) infection following a BCG vaccine in an infant with an infliximab-exposed mother has been published [5].

There is conflicting data with regard to ustekinumab treatment during pregnancy. The data on IL-17 inhibitors is limited. “The bottom line is that we do not have any data, so their use during pregnancy is questionable,” Prof. Lebwohl said. The same holds true for IL-23 blockers.

The use of conventional immunosuppressive drugs methotrexate and acitretin during pregnancy has shown to have a clear teratogenic effect [6,7]. Cyclosporine therapy is widely used during pregnancy and might be responsible for a higher rate of prematurity [8]. Patients that are treated with cyclosporine are often transplant patients that have a lot going on, so it needs to be used carefully, according to Prof. Lebwohl.

The largest and longest paediatric study with biologics in psoriasis reported today reported 5-year efficacy data of etanercept in children and adolescents with plaque psoriasis [9]. Etanercept was the first drug to get approved in paediatrics. In this study, the Psoriasis Area and Severity Index (PASI) response with etanercept was maintained over 5 years with very few side effects. There is also good data on long-term safety/efficacy with adalimumab in paediatric psoriasis patients over up to 1 year [10].

High doses of infliximab and certolizumab pegol have been used in the management of juvenile idiopathic arthritis but not in dermatologic indications.

Further, ustekinumab has been approved for adolescents after the phase 3 CADMUS study, where at least two thirds of patients aged 12-17 years treated with ustekinumab achieved cleared skin or minimal psoriasis at week 12 [11].

Current data on the use of secukinumab and brodalumab in children comes only from case reports. However, ixekizumab got approved recently as a result of the positive efficacy demonstrated in the IXORA-PEDS study (see Figure) [12].

IL-23 blockers are injected infrequently, which is convenient for children. There is little data on IL-23 blockers yet, but hopefully more will become available, as Prof. Lebwohl stated. The same holds true for apremilast.

Figure: IXORA-PEDS: PASI and sPGA responses with ixekizumab in paediatric patients with moderate-to-severe psoriasis: ixekizumab shows a rapid onset of action [Adapted from 12]

ETN, etanercept; ITT, intention-to-treat; IXE, ixekizumab; PASI, Psoriasis Area and Severity Index; NRI, non-responder imputation; Q4W, every 4 weeks.
*P<0.001 versus placebo

  1. Lebwohl M. AAD Virtual Meeting Experience, 12-14  June 2020.
  2. Pasut G. Biodrugs 2014;28 (Suppl 1): S15-23.
  3. Mariette X, et al. Ann Rheum Dis 2018;77:228-233.
  4. Viktil KK, et al. Scand J Rheumatol 2012; 41:196-201.
  5. Cheent K, et al. Crohns Colitis 2010:4:603-5.
  6. Powell HR, Ekert H. Med J Aust 1971;2:1076-7.
  7. De Die-Smulders CE, et al. Teratology 1995;52:215-9.
  8. Bar Oz B, et al. Transplantation 2001:71:1051-5.
  9. Paller AS, et al. J Am Acad Dermatol. 2016 Feb;74(2):280-287.
  10. Thaçi D, et al. EADV 2015. FC0206.
  11. Landells I, et al. J Am Acad Dermatol 2015;73:594-603.
  12. Paller AS, et al. Br J Dermatol 2020 Apr. 21 [online ahead of print].

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