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Conference summaries

Biologics in children

The Use of Biologics in Children

Presented by: Prof. Diamant Thaçi
Institute and Comprehensive Center for Inflammation Medicine
University Lübeck- Germany

Treating paediatric patients with inflammatory skin diseases is quite difficult as dermatologists need to treat the patient as well as their parents. There are few biologics that have been studied or are approved for use specifically in children and it is unclear whether these biologics apply to infants as well.1-3 Changes in treatment dosages for toddlers vs adolescents is also unclear. Since many of these agents are not specific to children, they are often used in an off-label capacity.

In 2017, the British Association of Dermatology published psoriasis guidelines that incorporated biologic guidelines specific for children (Table 1).4 In the same year, an Italian expert group also published recommendations for treatment in children with psoriasis (Table 1).5

Etanercept has demonstrated efficacy in children with psoriasis. In a study involving 95 patients on etanercept, Psoriasis Area Severity Index (PASI) 50 was achieved in 75% of patients, PASI 75 in 57% of patients, and PASI 90 in 27% of patients by week 12.6 This also included children who were overweight or obese.

Etanercept was approved for use in children by the European Medicines Agency (EMA), but denied approval from the Food and Drug Administration (FDA) in 2008. However, in November of 2016, the FDA reconsidered and approved etanercept for the treatment of children aged 4-17 with moderate to severe psoriasis.7 In that time, results from a second multicenter paediatric, long-term safety study, showed no serious or clinically significant drug-related adverse events for etanercept for up to 264 weeks or until age 18.8 No deaths, malignancies, or opportunistic infections were reported.

Ustekinumab is approved for use in children 12 years or older. A concern that has surfaced is whether to use the full dosage or half the dosage in these patients.

Landells et al.9 demonstrated that both the standard and half-standard dosage of ustekinumab led to statistical clearance as measured by PASI 75 and PASI 90 responses, albeit a significantly greater proportions receiving the full dosage achieved PASI 75 or PASI 90. There were no serious adverse events demonstrated with either dosage. In this patient population (12-17 years), the standard ustekinumab dose provided response comparable to that in adults.

Adalimumab is approved for use in children 4 years and older. When comparing methotrexate with 0.4 mg/kg and 0.8 mg/kg of adalimumab, the following results were observed demonstrating effectiveness of methotrexate, and both doses of adalumumab.10 Table 2.

The change in Pediatric Quality of Life Inventory (PedsQL) was significantly higher (10.8) in adalimumab 0.8 mg/kg compared to methotrexate (1.9, p = 0.05).10

In terms of systemic agent use for the treatment of paediatric psoriasis, the use of biologics has a lower mean number of adverse events per year compared to other non-biologic systemic agents (Table 3).11

The EMA Paediatric Committee requires all new medications to undergo mandatory paediatric investigation to determine if drugs may be suitable for children.12 Currently, numerous paediatric investigation plans are in place in Europe.12 Instead, in the public domain there are 5 clinical trials specific for children on different biologics including:13

As the biologic and mechanism of action is greater understood in autoinflammatory diseases, it provides more opportunity to consider the use of biologics for therapy in other dermatologic disorders. While psoriasis and atopic dermatitis are the primary areas for biologic use today, there are many other novel uses for biologics in paediatric dermatology that have reported preliminary success in the literature (Table 4).14

Dupilumab improved Eczema Area and Severity Index (EASI) scores in paediatric patients (Table 5).15 Peak Pruritus Numerical Rating Scale (PP-NRS) scores improved with dupilumab in adolescents (aged 12-17 years) (Table 6). 15

Key messages

  • There are many challenges in treating paediatric patients with biologics such as dealing with parents, different doses for adolescents vs infants, and lack of clear guidelines for paediatric use.
  • Etanercept has demonstrated efficacy in children with psoriasis both on a short- and long-term basis.
  • Ustekinumab and adalimumab demonstrated a higher rate of clearance (PASI 75) at the full dosage compared to half dosage, but both doses still demonstrated statistical clearance.
  • Biologics have a lower mean number of adverse events per year compared to other non-biologic systemic agents.
  • The EMA Paediatric Committee requires all new medications to undergo mandatory paediatric investigation to determine if drugs may be suitable for children.
  • There are other uses for biologics in paediatric dermatology that have reported preliminary success.


Present disclosure: The presenter disclosed that he has provided research/PI support for AbbVie, Almirall, Amgen, Boehringer-Ingelheim, BMS, Celgene, Dermira, Dignity, Elli-Lilly, Galapagos, Glaxo-Smith-Kline, Leo, Janssen-Cilag , Novartis, Pfizer, Regeneron/Sanofi, Sandoz, UCB. He has been a consultant for AbbVie, BMS, Celgene, Dignity, Galapagos, Lilly, Morphosis, Jansen-Cilag, Novartis, Pfizer, Regeneron/Sanofi, Samsung, UCB. He has received honoraria from AbbVie, Biogen-Idec, Celgene, Janssen, Leo-Pharma, Lilly, Medac, Pfizer, Roche-Possay, Novartis, Sandoz/Hexal, Sanofi/Regeneron, UCB. He was on a scientific advisory board for AbbVie, Amgen, Biogen-Idec, Celgene, Dermavant, Eli-Lilly, GSK, Pfizer, Novartis, Janssen, Sandoz/Hexal, Sanofi/Regeneron, UCB.

Written by: Debbie Anderson, PhD

Reviewed by: Victor Desmond Mandel, MD



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The Use of Biologics in Children

Prof. Diamant Thaçi

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