Are any of the following biologic agents, including Adalimumab (Humira) and its biosimilar Hyrimoz, Infliximab (Remicade) and its biosimilar Avsola, Certolizumab (Cimzia), Etanercept (Enbrel), Bimekizumab (Bimzelx), Secukinumab (Cosentyx), Brodalumab (Siliq), Ixekizumab (Taltz), Tildrakizumab (Ilumya), Risankizumab (Skyrizi), Ustekinumab (Stelara), Guselkumab (Tremfya), Spesolizumab (Spevigo), Apremilast (Otezla), Roflumilast (Zoryv), and Deucravacitinib (Sotyktu), approved for use in pediatric patients and available as oral agents?

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Last updated: May 7, 2025View editorial policy

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From the Guidelines

Among the listed medications, Adalimumab is approved for pediatric patients aged 12 and up, and other medications like Infliximab, Secukinumab, and Ustekinumab are used in pediatric patients based on adult data, but only Adalimumab has a clear approval for pediatric use as an injectable, not oral agent. When considering oral agents for pediatric patients, the options are limited. Apremilast (Otezla) is an oral medication, but it is only approved for adults, not pediatric patients 1. Roflumilast (Zoryv) is a topical agent, not an oral medication, and Deucravacitinib (Sotyktu) is also not approved for pediatric patients. Some key points to consider when treating pediatric patients include:

  • Age-appropriate dosing
  • Potential side effects
  • Specific approved indications for each medication
  • The need for careful consideration of the benefits and risks of each treatment option It's essential to consult the most recent and highest-quality studies, such as the 2025 North American clinical practice guidelines for the medical management of hidradenitis suppurativa in special patient populations 1, to ensure that treatment decisions are based on the best available evidence. In terms of oral agents, the current evidence does not support the use of most medications listed for pediatric patients, with the exception of some medications that may be used off-label or based on adult data. However, Adalimumab is the only medication with clear approval for pediatric use, although it is an injectable, not an oral agent.

From the Research

Approved Agents in Pediatric Patients

  • Etanercept (Enbrel) is approved for the treatment of juvenile idiopathic arthritis (JIA) and has been shown to be safe and efficacious in pediatric patients, including those under 4 years of age 2, 3, 4, 5
  • There is no evidence to suggest that the other listed agents (Adalimumab, Infliximab, Certolizumab, Bimekizumab, Secukinumab, Brodalumab, Ixekizumab, Tildrakizumab, Risankizumab, Ustekinumab, Guselkumab, Spesolizumab, Apremilast, Roflumilast, Deucravacitinib) are approved for use in pediatric patients

Oral Agents

  • Apremilast (Otezla) is an oral phosphodiesterase 4 inhibitor that has been approved for the treatment of moderate to severe chronic plaque psoriasis 6
  • Roflumilast (Zoryv) is a topical oral phosphodiesterase 4 inhibitor, but there is no specification of its use in moderate to severe psoriasis
  • Deucravacitinib (Sotyktu) is a oral TYK2 inhibitor, but there is no information on its approval status in pediatric patients or as an oral agent for psoriasis treatment

Loading Dose Information

  • The following agents have a loading dose: Infliximab, Bimekizumab, Secukinumab, Brodalumab, Ixekizumab, Tildrakizumab, Risankizumab, Ustekinumab, Guselkumab 2, 3, 4, 5, 6

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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