Pharmacokinetics and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: Results from a phase 2 open-label study

Paller, Amy S.; Hong, Ying; Becker, Emily; Lucas, R. de; Paris, Maria; Zhang, Wendy; Zhang, Zuoshun; Barcellona, Claire; Maes, Peter; Fiorillo, Loretta

doi:10.1016/j.jaad.2019.08.019

Cited by 33 publications

(22 citation statements)

References 24 publications

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“…The only study that reported on the efficacy of apremilast was a clinical trial by Paller et al (42 patients aged 6 to 17). 87 The participants were divided into three study groups consisting of children and adolescents with moderate to severe plaque psoriasis. The groups were based on age and weight-based doses.…”

Section: Apremilastmentioning

confidence: 99%

Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic

Haulrig¹,

Zachariae²,

Skov³

2021

PTT

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Psoriasis is a chronic inflammatory skin disease that affects up to 1.2% of children and adolescents. The treatment options for childhood psoriasis are often based on the same principles as in adults. However, most data on safety and efficacy derive from adult studies, and only a few of the frequently used treatments have achieved approval for use in children. The aim of this study was to review the current literature on off-label treatments for psoriasis in children and adolescents. We searched PubMed and identified 50 studies on offlabel treatments. Of these, 23 studies were clinical trials (four randomized). There are only a small number of available studies on off-label treatments for children and adolescents with psoriasis, and many of these are retrospective reviews with few participants. Despite the current lack of studies, we still recommend the use of unapproved treatments since we have clinical experience with treatments such as topical corticosteroids, vitamin D analogs, and methotrexate that have shown promising effects. Regular clinical trials are needed to investigate the safety and efficacy of unapproved treatments. Due to The Pediatric Investigation Plans issued by The European Union, new drugs developed by pharmaceutical companies are required to undergo clinical trials in a pediatric population to get their application for marketing authorization processed. This will hopefully lead to much more data on the efficacy and safety of the new treatments, including treatments for children and adolescents with psoriasis.

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Section: Apremilastmentioning

confidence: 99%

Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic

Haulrig¹,

Zachariae²,

Skov³

2021

PTT

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“…Apremilast has been approved by the FDA for use in adult psoriasis and psoriatic arthritis since 2014 and for use in treating oral ulcers of Behçet disease since 2019. [1][2][3]5,6 Recently, a phase 2, multicenter, open-label study on the use of apremilast in pediatric psoriasis patients (aged 12-17 years) demonstrated a similar safety profile with weight-based dosing 8 ; phase 3 trials in this population are in the recruitment phase (ClinicalTrials.gov Identifier NCT03701763).…”

Section: On-label Usage Profilementioning

confidence: 99%

Apremilast Uses and Relevance to the Military

Hathaway

Lyford

2021

Cutis

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Apremilast is a small-molecule biologic approved by the US Food and Drug Administration (FDA) for use in plaque psoriasis, psoriatic arthritis, and Behçet disease. Although apremilast is seemingly a less favorable choice for treating psoriasis in the era of injectable biologics, the drug is an important option for patients in the military. In this article, we review on-label indications and off-label uses for apremilast; highlight the importance of apremilast for managing psoriasis in the military population; and propose other patient populations in whom the use of apremilast is favorable. We also present a case report that highlights and embodies the benefit of apremilast for military service members.

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“…Phase II pediatric trial reveals only significant adverse effects are mild GI issues and upper tract respiratory infections on weight-based dosage regimen. 94,95 Contraindicated for pregnant and breastfeeding women, though animal models do not reveal any correlation between Apremilast and harmful effects on fetal development  Safety and effectiveness in pediatric patients < 18 years of age have not been established.  Pregnancy Category C: used during pregnancy only if potential benefit justifies the risk to the fetus.…”

Section: Apremilastmentioning

confidence: 99%

Risk assessment of therapeutic agents under consideration to treat COVID‐19 in paediatric patients and pregnant women

Barrett

2020

Brit J Clinical Pharma

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Aim. Repurposing strategies to address the COVID-19 pandemic have been accelerated. As both pregnant and pediatric patients are likely to be excluded from most planned investigations, the list of repurposed options and the available data on these drugs and vaccines provides a baseline risk assessment and identifies gaps for targeted investigation. Methods. Clinical trials have been searched and reviewed; twenty-three repurposed drugs and drug combinations and 9 candidate vaccines have been assessed regarding the availability of relevant data in pediatrics and pregnant women and to evaluate expected or unanticipated risk. Results. Thirteen of the repurposed drugs or drug combinations are indicated for use in pediatrics in some age category albeit for indications other than COVID-19; 10 of these are indicated for use in pregnant women. Even in cases where these drugs are indicated in the populations, source data from which safety and or dosing could be extrapolated for use in COVID-19 is sparse. Vaccine trials are ongoing and generally exclude pregnant women; only in a few instances have pediatric subgroups been planned for enrollment. Data from individual case studies and RWD may suggest that subpopulations of both pediatric patients and pregnant women may be more at risk, particularly those in an increased inflammatory state. Conclusion. In conjunction with more prospective collaboration, plans are evolving to ensure that we will be better prepared to address similar situations especially in pediatrics and pregnant women where experience is limited and actual practice relies heavily on leveraging data from other populations and indications.

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Pharmacokinetics and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: Results from a phase 2 open-label study

Cited by 33 publications

References 24 publications

Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic

Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic

Apremilast Uses and Relevance to the Military

Risk assessment of therapeutic agents under consideration to treat COVID‐19 in paediatric patients and pregnant women

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