Praxis Medical Insights

Atopic Dermatitis Age Requirements

The Taiwan FDA has approved upadacitinib for patients aged 12 years and above with moderate to severe atopic dermatitis inadequately controlled by conventional therapies 1, 2

There is no pediatric indication for rheumatoid arthritis, as the safety and efficacy have not been established in persons under 18 years of age for this indication 3

Special caution is warranted in patients over 65 years of age due to increased risks of serious infections, major adverse cardiovascular events, and malignancies observed in older populations with cardiovascular risk factors 4, 5
The European Medicines Agency has restricted tofacitinib use (a related JAK inhibitor) in patients older than 65 years due to increased risk of serious infections, though this specific restriction has not been uniformly applied to upadacitinib 3

For patients aged ≥65 years with cardiovascular risk factors, carefully weigh the increased risks of serious heart-related events, cancer, blood clots, and death against potential benefits 4, 5
Vaccination requirements apply to all patients ≥18 years old, including the recombinant zoster vaccine (Shingrix) given as a 2-dose series separated by 2-6 months, as herpes zoster risk increases with JAK inhibitors 6, 7
Older patients (≥53-65 years) had higher rates of malignancies in clinical trials, with almost all malignancies occurring in patients aged ≥53 years in upadacitinib studies 7

Do not overlook cardiovascular risk assessment in older patients, particularly those ≥50 years with at least one cardiovascular risk factor, as this population demonstrated increased serious adverse events in post-marketing studies 4, 5
Do not fail to complete age-appropriate vaccinations before initiating therapy, especially Shingrix for patients ≥18 years, as herpes zoster rates are significantly elevated with JAK inhibitors 6, 7