Age Cut-Off for Upadacitinib
For atopic dermatitis, upadacitinib is approved for patients 12 years of age and older, while for rheumatoid arthritis it is approved only for adults (18 years and older). 1
Atopic Dermatitis Age Requirements
Upadacitinib is FDA-approved for adolescents and adults 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable 1
The Taiwan FDA has approved upadacitinib for patients aged 12 years and above with moderate to severe atopic dermatitis inadequately controlled by conventional therapies 2
Clinical trial data supporting this age cut-off comes from the Measure Up 1, Measure Up 2, and AD Up studies, which enrolled adolescents aged 12-17 years and adults aged 18-75 years 3, 4
In these pivotal trials, both adolescents (12-17 years) and adults demonstrated robust efficacy, with EASI-75 response rates of 70-80% at week 16, supporting the 12-year minimum age threshold 4
Rheumatoid Arthritis Age Requirements
Upadacitinib is FDA-approved only for adults (18 years and older) with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers 1
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 2
Upper Age Limit Considerations
There is no absolute upper age cut-off specified in the FDA labeling for either indication 1
However, 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 2
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 2
In the safety study of tofacitinib in rheumatoid arthritis patients aged 50 years and older with at least one cardiovascular risk factor, increased rates of major adverse cardiovascular events and malignancies were observed, leading to FDA class-wide warnings for JAK inhibitors 2
Critical Age-Related Safety Considerations
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 2
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 2, 5
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 2
Common Pitfalls to Avoid
Do not prescribe upadacitinib for atopic dermatitis in children under 12 years of age, as safety and efficacy have not been established in this population 1
Do not assume the same age indications apply across all conditions—the 12-year minimum applies only to atopic dermatitis, not rheumatoid arthritis 1
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 2
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 (3-4 per 100 patient-years in Western populations, up to 9 per 100 patient-years in Asian populations) 5