WASHINGTON –and over 1,000 patient-years of exposure, Lawrence F. Eichenfield, MD, reported at the annual Revolutionizing Atopic Dermatitis conference.
In March 2023, thewas approved by the Food and Drug Administration for treating adolescents aged 12-17 with refractory moderate to severe AD – an expanded indication from the approval in adults in 2022.
The new analysis evaluated data from patients who participated in the phase 3 JADE clinical trials – MONO-1, MONO-2, TEEN, and REGIMEN – and were subsequently enrolled in the ongoing phase 3 extension trial. Compared with a previous post hoc analysis in which adolescent patients had approximately 1 year of exposure, this updated analysis includes a sizable portion of patients with more than 96 weeks of exposure.
“We’re starting to get good numbers of [adolescents] who’ve had about 2 years of exposure,” said, professor of dermatology and pediatrics and vice chair of the department of dermatology at the University of California, San Diego, during a late-breaking research session.
With a data cut for this analysis of September 2021, “we haven’t seen additive long-term [adverse] effects” with longer exposures, he said. In addition, “there were no unique safety concerns related to adolescents compared to the findings observed [in an] integrated safety analysis using the same data cut in which most patients were adults.”
(The analysis in adults covered 3,802 patients with over 5,000 patient-years of exposure, and was presented at the annual American Academy of Dermatology meeting in March 2023.)
Also presented in the late-breaking abstract session at RAD 2023 was a long-term safety study of
Abrocitinib in adolescents
For the safety analysis of abrocitinib (Cibinqo), data were pooled into two cohorts: A consistent-dose cohort of 490 adolescents who received the same dose (200 mg or 100 mg) during the entire duration of the qualifying JADE trials, and a variable-dose cohort of 145 adolescents who received different doses (200 mg or 100 mg) during the JADE REGIMEN qualifying trial.
Duration of exposure was 96 weeks or more in 37%-38% of the consistent-dose cohort and 68% of the variable-dose cohort.
In the consistent-dose cohort, adverse events occurred in 243 (84%) and 153 (76%) of patients receiving 200-mg doses and 100-mg doses, respectively. Incidence rates for severe adverse events were 5.87 per 100 patient-years at both doses, and rates for adverse events leading to study discontinuation were 6.96/100 patient-years at 200 mg and 5.13/100 patient-years at 100 mg.
“No meaningful dose-response relationship was observed for serious adverse events, or adverse events leading to discontinuation, or adverse events of special interest,” said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego.
The IRs of adverse events of special interest were 1.84/100 patient-years and 1.28/100 patient-years for serious infection; 2.11/100 patient-years, and 1.62/100 patient-years for all herpes zoster infections; and 0.69/100 patient-years and 0.32/100 patient-years for opportunistic herpes zoster infections in the 200-mg and 100-mg arms, respectively.
“Other than herpes zoster, there were no opportunistic infections observed and no tuberculosis cases,” he said. “There was one nonfatal venous thromboembolism in an adolescent who had a very strong family history of [pulmonary embolism], one retinal detachment [with a concurrent diagnosis of cataracts and of left eyebrow folliculitis], and no events of nonmelanoma skin cancer or other malignancies, major adverse cardiovascular events, or deaths.” The thromboembolism case was reported in the previous post hoc analysis.
In the variable-dose cohort, data were similar, Dr. Eichenfield said. The IRs for severe adverse events, adverse events leading to study withdrawal, and adverse events of special interest were consistent with those in the other cohort. And similarly, there were no reports of tuberculosis or other opportunistic infections (excluding herpes zoster), and no reports of nonmelanoma skin cancer (NMSC) or other malignancies, major adverse cardiovascular events (MACE), or death. In this cohort, there were no venous thromboembolism (VTE) reports.