乌鸦传媒

A safety update for abrocitinib has shown the drug to be safe out to nearly 4 years for the treatment of moderate-to-severe atopic dermatitis (AD). The risk of adverse events (AE) increased for certain patient populations, particularly people age ≥65.

The findings appeared in the .

The analysis included 3,802 patients from phase II and phase III studies. The most frequent serious infections with abrocitinib at 100 mg and 200 mg were herpes zoster (0.5% and 0.2%), pneumonia (0.2% with either dose), and herpes simplex (0.1% with either dose). For serious infections, body weight over 100 kg (221 lbs) was a risk factor.

Compared with younger adults, patients ages ≥65 had higher incidence of serious AEs (17.6 [95% CI 11.7-25.4] vs 6.7 [CI 5.8-7.8]), malignancy excluding non-melanoma skin cancer (2.4 [CI 0.6-6.0] vs 0.1 [CI 0.0-0.4]), non-melanoma skin cancer (2.4 [CI 0.6-6.1] vs 0.2 [CI 0.1-0.4]), lymphopenia (3.5 [CI 1.3-7.6] vs 0.1 [CI 0.0-0.3]), and venous thromboembolism (1.7 [CI 0.4-5.1] vs 0.1 [CI 0.0-0.3]).

The incidence of non-melanoma skin cancer was higher in current and former smokers (0.9 [CI 0.4-1.6]) compared with never smokers (0.0 [CI 0.0-0.1]).

All findings were consistent with previous safety analyses for abrocitinib, researchers wrote.

Co-author Justine Alderfer, PharmD is the senior medical director for dermatology at Pfizer, the maker of abrocitinib. Her exchange with the Reading Room has been edited for length and clarity.

What was the goal of this analysis?

Alderfer: The safety profile of medications can be further informed by pooling studies from clinical trials, resulting in a larger cohort of patients and longer-term observation.

This updated analysis expands on previously published integrated analysis of abrocitinib in patients with moderate-to-severe AD and reports results from a larger cohort of patients, with a longer follow-up and more patient-years of exposure. AEs of special interest were also assessed, providing further insights into infrequent or long-latency AEs.

What were your key findings on safety?

Alderfer: This updated safety analysis of abrocitinib with longer exposure up to a maximum of almost four years shows a profile consistent with previous studies and analyses, with no newly identified safety signals. This data continues to support the position that abrocitinib has a well-studied and manageable long-term safety profile in patients with moderate-to-severe AD.

What did you find regarding AEs of special interest?

Alderfer: This analysis evaluated events of special interest by baseline disease severity, sex, smoking status, and race. It also included an analysis of events stratified by age in patients ages ≥65 and 18 to <65.

Of note, patients ages ≥65 show a higher rate of serious AEs, a greater likelihood of developing low platelet count, low absolute lymphocyte counts, and a trend toward an increased risk for serious infections, non-melanoma skin cancer, malignancy excluding non-melanoma skin cancer, major adverse cardiovascular events, venous thromboembolism, pulmonary embolism, and risk of herpes zoster infection. Current or former smokers have a higher rate of non-melanoma skin cancer than those who never smoked.

Risk factors for herpes zoster infection include: history of herpes zoster, abrocitinib dose at 200 mg, age ≥65, an absolute lymphocyte count of <1 × 103/mm³ before the event, and residence in Asia compared with other regions of the world.

What are the takeaway messages for dermatologists?

Alderfer: Both patient selection and dose selection remain important considerations for physicians who prescribe abrocitinib for moderate-to-severe AD.

Warnings and precautions, as well as appropriate risk assessment measures as described in the abrocitinib product labels, should be followed to maintain a favorable or appropriate risk-benefit relationship.

Appropriate patient selection and monitoring as per the label are recommended based on the individual patient.