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Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.
Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.
Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).
Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.
Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.
Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.
Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.
Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).
Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.
Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.
Key clinical point: Abrocitinib showed manageable tolerability and a safety profile appropriate for long-term use in patients with moderate-to-severe atopic dermatitis (AD), provided patient and dose selection were carried out judiciously.
Major finding: In the placebo-controlled cohort, adverse events (AEs) occurred in 68.3%, 61.0%, and 55.0% of patients receiving abrocitinib 200 mg, abrocitinib 100 mg, and placebo, respectively, with the most common AEs being nausea, headache, and acne. In the all-abrocitinib cohort, AEs, serious AEs, and severe AEs were similar with abrocitinib 200 mg and 100 mg with incidence rates for serious infection being 2.33/100 patient-years (PY) and 2.65/100 PY, respectively.
Study details: Findings are from an integrated safety analysis using pooled data from 5 short- and 1 long-term extension study and included a placebo-controlled cohort (n=1,540) and an all-abrocitinib cohort (n=2,856).
Disclosures: This study was funded by Pfizer Inc. The authors declared receiving grants, research funding, honoraria, and personal fees and/or serving as a consultant, speaker, advisor, and/or investigator for various sources including Pfizer. Seven authors declared being employees and shareholders of Pfizer, Inc.
Source: Simpson EL et al. Am J Clin Dermatol. 2021 Aug 18. doi: 10.1007/s40257-021-00618-3.