What question did this study set out to answer?

To evaluate the long-term safety and tolerability of once-daily oral abrocitinib (100 mg and 200 mg) across pooled phase II and phase III clinical trials in patients with moderate-to-severe atopic dermatitis.

August 18, 2021American Journal of Clinical DermatologyOpen Access

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program

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Authors

ESEric L. SimpsonOregon Health & Science University JSJonathan I. SilverbergUniversity of Vermont ANAudrey NosbaumUniversité Claude Bernard Lyon 1

Discussion

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Implication

Randomized trials demonstrate manageable long-term safety for abrocitinib in moderate-to-severe atopic dermatitis, indicating acceptable tolerability with appropriate dose selection.

Key Points

To evaluate the long-term safety and tolerability of once-daily oral abrocitinib (100 mg and 200 mg) across pooled phase II and phase III clinical trials in patients with moderate-to-severe atopic dermatitis.
Integrated analysis of a phase IIb trial, four phase III trials, and one long-term extension study (NCT02780167, NCT03349060, NCT03575871, NCT03720470, NCT03627767, NCT03422822).
Evaluated a placebo-controlled cohort (n = 1540; 12–16 weeks) and an all-abrocitinib cohort (n = 2856; total exposure 1614 patient-years, with up to 108 weeks of follow-up).
In the placebo-controlled cohort (200 mg vs 100 mg vs placebo), dose-dependent adverse events included nausea (14.6% vs 6.1% vs 2.0%), headache (7.8% vs 5.9% vs 3.5%), and acne (4.7% vs 1.6% vs 0%).
Incidence rates per 100 patient-years for the 200-mg versus 100-mg doses were 2.33 versus 2.65 for serious infections, 4.34 versus 2.04 for herpes zoster, and 11.83 versus 8.73 for herpes simplex.
Incidence rates for malignancies and major adverse cardiovascular events were < 0.5 per 100 patient-years in both dose groups, and five venous thromboembolism events occurred (0.30 per 100 patient-years), all within the 200-mg group.

Cite This Study

Simpson et al. (2021) studied this question.

synapsesocial.com/papers/6aa933b05f8760adb38cb2ed https://doi.org/10.1007/s40257-021-00618-3

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Implication

Randomized trials demonstrate manageable long-term safety for abrocitinib in moderate-to-severe atopic dermatitis, indicating acceptable tolerability with appropriate dose selection.

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program

Discussion

Member takes

Implication

Key Points

Cite This Study

Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program

Discussion

Member takes

Implication

Key Points

Cite This Study

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