SAFETY
CIBINQO was studied in > 2850 patients with moderate-to-severe atopic dermatitis (AD)1,2
Pooled safety & long-term results up to ~1 year
Adverse Events
  • A proper assessment of long-term risk of malignancy requires longer periods of surveillance, which is ongoing
  • Nausea was most frequent in the first two weeks of CIBINQO therapy and generally resolved with continued therapy. The median duration of nausea was 15 days. Most of the cases were mild to moderate in severity
Biases
  • LTE studies may provide useful data on low frequency, long latency adverse events (AEs), risk factor analysis, and trends over exposure time. However, conduct of LTE studies where both treatment and dose are known to both investigator and patient is subject to certain biases and limitations, and therefore data should be interpreted with caution. Biases include, but are not limited to, patient selection (patient willingness or ineligibility to enroll, which may be due to prior serious AE), prior treatment, volunteer, observer, initial dose of study drug, investigator/patient expectation, responder/survivor, and study duration
Lymphopenia
  • Limitations include, but are not limited to: AE frequencies and incidence rates subject to change over time due to patient entry/exit; dose changes or study drug interruptions influenced by both investigator and patient; the number of patients and exposure for a specific safety event possibly differing depending on the timing of censored events; the number of observed patients with longer exposure times becoming lower
  • Additional limitations when evaluating efficacy endpoints from these studies include: A lack of placebo-control arm, limiting the estimate of treatment effect; data that may represent an enriched population of patients with continued efficacy and tolerability; the potential for responder or other bias in patients who remain in open-label studies for longer periods​​​​​​
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To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

Data shown are from studies that included adolescent patients. CIBINQO is approved for patients aged ≥18 years.

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*A total of 7 patients had NMSC (4 were taking 200 mg and 3 taking 100 mg).
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†A total of 4 patients had malignancy excluding NMSC (3 were taking 200 mg and 1 taking 100 mg).

‡MACE included 2 events of myocardial infarction and 1 event of sudden death.

ALC=absolute lymphocyte count; DVT=deep vein thrombosis; NMSC=nonmelanoma skin cancer; PE=pulmonary embolism. 

References: 1. CIBINQO™ (abrocitinib) Full Prescribing Information. April 2021. 2. Data on file. Pfizer Inc; New York, NY.
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