Laboratory abnormalities observed across clinical studies in moderate-to-severe AD patients treated with CIBINQO 200 mg or CIBINQO 100 mg¹

Thrombocytopenia 

• In placebo-controlled studies, for up to 16 weeks, treatment with CIBINQO was associated with a dose-related decrease in platelet count*
  • Confirmed platelet counts of <50 x 10³/mm³ were reported in 0.1% of patients exposed to CIBINQO 200 mg, and in 0 patients treated with CIBINQO 100 mg or placebo
• Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned toward baseline despite continued therapy
• Among all patients treated in clinical studies with consistent dosing regimens of either CIBINQO 100 mg or 200 mg, including the long-term extension study, the rate of confirmed platelet counts of <50 × 10³/mm³ was 0.17 per 100 patients-years for 200 mg and 0 per 100 patient-years for 100 mg, most occurring at Week 4^†
• Patients 65 years of age and older had a higher rate of platelet counts <75 × 10³/mm³

Lymphopenia

• In placebo-controlled studies, for up to 16 weeks, confirmed absolute lymphocyte count (ALC) <0.5 x 10³/mm³ occurred in 0.3% of patients treated with CIBINQO 200 mg and 0% of patients treated with CIBINQO 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure*
• Among all patients treated in clinical studies with consistent dosing regimens of either CIBINQO 100 mg or 200 mg, including the long-term extension, the rate of confirmed ALC <0.5 × 10³/mm³ was 0.56 per 100 patient-years for 200 mg and 0 per 100 patient-years for 100 mg, the highest rate was observed in patients 65 years of age and older

• In placebo-controlled studies, for up to 16 weeks, there was a dose-related increase in low-density lipoprotein cholesterol (LDL-c), total cholesterol, and high-density lipoprotein cholesterol (HDL-c) relative to placebo at week 4, which remained elevated through the final visit in the treatment period* 
• There was no meaningful change in the LDL/HDL ratio in patients treated with CIBINQO relative to patients treated with placebo    
• Events related to hyperlipidaemia occurred in 0.4% of patients exposed to CIBINQO 100 mg, 0.6% of patients exposed to CIBINQO 200 mg, and 0% of patients exposed to placebo
• The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Patients with abnormal lipid parameters should be further monitored and managed according to clinical guidelines, due to the known cardiovascular risks associated with hyperlipidaemia
  

• In placebo-controlled studies, for up to 16 weeks, significant increases in CPK values (>5 × ULN) occurred in 1.8% of patients treated with placebo, 1.8% of patients treated with CIBINQO 100 mg, and 3.8% of patients treated with CIBINQO 200 mg, respectively. Most elevations were transient and none led to discontinuation*

Prescribing information
Please see the CIBINQO Summary of Product Characteristics for more information.