Primary endpoints: The pivotal efficacy endpoints were the proportions of patients achieving IGA 0 or 1 (clear or almost clear with at least a 2-point improvement from baseline) and EASI-75 at Week 12 or Week 16 versus placebo. Secondary endpoints: Important supportive endpoints included PP-NRS4 improvement, occurrence of flare/loss of response in REGIMEN, and maintenance of IGA (0 or 1), EASI-75 and PP-NRS4 responses in EXTEND.
abrocitinib 100 mg orally once daily, taken with or without food and usable with or without medicated topical therapies. If there is insufficient improvement after 12 weeks, treatment should be discontinued. Reduce to 50 mg once daily in moderate renal impairment or with strong CYP2C19 inhibition/dual CYP2C19 and CYP2C9 inhibition; use is not recommended in severe renal impairment and must not be used in severe hepatic impairment.
Very common adverse reactions were nausea and herpes simplex; commonly reported reactions included headache, acne, increased blood creatine phosphokinase, dizziness and upper abdominal pain. The most frequent serious adverse reactions were infections, especially herpes simplex, herpes zoster and pneumonia. Discontinuation due to nausea occurred in 0.4% of patients.
Hypersensitivity to abrocitinib or excipients; active serious systemic infections including tuberculosis; severe hepatic impairment; pregnancy and lactation.
Clinical Trial Type and Population
The pivotal Phase 3 programme comprised MONO-1, MONO-2 and COMPARE; the pooled pivotal population was 1,616 patients. Across the placebo-controlled studies and REGIMEN, mean age was 32.1-37.7 years and 41.4%-51.1% were female; individual total sample sizes for each pivotal study were not separately reported in this document.
