An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology
Issue link: https://jcadonline.epubxp.com/i/934167
Get the latest news at otezlapro.com a Results were consistent between ESTEEM 1 and ESTEEM 2. b Week 16: secondary endpoint; all other timepoints: exploratory endpoints. c Baseline mean PASI scores: Placebo, 19; Otezla, 19; Total, 19. d 95% confi dence interval. e FAS; LOCF. f Week 16: Prespecifi ed exploratory endpoint. In the planned hierarchical statistical testing sequence for ESTEEM 1 and ESTEEM 2, effi cacy analyses preceding ScPGA were statistically signifi cant, allowing for control of the overall type 1 error rate at 0.05 signifi cance level in analysis of ScPGA. g Baseline ScPGA ≥3. Adverse Reactions X Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4) Use in Specific Populations X Pregnancy and Nursing Mothers: Otezla is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when Otezla is administered to a nursing woman X Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information Please turn the page for Brief Summary of Full Prescribing Information. STUDY DESIGN X Otezla was evaluated in 2 multicenter, double-blind, placebo-controlled trials of similar design. Patients with moderate to severe plaque psoriasis (N = 1257) were randomized 2:1 to Otezla 30 mg or placebo twice daily for 16 weeks, after a 5-day titration 1 X Inclusion criteria: Age ≥18 years, BSA involvement ≥10%, sPGA ≥3, PASI score ≥12, candidates for phototherapy or systemic therapy 1,3 X Results were similar between ESTEEM 1 and ESTEEM 2 3 ,4 BSA, body surface area; PASI, Psoriasis Area and Severity Index; ScPGA, Scalp Physician Global Assessment; sPGA, static Physician Global Assessment.