Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis
“Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast”
This is an open label pilot study of the impact of treatment with standard dosing of Otezla for 16 weeks on AM-endotype psoriasis patients, identified by elevated (>150% of normal): 1.) Intermediate (CD14++CD16+) monocytes, or 2.) circulating monocyte doublets, or 3.) circulating monocyte-platelet aggregates (MPA). Approximately 25 psoriasis patients with the AM-endotype will be followed during treatment over 16 weeks with 4 monthly individual blood draws will be enrolled. 10 untreated healthy controls will also be enrolled and will provide two blood draws (baseline and 16 weeks). These are needed to maintain quality control of the normal levels of the biomarkers being tested. All treated psoriasis subjects will receive apremilast through Week 16
Drug - Apremilast
Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dosage titration from Day 1 (10mg) to Day 5 (30mg). Following the titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
An Investigator Initiated Study of Monocyte Biomarkers in Moderate to Severe Plaque Psoriasis Subjects Treated With Apremilast