Reich K, et al. - This trial was formulated in order to gauge the long-term efficacy and safety of apremilast in biologic-naive patients with moderate to severe plaque psoriasis. Researchers also attempted to discern the safety of switching from etanercept to apremilast. Prominent and sustained improvements in skin, scalp, nails, and PROs (pruritus and quality of life) were illustrated via apremilast, over 104 weeks in the study cohort. It was deduced that the safety was consistent with the known safety profile of apremilast.

Methods

• During this trial, 250 patients were randomized to placebo, apremilast 30 mg BID, or etanercept 50 mg QW through Week 16.
• All patients continued or switched to apremilast through Week 104 (extension phase).
• An analysis was pursued of the skin, scalp, and nail involvement at Weeks 16, 52, and 104 with the aid of the Psoriasis Area and Severity Index (PASI; 0-72), Scalp Physician Global Assessment (ScPGA; 0-5), and Nail Psoriasis Severity Index (NAPSI; 0-8).
• Researchers contemplated the patient-reported outcomes (PROs) through the Dermatology Life Quality Index (DLQI; 0-32) and pruritus visual analog scale (VAS; 0-100 mm).

Results

• The apremilast-extension phase (Weeks 16–104) constituted 226 patients in the placebo/apremilast (n=73), apremilast/apremilast (n=74), and etanercept/apremilast (n=79) groups, and at Week 104, 50.7%, 45.9%, and 51.9% of these patients, respectively, maintained ≥75% reduction from baseline in PASI score (based on last observation carried forward analysis).
• The findings displayed the achievement of ScPGA 0 (clear) or 1 (minimal) by 50.0%-59.2% of patients, across treatment groups.
• NAPSI mean change from baseline was found to be -48.1% to -51.1%.
• It was noted that the DLQI score ≤5 was achieved by 66.0%-72.5% of patients; and pruritus VAS mean change from baseline was -24.4 to -32.3.
• No rise was noted in the AEs, in ≥5% of patients (diarrhea, nausea, nasopharyngitis, upper respiratory tract infection, and headache) with prolonged apremilast exposure.