Patients treated with systemic apremilast for moderate plaque psoriasis also demonstrated a substantial improvement in scalp and nail psoriasis, according to findings from the phase 3 UNVEIL study presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress.
After 16 weeks of apremilast treatment, 38.4% of patients achieved Scalp Physician Global Assessment (ScPGA) ratings of 0 ("clear") or 1 ("minimal") and a >=2-point reduction from baseline compared with 20% of patients on placebo (P < .05). This improvement was sustained through 52 weeks, at which point 46.9% of patients achieved ScPGA 0 or 1 and demonstrated a >=2-point reduction.
Among patients with nail psoriasis monitored with the Nail Psoriasis Severity Index (NAPSI), a -28.9% change from baseline in NAPSI was observed with apremilast versus -10.5% with placebo (P = .12). NAPSI-50 (50% reduction) was achieved by 26.8% of subjects receiving apremilast versus 18.5% of those receiving placebo (P = .50).
With apremilast at week 52, the mean percentage change from baseline in NAPSI score was -51.9%, and -52.7% in patients initially receiving placebo who were switched to apremilast. NAPSI-50 was achieved at 52 weeks by 62.5% and 69.6% of patients, respectively.
"Psoriasis occurring on the scalp and nail are difficult-to-treat manifestations of plaque psoriasis that often are disproportionately more distressing to patients than on other areas," said lead author Mark Jackson, MD, University of Louisville, Louisville, Kentucky, speaking here on September 17.
In a 2:1 fashion, UNVEIL randomised subjects to apremilast at 30 mg twice daily or placebo for 16 weeks; thereafter subjects on placebo were switched to apremilast and apremilast patients remained on treatment through week 52. All subjects initially were naïve to biological treatments and had moderate psoriasis, defined as psoriasis on 5% to 10% of the body surface and static PGA (sPGA) score of 3.
The most commonly reported adverse events (AEs), occurring in >=5% of patients overall, were diarrhoea, headache, nausea, upper respiratory-tract infection, decreased appetite, and vomiting.
"Safety and tolerability were consistent with other published studies; the incidence of adverse events did not increase with apremilast exposure through Week 52, and no new safety or tolerability issues were observed," the authors noted.
At baseline, 75.6% of enrolled patients had scalp psoriasis and 37.6% had nail psoriasis; these patients were assessed through week 52 using the ScPGA (range 0 clear to 4 severe) and NAPSI in the target nail.
[Presentation title: Improvement in Scalp and Nails With Apremilast in Patients With Moderate Plaque Psoriasis Naïve to Systematic and Biologic Therapy: 52-Week Results of the Unveil Study. Abstract #: P1946]