Apremilast in plaque psoriasis with limited skin involvement: Pooled results from six clinical trials

Results from a post hoc pooled analysis of the ADVANCE (NCT03721172), DISCREET (NCT03777436), STYLE (NCT03123471), EMBRACE (NCT03774875), UNVEIL (NCT02425826), and PROMINENT (NCT03930186) trials evaluating the efficacy of apremilast in patients with plaque psoriasis and limited skin involvement (affected body surface area [BSA], 3–10%), including those with high-impact site (HIS) involvement of the scalp, genital, and/or nails, were published in Dermatology and Therapy by Strober et al. Patients received oral apremilast 30 mg twice daily (BID) or placebo for 16 weeks, followed by open-label apremilast 30 mg BID through Week 32 (ADVANCE, DISCREET, and STYLE) or Week 52 (EMBRACE and UNVEIL); patients received apremilast 30 mg BID through Week 32 in PROMINENT. Overall endpoints included the proportions of patients achieving BSA ≤3%, a Psoriasis Area and Severity Index (PASI) score <3, a static Physician’s Global Assessment (sPGA) score of 0/1, and a Dermatology Life Quality Index (DLQI) score of 0/1 at Weeks 16 and 32. Site-specific disease activity measures were also assessed at Weeks 16 and 32.  

Key data: At Week 16, a greater proportion of patients receiving apremilast (n = 671) vs placebo (n = 481) attained BSA ≤3% (adjusted treatment difference [aTD], 25.1; 95% confidence interval [CI], 19.7–30.6), PASI <3 (aTD, 23.0; 95% CI, 17.0–28.9), sPGA 0/1 (aTD, 17.9; 95% CI, 13.2–22.5), and DLQI 0/1 (25.8% vs 8.1%; all p < 0.0001). At Week 16, apremilast vs placebo demonstrated higher rates of Scalp Physician’s Global Assessment (ScPGA) 0/1 in patients with scalp involvement (aTD, 22.5; 95% CI, 15.5–29.6; p < 0.0001) and sPGA of Genitalia (sPGA-G) 0/1 in patients with genital involvement (aTD, 20.3; 95% CI, 9.2–31.4; p < 0.001), as well as a greater reduction in Nail Psoriasis Severity Index (NAPSI) score in patients with nail involvement (aTD, −24.3; 95% CI, −37.2 to −11.4; p < 0.001). Responses were generally maintained through Week 32. 

Key learning: In this pooled analysis, apremilast demonstrated significant improvements in skin clearance and quality of life (QoL) vs placebo, with responses generally maintained through Week 32 in patients with plaque psoriasis and limited skin involvement, including those with scalp, genital area, and/or nail involvement. These findings support apremilast as a systemic treatment option for this patient population.