The efficacy and safety of apremilast for the treatment of mild to moderate plaque psoriasis found support in study data published in the Journal of the American Academy of Dermatology.
This phase 3, double-blind, placebo-controlled study enrolled adult patients with mild to moderate plaque psoriasis at clinics in the United States and Canada. The trial was registered in October 2018; enrollment began in March 2019. Patients were randomly assigned (1:1) to 16 weeks of either apremilast 30 mg twice daily or placebo twice daily.
Disease severity was evaluated using the static Physician Global Assessment (sPGA) and the Psoriasis Area and Severity Index (PASI). Psoriasis-involved body surface area (BSA) was also assessed. Treatment assignment was stratified by baseline disease severity. Following the initial placebo-controlled treatment phase, all patients received apremilast for an additional 16 weeks, followed by a 4-week post-treatment observational phase.
The primary efficacy endpoint was the percentage of patients achieving an sPGA score of 0 (“clear”) or 1 (“almost clear”) with a 2-point or more reduction from baseline by week 16. Secondary endpoints included achievement of a 75% reduction in psoriasis-involved BSA (BSA-75); achievement of psoriasis-involved BSA 3% or less; achievement of a 4-point or greater reduction in Whole Body Itch on the Numeric Rating Scale; achievement of a Scalp PGA of 0-1 with a 2-point or greater reduction; and reductions from baseline in BSA, PASI, and Dermatology Life Quality Index (DLQI). Patients were monitored for adverse events throughout the study.
A total of 595 patients were randomly assigned: 298 to placebo and 297 to apremilast. Baseline demographic and clinical characteristics were comparable between study arms. Mean age was 49.2 ± 14.7 years in the apremilast group and 48.3 ± 14.5 years in the placebo group. Women comprised 41.4% and 49.3% of the apremilast and placebo groups, respectively. The majority (69.4%) of patients had moderate plaque psoriasis; 30.5% had mild psoriasis. Of 595 patients initially randomized, 504 completed the placebo-controlled phase (84.7%). Attrition rates were not significantly different between study arms. At week 16, sPGA response was observed in a significantly greater percentage of the apremilast group compared with the placebo group (21.6% vs. 4.1%; P <.0001). Secondary endpoints were also more often achieved by the apremilast vs placebo groups: BSA-75 (33.0% vs 7.4%), BSA 3% or less (61.0% vs 22.9%), 4-point or greater reduction in Whole Body Itch (43.2% vs 18.6%), and Scalp PGA of 0-1 with 2-point or greater reduction (44.0% vs. 16.6%) (all P <.0001). In addition, the apremilast group reported greater reductions from baseline on BSA, PASI, and DLQI compared with the placebo group (all P <.0001).
The safety analysis included 594 patients who received 1 dose or more of either apremilast or placebo. Overall, 65.4% and 47.0% of patients in the apremilast and placebo groups, respectively, reported adverse events. The most common treatment-emergent adverse events in the apremilast group were diarrhea (16.4%), headache (13.1%), nausea (12.8%), nasopharyngitis (7.4%), and upper respiratory tract infection (5.7%). Most manifestations of these side effects were mild to moderate. The investigators noted that 1 patient who received apremilast experienced a serious adverse event. Few patients withdrew from the study because of adverse events: 13 in the apremilast group (4.4%) and 7 in the placebo group (2.4%).
Results from this trial support the efficacy and safety of apremilast for the treatment of mild to moderate plaque psoriasis, the researchers wrote. Patients in the apremilast arm were more likely than control patients to achieve sPGA response. No new safety signals were observed.
As a study limitation, investigators cited the absence of an active comparator arm; the relative efficacy of apremilast compared with other systemic treatments remains unclear. Further study is necessary to better establish the real-world effectiveness of apremilast, they believe.
“Apremilast significantly and clinically meaningfully reduced overall psoriasis severity and improved scalp psoriasis, whole body itch, and QOL in patients with mild to moderate plaque psoriasis,” investigators concluded.
Disclosure: This research was supported by Amgen, Inc. Please see the original reference for a full list of disclosures
Gold LS, Papp K, Pariser D, et al. Efficacy and safety of apremilast in patients with mild to moderate plaque psoriasis: results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2021:S0190-9622(21)02193-9. doi: 10.1016/j.jaad.2021.07.040