In biologic-naive patients with moderate to severe plaque psoriasis, treatment with apremilast is safe and effective for up to 104 weeks and is associated with significant and sustained improvements in skin, scalp, nails, pruritus, and quality of life, according to results of the extension portion of the global phase 3b LIBERATE trial (ClinicalTrials.gov identifier: NCT01690299) published in the Journal of the European Academy of Dermatology and Venereology.
In the initial phase of the LIBERATE study, a total of 250 patients were randomly assigned to receive placebo, apremilast 250 mg twice daily, or etanercept 50 mg once weekly through week 16. In the extension phase of the trial, all patients continued or switched to apremilast through week 104.
Improvements in skin, scalp, and nail involvement at weeks 16, 52, and 104 were assessed using the Psoriasis Area and Severity Index (PASI; 0 to 72), Scalp Physician Global Assessment (0 to 5), and Nail Psoriasis Severity Index (0 to 8). Patient-reported outcomes were evaluated with the Dermatology Life Quality Index (0 to 32) and pruritus visual analog scale (1 to 100 mm).
At week 16, significantly higher proportions of those treated with apremilast vs those treated with placebo achieved PASI-75 (ie, ≥75% reduction from baseline in PASI; 39.8% vs 11.9% respectively; P <.0001). Similarly, achievement of 5-point static Physician Global Assessment response was significantly greater in the apremilast arm vs the placebo arm at week 16 (21.7% vs 3.6%, respectively; P =.0005).
In the apremilast-extension phase of LIBERATE (weeks 16-104), a total of 226 patients were randomly assigned to 1 of 3 treatment groups: placebo/apremilast (n=73); apremilast/apremilast (n=74); and etanercept/apremilast (n=79). At week 104 (study conclusion), 50.7%, 45.9%, and 51.9% of patients, respectively, maintained PASI-75 response.
Across all 3 treatment arms, Scalp Physician Global Assessment of 0 (clear) or 1 (minimal) was attained by 50.5% to 59.2% of participants; Nail Psoriasis Severity Index mean change from baseline was –48.1% to –51.1%; Dermatology Life Quality Index score ≤5 was attained by 66.0% to 72.5% of patients; and pruritus visual analog scale mean change from baseline was –24.4 to –32.3. Prolonged apremilast exposure was not associated with an increase in adverse events in ≥5% of patients (ie, diarrhea, nausea, nasopharyngitis, upper respiratory tract infection, and headache).
The investigators concluded that apremilast is safe and efficacious for up to 104 weeks in patients with moderate to severe plaque psoriasis, with improvements in skin, scalp, nails, pruritus, and quality of life reported. Safety and efficacy were maintained in those who switched from etanercept to apremilast and remained in the study at week 104. The improved quality of life reported among participants may motivate them to maintain treatment over time, which may lead to improved disease control.
Reich K, Gooderham M, Bewley A, et al. Safety and efficacy of apremilast through 104 weeks in patients with moderate to severe psoriasis who continued on apremilast or switched from etanercept treatment: findings from the LIBERATE study [published online December 8, 2017]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.14738