Apremilast Significantly Improves Genital Psoriasis Symptoms and QoL, reveals study

Genital psoriasis is an ultra-common and distressing presentation of psoriasis that affects patients' quality of life and frequently brings significant social stigma. It has limited treatment options, especially with oral systemic agents. Apremilast is indicated for treating psoriasis, but this is the first study examining its effectiveness for treating genital psoriasis.

The DISCREET trial was a phase 3, randomized, double-blind, placebo-controlled study, NCT03777436, to determine the efficacy and safety of apremilast 30 mg twice daily in patients with moderate-to-severe genital psoriasis. This study consisted of a 16-week treatment period with an extension phase. Patients were stratified according to <10% and ≥10% affected body surface area to ensure balanced groups.

289 patients were randomized to apremilast, n=143, or placebo, n=146; the primary endpoint was the proportion of patients achieving a modified static Physician Global Assessment of Genitalia sPGA-G) score of 0 or 1 at Week 16 with at least a 2-point reduction from baseline. Secondary endpoints included improvements in genital signs and symptoms, overall skin involvement, and patient-reported quality of life outcomes.

Key Findings

1. At week 16, 39.6% of patients treated with apremilast achieved the primary endpoint, as compared with 19.5% of patients receiving placebo, which corresponded to a difference of 20.1% between groups, statistically significant with P = .0003, thus confirming the efficacy of apremilast in the management of genital psoriasis.

2. Treatment with apremilast was associated with dramatic improvements in genital signs and symptoms; significant reductions in itching, discomfort, and other psoriasis-related symptoms were reported. Besides genital area improvement, there were overall betterments of psoriasis symptoms in patients at other body areas.

3. The researchers also showed that among individuals treated with apremilast, there was a significant improvement in quality-of-life measures, supporting the suggestion of better functioning in everyday life and reduced encumbrances related to emotional factors specific to genital psoriasis.

4. The most frequently emergent adverse events in the apremilast group were diarrhea, headache, nausea, and nasopharyngitis. These adverse effects were of mild or moderate intensity, as would be consistent with a generally expected safety profile.

These results bring to the forefront an oral treatment option with apremilast in patients with genital psoriasis, where therapeutic choices have been few in this population. The significant improvement in symptoms of genital psoriasis, in combination with overall improvements in skin condition and quality of life, underlines the clinical relevance of apremilast in the management of this condition.

In this first randomized controlled study of an oral systemic treatment specifically for genital psoriasis, apremilast showed significant clinical efficacy and quality-of-life improvements. At Week 16, almost 40% of patients achieved a meaningful decrease in the symptoms of genital psoriasis, underscoring apremilast as another valid treatment option for this frequently stigmatizing condition. The results confirm apremilast's part as an important addition to the treatment landscape for genital psoriasis, offering patients a much-needed therapeutic alternative.

Reference:

Merola, J. F., Parish, L. C., Guenther, L., Lynde, C., Lacour, J.-P., Staubach, P., Cheng, S., Paris, M., Picard, H., Deignan, C., Jardon, S., Chen, M., & Papp, K. A. (2024). Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis: Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial. Journal of the American Academy of Dermatology, 90(3), 485–493. https://doi.org/10.1016/j.jaad.2023.10.020