Apremilast shows genital psoriasis improvement

Key takeaways:

• Genital psoriasis treatment is challenging due to sensitivity of the area and lack of studies.
• Patients treated with apremilast vs. placebo had a clinically and statistically significant response.

Patients with genital psoriasis had a clinically significant response to apremilast treatment, according to phase 3 trial results.

“Genital psoriasis (G-PsO) may be the most stigmatizing form of psoriasis, affecting up to 63% of adults with psoriasis at some time,” Joseph F. Merola, MD, MMSc, FAAD, vice chair of clinical trials and innovation, department of dermatology, Brigham and Women’s Hospital, and associate professor, Harvard Medical School, and colleagues wrote. “Studies about the safety and efficacy of treatment for G-PsO are limited, and treatment is challenging.”

This form of the disease greatly impacts quality of life, and due to the sensitive nature of genital skin, most first-line treatments such as topical steroids are often associated with higher risks.

The randomized, placebo-controlled, phase 3 DISCREET trial enrolled 289 patients, of which 230 completed the trial, randomly assigned to receive apremilast or placebo for 16 weeks.

Modified static Physician Global Assessment (sPGA) of genitalia response was achieved by 39.6% of the apremilast group compared with 19.5% of the placebo group (P = .0003). At week 16, overall sPGA response was achieved by 22.2% in the apremilast group vs. 6.9% of the placebo group (P = .0004).

The Genital Psoriasis Itch Numeric Rating Scale response rate was 47.3% in the treatment arm compared with 19.6% of the placebo arm (P < .0001).

Body surface area and DLQI improvements were also greater in the apremilast group than in the placebo group.

Treatment-emergent adverse events occurred in 72% of the apremilast group and 57.2% of the placebo group, with the most common being diarrhea, headache, nausea and nasopharyngitis. Nineteen patients withdrew from the trial due to treatment-emergent adverse events, including 10 from the apremilast arm and nine from the placebo group.

“Apremilast significantly reduced G-PsO, including clinical findings (ie, itch, pain, discomfort, stinging, burning, redness, scaling and cracking) and improved [quality of life] in patients with moderate to severe G-PsO who were adequately controlled by or intolerant to topical therapies,” the authors wrote. “Apremilast had acceptable safety, with [adverse events] consistent with the known safety profile.”