USA: A recent phase 3 randomized clinical trial published in the Journal of the American Academy of Dermatology has shed light on the safety and efficacy of apremilast in patients with genital psoriasis. The study revealed that these patients showed a clinically significant response to apremilast treatment.

Apremilast demonstrated statistically and clinically meaningful genital PGA responses and improvement of symptoms, signs, QoL, and severity in this first randomized, controlled study of oral systemic treatment in genital psoriasis patients.

Genital psoriasis (G-PsO) may be the most stigmatizing form of psoriasis that affects about 63% of adults with psoriasis at some time. Studies about the efficacy and safety of treatment for G-PsO are limited, and treatment is challenging. This form of the disease has a great impact on the quality of life, and due to genital skin's sensitive nature, most first-line treatments such as topical steroids are often tied with higher risks.

Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment. Joseph F. Merola, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA, and colleagues aimed to determine the safety and efficacy of apremilast 30 mg twice daily in patients with genital psoriasis.

The randomized, placebo-controlled, phase 3 DISCREET trial enrolled 289 patients with moderate-to-severe genital psoriasis, of which 230 completed the trial. They were randomly assigned to apremilast (n=143) or placebo (n=146) for 16 weeks, followed by an apremilast extension period.

The study led to the following findings:

  • At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment (PGA) of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction); treatment difference was significant (20.1%).
  • Improvements in genital signs and symptoms, skin involvement, and quality of life (QoL) were observed.
  • Common treatment-emergent adverse events were headache, diarrhoea, 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.

The findings revealed that apremilast significantly reduced genital psoriasis, including clinical findings (cracking, scaling, redness, burning, stinging, discomfort, pain, and itch) and improved the quality of life in patients with moderate to severe G-PsO who were adequately controlled by or intolerant to topical therapies.

Apremilast was shown to have acceptable safety, with [adverse events] consistent with the known safety profile.

Reference:

Merola JF, et al. J Am Acad Dermatol. 2023;doi:10.1016/j.jaad.2023.10.020.




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