Apremilast shows promise as first oral treatment for genital psoriasis
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Key takeaways:
- Regardless of body surface area involvement, apremilast showed consistent improvement in genital psoriasis vs. placebo.
- Patients taking apremilast also reported improved genital itch and quality of life.
NEW ORLEANS — Apremilast 30 mg significantly improved genital psoriasis severity and quality of life compared with placebo in the first trial to study an oral treatment for this indication, according to a presentation here.
In the multicenter, double-blind, phase 3 DISCREET study, researchers analyzed the efficacy of apremilast in patients with genital psoriasis.
“Genital psoriasis, which affects up to 63% of adults with psoriasis, remains highly stigmatized, underdiagnosed and undertreated,” Joseph F. Merola, MD, MMSc, of Brigham and Women’s Hospital, Harvard Medical School, Boston, and colleagues wrote in a poster presented at the American Academy of Dermatology Annual Meeting. “[DISCREET] is the first trial to study an oral treatment for moderate to severe genital psoriasis.”
Patients were randomly assigned to 30 mg apremilast or placebo twice daily based on body surface area (BSA) involvement. For those with less than 10% BSA, 82 received the study drug and 84 received placebo, whereas for those with 10% BSA or more, 61 were assigned to the study drug and 62 to placebo.
Patients taking apremilast had a mean age of 44 years and mean a duration of genital psoriasis of 11 years, whereas those taking placebo had a mean age of 46 years and a mean duration of 12 years. Both groups were comprised of 70% men.
The primary endpoint was a modified static Physician Global Assessment of Genitalia (sPGA-G) score of 0 or 1 with a greater than or equal to 2-point reduction from baseline at week 16. Secondary endpoints included a reduction in genital itch and sPGA response, as well as quality of life improvement.
Results showed a greater proportion of patients taking apremilast vs. placebo achieved the primary endpoint at week 16.
In the group with less than 10% BSA involvement, the sPGA-G response rate of apremilast-treated patients was 35.2% compared with 18.6% in placebo-treated patients, with a treatment difference of 16.6% (95% CI, 2.7-30.5). In the groups with greater than or equal to 10% BSA involvement, the sPGA-G response rate was 45.6% for apremilast and 20.8% for placebo, with a treatment difference of 24.8% (95% CI, 7.7-41.9).
Genital itch response rates similarly favored apremilast in both the less than 10% BSA group (38.9%) and greater than or equal to 10% group (57.5%) compared with placebo (15.3% and 25.3%, respectively). The groups experienced similar results in sPGA response (BSA < 10%, 20.1% apremilast vs. 5.4% placebo; BSA 10%, 25% apremilast vs. 9% placebo.
Apremilast patients also reported a higher quality of life improvement compared with placebo by least squares mean change from baseline score differences of –2 (95% CI, –3.9 to –2) and –3.6 (95% CI, –6.3 to –0.9) in the respective BSA groups.
“In the DISCREET study, apremilast significantly improved genital psoriasis and quality of life compared to placebo at week 16 and was well tolerated in patients,” Merola and colleagues wrote.