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Apremilast for patients with genital psoriasis: Week 32 results from the phase III DISCREET trial
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The multicenter, randomized, double-blind, placebo-controlled phase III DISCREET trial (NCT03777436) evaluated the safety and efficacy of apremilast, an oral PDE4 inhibitor, in patients with moderate-to-severe genital psoriasis.1 Patients were randomized 1:1 to receive either apremilast 30 mg twice daily (n = 143) or placebo (n = 146) for 16 weeks.1 At Week 16, all patients (n = 229) entered the apremilast extension phase and received apremilast up to Week 32.1 Week 16 results were previously reported by the PsOPsA Hub. Week 32 results were presented at the EADV 2024 Congress by Joseph Merola.1 |
| Key learnings |
| At Week 32, the modified genital PGA response rates were 40.3% and 51.8% and the overall sPGA rates were 30.3% and 33.6% in patients who received apremilast and placebo/apremilast, respectively. |
| GPI-NRS response rates were 46.5% and 48.4% in patients who received apremilast and placebo/apremilast, respectively. |
| DLQI improved from baseline by −48.6% and −55.9% and DLQI-Q9, focused on sexual function, improved by −58.8% and −57.2% in patients who received apremilast and placebo/apremilast, respectively. |
| The safety outcomes were consistent with the known safety profile of apremilast and similar to the Week 16 analysis. |
| Patients with moderate-to-severe genital psoriasis treated with apremilast had a clinically meaningful reduction in disease severity, signs, and symptoms, and improved quality of life, regardless of apremilast or placebo treatment in the first 16 weeks. |
Abbreviations: DLQI, Dermatology Life Quality Index; DLQI-Q9, DLQI question 9; EADV, European Academy of Dermatology and Venereology; GPI-NRS, Genital Psoriasis Itch Numeric Rating Scale; PDE4, phosphodiesterase 4; PGA, Physician’s Global Assessment; QoL, quality of life; sPGA, static PGA.
- Merola J. Apremilast in patients with moderate to severe genital psoriasis: Week 32 results from the phase 3 DISCREET study. Oral Abstract #FC06.05. Presented at: European Academy of Dermatology and Venereology Congress; Sep 25–28, 2024; Amsterdam, NL.
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