TY - JOUR
T1 - Efficacy and safety of apremilast in patients with moderate-to-severe genital psoriasis
T2 - Results from DISCREET, a phase 3 randomized, double-blind, placebo-controlled trial
AU - Merola, Joseph F.
AU - Parish, Lawrence Charles
AU - Guenther, Lyn
AU - Lynde, Charles
AU - Lacour, Jean Philippe
AU - Staubach, Petra
AU - Cheng, Sue
AU - Paris, Maria
AU - Picard, Hernan
AU - Deignan, Cynthia
AU - Jardon, Shauna
AU - Chen, Mindy
AU - Papp, Kim A.
N1 - Publisher Copyright:
© 2023 American Academy of Dermatology, Inc.
PY - 2024/3
Y1 - 2024/3
N2 - Background: Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment. Objective: To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis. Methods: DISCREET, a phase 3, placebo-controlled trial (NCT03777436), randomized patients with moderate-to-severe genital psoriasis (stratified by affected body surface area <10% or ≥10%) to apremilast or placebo for a 16-week period, followed by an apremilast extension period. Week 16 results are presented. Results: Patients were randomized to apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction); treatment difference was significant (20.1%, P = .0003). Improvements in genital signs and symptoms, skin involvement, and quality of life were observed. Common treatment-emergent adverse events were diarrhea, headache, nausea, and nasopharyngitis. Limitations: Lack of active-comparator. Conclusions: Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and quality of life in this first randomized, controlled study of an oral systemic treatment in patients with genital psoriasis.
AB - Background: Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment. Objective: To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis. Methods: DISCREET, a phase 3, placebo-controlled trial (NCT03777436), randomized patients with moderate-to-severe genital psoriasis (stratified by affected body surface area <10% or ≥10%) to apremilast or placebo for a 16-week period, followed by an apremilast extension period. Week 16 results are presented. Results: Patients were randomized to apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction); treatment difference was significant (20.1%, P = .0003). Improvements in genital signs and symptoms, skin involvement, and quality of life were observed. Common treatment-emergent adverse events were diarrhea, headache, nausea, and nasopharyngitis. Limitations: Lack of active-comparator. Conclusions: Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and quality of life in this first randomized, controlled study of an oral systemic treatment in patients with genital psoriasis.
KW - apremilast
KW - efficacy
KW - genital psoriasis
KW - moderate to severe
KW - safety
KW - systemic
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U2 - 10.1016/j.jaad.2023.10.020
DO - 10.1016/j.jaad.2023.10.020
M3 - Article
C2 - 37852306
AN - SCOPUS:85179487356
SN - 0190-9622
VL - 90
SP - 485
EP - 493
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 3
ER -