Evidence map›Paper›PMID 41369155›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2026

Results from the 32-week, phase 3 DISCREET study of apremilast in patients with moderate to severe genital psoriasis.

Joseph F Merola, Lyn Guenther, Charles Lynde, Kim A Papp, Lawrence Charles Parish, Paul Yamauchi, Sue Cheng, Hamid Amouzadeh, Cynthia Deignan, Shauna Jardon and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03777436 (A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03777436 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double Blind-Study of the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Moderate to Severe Genital Psoriasis

TypeinterventionalSponsorAmgenRan2019 to 2022Enrolled289ConditionsPsoriasisArmsApremilast, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Results from the 32-week, phase 3 DISCREET study of apremilast in patients with moderate to severe genital psoriasis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Joseph F MerolaDivision of Rheumatology, Department of Dermatology, UT Southwestern Medical Center, Dallas, Texas, USA.
Lyn GuentherGuenther Research Inc., London, Ontario, Canada.
Charles LyndeLynde Institute for Dermatology, Markham, Ontario, Canada.
Kim A PappProbity Medical Research, Waterloo, Ontario, Canada.ORCID https://orcid.org/0000-0001-9557-3642
Lawrence Charles ParishPaddington Testing Company, Inc., Philadelphia, Pennsylvania, USA.ORCID https://orcid.org/0000-0002-4612-1508
Paul YamauchiDermatology Institute & Skin Care Center, Santa Monica, California, USA.
Sue ChengAmgen Inc., Thousand Oaks, California, USA.
Hamid AmouzadehAmgen Inc., Thousand Oaks, California, USA.
Cynthia DeignanAmgen Inc., Thousand Oaks, California, USA.
Shauna JardonAmgen Inc., Thousand Oaks, California, USA.
Mindy ChenAmgen Inc., Thousand Oaks, California, USA.
Andreas PinterUniversity Hospital of the Goethe University, Frankfurt am Main, Germany.ORCID https://orcid.org/0000-0002-1330-1502

Funding

Amgen, Inc.
6 · The paper itself

Abstract

backgroundGenital psoriasis is highly prevalent among patients with psoriasis, is often stigmatized, causes pain and discomfort and negatively impacts quality of life. Apremilast is an oral phosphodiesterase 4 inhibitor approved for treating psoriasis and has demonstrated safety and efficacy in treating genital psoriasis, as seen in the primary 16-week DISCREET results.

objectivesTo assess the efficacy and safety of apremilast 30 mg twice daily in patients with moderate to severe genital psoriasis over the 32-week study duration.

methodsDISCREET was a phase 3, multicentre, randomized, double-blind trial that evaluated apremilast 30 mg twice daily versus placebo in a 16-week placebo-controlled phase (randomization 1:1) followed by a 16-week apremilast extension phase. Patients had moderate to severe genital psoriasis, defined as a modified static Physician's Global Assessment of Genitalia (genital PGA) score of ≥3. They also either had disease inadequately controlled by or were intolerant to topical therapy. We report the results through Week 32.

resultsOf 289 patients randomized, 229 continued to the apremilast extension phase (Weeks 16-32): 110 in the placebo/apremilast group and 119 in the apremilast/apremilast group. At 32 weeks, 51.8% (95% CI: 42.6, 60.9) of patients in the placebo/apremilast group and 40.3% (95% CI: 32.0, 49.3) of patients in the apremilast/apremilast group had achieved a modified genital PGA response (score of 0/1 with ≥2-point reduction from baseline). At Week 32, similar improvements in skin, genital signs and symptoms and quality of life were observed in patients who started apremilast at Week 16 or at randomization. Frequently reported treatment-emergent adverse events during all-apremilast exposure were diarrhoea (25.4%), nausea (19.4%) and headache (17.9%).

conclusionsApremilast is an effective oral systemic therapy in patients with moderate to severe genital psoriasis and has shown consistent clinical efficacy, lessening of symptoms and quality-of-life benefit in DISCREET. CLINICAL TRIAL ID: NCT03777436.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalGenital Diseases, FemaleGenital Diseases, MalePhosphodiesterase 4 InhibitorsPsoriasisThalidomideAdultDouble-Blind MethodFemaleHumansMaleMiddle AgedQuality of LifeSeverity of Illness IndexTreatment OutcomeAnti-Inflammatory Agents, Non-SteroidalapremilastPhosphodiesterase 4 InhibitorsThalidomideapremilastclinical trialgenitaliapsoriasisrandomized controlled trial

Identifiers

PMID41369155
PMCPMC12843872

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.