ArticleDermatology and therapy2022
Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study.
Article in Dermatology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03930186 (A Phase 3b, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
A Phase 3b, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.
- Efficacy and Safety of Nail Psoriasis Targeted Therapies: A Systematic Review.American journal of clinical dermatology · 2023Pooled it
- Efficacy and safety of different doses of apremilast in mild to-moderate psoriasis: A randomized controlled study.Indian journal of pharmacology · 2026Trial
- Can Week 4 PASI Response Serve as an Early Predictor of Apremilast Efficacy in Psoriasis? A Single-Centre Preliminary Study.Acta dermato-venereologica · 2025Article
- Clinical Characteristics and Safety Profiles of Japanese Psoriasis Patients Who Continued Apremilast Treatment for 6 and 12 Months: A Post Hoc Analysis of an Apremilast Postmarketing Surveillance Study.The Journal of dermatology · 2025Article
- Safety assessment of apremilast: real-world adverse event analysis from the FAERS database.Archives of dermatological research · 2025Article
- Safety and effectiveness of apremilast in Japanese patients with psoriatic disease: Results of a post-marketing surveillance study.The Journal of dermatology · 2024Article
- Consistent Efficacy of Apremilast in Patients with Psoriasis Regardless of Baseline Disease Severity or Special Area Involvement: Subgroup Analysis from PROMINENT.Dermatology and therapy · 2024Article
- Phosphodiesterase-4 Inhibition in the Management of Psoriasis.Pharmaceutics · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPatients with mild-to-moderate plaque psoriasis often experience reduced quality of life and increased disease burden due to itch or involvement of psoriasis in special areas such as the scalp and nails. Systemic therapy may be used concurrently with topical therapy in patients with active disease not controlled by topical therapy alone. The objective of PROMINENT was to evaluate the efficacy and safety of apremilast in combination with topical therapy in patients with mild-to-moderate psoriasis in Japan.
methodsPROMINENT, a phase 3b, open-label, single-arm study in Japan, enrolled adults ≥ 20 years of age with plaque psoriasis [static Physician Global Assessment (sPGA) 2 (mild) or 3 (moderate)] not adequately controlled by topical therapy. Patients received apremilast 30 mg twice daily for 16 weeks in addition to their existing topical therapy, with the option of topical therapy reduction at the discretion of their physician while continuing apremilast treatment from weeks 16 to 32.
resultsOf the 152 patients enrolled in the study, 136 completed week 32. The primary endpoint of sPGA response [score 0 (clear) or 1 (almost clear)] was achieved by 43.7% of patients at week 16, and 40.8% maintained response at week 32. Clinically meaningful improvements in skin, scalp, and nails were observed in > 40% of patients at weeks 16 and 32. Similarly, improvements in pruritus, quality of life, and treatment satisfaction were observed at week 16 and maintained at week 32. Common treatment-emergent adverse events through week 32 included gastrointestinal events, nasopharyngitis, and headache.
conclusionsApremilast in combination with topical therapy resulted in clinically meaningful and sustained efficacy in physician- and patient-reported outcomes at weeks 16 and 32 in Japanese patients with mild-to-moderate psoriasis. Tolerability was consistent with available prior safety data for apremilast.
trial registrationClinicalTrials.gov identifier, NCT03930186.
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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.