A Pilot Study of an Oral Phosphodiesterase Inhibitor (Apremilast) for Atopic Dermatitis in Adults
Open accessAbstract
OBJECTIVE: To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis. DESIGN: This investigator-initiated, open-label pilot study evaluated 2 doses of apremilast in patients with atopic dermatitis. Differential gene analysis was performed from peripheral whole blood using data before and after treatment. SETTING: University-based dermatology clinical research unit. PATIENTS: Sixteen adult patients with atopic dermatitis. INTERVENTION: A specific phosphodiesterase 4 inhibitor, apremilast. MAIN OUTCOME MEASURES: The primary outcome was incidence of adverse events. Secondary outcomes included the differences in pruritus, Dermatology Life Quality Index (DLQI), and Eczema Area and Severity Index (EASI) scores between the baseline visit and end-ofstudy visit for each cohort. RESULTS: The group receiving apremilast, 20 mg twice daily, displayed a significant reduction from baseline of pruritus (P=.02) and the DLQI (P=.003) at 3 months. The group receiving apremilast, 30 mg twice daily, displayed a significant reduction of the EASI (P=.008) and the DLQI (P=.01) at 3 months. At 6 months, there was a significant reduction of the EASI (P=.002), the visual analog scale (P=.03), and the DLQI (P=.03). Gene ontologic analyses comparing baseline with samples during treatment revealed alterations in immune response pathways, especially those related to cyclic adenosine monophosphate–mediated signaling. CONCLUSIONS: These results support further development of apremilast for treatment of atopic dermatitis. Larger randomized controlled studies are needed to more adequately evaluate both safety and efficacy. Limitations include the small sample size and absence of a control. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01393158.
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Pilot open-label studies of apremilast provided promising results.
“Pilot open-label studies of this PDE4 inhibitor provided promising results129,130.”
From Atopic dermatitis: an expanding therapeutic pipeline for a complex disease (2022) · cites this paper as [129]
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- Authors
- Samrao, A., Berry, T. M., Goreshi, R., & Simpson, E. L.
- Affiliations
- University of California, Los Angeles (US)
- Oregon Health & Science University (US)
- Venue
- Archives of Dermatology
- Publisher
- American Medical Association (AMA)
- Published
- 2012-08-01
- Volume
- 148
- Issue
- 8
- Pages
- 890-7
- ISSN
- 0003-987X (ISSN-L)
- PMC
- PMC3614494
- OpenAlex
- W2139133242
- Cited by
- 166
- References
- 29
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 4 · 2023: 3 · 2022: 13 · 2021: 15 · 2020: 9 · 2019: 21 · 2018: 24 · 2017: 29 · 2016: 13 · 2015: 12 · 2014: 5 · 2013: 8 · 2012: 2
- FWCI
- 10.80
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Archives of Dermatology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR000128)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (K23AR057486)
- National Center for Research Resources (KL2RR024141)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Dermatology › Dermatology and Skin Diseases
- Health Sciences › Medicine › Physiology › Asthma and respiratory diseases
- Health Sciences › Medicine › Dermatology › Cutaneous lymphoproliferative disorders research
- Keywords
- apremilast, atopic dermatitis, phosphodiesterase-4 inhibitors, pruritus, quality of life, eczema severity, adverse events, cAMP signaling, immune pathways, peripheral blood gene expression
- MeSH terms
- Adult, Dermatitis, Atopic, Female, Humans, Macrophages, Male, Middle Aged, Monocytes, Nausea, Pilot Projects, Pruritus, Quality of Life, Severity of Illness Index, Thalidomide, Signal Transduction, Cyclic AMP Response Element-Binding Protein, Interleukin-12, Oligonucleotide Array Sequence Analysis, Gene Expression Profiling, Phosphodiesterase 4 Inhibitors
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