A Pilot Study of an Oral Phosphodiesterase Inhibitor (Apremilast) for Atopic Dermatitis in Adults
| Autor: | Trista M. Berry, Eric L. Simpson, Aman Samrao, Renato Goreshi |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Visual analogue scale Pilot Projects Dermatology Severity of Illness Index Eczema Area and Severity Index Article Monocytes Dermatitis Atopic Internal medicine medicine Humans Cyclic AMP Response Element-Binding Protein Adverse effect Oligonucleotide Array Sequence Analysis business.industry Gene Expression Profiling Macrophages Pruritus Nausea General Medicine Dermatology Life Quality Index Atopic dermatitis Middle Aged medicine.disease Interleukin-12 Thalidomide Clinical research Immunology Cohort Quality of Life Female Phosphodiesterase 4 Inhibitors Apremilast business Signal Transduction medicine.drug |
| Zdroj: | Archives of Dermatology. 148 |
| ISSN: | 0003-987X |
| DOI: | 10.1001/archdermatol.2012.812 |
| Popis: | 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-of-study 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 |
| Databáze: | OpenAIRE |
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