Abstract | BACKGROUND: OBJECTIVE: METHODS: A total of 1255 patients were randomized (2:1) to apremilast 30 mg twice daily or placebo. At week 16, placebo patients switched to apremilast through week 32, followed by a randomized withdrawal phase to week 52. A priori efficacy analyses included patients with nail (target nail Nail Psoriasis Severity Index score ≥1) and moderate to very severe scalp (Scalp Physician Global Assessment score ≥3) psoriasis at baseline. RESULTS: At baseline, 66.1% and 64.7% of patients had nail psoriasis; 66.7% and 65.5% had moderate to very severe scalp psoriasis in ESTEEM 1 and 2. At week 16, apremilast produced greater improvements in Nail Psoriasis Severity Index score versus placebo; mean percent change: -22.5% versus +6.5% (ESTEEM 1; P < .0001) and -29.0% versus -7.1% (ESTEEM 2; P = .0052). At week 16, apremilast produced greater NAPSI-50 response (50% reduction from baseline in target nail Nail Psoriasis Severity Index score) versus placebo (both studies P < .0001) and ScPGA response (Scalp Physician Global Assessment score 0 or 1) versus placebo (both studies P < .0001). Improvements were generally maintained over 52 weeks in patients with Psoriasis Area and Severity Index response at week 32. LIMITATIONS: Baseline randomization was not stratified for nail/scalp psoriasis. CONCLUSION:
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Authors | Phoebe Rich, Melinda Gooderham, Hervé Bachelez, Joana Goncalves, Robert M Day, Rongdean Chen, Jeffrey Crowley |
Journal | Journal of the American Academy of Dermatology
(J Am Acad Dermatol)
Vol. 74
Issue 1
Pg. 134-42
(Jan 2016)
ISSN: 1097-6787 [Electronic] United States |
PMID | 26549249
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Phosphodiesterase 4 Inhibitors
- Thalidomide
- apremilast
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Topics |
- Administration, Oral
- Adult
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Nail Diseases
(drug therapy, pathology)
- Phosphodiesterase 4 Inhibitors
(administration & dosage)
- Psoriasis
(diagnosis, drug therapy)
- Risk Assessment
- Scalp Dermatoses
(drug therapy, pathology)
- Severity of Illness Index
- Thalidomide
(administration & dosage, analogs & derivatives)
- Time Factors
- Treatment Outcome
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