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Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis: Results of 2 phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2).

AbstractBACKGROUND:
In the phase III double-blind Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2, apremilast, an oral phosphodiesterase 4 inhibitor, demonstrated efficacy in moderate to severe psoriasis.
OBJECTIVE:
We sought to evaluate efficacy of apremilast in nail/scalp psoriasis in ESTEEM 1 and 2.
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:
Apremilast reduces the severity of nail/scalp psoriasis.
AuthorsPhoebe Rich, Melinda Gooderham, Hervé Bachelez, Joana Goncalves, Robert M Day, Rongdean Chen, Jeffrey Crowley
JournalJournal 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
PMID26549249 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 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
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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