期刊
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
卷 73, 期 1, 页码 37-49出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2015.03.049
关键词
apremilast; clinical trial; ESTEEM; phosphodiesterase 4 inhibitor; psoriasis; treatment
类别
资金
- AbbVie
- Amgen
- Biogen Idec
- Celgene
- Centocor
- Covagen
- Forward Pharma
- GlaxoSmithKline
- Janssen-Cilag
- LEO Pharma
- Lilly
- Medac
- Merck Sharp Dohme
- Novartis
- Pfizer
- Takeda
- Vertex
- Abbott
- Acambis
- Allergan
- Assos Pharma
- Astellas Pharma US
- Asubio
- Berlex Laboratories (Bayer HealthCare Pharmaceuticals)
- Biolife
- Biopelle
- Breckinridge Pharma
- Colbar
- CollaGenex
- Combinatrix
- Connetics
- Coria
- Dermik Laboratories
- Dow Pharmaceutical Sciences
- Dusa
- Embil Pharmaceuticals
- EOS
- Ferndale Laboratories
- Galderma
- Genentech
- Health Point
- Intendis
- Innovail
- Johnson Johnson
- Laboratory Skin Care
- 3M
- Medical International Technologies
- Merck
- Medicis Pharmaceutical
- Merz
- Nano Bio
- Nucryst Pharmaceuticals
- Obagi
- Onset
- OrthoNeutrogena
- Promius
- QLT
- Pharma-Derm
- Quatrix
- Serono (Merck Serono International SA)
- SkinMedica
- Stiefel
- TolerRx
- Triax
- Valeant Pharmaceuticals Intl
- Warner-Chilcott
- ZAGE
- Janssen
- Ortho-McNeil-Janssen Pharmaceuticals
- Actelion
- Sandoz
- Trident
- UCB
Background: Apremilast works intracellularly to regulate inflammatory mediators. Objective: ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque psoriasis. Methods: This phase III, multicenter, double-blind, placebo-controlled study randomized adults (2: 1) to apremilast or placebo. At week 16, the placebo group switched to apremilast through week 32, followed by a randomized treatment withdrawal phase to week 52. Binary end points were analyzed using chi(2) test; continuous end points used analysis of covariance. Results: In all, 844 patients were randomized (n = 282, placebo; n = 562, apremilast). At week 16, significantly more patients taking apremilast achieved 75% or greater reduction from baseline Psoriasis Area and Severity Index score (PASI-75) (33.1%) versus placebo (5.3%, P < .0001; primary end point). Most (61.0%) patients rerandomized to apremilast at week 32 achieved PASI-75 at week 52 versus 11.7% rerandomized to placebo. Of patients rerandomized to apremilast at week 32, mean percentage change from baseline PASI score was -88% to -81% (weeks 32-52). During the placebo-controlled period, 55.7% and 69.3% of patients randomized to placebo and apremilast, respectively, had 1 or more adverse events. Most adverse events were mild/moderate in severity. No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period. Limitations: Data were limited to 52 weeks and may not generalize to nonplaque psoriasis. Conclusions: Apremilast was effective in moderate to severe plaque psoriasis.
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