Kim Papp1, Kristian Reich2, Craig L Leonardi3, Leon Kircik4, Sergio Chimenti5, Richard G B Langley6, ChiaChi Hu7, Randall M Stevens7, Robert M Day7, Kenneth B Gordon8, Neil J Korman9, Christopher E M Griffiths10. 1. Probity Medical Research, Waterloo, Ontario, Canada. Electronic address: kapapp@probitymedical.com. 2. Dermatologikum Hamburg, Hamburg, Germany. 3. Department of Dermatology, Saint Louis University School of Medicine, Saint Louis, Missouri. 4. Physicians Skin Care, PLLC, Louisville, Kentucky; Mount Sinai Medical Center, New York, New York. 5. University of Rome Tor Vergata, Rome, Italy. 6. Dalhousie University, Halifax, Nova Scotia, Canada. 7. Celgene Corporation, Summit, New Jersey. 8. Northwestern University, Chicago, Illinois. 9. University Hospitals Case Medical Center, Cleveland, Ohio. 10. Dermatology Center, Salford Royal Hospital, University of Manchester, Manchester, United Kingdom.
Abstract
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 χ(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.
RCT Entities:
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 χ(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.
Authors: Seemal R Desai; Ilona J Frieden; Joel M Gelfand; Whitney High; Arthur Kavanaugh; Ashfaq A Marghoob; David M Ozog; Ted Rosen; Linda Stein Gold; Bruce Strober; Neil Swanson; George Martin Journal: J Clin Aesthet Dermatol Date: 2015-09
Authors: Shan Yu; Aaron D Pearson; Reyna Kv Lim; David T Rodgers; Sijia Li; Holly B Parker; Meredith Weglarz; Eric N Hampton; Michael J Bollong; Jiayin Shen; Claudio Zambaldo; Danling Wang; Ashley K Woods; Timothy M Wright; Peter G Schultz; Stephanie A Kazane; Travis S Young; Matthew S Tremblay Journal: Mol Ther Date: 2016-10-12 Impact factor: 11.454
Authors: Ursula Wiedermann; Harald H Sitte; Heinz Burgmann; Alexander Eser; Petra Falb; Heidemarie Holzmann; Maria Kitchen; Marcus Köller; Herwig Kollaritsch; Michael Kundi; Hans Lassmann; Ingomar Mutz; Winfried F Pickl; Elisabeth Riedl; Maria Sibilia; Florian Thalhammer; Barbara Tucek; Werner Zenz; Karl Zwiauer Journal: Wien Klin Wochenschr Date: 2016-07-25 Impact factor: 1.704