Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled.

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Presentation transcript:

Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1) Kim Papp, MD, PhD, Kristian Reich, MD, PhD, Craig L. Leonardi, MD, Leon Kircik, MD, Sergio Chimenti, MD, Richard G.B. Langley, MD, ChiaChi Hu, EdM, MS, Randall M. Stevens, MD, Robert M. Day, PhD, Kenneth B. Gordon, MD, Neil J. Korman, MD, PhD, Christopher E.M. Griffiths, MD, FMedSci Journal of the American Academy of Dermatology Volume 73, Issue 1, Pages 37-49 (July 2015) DOI: 10.1016/j.jaad.2015.03.049 Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis 1 study design. ∗Doses of apremilast were titrated during the first week of administration and at week 16 when placebo patients were switched to apremilast. §Patients restarted apremilast at the time of loss of effect versus baseline (loss of 75% or greater reduction from baseline Psoriasis Area and Severity Index score [PASI-75]) but no later than week 52. ‡Patients initially on placebo or randomized to apremilast 30 mg twice a day (BID) who did not attain a PASI-75 were able to add topicals and/or ultraviolet (UV) B phototherapy at week 32 at the discretion of the investigator. Journal of the American Academy of Dermatology 2015 73, 37-49DOI: (10.1016/j.jaad.2015.03.049) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Patient disposition. ∗One death occurred in a patient randomized to apremilast after receiving the last dose of study medication in the placebo-controlled phase. The patient was considered to have completed the placebo-controlled phase. §Includes 4 patients who had a 75% or greater reduction from baseline Psoriasis Area and Severity Index score, were erroneously not rerandomized, and completed the study. BID, Twice a day. Journal of the American Academy of Dermatology 2015 73, 37-49DOI: (10.1016/j.jaad.2015.03.049) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 3 A, Mean percentage change in Nail Psoriasis Severity Index (NAPSI) score. Reduction in NAPSI score indicates improvement. Patients with a non-zero baseline value and 1 or more postbaseline values are included. B, Proportion of patients achieving Scalp Physician Global Assessment (ScPGA) score 0 (clear) or 1 (minimal) at week 16. Patients with ScPGA score of 3 or more (moderate to very severe) at baseline and 1 or more postbaseline values are included. BID, Twice a day. ∗P < .0001 versus placebo. Journal of the American Academy of Dermatology 2015 73, 37-49DOI: (10.1016/j.jaad.2015.03.049) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 4 A, Proportion of patients achieving 75% or greater reduction from baseline Psoriasis Area and Severity Index (PASI) score (PASI-75) response over 32 weeks. B, Mean percentage improvement in PASI from baseline over 32 weeks. C, Mean change (mm) in pruritus visual analog scale (VAS) score from baseline over 32 weeks. Two-sided 95% confidence intervals are shown. BID, Twice a day. Journal of the American Academy of Dermatology 2015 73, 37-49DOI: (10.1016/j.jaad.2015.03.049) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 5 Mean percentage change (2-sided 95% confidence intervals) in Psoriasis Area and Severity Index (PASI) over 52 weeks. A, Patients randomized to apremilast at baseline with 75% or greater reduction from baseline PASI score (PASI-75) response at week 32 who were rerandomized to apremilast (data for patients who were rerandomized to placebo during the randomized treatment withdrawal phase are not shown). B, Patients randomized to placebo at baseline who were PASI-75 responders at week 32 and entered the randomized treatment withdrawal phase. Patient numbers begin at week 2. BID, Twice a day. Journal of the American Academy of Dermatology 2015 73, 37-49DOI: (10.1016/j.jaad.2015.03.049) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions