Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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33 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY May 2018 • Volume 11 • Number 5 O R I G I N A L R E S E A R C H P Plaque psoriasis is a common immune- mediated skin condition propagated by interleukin (IL)-17A and other pro- inflammatory cytokines. 1 Ixekizumab, a high- affinity monoclonal antibody that selectively targets IL-17A, has been shown to result in a significant improvement in psoriasis following 12 and 60 weeks of treatment. 2,3,4 Although the long-term efficacy of ixekizumab has been evaluated, the time to meaningful clinical improvement has not been fully assessed. In addition, the relationship between ixekizumab treatment and a visual improvement in skin over time has not been reported. The primary objective of this study was to determine the time to improvement in disease as measured by a 1-point or greater improvement from baseline in the 6-point Patient's Global Assessment (PatGA) scale. Secondary objectives included evaluation of the time course of clinical response to ixekizumab, which was measured by the percent improvement from baseline in the Psoriasis Area and Severity Index (PASI), the change from baseline in the Itch Numeric Rating Scale (NRS), and the time to a 2-point or greater improvement from baseline in the PatGA. Efficacy was also measured by the percentage of patients achieving a static Physician's Global Assessment (sPGA) score of 0 or 1 or an sPGA score of 0. Standardized, sequential photographs were taken of each patient as visual evidence of improvement. METHODS Patients were at least 18 years old with a history of moderate-to-severe plaque A B S T R A C T Objective: The purpose of this study was to evaluate the speed of onset of clinical response to ixekizumab (IXE) and assess the progression of visible improvement in patients with moderate- to-severe plaque psoriasis. Design: This was an interventional, randomized, open-label, Phase IIIb clinical trial. Setting: This was a single center study at the Mount Sinai School of Medicine. Participants: Twelve patients were randomized at a ratio of 1:1 to receive 80mg of ixekizumab every two (IXE Q2W) or four (IXE Q4W) weeks following a starting dose of 160mg of ixekizumab. After Week 12, all patients received 80mg IXE Q4W through Week 44. Measurements: Clinical response was measured using the Patient's Global Assessment (PatGA), the Psoriasis Area and Severity Index (PASI), the static Physician's Global Assessment (sPGA), and the Itch Numeric Rating Scale (Itch NRS). Sequential patient photographs were taken at regular intervals during the study to evaluate visible improvement in plaque psoriasis. Results: The median time to an improvement of at least 1 point or 2 points from baseline in PatGA score was 5.0 and 10.0 days for patients randomized to IXE Q2W and 6.0 and 13.5 days for patients randomized to IXE Q4W. All patients achieved at least a 50- or 75-percent improvement in PASI from baseline by Weeks 2 and 4, respectively. At least half of the patients achieved at least a 4-point improvement from baseline in Itch NRS by Day 14. Improvement in disease was visibly evident within one week of treatment in patient photographs. Conclusion: Ixekizumab results in a rapid and visible improvement in plaque psoriasis in as early as one week of treatment. KEYWORDS: Plaque psoriasis, ixekizumab, early onset, randomized, Phase IIIb, photographs Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis by SAAKSHI KHATTRI, MD; ORIN GOLDBLUM, MD; KATHLEEN SOLOTKIN, MSN; YASMIN AMIR, MD; MICHELLE S. MIN, MD, MSCI; TERRI RIDENOUR, BSN, MBA; FAN EMILY YANG, PhD; and MARK LEBWOHL, MD, FAAD Dr. Khattri, Dr. Amir, Dr. Min, and Dr. Lebwohl are with the Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York, New York. Dr. Khattri is also with the Laboratory for Investigative Dermatology at the Rockefeller University in New York, New York. Dr. Min is also with Boston University School of Medicine in Boston, Massachusetts. Dr. Goldblum, Ms. Solotkin, Ms. Ridenour, and Dr. Yang are with Eli Lilly and Company in Indianapolis, Indiana. J Clin Aesthet Dermatol. 2018;11(5):33–37 FUNDING: Funding provided by Eli Lilly and Company. DISCLOSURES: Dr. Khattri has received grant/research support from and is an investigator for Eli Lilly and Company. Dr. Lebwohl is an employee of Mount Sinai, which receives research funds from AbGenomics, Amgen, Anacor, Boehringer Ingelheim, Celgene, Ferndale, Janssen Biotech, Kadmon, LEO Pharma, Eli Lilly and Company, Medimmune, Novartis, Pfizer, Sun Pharma, and Valeant. Dr. Goldblum, Ms. Solotkin, Ms. Ridenour, and Dr. Yang own stock and are employees of Eli Lilly and Company. Dr. Amir and Dr. Min have no conflicts of interest relevant to the content of this article. CORRESPONDENCE: Orin Goldblum, MD; Email: Goldblum_orin_m@lilly.com

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