Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis

August 2020 | Volume 19 | Issue 8 | Original Article | 741 | Copyright © August 2020


Published online July 24, 2020

doi:10.36849/JDD.2020.5116

Phoebe Rich MD,a Orin Goldblum MD,b Damon Disch PhD,b Chen-Yen Lin PhD,b Joseph F. Merola MD,c Boni Elewski MDd

aOregon Health and Science University’s Center for Health and Healing, Portland, OR bEli Lilly and Company, Indianapolis, IN cBrigham and Women's Hospital, Harvard Medical School, Boston, MA dUniversity of Alabama at Birmingham, Birmingham, AL

Abstract
Background: Presence of nail psoriasis in patients with plaque psoriasis may be an indicator of greater disease severity. Previously, patients with nail psoriasis have had delayed skin clearance after treatment compared to patients without nail psoriasis.
Objective: This post-hoc analysis evaluated the efficacy of ixekizumab in clearance of plaque psoriasis in patients with and without nail psoriasis.
Methods: Data were integrated from two phase 3 clinical trials (UNCOVER-2 and UNCOVER-3; N=2570) to assess skin response over 12 weeks of treatment with subcutaneous placebo, etanercept, or ixekizumab in patients with and without nail psoriasis. Nail response was assessed using Nail Psoriasis Severity Index (NAPSI) and skin response was assessed as the percentage of patients achieving 75%, 90%, or 100% improvement in Psoriasis Area and Severity Index (PASI 75, PASI 90, PASI 100) or a score of 0 or 1 on the static Physician Global Assessment (sPGA 0 or 0,1).
Results: From baseline to week 12, progressive improvement in psoriasis occurred with ixekizumab and etanercept treatment; however, significantly more patients with nail psoriasis than without mild PASI 75 at weeks 8 and 12 and sPGA (0,1) at week 12 with ixekizumab. Significantly more patients with severe nail psoriasis than mild achieved PASI 75 at weeks 8 and 12 with ixekizumab. Conclusion: Patients with and without nail psoriasis responded well to ixekizumab. The presence of nail psoriasis did not negatively affect skin clearance in patients treated with ixekizumab.
ClinicalTrials.gov: NCT01597245, NCT01646177

J Drugs Dermatol. 2020;19(8):741-746. doi:10.36849/JDD.2020.5116

INTRODUCTION

Psoriasis is a chronic, inflammatory disease that affects millions of people in North America and Europe and is characterized by plaques that may appear on various parts of the body.1 While skin manifestations are the most common characteristic of the disease, nail involvement is an often-overlooked clinical symptom. The prevalence of nail psoriasis is greater than 50% in patients with plaque psoriasis.2

Nail involvement may have a negative impact on patient’s quality of life in addition to skin manifestations alone, and the management of nail psoriasis can be challenging.3,4 The presence of nail psoriasis may be an indicator of disease chronicity or severity, as well as a strong indicator of psoriatic arthritis.4, 5 Many patients with nail psoriasis have reported pain as well as interference with daily activities and work productivity.6 Nail psoriasis is widely acknowledged to be more difficult to treat than skin lesions.7 Although there have been many recent advances in the treatment of skin psoriasis, the options for nail psoriasis are more limited. Additionally, previous studies have shown that patients with nail psoriasis treated with biological agents had delayed skin clearance compared to those without nail psoriasis.8,9

Ixekizumab, a humanized immunoglobulin G subclass 4 (IgG4), high-affinity, anti-interleukin (IL)-17A monoclonal antibody, has been shown in phase 2 and phase 3 clinical trials, including UNCOVER-2 and UNCOVER-3, to be effective in the clearance of plaque and nail psoriasis.10-14 This post-hoc, integrated analysis of the UNCOVER-2 and UNCOVER-3 trials evaluates the effects of ixekizumab on plaque psoriasis in patients with varying levels of baseline nail involvement after 12 weeks of treatment.