Journal of Clinical and Aesthetic Dermatology

MAY 2018

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

Issue link: https://jcadonline.epubxp.com/i/979610

Contents of this Issue

Navigation

Page 34 of 55

35 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 Anterior and posterior photographs were taken of the torso, upper extremities, groin, buttocks, and lower extremities of each patient under similar lighting and magnification conditions by a professional photographer. Photographs were taken twice-weekly (Weeks 0–3), onc e-weekly (Weeks 4–8), every two weeks (Weeks 8–12), then every 12 weeks (Weeks 12–48) with a two-day minimum between photos. Time-to-event analysis was used to assess the time to a 1-point or greater improvement or a 2-point or greater improvement from baseline in the PatGA using the Kaplan-Meier product limit method. Response rates were summarized using nonresponder imputation to account for missing data. Safety data were summarized by frequency of adverse events occurring during the induction dosing period and the maintenance dosing period. RESULTS Twelve patients were randomized to receive either IXE Q2W (6 patients) or IXE Q4W (6 patients) through Week 12. The baseline demographics and disease characteristics for each treatment regimen are provided in Table 1. For patients randomized to IXE Q2W, the median time to a 1-point or greater improvement and a 2-point or greater improvement in the PatGA from baseline was 5.0 and 10.0 days, respectively. The median time to a 1-point or greater improvement and a 2-point or greater improvement from baseline in PatGA was 6.0 and 13.5 days for patients randomized to IXE Q4W, respectively. By Weeks 2 and 4, all patients achieved at least 50- or 75-percent PASI improvement from baseline, respectively (Figure 1). Of 11 patients with a baseline Itch NRS sc ore of at least 4 (1 patient had a baseline Itch NRS sc ore of 1), at least half (Q2W: 3 patients, 50.0%; Q4W: 3 patients, 60.0%) achieved at least a 4-point Itch NRS improvement from baseline by Day 14 (Figure 1C). Patient photographs demonstrated visible improvement in disease within one week of treatment (Figures 2–4 and Supplemental Video [click HERE to access video (in e-edition) or visit http://jcadonline.com/wp-content/ uploads/Supplemental-Video.mp4). Treatment emergent adverse events (TEAEs) were mild to moderate in severity except for one severe TEAE of arthralgia TABLE 1. Baseline demographics and disease characteristics DEMOGRAPHIC IXE Q2W (N=6) IXE Q4W (N=6) Age, years 41.8 (12.5) 55.2 (7.4) Male, n (%) 5 (83.3) 3 (50.0) Caucasian, n (%) 4 (66.7) 5 (83.3) Duration of psoriasis, years 17.4 (13.0) 22.2 (23.4) Weight, kg 67.7 (15.7) 81.4 (20.9) Percent BSA 25.5 (20.4) 32.5 (18.3) PatGA 4.8 (0.4) 4.8 (0.4) PASI score 21.0 (9.2) 25.2 (8.4) Itch NRS score 8.2 (1.6) 7.2 (3.2) sPGA score 3.8 (0.8) 4.0 (0.6) Data are provided as mean (SD) unless otherwise indicated; BSA: Body Surface Area; NRS: Numeric Rating Scale; IXE: Ixekizumab; PASI: Psoriasis Area and Severity Index; PatGA: Patient's Global Assessment; Q2W: Every 2 weeks; Q4W: Every 4 weeks; SD: Standard deviation; sPGA: static Physician's Global Assessment FIGURE 2. Visible clearance of psoriatic plaques over 48 weeks of treatment with IXE Q2W/Q4W—A 37-year-old man, with baseline PASI score of 32.5 and baseline BSA of 58%, achieved PASI 75 at Week 4 and PASI 90 at Week 12, which was maintained through Week 48. BSA: body surface area; IXE: ixekizumab; PASI: Psoriasis Area and Severity Index; Q2W: every two weeks; Q2W/Q4W, 80mg IXE Q2W during the induction dosing period and Q4W during the maintenance dosing period; Q4W: every four weeks

Articles in this issue

Links on this page

Archives of this issue

view archives of Journal of Clinical and Aesthetic Dermatology - MAY 2018