Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

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

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JCAD S22 journal of clinical and aesthetic dermatology JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) M edicine, New York, NY; 8 E li Lilly and C ompany, Indianapolis, IN; 9 Dermatologikum Hamburg and Georg- August University, Göttingen, Germany Introduction: In moderate-to-severe psoriasis, long-term treatment is usually required to achieve adequate control of disease activity. This p ublication analyzes the safety of ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A (IL-17A), approved for the treatment of psoriasis. Methods: Treatment-emergent adverse event (TEAE) and serious adverse event (SAE) data were integrated from the induction period of three randomized, controlled trials (RCTs) (0–12 weeks), the maintenance period of 2 of the 3 RCTs with a randomized withdrawal design (12–60 weeks), and all patients exposed to IXE from all seven psoriasis trials (controlled and uncontrolled). For the induction period, patients with moderate-to-severe psoriasis were randomized to IXE every two (IXE Q2W; N=1167) or four weeks (IXE Q4W; N=1161) after a 160mg starting dose, etanercept (ETN) (50mg biweekly; N=739), or placebo (N=791). The maintenance period included IXE- treated patients who had an sPGA 0,1 at Week 12 (responders) who then were re-randomized to IXE Q4W (N=416), IXE every 12 weeks (IXE Q12W, N=408), or the placebo/withdrawal group (N=402). The group of all patients exposed to IXE (N=4209) accounted for 6,480 patient-years (PY) of exposure. Comparisons of induction and maintenance periods were descriptive. Results: During the induction period, the frequency of any TEAE was higher in total IXE (58.6%), IXE Q2W (58.4%), IXE Q4W (58.8%), and ETN (54.0%) compared to placebo (46.8%). M ost TEAEs were mild or moderate. T he frequency of AEs reported as severe, SAEs, and discontinuations due to AEs did not differ among treatment groups. During the maintenance period, the exposure-adjusted incidence rate (IR – per hundred PY) of TEAEs was lower for IXE Q4W patients than for t he PBO/withdrawal group (IR: PBO, 123.8; IXE Q12W, 106.2; IXE Q4W, 95.6), with no significant difference observed between the IXE Q12W and IXE Q4W groups. Among all patients exposed to IXE, the exposure-adjusted IR of TEAEs was 54.4. Most TEAEs were mild or moderate. Conclusion: IXE had a safety profile that was similar to ETN during the induction period. The overall incidence of AEs in the Q2W and Q4W dosing regimens were similar. Financial diclosures/funding: The study was sponsored by Eli Lilly and Company. Median Time to Treatment Response in Patients with Moderate-to-severe Plaque Psoriasis Treated with Brodalumab 210mg or Ustekinumab: A Pooled Analysis of Data from Two Phase 3 Randomized Clinical Trials (AMAGINE-2 and AMAGINE-3) Presenters: Andrew Blauvelt, MD, MBA, 1 Mark G. Lebwohl, MD, 2 Lawrence J. Green, MD, 3 Sylvia Hsu, MD, FAAD, 4 Varsha Bhatt, PhD, 5 Shipra Rastogi, PhD, MBA, 6 Radhakrishnan Pillai, PhD, 5 Robert Israel, MD 6 Affiliations: 1 Oregon Medical Research Center, Portland, OR; 2 Icahn School of Medicine at Mount Sinai, New York, NY; 3 Department of Dermatology, George Washington University School of Medicine, Washington, DC; 4 Department of Dermatology, Baylor College of Medicine, Houston, TX; 5 Dow P harmaceutical Sciences (a division of V aleant Pharmaceuticals North America, LLC), Petaluma, CA; 6 Valeant Pharmaceuticals North America LLC, Bridgewater, NJ Background: Brodalumab is a human monoclonal antibody that binds to and blocks IL-17RA, the receptor s ubunit shared by the pro-inflammatory cytokines IL-17A, IL-17F, and IL-17A/F. While results from Phase 3 studies demonstrated high degrees of efficacy for brodalumab in the treatment of moderate-to-severe plaque psoriasis, also important is its speed of response compared to ustekinumab. Objective: To investigate the median time to response for brodalumab 210mg Q2W versus ustekinumab in the treatment of moderate-to-severe plaque psoriasis. Methods: 12-week induction phase data were analyzed from two multicenter, randomized, double-blind Phase 3 studies in moderate-to-severe psoriasis. Patients were treated with brodalumab, ustekinumab, or placebo. Co-primary endpoints were proportion of patients at Week 12 who achieved: 1) static Physician's Global Assessment (sPGA) scores of 0 or 1; 2) Psoriasis Area and Severity Index (PASI) 75 response (brodalumab vs. placebo); and 3) PASI 100 response (brodalumab vs. ustekinumab). Median time to response was evaluated from Kaplan- Meier estimates of the time taken for 50 percent of the patients to achieve co-primary endpoints. Results: Overall, 1,236 patients were treated with brodalumab 210mg Q2W and 613 with ustekinumab. At Week 12, 79.1 and 59.1 percent of brodalumab and ustekinumab-treated patients, respectively, achieved sPGA 0/1 (P<0.001); 85.7 and 69.7 percent achieved PASI 75 (P<0.001); and 40.5% and 20.1 percent achieved PASI 100

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