Alexander Egeberg1, Jashin J Wu2, Neil Korman3, James A Solomon4, Orin Goldblum5, Fangyi Zhao5, Lotus Mallbris5. 1. Herlev and Gentofte Hospital, Hellerup, Denmark. Electronic address: alexander.egeberg@gmail.com. 2. Kaiser Permanente Los Angeles Medical Center, Los Angeles, California. 3. University Hospitals Case Medical Center, Cleveland, Ohio. 4. Ameriderm Research, Ormond Beach, Florida; University of Central Florida, Orlando, Florida; University of Illinois, Urbana, Illinois. 5. Eli Lilly and Company, Indianapolis, Indiana.
Abstract
BACKGROUND: The impact of ixekizumab treatment for psoriasis on cardiovascular-related parameters in patients is unknown. OBJECTIVE: To investigate cardiovascular-related parameters in patients with psoriasis treated with ixekizumab. METHODS: In phase 3 trials, patients with moderate-to-severe psoriasis were randomized and treated with placebo, ixekizumab, or etanercept during the induction period (weeks 0-12; UNCOVER-1, UNCOVER-2, and UNCOVER-3). At week 12, responders were rerandomized to receive placebo or ixekizumab through the maintenance period (weeks 12-60; UNCOVER-1 and UNCOVER-2). Laboratory measures (fasting lipid profiles, glucose level, or high-sensitivity C-reactive protein [hsCRP] level), weight, blood pressure, and electrocardiograms were obtained through 60 weeks. RESULTS: Baseline parameters were within normal ranges with the exception of elevated triglyceride and hsCRP levels. After maintenance dosing, no significant changes were observed versus placebo for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, triglyceride, apolipoprotein A1, apolipoprotein B, or fasting glucose levels or for systolic/diastolic blood pressure at 60 weeks. Importantly, low-density lipoprotein-to-high-density lipoprotein ratios remained stable during the induction and maintenance periods. HsCRPconcentrations were significantly reduced versus placebo at 12 weeks and remained reduced at 60 weeks, although not significantly. Although transient changes were observed for some parameters during the induction period, these changes did not persist into the maintenance period. LIMITATIONS: A lack of echocardiogram evaluations. CONCLUSIONS:Ixekizumab had a neutral impact on cardiovascular-related parameters in patients with psoriasis.
RCT Entities:
BACKGROUND: The impact of ixekizumab treatment for psoriasis on cardiovascular-related parameters in patients is unknown. OBJECTIVE: To investigate cardiovascular-related parameters in patients with psoriasis treated with ixekizumab. METHODS: In phase 3 trials, patients with moderate-to-severe psoriasis were randomized and treated with placebo, ixekizumab, or etanercept during the induction period (weeks 0-12; UNCOVER-1, UNCOVER-2, and UNCOVER-3). At week 12, responders were rerandomized to receive placebo or ixekizumab through the maintenance period (weeks 12-60; UNCOVER-1 and UNCOVER-2). Laboratory measures (fasting lipid profiles, glucose level, or high-sensitivity C-reactive protein [hsCRP] level), weight, blood pressure, and electrocardiograms were obtained through 60 weeks. RESULTS: Baseline parameters were within normal ranges with the exception of elevated triglyceride and hsCRP levels. After maintenance dosing, no significant changes were observed versus placebo for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, triglyceride, apolipoprotein A1, apolipoprotein B, or fasting glucose levels or for systolic/diastolic blood pressure at 60 weeks. Importantly, low-density lipoprotein-to-high-density lipoprotein ratios remained stable during the induction and maintenance periods. HsCRP concentrations were significantly reduced versus placebo at 12 weeks and remained reduced at 60 weeks, although not significantly. Although transient changes were observed for some parameters during the induction period, these changes did not persist into the maintenance period. LIMITATIONS: A lack of echocardiogram evaluations. CONCLUSIONS:Ixekizumab had a neutral impact on cardiovascular-related parameters in patients with psoriasis.
Authors: Christopher E M Griffiths; Melinda Gooderham; Jean-Frederic Colombel; Tadashi Terui; Ana P Accioly; Gaia Gallo; Danting Zhu; Andrew Blauvelt Journal: Dermatol Ther (Heidelb) Date: 2022-05-27