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Kristian Reich, Craig Leonardi, Mark Lebwohl, Francisco Kerdel, Yukari Okubo, Ricardo Romiti, Orin Goldblum, Ellen B Dennehy, Lisa Kerr, Howard Sofen
BACKGROUND: Scalp is a frequently affected and difficult-to-treat area in psoriasis patients. OBJECTIVES: We assessed the efficacy of ixekizumab in the treatment of patients with scalp psoriasis over 60 weeks using the Psoriasis Scalp Severity Index (PSSI). METHODS: In three Phase 3, multicenter, double-blind, placebo-controlled trials, patients with moderate-to-severe psoriasis in UNCOVER-1 (N = 1296), UNCOVER-2 (N = 1224), and UNCOVER-3 (N = 1346) were randomized to subcutaneous 80 mg ixekizumab every 2 weeks (Q2W) or every 4 weeks (Q4W) after a 160 mg starting dose, or placebo through Week 12...
October 19, 2016: Journal of Dermatological Treatment
Hidehisa Saeki, Hidemi Nakagawa, Ko Nakajo, Taeko Ishii, Yoji Morisaki, Takehiro Aoki, Gregory S Cameron, Olawale O Osuntokun
Psoriasis, a chronic, immune-mediated skin disease characterized by red, scaly plaques, affects approximately 0.3% of the population in Japan. The aim of this open-label study was to evaluate the long-term efficacy and safety of ixekizumab, a humanized, anti-interleukin-17A monoclonal antibody, in Japanese patients with plaque psoriasis (n = 78, including 11 psoriatic arthritis), erythrodermic psoriasis (n = 8) and generalized pustular psoriasis (n = 5). Ixekizumab was administrated s.c. at baseline (week 0, 160 mg), from weeks 2 to 12 (80 mg every 2 weeks), and from weeks 16 to 52 (80 mg every 4 weeks)...
October 11, 2016: Journal of Dermatology
M Galluzzo, S D'Adamio, L Bianchi, M Talamonti
Psoriasis is a complex disease in which the alteration of the IL-23/Th17 axis appears to be crucial for its pathogenic mechanisms, and anti-IL17 agents are rapidly becoming important therapeutic tools. Brodalumab, a fully human Chinese hamster ovary cell-derived immunoglobulin G2 (IgG2) anti-IL-17RA monoclonal antibody, is currently the most-developed treatment that binds to the IL-17RA. The authors review and provide updates of efficacy and safety by several studies on brodalumab. Areas covered: A PubMed search was performed for relevant literature...
October 10, 2016: Expert Review of Clinical Immunology
A B Gottlieb, J-P Lacour, N Korman, S Wilhelm, Y Dutronc, A Schacht, J Erickson, L Zhang, L Mallbris, S Gerdes
BACKGROUND: Biologics are effective for the treatment of psoriasis. However, treatment outcomes may differ among biologic-naïve patients and those switched from previous biological therapies. OBJECTIVES: The study's objective was to investigate efficacy and safety of ixekizumab, a high-affinity anti-interleukin-17A antibody, in patients with psoriasis with and without previous exposure to biologics. METHODS: Data were integrated from the 12-week induction phase of 2 etanercept-controlled Phase III trials...
October 1, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
Alexandra B Kimball, Thomas Luger, Alice Gottlieb, Luis Puig, Roland Kaufmann, Enkeleida Nikaï, Baojin Zhu, Emily Edson-Heredia, Hilde Carlier, Chen-Yen Lin, Orin Goldblum, Gil Yosipovitch
BACKGROUND: Itch is a prevalent symptom of psoriasis that impacts quality of life. OBJECTIVE: We sought to describe improvements in itch severity, skin pain, and bothersomeness of skin appearance caused by psoriasis among patients who received ixekizumab, etanercept, or placebo in three 12-week, phase III clinical trials (UNCOVER-1, -2, and -3). METHODS: The itch numeric rating scale evaluated psoriasis itch severity in all 3 trials. Skin pain was assessed by skin pain visual analog scale...
September 27, 2016: Journal of the American Academy of Dermatology
Trang T Vu H, Melinda Gooderham, Kim Papp
The interleukin (IL)-17 family of cytokines has emerged as an important pro-inflammatory mediator of psoriasis and psoriatic arthritis (PsA). Ixekizumab is an IL17A inhibitor that has been approved for the treatment of chronic plaque psoriasis. Phase III studies of ixekizumab in treating of PsA demonstrated promise by minimizing disease severity and progression. Areas covered: This review focuses on the biologic properties, pharmacokinetics and key clinical trial results that demonstrated the safety and efficacy of ixekizumab in treating psoriatic disease...
October 3, 2016: Expert Review of Clinical Pharmacology
Molly Campa, Alan Menter
INTRODUCTION: Interleukin-17 has recently been identified as a key player in the pathogenesis of psoriasis. As such, several drugs targeting IL-17 are in various stages of clinical development. AREAS COVERED: In this review, the authors describe several emerging therapies and drug candidates targeting IL-17. The authors detail many biologic injectable drug candidates as well as numerous potential oral and topical small molecule drug candidates. EXPERT OPINION: Approval of IL-17 inhibitors has significantly improved the treatment options for psoriasis patients...
September 30, 2016: Expert Opinion on Investigational Drugs
Agnieszka Wasilewska, Marta Winiarska, Małgorzata Olszewska, Lidia Rudnicka
Psoriasis is a chronic skin disease caused by the excessive secretion of inflammatory cytokines. Available therapeutic options include biologic drugs such as tumor necrosis factor alpha inhibitors and interleukin 12/23 (IL-12/23) inhibitors. The recent discovery of IL-17, which contributes to development of psoriasis, opened new possibilities for further treatment modalities. Currently, one anti-IL17 biological agent is approved for the treatment - a fully human monoclonal antibody that targets IL-17A (secukinumab)...
August 2016: Postȩpy Dermatologii i Alergologii
Daniel A Hussar, Christine A Dimaculangan
No abstract text is available yet for this article.
September 2016: Journal of the American Pharmacists Association: JAPhA
D M Saunte, U Mrowietz, L Puig, C Zachariae
The recognition of the central role of interleukin 17A (IL-17A) in the pathogenesis of psoriasis has led to the development of several monoclonal antibodies targeting this cytokine or its receptors for therapeutic purposes. IL-17A also plays an important role in the immunological protection against infections, especially those due to Candida sp., as evidenced by findings in patients with genetic defects in IL-17 related immune responses. To assess the potential of anti-Il-17 treatment to promote Candida infections, here we have systematically reviewed published clinical trials of patients with psoriasis or psoriatic arthritis...
August 31, 2016: British Journal of Dermatology
Andrea Chiricozzi, Marco Romanelli, Rosita Saraceno, Tiago Torres
INTRODUCTION: An emerging class of agents blocking IL-17 signaling represents a very promising therapeutic approach. One of these agents, brodalumab, has been associated with an increased risk of suicide behavior. AREAS COVERED: This review sought to provide an overview strictly focused on suicide behavior signals related to the use of IL-17 agents. Data collection regarding this peculiar safety aspect was primarily based on: (i) a revision of safety outcomes belonging to phase II and phase III trials; (ii) a systematic search using the Pubmed Medline database; and (iii) collecting recent data issued as posters or communications in eminent international meetings...
August 24, 2016: Expert Opinion on Drug Safety
Philip J Mease, Désirée van der Heijde, Christopher T Ritchlin, Masato Okada, Raquel S Cuchacovich, Catherine L Shuler, Chen-Yen Lin, Daniel K Braun, Chin H Lee, Dafna D Gladman
OBJECTIVE: To assess the safety and efficacy of ixekizumab, a monoclonal antibody that inhibits interleukin-17A, in a double-blind phase III trial enrolling patients with active psoriatic arthritis (PsA). METHODS: Patients naive to biologic therapy with active PsA were randomised to subcutaneous injections of placebo (N=106), adalimumab 40 mg once every 2 weeks (active reference; N=101), ixekizumab 80 mg once every 2 weeks (IXEQ2W) (N=103), or ixekizumab 80 mg once every 4 weeks (IXEQ4W) (N=107)...
August 23, 2016: Annals of the Rheumatic Diseases
Ellen B Dennehy, Lu Zhang, David Amato, Orin Goldblum, Phoebe Rich
BACKGROUND: Ixekizumab, a monoclonal antibody that selectively targets interleukin-17A, has been established as safe and effective in 3 Phase 3 trials for the treatment of moderate to severe plaque psoriasis. The lifetime incidence of psoriatic nail disease is 80%-90% of patients, and approximately 50% of patients with psoriasis have nail involvement.<BR /> MATERIALS AND METHODS: The design of UNCOVER-3, a Phase 3, multicenter, double-blind, placebo- and active-controlled trial that evaluated the efficacy and safety of ixekizumab for moderate to severe psoriasis, has been published previously...
August 1, 2016: Journal of Drugs in Dermatology: JDD
W Rungapiromnan, Z Z N Yiu, R B Warren, C E M Griffiths, D M Ashcroft
BACKGROUND: Concerns have been raised regarding an increased risk of major adverse cardiovascular events (MACEs) (myocardial infarction, cerebrovascular accident, or cardiovascular death) in patients treated with anti-interleukin (IL)-12/23 agents for moderate-to-severe psoriasis. OBJECTIVE: To examine the risk of MACEs in adult patients with plaque psoriasis that are exposed to biologic therapies via a meta-analysis of randomised controlled trials (RCTs). METHODS: (i) Data sources: Systematic searches were performed in the Cochrane Library, MEDLINE and EMBASE, US Food and Drug Administration, European Medicines Agency, individual pharmaceutical companies online search platforms and 5 trials registers (until 31 March 2016)...
August 12, 2016: British Journal of Dermatology
K Callis Duffin, J Bagel, M Bukhalo, I J Clement, S L Choi, F Zhao, A Gill, B Pangallo, C Shuler, L Mallbris, K Jackson
BACKGROUND: The efficacy of ixekizumab, an anti-interleukin-17A (anti-IL-17A) monoclonal IgG4 antibody, was demonstrated in moderate-to-severe psoriasis patients when administered via prefilled syringe (PFS). OBJECTIVE: To evaluate the effect of two drug delivery devices on the pharmacokinetics (PK) of ixekizumab as well as efficacy and safety with both devices. METHODS: In the first 12 weeks of an open-label, phase 3 study, moderate-to-severe psoriasis patients were randomized to ixekizumab delivery via PFS or autoinjector device...
August 8, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
A Simon Pickard, Melinda Gooderham, Dipl-Vw Susanne Hartz, Claudia Nicolay
AIMS: To determine if EuroQoL 5-Dimension Health Questionnaire (EQ-5D) health utility scores were able to discriminate among different levels of improvement in psoriasis severity following therapy. MATERIALS AND METHODS: Data were from three placebo-controlled phase 3 ixekizumab studies (UNCOVER-1, UNCOVER-2, and UNCOVER-3) with patients who had baseline Dermatology Life Quality Index scores >10 (DLQI >10). Psoriasis severity (Psoriasis Area and Severity Index [PASI]), general health utility (EQ-5D), and psoriasis-specific utility (EQ-PSO, UNCOVER-3 only) were assessed...
July 29, 2016: Journal of Medical Economics
Carolyn Stull, Shoshana Grossman, Gil Yosipovitch
Pruritus is a common and significant symptom among patients with psoriasis. Pruritus is often present beyond the borders of psoriatic plaques, and frequently affects the scalp and genital regions. Psoriatic itch may be severe and can profoundly affect quality of life and sleep, even in the context of mild-to-moderate disease. These features often make the treatment of psoriatic pruritus challenging. However, there are a variety of effective topical and systemic treatment modalities available to address this symptom...
July 26, 2016: American Journal of Clinical Dermatology
Dennis J Cada, Uzoma Mbogu, Ross J Bindler, Danial E Baker
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are sent in print and are also available on-line...
June 2016: Hospital Pharmacy
Michele B Kaufman
Obiltoxaximab injection (Anthim) for anthrax infection; ixekizumab (Taltz) for psoriasis; and reslizumab (Cinqair) for severe asthma.
June 2016: P & T: a Peer-reviewed Journal for Formulary Management
Kenneth B Gordon, Andrew Blauvelt, Kim A Papp, Richard G Langley, Thomas Luger, Mamitaro Ohtsuki, Kristian Reich, David Amato, Susan G Ball, Daniel K Braun, Gregory S Cameron, Janelle Erickson, Robert J Konrad, Talia M Muram, Brian J Nickoloff, Olawale O Osuntokun, Roberta J Secrest, Fangyi Zhao, Lotus Mallbris, Craig L Leonardi
BACKGROUND: Two phase 3 trials (UNCOVER-2 and UNCOVER-3) showed that at 12 weeks of treatment, ixekizumab, a monoclonal antibody against interleukin-17A, was superior to placebo and etanercept in the treatment of moderate-to-severe psoriasis. We report the 60-week data from the UNCOVER-2 and UNCOVER-3 trials, as well as 12-week and 60-week data from a third phase 3 trial, UNCOVER-1. METHODS: We randomly assigned 1296 patients in the UNCOVER-1 trial, 1224 patients in the UNCOVER-2 trial, and 1346 patients in the UNCOVER-3 trial to receive subcutaneous injections of placebo (placebo group), 80 mg of ixekizumab every 2 weeks after a starting dose of 160 mg (2-wk dosing group), or 80 mg of ixekizumab every 4 weeks after a starting dose of 160 mg (4-wk dosing group)...
July 28, 2016: New England Journal of Medicine
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