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Jawad Bilal, Adam Berlinberg, Sandipan Bhattacharjee, Jaren Trost, Irbaz Bin Riaz, Drew J B Kurtzman
OBJECTIVE: To systematically analyze the efficacy and safety of interleukin (IL)-12/23, IL-17, and selective IL-23 inhibitors in moderate to severe plaque psoriasis. METHODS AND RESULTS: 24 randomized placebo-controlled trials were included. Compared to placebo, risk ratios (RR) of achieving PASI-75 and PGA/IGA 0/1 respectively were 20.20 (95% CI 13.82-29.54, p < 0.00001) and 14.55 (10.42-20.31, p < 0.00001) for ustekinumab 90mg, 13.75 (8.49-22.28, p < 0...
March 13, 2018: Journal of Dermatological Treatment
Hannah A Blair
Brodalumab (Kyntheum® ) is a human anti-interleukin-17 receptor A (IL-17RA) monoclonal antibody available for use in patients with moderate to severe plaque psoriasis. In the phase III AMAGINE trials in this patient population, 12 weeks of induction therapy with subcutaneous brodalumab was superior to placebo in terms of the proportion of patients with ≥ 75% improvement in the Psoriasis Area and Severity Index score (PASI 75) and the proportion of patients with a static Physician Global Assessment score of 0 or 1...
March 8, 2018: Drugs
A B Gottlieb, K Gordon, S Hsu, B Elewski, L F Eichenfield, L Kircik, S Rastogi, R Pillai, R Israel
BACKGROUND: Patients with psoriasis have lesional symptoms, including itch, which can reduce quality of life. The efficacy and safety of brodalumab, an interleukin-17 receptor A antagonist, in treating moderate-to-severe psoriasis have been reported in 3 randomized, controlled, phase 3 trials (AMAGINE-1/-2/-3). OBJECTIVE: The effect of brodalumab on lesional symptoms was assessed using the psoriasis symptom inventory (PSI), a validated patient-reported instrument...
March 6, 2018: Journal of the European Academy of Dermatology and Venereology: JEADV
K A Papp, K B Gordon, R G Langley, M G Lebwohl, A B Gottlieb, S Rastogi, R Pillai, R J Israel
BACKGROUND: Biologics used increasingly used for treating moderate-to-severe psoriasis. Efficacy may differ in patients with previous biologics exposure. OBJECTIVE: To investigate the impact of previous biologic exposure on efficacy and safety of brodalumab and ustekinumab in moderate-to-severe plaque psoriasis. METHODS: Two placebo- and ustekinumab-controlled phase 3 clinical trials. Initial 12-week induction phase where patients were treated with brodalumab (210mg Q2W or 140mg Q2W), ustekinumab or placebo...
February 28, 2018: British Journal of Dermatology
Judith Rademacher, Denis Poddubnyy
The treatment of axial spondyloarthritis(axSpA) has been for nearly 15 years constricted to non-steroidal antirheumatic drugs and TNFα inhibitors. With the approval of secukinumab, a drug targeting the interleukin(IL)-17 axis became available. Nonetheless, an unmet need for further emerging therapeutic options remains. Areas covered: This review summarizes the recent and ongoing clinical trials with novel drugs in axSpA. Besides secukinumab, further therapeutics directed against the IL-17A (e.g. ixekizumab) as well as the dual IL-17A and F inhibitor bimekizumab and the IL-17RA antibody brodalumab are in development...
March 1, 2018: Expert Opinion on Emerging Drugs
Kevin L Winthrop, Xavier Mariette, Jose T Silva, Esther Benamu, Leonard H Calabrese, Alexandre Dumusc, Josef S Smolen, José María Aguado, Mario Fernández-Ruiz
BACKGROUND: The present review is part of the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies. AIMS: To review, from an Infectious Diseases perspective, the safety profile of agents targeting interleukins, immunoglobulins and complement factors and to suggest preventive recommendations. SOURCES: Computer-based MEDLINE searches with MeSH terms pertaining to each agent or therapeutic family...
February 12, 2018: Clinical Microbiology and Infection
Anne M Loos, Shanshan Liu, Celia Segel, Daniel A Ollendorf, Steven D Pearson, Jeffrey A Linder
BACKGROUND: The comparative effectiveness of available targeted immunomodulators for moderate-to-severe psoriasis has not been evaluated. OBJECTIVE: To evaluate the comparative effectiveness of targeted immunomodulators for adults with moderate-to-severe plaque psoriasis. METHODS: Systematic literature review of placebo-controlled and head-to-head randomized trials of eight targeted immunomodulators that evaluated clinical benefits or harms...
February 10, 2018: Journal of the American Academy of Dermatology
Steven R Feldman, Jashin J Wu, Shipra Rastogi, Brandy Menges, Melissa Lingohr-Smith, Jay Lin
INTRODUCTION: Brodalumab is a new biologic approved by the U.S. Food and Drug Administration in 2017 for the treatment of moderate-severe psoriasis. We evaluated the impact of the introduction of brodalumab on the pharmacy budget on U.S. commercial health plans. METHODS: An Excel-based health economic decision analytic model with a U.S. health plan perspective was developed. The model incorporated published moderate-to-severe psoriasis prevalence data; market shares of common biologic drugs, including adalimumab, ustekinumab, secukinumab, ixekizumab, and etanercept, used for the treatment of moderate-severe psoriasis; 2017-year Wholesale Acquisition Costs for the biologic drugs; drug dispensing fee; patient co-pay; and drug contracting discount...
January 22, 2018: Journal of Medical Economics
Scott M Whitlock, Clinton W Enos, April W Armstrong, Alice Gottlieb, Richard G Langley, Mark Lebwohl, Joseph F Merola, Caitriona Ryan, Michael P Siegel, Jeffrey M Weinberg, Jashin J Wu, Abby S Van Voorhees
BACKGROUND: There is a significant association between psoriasis and inflammatory bowel disease (IBD). Many treatments for psoriasis and psoriatic arthritis are also used for IBD. OBJECTIVE: To assess therapeutic options for patients with psoriasis and concurrent IBD. METHODS: A systematic literature search was performed for clinical studies of biologic and systemic psoriasis medications in psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn's disease, for the period from January 1, 1947, to February 14, 2017...
February 2018: Journal of the American Academy of Dermatology
Laura Sawyer, Iain Fotheringham, Emily Wright, Najeeda Yasmeen, Carl Gibbons, Anders Holmen Møller
PURPOSE: To evaluate the relative efficacy of brodalumab compared with approved biologic therapies and apremilast for moderate-to-severe psoriasis. METHODS: We searched MEDLINE, Embase and Cochrane for randomized controlled trials reporting induction phase responses. The primary analysis examined the proportion of patients achieving Psoriasis Area Severity Index (PASI) 50, 75, 90 or 100 responses using a random-effects Bayesian multinomial likelihood model with probit link, with and without adjustment for variation in study-level placebo responses...
January 11, 2018: Journal of Dermatological Treatment
Hélène Kaplon, Janice M Reichert
The pace of antibody therapeutics development accelerated in 2017, and this faster pace is projected to continue through 2018. Notably, the annual number of antibody therapeutics granted a first approval in either the European Union (EU) or United States (US) reached double-digits (total of 10) for the first time in 2017. The 10 antibodies granted approvals are: brodalumab, dupilumab, sarilumab, guselkumab, benralizumab, ocrelizumab, inotuzumab ozogamicin, avelumab, duvalumab, and emicizumab. Brodalumab, however, had already been approved in Japan in 2016...
January 4, 2018: MAbs
Daniel A Hussar, Mariya Kotova
No abstract text is available yet for this article.
January 2018: Journal of the American Pharmacists Association: JAPhA
Yifan Hu, Zeyu Chen, Yu Gong, Yuling Shi
Psoriasis is an immune-mediated polygenic inherited skin disease. Many biologic agents have been approved for the treatment of moderate-to-severe plaque psoriasis. The most commonly utilized biologics include TNF-α antagonists (etanercept, infliximab, and adalimumab), IL-12/23P40 antagonist (ustekinumab), IL-23P19 antagonist (guselkumab), IL-17A antagonist (secukinumab and ixekizumab), and IL-17RA antagonist (brodalumab). However, some patients may fail to respond well to their first biologic agent. Reasons for failure include primary failure (lack of initial efficacy), secondary failure (loss of efficacy over time) or the development of adverse effects...
December 16, 2017: Clinical Drug Investigation
Masahiro Kamata, Yayoi Tada
The advent of biologics brought a paradigm shift in ways to treat psoriatic patients because they have dramatic efficacy. At the same time, safety concerns about biologics have been raised. In this paper, we focus on the safety profile of biologics for psoriasis. As of 2017, six biologics are available in Japan. Two tumor necrosis factor-α inhibitors; infliximab and adalimumab, one anti-interleukin (IL)-12/23p40 antibody; ustekinumab, and IL-17 inhibitors; secukinumab, ixekizumab and brodalumab. Secukinumab and ixekizumab are anti-IL-17A antibodies...
March 2018: Journal of Dermatology
Geoffrey Mospan, Cortney Mospan, Shayna Vance, Alyssa Bradshaw, Kalyn Meosky, Kirklin Bowles
In 2017, the FDA approved several new drugs for use in primary care. This article highlights the following new drugs: brodalumab (Siliq), dapagliflozin and saxagliptin (Qtern), dupilumab (Dupixent), oxymetazoline (Rhofade), safinamide (Xadago), and sarilumab (Kevzara).
December 15, 2017: Nurse Practitioner
Mina Amin, Kavita Darji, Daniel J No, Tina Bhutani, Jashin J Wu
BACKGROUND: The development of biologic agents directed against distinct cytokines and receptors has advanced the therapeutic options available for psoriasis patients. Evidence from preclinical studies suggests that IL-17 may contribute to the pathogenesis of psoriasis. OBJECTIVE: The objective was to review the safety and efficacy profile for each IL-17 inhibitor by evaluating phase III clinical trial data. METHODS: We reviewed the results of phase III clinical trials for the IL-17 inhibitors secukinumab, ixekizumab, and brodalumab...
November 10, 2017: Journal of Dermatological Treatment
Mark G Lebwohl, Kim A Papp, Lauren B Marangell, John Koo, Andrew Blauvelt, Melinda Gooderham, Jashin J Wu, Shipra Rastogi, Susan Harris, Radhakrishnan Pillai, Robert J Israel
BACKGROUND: Individuals with psoriasis are at increased risk for psychiatric comorbidities, including suicidal ideation and behavior (SIB). OBJECTIVE: To distinguish between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis being treated with brodalumab, a fully human anti-interleukin 17 receptor A monoclonal antibody. METHODS: Data were evaluated from a placebo-controlled, phase 2 clinical trial; the open-label, long-term extension of the phase 2 clinical trial; and three phase 3, randomized, double-blind, controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3) and their open-label, long-term extensions of patients with moderate-to-severe psoriasis...
October 3, 2017: Journal of the American Academy of Dermatology
T Oiwa, T Honda, A Otsuka, K Kabashima
No abstract text is available yet for this article.
October 6, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
Hema N Viswanathan, Alex Mutebi, Cassandra E Milmont, Kenneth Gordon, Hilary Wilson, Hao Zhang, Paul A Klekotka, Dennis A Revicki, Matthias Augustin, Gregory Kricorian, Ajay Nirula, Bruce Strober
OBJECTIVES: The Psoriasis Symptom Inventory (PSI) is a patient-reported outcome instrument that measures the severity of psoriasis signs and symptoms. This study evaluated measurement properties of the PSI in patients with moderate to severe plaque psoriasis. METHODS: This secondary analysis used pooled data from a phase 3 brodalumab clinical trial (AMAGINE-1). Outcome measures included the PSI, Psoriasis Area and Severity Index (PASI), static Physician's Global Assessment (sPGA), psoriasis-affected body surface area, 36-item Short-Form Health Survey version 2, and the Dermatology Life Quality Index (DLQI)...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Xiao-Dong Fan, Xiang Xia, Chun-Yan Zhang, Wen-Qiang Kong, Chun-Yang Zhou, Biao DU
OBJECTIVE: To evaluate the efficacy and safety of anti-interleukin-17 antibody in the treatment of plaque psoriasis. METHDOS: Randomized controlled trials (RCT) of anti-interleukin-17 antibody (Secukinumab, Brodalumab, and Ixekizumab) in the treatment of plaque psoriasis published between January, 2000 and March, 2017 were searched from PubMed, Cochrane Library, EBSCO, EMbase, CBM, CNKI, VIPdetabase, and Wangfang database. The quality of the retrieved trials was evaluated and the results of studies were analyzed using RevMan 5...
September 20, 2017: Nan Fang Yi Ke da Xue Xue Bao, Journal of Southern Medical University
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