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Kristian Reich, Kimberley Jackson, Susan Ball, Sandra Garces, Lisa Kerr, Laiyi Chua, Talia M Muram, Andrew Blauvelt
Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is efficacious for moderate-to-severe plaque psoriasis. We examined relationships between serum ixekizumab concentrations, treatment-emergent anti-drug antibodies (TE-ADA), and efficacy during 60 weeks of treatment in a randomized, controlled, phase 3 study. Steady-state ixekizumab serum trough concentrations were rapidly achieved and associated with high clinical responses at week 12 with a starting dose of 160 mg followed by 80 mg every 2 weeks...
May 8, 2018: Journal of Investigative Dermatology
C Ryan, A Menter, L Guenther, A Blauvelt, R Bissonnette, K Meeuwis, J Sullivan, J C Cather, G Yosipovitch, A B Gottlieb, J F Merola, K Callis Duffin, S Fretzin, O O Osuntokun, R Burge, A N Naegeli, F E Yang, C-Y Lin, K Todd, A Potts Bleakman
BACKGROUND: Genital psoriasis (GenPs) is a common, debilitating, and difficult to treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. OBJECTIVE: To determine the efficacy of ixekizumab versus placebo in patients with moderate-to-severe GenPs with BSA≥1%. METHODS: Subjects with moderate-to-severe GenPs (defined as a baseline static Physician's Global Assessment of Genitalia [sPGA-G] score of ≥3) with BSA≥1% were randomized 1:1 to receive placebo (N=74) or the recommended dosing of ixekizumab (N=75)...
May 10, 2018: British Journal of Dermatology
Logan W Thomas, Erica B Lee, Jashin J Wu
Three main biologics target the IL-17 pathway; these include secukinmab, ixekizumab, brodalumab, all of which are approved for treatment of moderate-to-severe plaque psoriasis. We performed a systematic review of the literature to determine if IL-17 inhibitors are prone to developing ADA and how efficacy of treatment is influenced. A total of 14 papers were reviewed. Only one secukinmab trial detected treatment-emergent ADA in 4 out of 996 (0.41%) patients during the 52-week treatment period. Two of these patients (1 on 150-mg retreatment as needed and 1 on 150-mg fixed interval) were found to have neutralizing antibodies, however they were not associated with decreased efficacy...
May 8, 2018: Journal of Dermatological Treatment
Lajos Kemény, Lovisa Berggren, Martin Dossenbach, Yves Dutronc, Carle Paul
PURPOSE: To evaluate short- and long-term efficacy and safety of ixekizumab in patients according to psoriasis severity. MATERIALS AND METHODS: Data were integrated from clinical trials (UNCOVER-2, UNCOVER-3). Patients received placebo, 80-mg ixekizumab every 2 weeks (IXEQ2W), every 4 weeks (IXEQ4W), or 50-mg etanercept (ETN) biweekly for 12 weeks, then open-label IXEQ4W (UNCOVER-3). Psoriasis severity was categorized by baseline Psoriasis Area and Severity Index (PASI <20 and ≥20)...
May 4, 2018: Journal of Dermatological Treatment
Erica B Lee, Mina Amin, Tina Bhutani, Jashin J Wu
Many new biologics are being studied for use in psoriasis. In this review, we evaluate and summarize findings about emerging biologic therapies for psoriasis. We reviewed published data from phase 2 and 3 clinical trials of 2 IL-17 inhibitors (ixekizumab and brodalumab); 3 IL-23 inhibitors (guselkumab, tildrakizumab, and risankizumab); and 1 tumor necrosis factor (TNF) inhibitor (certolizumab pegol). Janus kinase inhibitors were not included in our review, as they currently are not approved by the US Food and Drug Administration (FDA) and there are no plans to further develop this class for treatment of psoriasis...
March 2018: Cutis; Cutaneous Medicine for the Practitioner
Jashin J Wu, Steven R Feldman, Shipra Rastogi, Brandy Menges, Melissa Lingohr-Smith, Jay Lin
PURPOSE: To compare the cost-effectiveness of the newly approved biologic drug, brodalumab, with other commonly used biologics for the treatment of moderate-to-severe psoriasis in the U.S. METHODS: An economic model was constructed in Excel to compare average costs to achieve Psoriasis Area and Severity Index (PASI) 75, 90, and 100 among moderate-to-severe psoriasis patients treated with biologics. Total annual costs to health plans associated with treatment with 5 different biologics were estimated and cost-effectiveness compared using the estimated average cost per PASI 75, PASI 90, and PASI 100...
April 16, 2018: Journal of Dermatological Treatment
Claus Zachariae, Kenneth Gordon, Alexandra Kimball, Mark Lebwohl, Andrew Blauvelt, Craig Leonardi, Daniel Braun, Missy McKean-Matthews, Russel Burge, Gregory Cameron
BACKGROUND: Ixekizumab has demonstrated improvement in moderate-to-severe psoriasis patients by selectively targeting interleukin-17A, a pro-inflammatory cytokine important in psoriasis pathogenesis. OBJECTIVE: To report 4-year efficacy and safety results from the open-label extension (OLE) of this phase 2 trial. METHODS: Analysis was by last observation carried forward. Patients received ixekizumab 120 mg then 80 mg subcutaneously once every 4 weeks...
April 10, 2018: Journal of the American Academy of Dermatology
April W Armstrong, Keith A Betts, James E Signorovitch, Murali Sundaram, Junlong Li, Arijit X Ganguli, Eric Q Wu
BACKGROUND: The clinical benefits of biologic therapies for moderate-to-severe psoriasis are well established, but wide variations exist in patient response. OBJECTIVES: To determine the number needed to treat (NNT) to achieve a 75% and 90% reduction in the Psoriasis Area and Severity Index (PASI-75/90) with FDA-approved agents and evaluate the incremental cost per PASI-75 or PASI-90 responder. METHODS: The relative probabilities of achieving PASI-75 and PASI-90, as well as NNTs, were estimated using a network meta-analysis...
April 23, 2018: Current Medical Research and Opinion
Andrew Blauvelt, Kim A Papp, Christopher E M Griffiths, Luis Puig, Jamie Weisman, Yves Dutronc, Lisa Farmer Kerr, Dapo Ilo, Lotus Mallbris, Matthias Augustin
The article Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3) written by Andrew Blauvelt.
March 29, 2018: American Journal of Clinical Dermatology
P Fleming
No abstract text is available yet for this article.
March 2018: British Journal of Dermatology
Joseph F Merola, David A Amato, Kyoungah See, Russel Burge, Craig Mallinckrodt, Clement K Ojeh, Alice Gottlieb
Clinical outcome measures are becoming more important in psoriasis treatment. Reliable and standardized measures of severity feasible for clinical practice are needed. Our objective was to investigate BSA and the product of BSA and sPGA (BSA*sPGA) as potential proxy measures for PASI scores. Data were pooled from three multicenter, randomized, double-blind, placebo-controlled, phase 3 trials of ixekizumab in patients with moderate-to-severe psoriasis (UNCOVER-1, -2, -3; N=3866). Assessments included PASI, BSA, and BSA*sPGA...
March 22, 2018: Journal of Investigative Dermatology
Alice B Gottlieb, Kim A Papp, Charles A Birbara, Catherine L Shuler, Russel Burge, Janelle Erickson, Lisa Kerr, Philip J Mease
No abstract text is available yet for this article.
March 17, 2018: Journal of the American Academy of Dermatology
Sebastian Spindeldreher, Bernard Maillère, Evelyne Correia, Maxime Tenon, Anette Karle, Philip Jarvis, Frank Kolbinger
In the original publication, information regarding "ustekinumab" was incorrectly published under the Methods section. The correct information in the section "Antibodies and Control Protein" should be "(secukinumab, 150 mg/mL; ixekizumab, 90 mg/mL; adalimumab, 50 mg/mL; ustekinumab 90 mg/ml)". Infliximab, which is mentioned in that section, was not used in the study.
March 17, 2018: Dermatology and Therapy
Jose-Manuel Carrascosa, Ira Jacobs, Danielle Petersel, Robert Strohal
Psoriasis is a chronic, inflammatory, lifelong disease with a high prevalence (afflicting approximately 1-5% of the population worldwide) and is associated with significant morbidity. The introduction of biologic therapies has improved the management of this disease. Multiple biologic medicines that block cytokine signaling, including tumor necrosis factor (TNF) antagonists (adalimumab, etanercept, and infliximab) and inhibitors of interleukin (IL)-17 (brodalumab, ixekizumab, and secukinumab), IL-23 (guselkumab), or IL-12/23 (ustekinumab), are approved for the treatment of psoriasis...
March 16, 2018: Dermatology and Therapy
Alexander Egeberg, Jashin J Wu, Neil Korman, James A Solomon, Orin Goldblum, Fangyi Zhao, Lotus Mallbris
BACKGROUND: The impact of ixekizumab treatment for psoriasis on cardiovascular-related parameters in patients is unknown. OBJECTIVE: We investigated 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/-2/-3). At week 12, responders were re-randomized to receive placebo or ixekizumab through the maintenance period (Weeks 12-60; UNCOVER-1/-2)...
March 13, 2018: Journal of the American Academy of Dermatology
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
(no author information available yet)
No abstract text is available yet for this article.
February 2018: Australian Prescriber
Bram L T Ramaekers, Robert F Wolff, Xavier Pouwels, Marije Oosterhoff, Anoukh Van Giessen, Gill Worthy, Caro Noake, Nigel Armstrong, Jos Kleijnen, Manuela A Joore
The National Institute for Health and Care Excellence invited Eli Lilly and Company Ltd, the company manufacturing ixekizumab (tradename Taltz® ), to submit evidence for the clinical and cost effectiveness of ixekizumab. Ixekizumab was compared with tumour necrosis factor-α inhibitors (etanercept, infliximab, adalimumab), ustekinumab, secukinumab, best supportive care and, if non-biological treatment or phototherapy is suitable, also compared with systemic non-biological therapies and phototherapy with ultraviolet B radiation for adults with moderate-to-severe plaque psoriasis...
February 26, 2018: PharmacoEconomics
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 2018: Expert Opinion on Emerging Drugs
Neil H Shear, Carle Paul, Andrew Blauvelt, Melinda Gooderham, Craig Leonardi, Kristian Reich, Mamitaro Ohtsuki, Beth Pangallo, Wen Xu, Susan Ball, Terri Ridenour, Hitoe Torisu-Itakura, Noah Agada, Lotus Mallbris
<p>BACKGROUND: Injection-site reactions (ISRs) are reported with biologic therapies. The objective of this study was to comprehensively characterize ISRs among moderate-to-severe psoriasis patients treated with ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A.</p> <p>METHODS: ISRs are presented from UNCOVER-1, UNCOVER-2, and UNCOVER-3 (12 weeks) and all ixekizumab-exposed patients in 11 controlled and uncontrolled trials (156 weeks).</p> <p>RESULTS: At week 12, reported ISR frequency with 80 mg ixekizumab every 2 weeks (IXE Q2W, 16...
February 1, 2018: Journal of Drugs in Dermatology: JDD
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