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https://www.readbyqxmd.com/read/28632883/importance-of-immunogenicity-testing-for-cost-effective-management-of-psoriasis-patients-treated-with-adalimumab
#1
Fernando Mota, Esmeralda Neves, José Carlos Oliveira, Manuela Selores, Tiago Torres
INTRODUCTION: Up to 30% of patients treated with anti-tumor necrosis factor drugs do not respond adequately, and up to 50% lose response over time. Immunogenicity is now known to be one of the main causes of this loss of response. METHODS: Serum levels of adalimumab and anti-drug antibodies (ADAs) were measured in 19 patients with psoriasis. RESULTS: Eighty-nine percent of the patients were responders (Psoriasis Area Severity Index (PASI) > 75) and 11% were partial responders (PASI 50-75)...
June 2017: Acta Dermatovenerologica Alpina, Panonica, et Adriatica
https://www.readbyqxmd.com/read/28629323/fetal-death-in-utero-and-miscarriage-in-a-patient-with-crohn-s-disease-under-therapy-with-ustekinumab-case-report-and-review-of-the-literature
#2
C Venturin, S Nancey, P Danion, M Uzzan, M Chauvenet, C Bergoin, X Roblin, B Flourié, G Boschetti
BACKGROUND: Ustekinumab is a fully human monoclonal antibody against the p40 subunit of interleukin (IL) 12 and 23 which is involved in the pathogenesis of several inflammatory diseases. Ustekinumab is approved for psoriasis and psoriatic arthritis treatment and has been successfully evaluated in phase II and III trials for patients with Crohn's disease (CD). CASE PRESENTATION: We report here the case of a patient who became pregnant during treatment with ustekinumab for a refractory CD and which ended in miscarriage...
June 19, 2017: BMC Gastroenterology
https://www.readbyqxmd.com/read/28623612/challenges-in-longitudinal-exposure-response-modeling-of-data-from-complex-study-designs-a-case-study-of-modeling-cdai-score-for-ustekinumab-in-patients-with-crohn-s-disease
#3
Chuanpu Hu, Omoniyi J Adedokun, Yang Chen, Philippe O Szapary, Christopher Gasink, Amarnath Sharma, Honghui Zhou
Informative exposure-response modeling of clinical endpoints is important in drug development to identify optimum dose and dosing regimens. Despite much recent progress in mechanism-based longitudinal modeling of clinical data, challenges remain in clinical trials of diseases such as Crohn's disease, where a commonly used composite endpoint Crohn's Disease Activity Index (CDAI) has considerable variation in its administration and scoring between different assessors and complex study designs typically include maintenance phases with randomized withdrawal re-randomizations and other response driven dose adjustments...
June 16, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28612180/immunogenicity-of-biologics-in-chronic-inflammatory-diseases-a-systematic-review
#4
REVIEW
Vibeke Strand, Alejandro Balsa, Jamal Al-Saleh, Leonor Barile-Fabris, Takahiko Horiuchi, Tsutomu Takeuchi, Sadiq Lula, Charles Hawes, Blerina Kola, Lisa Marshall
OBJECTIVES: A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety. METHODS: Literature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn's disease, and ulcerative colitis...
June 13, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28611632/infliximab-induced-aseptic-meningitis-during-the-treatment-of-psoriatic-arthritis
#5
Yuki Matsuura-Otsuki, Takaaki Hanafusa, Hiroo Yokozeki, Kyoko Watanabe
A 42-year-old Japanese man presented with persistent headache during treatment for psoriatic arthritis (PsA) with infliximab. Treatment with infliximab was initiated 3 years before and the psoriatic skin lesions with arthritis were well controlled. However, after 21 doses of infliximab, the skin lesions and joint pain exacerbated and became intractable. Ten days after the dosage of infliximab was increased, the patient experienced headache and nausea with high fever. He had scaly, well-circumscribed erythemas on his trunk, extremities, and deformed nails...
May 2017: Case Reports in Dermatology
https://www.readbyqxmd.com/read/28609574/factors-associated-with-the-choice-of-the-first-biologic-in-psoriasis-real-life-analysis-from-the-psobioteq-cohort
#6
Emilie Sbidian, Caroline Giboin, Hervé Bachelez, Carle Paul, Marie Beylot-Barry, Alain Dupuy, Manuelle Viguier, Jean-Philippe Lacour, Jean-Luc Schmutz, Pierre Bravard, Emmanuel Mahé, Nathalie Beneton, Laurent Misery, Emmanuel Delaporte, Philippe Modiano, Sébastien Barbarot, Elodie Regnier, Denis Jullien, Marie-Aleth Richard, Pascal Joly, Florence Tubach, Olivier Chosidow
BACKGROUND: Decision making is a complex process. The aim of our study was to assess factors associated with the choice of the first biological treatment in patients with moderate-to-severe psoriasis. METHODS: Data on all patients included in the French prospective, observational, cohort, Psobioteq and initiating a first biologic prescription between July 2012 and July 2016 were analysed. Demographic information and clinical features were collected during routine clinical assessments by the dermatology team at the recruiting centres using a standardized case report form...
June 13, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28608740/number-needed-to-treat-and-costs-per-responder-among-biologic-treatments-for-moderate-to-severe-plaque-psoriasis-in-japan
#7
Shinichi Imafuku, Ataru Nakano, Hidetoshi Dakeshita, Junlong Li, Keith A Betts, Annie Guerin
BACKGROUND: Biologics have been shown to improve the outcomes of patients with psoriasis but their cost is an issue. OBJECTIVE: Determine the number needed to treat (NNT) to achieve a 75%/90% reduction in the Psoriasis Area and Severity Index (PASI-75/90) and evaluate the incremental cost per PASI-75/90 responder (CPR) relative to placebo in Japan. METHODS: A network meta-analysis was conducted to estimate the relative probabilities of achieving PASI-75/90 and NNTs...
June 13, 2017: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/28602039/secukinumab-demonstrates-greater-sustained-improvements-in-daily-activities-and-personal-relationships-than-ustekinumab-in-patients-with-moderate-to-severe-plaque-psoriasis-52-week-results-from-the-clear-study
#8
A Blauvelt, K Reich, S Mehlis, F Vanaclocha, H Sofen, W Abramovits, Y Zhao, I Gilloteau, E Davenport, N Williams, A Guana, S Tyring
BACKGROUND: Psoriasis can greatly impact patients' lives by influencing clothing worn as well as by impairing sexual functioning. Secukinumab, a human monoclonal antibody selectively neutralizing interleukin-17A, has demonstrated good efficacy and safety in the treatment of moderate-to-severe psoriasis and psoriatic arthritis with a rapid onset of action and sustained response. OBJECTIVE: This analysis using the CLEAR study, a phase 3b double-blind study comparing the efficacy and safety of secukinumab versus ustekinumab in adults with moderate-to-severe plaque psoriasis, evaluated the treatment effects on patient's daily activities and personal relationships...
June 11, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28600818/extension-of-ustekinumab-maintenance-dosing-interval-in-moderate-to-severe-psoriasis-results-of-a-phase-3b-randomized-double-blinded-active-controlled-multicenter-study-pstellar
#9
A Blauvelt, L K Ferris, P S Yamauchi, A Qureshi, C L Leonardi, K Farahi, S Fakharzadeh, M-C Hsu, S Li, M Chevrier, K Smith, K Goyal, Y Chen, E J Muñoz-Elías, K Callis Duffin
BACKGROUND: Phase 3 studies showed some patients maintained response for ≥6 months post-ustekinumab discontinuation. OBJECTIVES: To assess clinical responses with extended ustekinumab maintenance dosing intervals. METHODS: Adults with moderate-to-severe plaque psoriasis received ustekinumab (45mg/90mg for weight ≤100 kg/>100 kg) at Week0, Week4, Week16 during open-label treatment. Patients achieving a Week 28 Physician's Global Assessment score of cleared/minimal (PGA=0/1) were randomized 1:4 to Group1 (approved every-12-weeks [q12wk] maintenance) or Group2 (q12-24wk response-based dosing determined by time-to-loss-of-PGA=0/1)...
June 10, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28581873/budget-impact-model-in-moderate-to-severe-psoriasis-vulgaris-assessing-effects-of-calcipotriene-and-betamethasone-dipropionate-foam-on-per-patient-standard-of-care-costs
#10
Carl V Asche, Minchul Kim, Steven R Feldman, Panagiotis Zografos, Minyi Lu
AIMS: To develop a budget impact model (BIM) for estimating the financial impact of formulary adoption and uptake of calcipotriene and betamethasone dipropionate (C/BD) foam (0.005%/0.064%) on the costs of biologics for treating moderate-to-severe psoriasis vulgaris in a hypothetical US healthcare plan with 1 million members. METHODS: This BIM incorporated epidemiologic data, market uptake assumptions, and drug utilization costs, simulating the treatment mix for patients who are candidates for biologics before (Scenario #1) and after (Scenario #2) the introduction of C/BD foam...
June 19, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28575273/positioning-ustekinumab-in-crohn-s-disease-from-clinical-evidence-to-clinical-practice
#11
Silvio Danese, Stefanos Bonovas, Laurent Peyrin-Biroulet
Biological medicines have revolutionized the treatment of Crohn's disease (CD). Yet, the management of patients not responding to tumor necrosis factor (TNF) antagonists remains a clinical challenge. Ustekinumab is a human monoclonal antibody blocking the biological activity of interleukins 12 and 23, which regulate the immune system and immune-mediated inflammatory disorders. It has recently been approved for the treatment of adult patients with moderately to severely active CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF antagonist, or have medical contraindications to such therapies...
June 2, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28573876/a-safety-assessment-of-biological-therapies-targeting-the-il-23-il-17-axis-in-inflammatory-bowel-diseases
#12
Bram Verstockt, Barbara Deleenheer, Gert Van Assche, Séverine Vermeire, Marc Ferrante
Many different compounds targeting the interleukin 23/17 axis have been developed and successfully studied in several autoimmune diseases, including inflammatory bowel diseases. Nevertheless, interfering with key immunological pathways raises potential safety concerns. This review focuses on the safety profile of these novel biological therapies. Areas covered: A literature search until March 2017 was performed to collect safety data on different compounds targeting this pathway, with emphasis on ustekinumab and secukinumab...
June 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28570371/prolongation-of-biologic-dosing-intervals-in-patients-with-stable-psoriasis-a-feasibility-study
#13
Ji S van Bezooijen, Martijn van Doorn, Marco W J Schreurs, Birgit C P Koch, Henk Te Velthuis, Errol P Prens, Teun van Gelder
BACKGROUND: Biologics are usually licensed according to the "one dose fits all" principle. It is therefore suspected that a significant number of psoriasis patients are overtreated. However, evidence for successful dose reduction of biologics in psoriasis is scarce. The aim of this study was to investigate whether the dosing interval of three biologics, adalimumab, etanercept, or ustekinumab could be prolonged successfully in patients with plaque psoriasis. METHODS: In a prospective exploratory cohort study, 59 psoriasis patients on maintenance treatment with adalimumab, etanercept, or ustekinumab were included...
May 31, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28567556/minimal-disease-activity-in-patients-with-psoriatic-arthritis-treated-with-ustekinumab-results-from-a-24-week-real-world-study
#14
Maddalena Napolitano, Luisa Costa, Francesco Caso, Matteo Megna, Raffaele Scarpa, Nicola Balato, Fabio Ayala, Anna Balato
Psoriatic arthritis (PsA) is a chronic inflammatory joint disease affecting around 40% of psoriasis patients. Minimal disease activity (MDA) criteria have been proposed to identify a state of low disease activity, one of the principal goals of treatment for psoriatic disease. This study investigated treatment with ustekinumab (UST) in the context of a real-world setting. Thirty-four PsA patients who had failure or inadequate response to conventional synthetic disease-modifying antirheumatic drugs or to anti-tumour necrosis factor alpha were enrolled...
May 31, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28562100/developments-with-experimental-and-investigational-drugs-for-axial-spondyloarthritis
#15
Gaëlle Clavel, Marie-Christophe Boissier, Johanna Sigaux, Luca Semerano
Axial spondyloarthritis (AxS pA) is a chronic inflammatory disease for which, until recently, there were no valid therapeutic alternatives to TNF-α blocking agents. This unmet clinical need led to explore several therapeutic targets, from proinflammatory cytokines to intracellular signaling systems. The recent approval of Secukinumab, an anti-IL-17A monoclonal antibody, marked a new step in the evolution of AxSpA treatment. Areas covered: the authors review and discuss all the biological or synthetic agents that are currently developed or that have been tested in AxSpA...
June 6, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28546254/response-to-ustekinumab-inhibits-th1-and-th17-polarisation-in-a-giant-cell-arteritis-patient-by-samson-et-al
#16
Richard Conway, Ursula Fearon, Eamonn S Molloy
No abstract text is available yet for this article.
May 25, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28543445/psoriasis-in-those-planning-a-family-pregnant-or-breast-feeding-the-australasian-psoriasis-collaboration
#17
REVIEW
Marius Rademaker, Karen Agnew, Megan Andrews, Katherine Armour, Chris Baker, Peter Foley, John Frew, Kurt Gebauer, Monisha Gupta, Debra Kennedy, Gillian Marshman, John Sullivan
The Australasian Psoriasis Collaboration has reviewed the evidence for managing moderate to severe psoriasis in those who are pregnant or are breast-feeding, or planning a family. The severity of the psoriasis, associated comorbidities and specific anti-psoriasis treatment, along with other exposures, can have a deleterious effect on pregnancy outcomes. Psoriasis itself increases the risk of preterm and low birthweight babies, along with spontaneous and induced abortions, but no specific birth defects have been otherwise demonstrated...
May 23, 2017: Australasian Journal of Dermatology
https://www.readbyqxmd.com/read/28542874/comparison-of-ixekizumab-with-ustekinumab-in-moderate-to-severe-psoriasis-24-week-results-from-ixora-s-a-phase-3-study
#18
K Reich, A Pinter, J P Lacour, C Ferrandiz, G Micali, L E French, M Lomaga, Y Dutronc, C Henneges, S Wilhelm, S Hartz, C Paul
BACKGROUND: The interleukin (IL)-23/IL-17 axis has been shown critical in the pathogenesis of psoriasis. OBJECTIVES: To present the primary endpoint (Week 12) and safety/efficacy data up to Week 24 from a head-to-head trial (IXORA-S) of the IL-17A inhibitor, ixekizumab (IXE), vs. the IL-12/23 inhibitor ustekinumab (UST). METHODS: Randomised patients received IXE (160-mg starting dose, then 80 mg every two weeks for 12 weeks, then 80 mg every four weeks, N=136) or UST (45 mg/90 mg weight-based dosing per label, N=166)...
May 19, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28532819/il-23-th17-targeted-therapies-in-sapho-syndrome-a-case-series
#19
Daniel Wendling, François Aubin, Frank Verhoeven, Clément Prati
SAPHO syndrome is a rare entity with skin and rheumatologic inflammatory presentation. The treatment is not standardized, and in case of inadequate response to anti inflammatory drugs, the use of anti TNF or anti IL-1 biologic treatments has been reported. The IL-23/Th17 axis may be involved in SAPHO syndrome. We report the results of six courses of IL-23 and IL-17 targeted therapies (3 ustekinumab and 3 secukinumab) in patients with SAPHO syndrome unresponsive to previous treatments (csDMARDs and bDMARDs)...
May 19, 2017: Joint, Bone, Spine: Revue du Rhumatisme
https://www.readbyqxmd.com/read/28528528/ustekinumab-a-review-in-moderate-to-severe-crohn-s-disease
#20
Yvette N Lamb, Sean T Duggan
Ustekinumab (Stelara(®)) has been recently approved in the EU and the USA as intravenous induction and subcutaneous maintenance therapy for adult patients with moderately to severely active Crohn's disease who have failed or were intolerant to treatment with immunomodulators, corticosteroids or at least one tumour necrosis factor (TNF) antagonist. Ustekinumab, a monoclonal antibody to the shared p40 subunit of the proinflammatory interleukin (IL)-12 and IL-23 cytokines, has a unique mechanism of action distinct from that of TNF antagonists...
May 20, 2017: Drugs
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