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Ustekinumab crohn's

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https://www.readbyqxmd.com/read/29220430/postoperative-outcomes-in-ustekinumab-treated-patients-undergoing-abdominal-operations-for-crohn-s-disease
#1
Amy L Lightner, Nicholas P McKenna, Chung Sang Tse, Neil Hyman, Radhika Smith, Gayane Ovsepyan, Phillip Fleshner, Kristen Crowell, Walter Koltun, Marc Ferrante, Andre D'Hoore, Nathalie Lauwers, Bram Verstockt, Antonino Spinelli, Francesca DiCandido, Laura E Raffals, Kellie L Mathis, Edward V Loftus
Introduction: Ustekinumab, a monoclonal antibody targeting interleukins-12 and -23 is used to treat adults with Crohn's disease (CD). We determined the 30-day postoperative infectious complication rate among CD patients who received ustekinumab within 12 weeks prior to an abdominal operation as compared to patients who received anti-tumor necrosis factor (TNF) agents. Methods: A retrospective chart review of adults with CD who underwent an abdominal operation between 1/1/2015 and 5/1/2017 was performed across six sites...
December 6, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29192397/ustekinumab-for-treating-moderately-to-severely-active-crohn-s-disease-after-prior-therapy-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#2
Robert Hodgson, Matthew Walton, Mousumi Biswas, Teumzghi Mebrahtu, Nerys Woolacott
As part of the single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited Janssen to submit evidence on the clinical and cost effectiveness of their drug ustekinumab, an interleukin-12/23 inhibitor, for treating moderate-to-severe active Crohn's disease (CD). The Centre for Reviews and Dissemination (CRD) and Centre for Health Economics (CHE) Technology Appraisal Group at the University of York was commissioned to act as the independent Evidence Review Group (ERG)...
November 30, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29180886/next-generation-of-biologics-for-the-treatment-of-crohn-s-disease-an-evidence-based-review-on-ustekinumab
#3
REVIEW
Aranzazu Jauregui-Amezaga, Michael Somers, Heiko De Schepper, Elisabeth Macken
The limited efficacy of the currently available medical therapies in a proportion of patients with Crohn's disease has led to the research and development of molecules that can block new inflammatory pathways. Ustekinumab is a fully human IgG1 monoclonal antibody which targets the common p40 subunit of the cytokines interleukin-12 as well as interleukin-23. Consequently, the Th1 and Th17 inflammatory responses are inhibited. Ustekinumab has been recently approved for its use in patients with Crohn's disease...
2017: Clinical and Experimental Gastroenterology
https://www.readbyqxmd.com/read/29142515/efficacy-and-safety-of-ustekinumab-in-japanese-patients-with-moderately-to-severely-active-crohn-s-disease-a-subpopulation-analysis-of-phase-3-induction-and-maintenance-studies
#4
Toshifumi Hibi, Yuya Imai, Yoko Murata, Nobuko Matsushima, Richuan Zheng, Christopher Gasink
Background/Aims: Efficacy and safety of ustekinumab were evaluated in a Japanese subpopulation with moderately to severely active Crohn's disease (CD) in UNITI-1, UNITI-2 and IM-UNITI studies and results were compared with the overall population. Methods: Overall, patients in UNITI-1 (Japan, n=56; failed response to tumor necrosis factor antagonist) and UNITI-2 (Japan, n=26; failed response to prior conventional therapy) were randomized to placebo or ustekinumab intravenous induction (130 mg or ~6 mg/kg) at week 0...
October 2017: Intestinal Research
https://www.readbyqxmd.com/read/29139091/pharmacological-approach-to-the-management-of-crohn-s-disease-patients-with-perianal-disease
#5
REVIEW
Fernando Bermejo, Iván Guerra, Alicia Algaba, Antonio López-Sanromán
Perianal localization of Crohn's disease involves significant morbidity, affects quality of life and results in an increased use of healthcare resources. Medical and surgical therapies contribute to its management. The objective of this review is to address the current understanding in the management of perianal Crohn's disease, with the main focus in reviewing pharmacological therapies, including stem cells. In complex fistulas, once local sepsis has been controlled by surgical drainage and/or antibiotics, anti-TNF drugs (infliximab, adalimumab) are the first-line therapy, with or without associated immunomodulators...
November 14, 2017: Drugs
https://www.readbyqxmd.com/read/29115855/an-indirect-comparison-of-ustekinumab-and-vedolizumab-in-the-therapy-of-tnf-failure-crohn-s-disease-patients
#6
Paweł Kawalec, Paweł Moćko
AIM: An indirect comparison of ustekinumab versus vedolizumab in patients with active moderate-to-severe Crohn's disease who were nonresponsive or intolerant to previous TNF-antagonist therapy. METHODS: A systematic review was performed in Medline via PubMed, Embase, Cochrane Library, until 30 April 2017. Inclusion criteria were: randomized controlled trials, patients treated for Crohn's disease, ustekinumab or vedolizumab therapy. Included trials were critically appraised and afterward indirect comparison by Bucher was conducted; the manuscript was prepared in accordance to the PRISMA requirements...
November 8, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/29045603/ustekinumab-drug-levels-in-maternal-and-cord-blood-in-a-woman-with-crohn-s-disease-treated-until-33-weeks-gestation
#7
Catherine R Rowan, Garret Cullen, Hugh E Mulcahy, Denise Keegan, Kathryn Byrne, Deirdre J Murphy, Juliette Sheridan, Glen A Doherty
A 35-year old woman with ileocolonic, perianal and vulval Crohn's disease was treated with subcutaneous ustekinuamb (USK) throughout pregnancy. Dose intervals were shortened from 6-weekly to 4-weekly to maintain clinical remission. The last dose of USK was administered at 33 weeks gestation and a healthy baby boy was delivered by caesarean section at 37 weeks. Maternal trough USK levels remained stable during pregnancy. Cord blood USK levels were nearly two-fold higher than contemporaneous maternal serum levels...
October 16, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29042094/ustekinumab-to-treat-crohn-s-disease
#8
Javier P Gisbert, María Chaparro
Ustekinumab is a monoclonal antibody directed against the p40 subunit, which is part of interleukins IL-12 and IL-23. The efficacy of ustekinumab versus placebo in terms of clinical response and remission of induction has been shown in phase3 clinical trials. When used as subcutaneous maintenance therapy, the therapeutic benefit of ustekinumab over placebo has been confirmed in both clinical response and remission in patients who have responded clinically to induction therapy. In addition, ustekinumab has demonstrated an improvement in mucosal healing parameters...
October 14, 2017: Gastroenterología y Hepatología
https://www.readbyqxmd.com/read/28961959/the-expanding-therapeutic-armamentarium-for-inflammatory-bowel-disease-how-to-choose-the-right-drug-s-for-our-patients
#9
Pieter Hindryckx, Niels Vande Casteele, Gregor Novak, Reena Khanna, Geert D'Haens, William J Sandborn, Silvio Danese, Vipul Jairath, Brian G Feagan
The therapeutic landscape for inflammatory bowel disease (IBD) is rapidly evolving. Two new biologic drugs, vedolizumab and ustekinumab, have recently entered the marketplace, the first biosimilars have been introduced, and several other agents are at an advanced stage of clinical development. In parallel, therapeutic goals have shifted from symptom control towards mucosal healing and prevention of bowel damage. In the coming years, gastroenterologists will be faced with unprecedented choices when selecting the best treatment for their patients with IBD...
August 25, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28885058/ustekinumab-use-in-crohn-s-disease-a-canadian-tertiary-care-centre-experience
#10
Astrid-Jane Greenup, Greg Rosenfeld, Brian Bressler
OBJECTIVES: Real world data regarding clinical response to ustekinumab in Crohn's disease is lacking. We report our experience of ustekinumab use using a novel subcutaneous (SC) induction strategy and aim to identify predictors of response. MATERIALS AND METHODS: A retrospective, observational study of compassionate ustekinumab use in Crohn's disease was conducted with the use of a standard or high dose SC induction protocol. Symptomatic response was assessed after 3 months (short-term), and if remaining on therapy, within 3-12 months (medium-term) and at least 12 months (long-term)...
September 8, 2017: Scandinavian Journal of Gastroenterology
https://www.readbyqxmd.com/read/28858074/efficacy-of-combination-vedolizumab-and-ustekinumab-for-refractory-crohn-s-disease
#11
Kayci Huff-Hardy, Mai Bedair, Rebecca Vazquez, Ezra Burstein
No abstract text is available yet for this article.
August 29, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28838418/ustekinumab-and-anti-interleukin-23-agents-in-crohn-s-disease
#12
REVIEW
Parakkal Deepak, William J Sandborn
This article reviews the available data regarding the efficacy of ustekinumab across published randomized clinical trials and open-label experience from tertiary medical centers, safety data, including in pregnancy, and its use in patients who have failed tumor necrosis factor (TNF) antagonists as well as patients who have not failed TNF antagonists. We have proposed an algorithm for positioning the use of ustekinumab among other agents (TNF antagonists, vedolizumab) in moderate-severe Crohn's disease. The article also enumerates drugs that are specific interleukin-23 blockers, including brazikumab (MEDI2070), risankizumab, LY3074828, tildrakizumab, and guselkumab, and the current status of their clinical trials...
September 2017: Gastroenterology Clinics of North America
https://www.readbyqxmd.com/read/28765121/novel-therapies-for-immune-mediated-inflammatory-diseases-what-can-we-learn-from-their-use-in-rheumatoid-arthritis-spondyloarthritis-systemic-lupus-erythematosus-psoriasis-crohn-s-disease-and-ulcerative-colitis
#13
REVIEW
Kenneth F Baker, John D Isaacs
The past three decades have witnessed remarkable advances in our ability to target specific elements of the immune and inflammatory response, fuelled by advances in both biotechnology and disease knowledge. As well as providing superior treatments for immune-mediated inflammatory diseases (IMIDs), such therapies also offer unrivalled opportunities to study the underlying immunopathological basis of these conditions.In this review, we explore recent approaches to the treatment of IMIDs and the insights to pathobiology that they provide...
August 1, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28660802/efficacy-and-safety-of-ustekinumab-in-the-induction-therapy-of-tnf-%C3%AE-refractory-crohn-s-disease-patients-a-systematic-review-and-meta-analysis
#14
Paweł Kawalec, Paweł Moćko, Iwona Malinowska-Lipien, Tomasz Brzostek
AIM: The aim of the systematic review and meta-analysis was to assess the efficacy and safety of ustekinumab in the induction therapy of anti-TNF-α failure patients with Crohn's disease. METHODS: A systematic literature search was conducted in Medline (PubMed), EMBASE, Cochrane Library until 30 December 2016. We included randomized controlled trials that compared efficacy (clinical response and remission) and safety profile of ustekinumab in TNF-α failure Crohn's disease patients; primary and secondary TNF-α nonresponders or intolerant patients were also assessed...
October 2017: Journal of Comparative Effectiveness Research
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
#15
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
#16
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...
October 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28612180/immunogenicity-of-biologics-in-chronic-inflammatory-diseases-a-systematic-review
#17
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/28575273/positioning-ustekinumab-in-crohn-s-disease-from-clinical-evidence-to-clinical-practice
#18
Silvio Danese, Stefanos Bonovas, Laurent Peyrin-Biroulet
Biological medicines have revolutionised the treatment of Crohn's disease [CD]. Yet, the management of patients not responding to tumour 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. Ustekinumab 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...
October 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28528528/ustekinumab-a-review-in-moderate-to-severe-crohn-s-disease
#19
REVIEW
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...
July 2017: Drugs
https://www.readbyqxmd.com/read/28477389/paradoxical-ulcerative-colitis-during-adalimumab-treatment-of-psoriasis-resolved-by-switch-to-ustekinumab
#20
A G A Kolios, L Biedermann, A Weber, A A Navarini, J Meier, A Cozzio, L E French
Here we report the case of a psoriasis patient who developed an ulcerative colitis (UC) most likely caused by Adalimumab. After cessation of Adalimumab, colitis improved significantly. However, since psoriasis worsened, the patient was switched to Ustekinumab which resulted in complete cessation of colitis. During the two-year follow-up under Ustekinumab therapy no further gastrointestinal complaints occurred. Paradoxical psoriasis manifestations in inflammatory bowel disease (IBD) under TNF-inhibitor therapy have been reported and rarely paradoxical IBD occurred (mostly Crohn's disease) in rheumatologic patients treated with Infliximab or Etanercept...
May 6, 2017: British Journal of Dermatology
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