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https://www.readbyqxmd.com/read/28324167/efficacy-and-safety-of-golimumab-52-week-maintenance-therapy-in-japanese-patients-with-moderate-to-severely-active-ulcerative-colitis-a-phase-3-double-blind-randomized-placebo-controlled-study-pursuit-j-study
#1
Toshifumi Hibi, Yuya Imai, Asako Senoo, Kentaro Ohta, Yoshifumi Ukyo
BACKGROUND: The global phase 3 studies of golimumab [PURSUIT-SC and PURSUIT-maintenance (M)], an anti-tumor necrosis factor-α (anti-TNFα) antibody, have demonstrated clinical efficacy and safety as induction and maintenance therapies in patients with moderate to severely active ulcerative colitis (UC). This study aimed to evaluate the efficacy and safety of golimumab as maintenance therapy in the Japanese population. METHODS: In this phase 3, double-blind (DB), placebo-controlled, parallel group, randomized withdrawal study, 144 Japanese patients with moderately to severely active UC received golimumab doses of 200 mg (at week 0) and 100 mg (at week 2) subcutaneously during the 6-week open-label induction phase...
March 21, 2017: Journal of Gastroenterology
https://www.readbyqxmd.com/read/28286562/golimumab-pharmacokinetics-in-ulcerative-colitis-a-literature-review
#2
REVIEW
Ines Harzallah, Josselin Rigaill, Nicolas Williet, Stephane Paul, Xavier Roblin
Golimumab (GLM) is the latest anti-tumor necrosis factor (TNF) that gained its marketing license. Thanks to the PURSUIT induction and maintenance trials, it was approved for the treatment of ulcerative colitis (UC) in 2013. The other anti-TNF drugs available are infliximab and adalimumab. These two drugs have validated algorithms concerning prescription and therapeutic drug monitoring (TDM) but little is known about GLM. The available data on GLM's exposure-response relationship in UC are from the PURSUIT trials and are recently published...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28284845/risks-of-malignancies-related-to-tofacitinib-and-biological-drugs-in-rheumatoid-arthritis-systematic-review-meta-analysis-and-network-meta-analysis
#3
José Ramón Maneiro, Alejandro Souto, Juan J Gomez-Reino
OBJECTIVE: To summarize and compare the risks of malignancies accompanying biologic DMARDs (b-DMARDs) and tofacitinib in rheumatoid arthritis (RA) in randomized clinical trials (RCTs) and long-term extension studies (LTEs). METHODS: Articles in Medline, Embase, Cochrane Library, and the Web of Science dated from 2000 to February 2015. Selection criteria were as follows: (1) focus on RCTs or LTEs in RA; (2) treatment with b-DMARDs or tofacitinib; (3) data on malignancies; and (4) a minimum follow-up of 12 weeks...
February 16, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28282491/biologics-or-tofacitinib-for-people-with-rheumatoid-arthritis-unsuccessfully-treated-with-biologics-a-systematic-review-and-network-meta-analysis
#4
REVIEW
Jasvinder A Singh, Alomgir Hossain, Elizabeth Tanjong Ghogomu, Amy S Mudano, Lara J Maxwell, Rachelle Buchbinder, Maria Angeles Lopez-Olivo, Maria E Suarez-Almazor, Peter Tugwell, George A Wells
BACKGROUND: Biologic disease-modifying anti-rheumatic drugs (DMARDs: referred to as biologics) are effective in treating rheumatoid arthritis (RA), however there are few head-to-head comparison studies. Our systematic review, standard meta-analysis and network meta-analysis (NMA) updates the 2009 Cochrane overview, 'Biologics for rheumatoid arthritis (RA)' and adds new data. This review is focused on biologic or tofacitinib therapy in people with RA who had previously been treated unsuccessfully with biologics...
March 10, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28280401/review-of-the-treatment-of-psoriatic-arthritis-with-biological-agents-choice-of-drug-for-initial-therapy-and-switch-therapy-for-non-responders
#5
REVIEW
Salvatore D'Angelo, Giuseppina Tramontano, Michele Gilio, Pietro Leccese, Ignazio Olivieri
Psoriatic arthritis (PsA) is a heterogeneous chronic inflammatory disease with a broad clinical spectrum and variable course. It can involve musculoskeletal structures as well as skin, nails, eyes, and gut. The management of PsA has changed tremendously in the last decade, thanks to an earlier diagnosis, an advancement in pharmacological therapies, and a wider application of a multidisciplinary approach. The commercialization of tumor necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab) as well as interleukin (IL)-12/23 (ustekinumab) and IL-17 (secukinumab) inhibitors is representative of a revolution in the treatment of PsA...
2017: Open Access Rheumatology: Research and Reviews
https://www.readbyqxmd.com/read/28279079/the-safety-of-biological-pharmacotherapy-for-the-treatment-of-ulcerative-colitis
#6
Gionata Fiorino, Stefanos Bonovas, Clelia Cicerone, Mariangela Allocca, Federica Furfaro, Carmen Correale, Silvio Danese
Biological agents are effective in ulcerative colitis (UC). Currently, 3 anti-TNF agents (infliximab, adalimumab, and golimumab) and 1 anti-integrin agent (vedolizumab) are approved for the treatment of UC. The mechanism of action of biologic agents can also give rise to several side effects, some even serious. It remains uncertain to what extent biologic treatments may be associated with an increased rate of infections, malignancies and other adverse events Areas covered: Our aim is to review the relevant data available in the literature and briefly summarize the safety profile of biological therapy in UC...
March 10, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28277444/bilateral-retrobulbar-optic-neuropathy-associated-with-golimumab
#7
Marta de Frutos-Lezaun, Aritz Bidaguren, Patricia de la Riva, Carlos F Meneses, Javier Olascoaga
We report the first documented case of retrobulbar optic neuropathy associated with golimumab. A 48-year-old man was admitted with a 3-week history of progressive visual loss of his left eye. He had received a second infusion of golimumab for ankylosing spondylitis 10 days before admission. A magnetic resonance imaging scan showed enhancement of both optic nerves and visual evoked potentials were consistent with demyelinating bilateral optic neuropathy, although visual acuity drop in the right eye could not be determined because of deep amblyopia...
March 9, 2017: Clinical Neuropharmacology
https://www.readbyqxmd.com/read/28276288/golimumab-for-moderate-to-severe-ulcerative-colitis
#8
Anne S Strik, Sophie E Berends, Ron A Mathôt, Geert R D'Haens, Mark Löwenberg
Golimumab (GLM) is a subcutaneously administered human anti-tumor necrosis factor (TNF) agent that has been approved by the regulatory authorities for the treatment of moderate to severe ulcerative colitis (UC) in 2013. Areas covered: Maintained clinical remission rates up to 50% have been shown in UC patients receiving GLM, and higher GLM serum concentrations have been associated with improved clinical outcomes. Approximately 50% of UC patients do not respond to induction therapy with GLM, and up to 40% of GLM responders will lose response over time...
March 9, 2017: Expert Review of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28271250/cost-effectiveness-of-vedolizumab-compared-with-infliximab-adalimumab-and-golimumab-in-patients-with-ulcerative-colitis-in-the-united-kingdom
#9
Michele R Wilson, Annika Bergman, Helene Chevrou-Severac, Ross Selby, Michael Smyth, Matthew C Kerrigan
OBJECTIVE: To examine the clinical and economic impact of vedolizumab compared with infliximab, adalimumab, and golimumab in the treatment of moderately to severely active ulcerative colitis (UC) in the United Kingdom (UK). METHODS: A decision analytic model in Microsoft Excel was used to compare vedolizumab with other biologic treatments (infliximab, adalimumab, and golimumab) for the treatment of biologic-naïve patients with UC in the UK. Efficacy data were obtained from a network meta-analysis using placebo as the common comparator...
March 8, 2017: European Journal of Health Economics: HEPAC: Health Economics in Prevention and Care
https://www.readbyqxmd.com/read/28264816/eular-recommendations-for-the-management-of-rheumatoid-arthritis-with-synthetic-and-biological-disease-modifying-antirheumatic-drugs-2016-update
#10
Josef S Smolen, Robert Landewé, Johannes Bijlsma, Gerd Burmester, Katerina Chatzidionysiou, Maxime Dougados, Jackie Nam, Sofia Ramiro, Marieke Voshaar, Ronald van Vollenhoven, Daniel Aletaha, Martin Aringer, Maarten Boers, Chris D Buckley, Frank Buttgereit, Vivian Bykerk, Mario Cardiel, Bernard Combe, Maurizio Cutolo, Yvonne van Eijk-Hustings, Paul Emery, Axel Finckh, Cem Gabay, Juan Gomez-Reino, Laure Gossec, Jacques-Eric Gottenberg, Johanna M W Hazes, Tom Huizinga, Meghna Jani, Dmitry Karateev, Marios Kouloumas, Tore Kvien, Zhanguo Li, Xavier Mariette, Iain McInnes, Eduardo Mysler, Peter Nash, Karel Pavelka, Gyula Poór, Christophe Richez, Piet van Riel, Andrea Rubbert-Roth, Kenneth Saag, Jose da Silva, Tanja Stamm, Tsutomu Takeuchi, René Westhovens, Maarten de Wit, Désirée van der Heijde
Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib)...
March 6, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28230558/risk-for-overall-infection-with-anti-tnf-and-anti-integrin-agents-used-in-ibd-a-systematic-review-and-meta-analysis
#11
Eric D Shah, Jeremy P Farida, Corey A Siegel, Kelly Chong, Gil Y Melmed
BACKGROUND: The overall risk for infection with contemporary biological agents in treating Crohn's disease (CD) and ulcerative colitis (UC) has not been systematically assessed. METHODS: We performed a PubMed and Cochrane database literature search to evaluate randomized, placebo-controlled trials of biologics in treating UC and CD. Meta-analysis was performed using a DerSimonian and Laird random effects model. We determined relative risk (RR) of harm against placebo; number needed to harm (NNH) was reported when appropriate...
April 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28217835/symmetrical-drug-related-intertriginous-and-flexural-exanthema-sdrife-induced-by-golimumab
#12
Shiang-Yu Yang, Cheng-Che Lan, Stephen Chu-Sung Hu
No abstract text is available yet for this article.
February 20, 2017: International Journal of Dermatology
https://www.readbyqxmd.com/read/28216195/golimumab-in-real-life-settings-2-years-drug-survival-and-predictors-of-clinical-outcomes-in-rheumatoid-arthritis-spondyloarthritis-and-psoriatic-arthritis
#13
Florenzo Iannone, Leonardo Santo, Maria Grazia Anelli, Romano Bucci, Angelo Semeraro, Laura Quarta, Francesca D'Onofrio, Antonio Marsico, Giorgio Carlino, Oriana Casilli, Fabio Cacciapaglia, Carmelo Zuccaro, Paola Chiara Falappone, Francesco Paolo Cantatore, Maurizio Muratore, Giovanni Lapadula
OBJECTIVES: To assess the drug survival of golimumab, and predictors thereof, in patients affected with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA) in a prospective observational cohort. METHODS: This is a non-interventional, longitudinal study on RA, SpA, and PsA patients starting treatment with golimumab. Endpoints were the 2 years persistence rate of golimumab and predictors of therapy discontinuation. Drug retention was analyzed using Kaplan-Meier and Cox models...
January 18, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28213565/anti-tnf-induced-remission-in-very-early-peripheral-spondyloarthritis-the-crespa-study
#14
Philippe Carron, Gaëlle Varkas, Heleen Cypers, Liesbet Van Praet, Dirk Elewaut, Filip Van den Bosch
OBJECTIVE: To evaluate the efficacy and safety of golimumab to induce clinical remission in patients with very early, active peripheral spondyloarthritis (pSpA). METHODS: Clinical REmission in peripheral SPondyloArthritis is a monocentric study of golimumab treatment in patients with pSpA. All patients fulfilled the Assessment of SpondyloArthritis international Society classification criteria for pSpA, with a symptom duration ≤12 weeks. Patients were randomised 2:1 to receive golimumab 50 mg every 4 weeks or matching placebo for 24 weeks...
February 17, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28205212/sarcoidosis-extent-relates-to-molecular-variability
#15
Calixte S Monast, Katherine Li, Marc A Judson, Robert P Baughman, Eric Wadman, Rosemary Watt, Philip E Silkoff, Elliot S Barnathan, Carrie Brodmerkel
The molecular basis of sarcoidosis phenotype heterogeneity and its relationship to effective treatment of sarcoidosis have not been elucidated. Peripheral samples from sarcoidosis subjects who participated in a phase 2 study of golimumab (anti-TNFα) and ustekinumab (anti-IL12p40) were used to measure the whole blood transcriptome and levels of serum proteins. Differential gene and protein expression analyses were used to explore the molecular differences between sarcoidosis phenotypes as defined by extent of organ involvement...
February 16, 2017: Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/28175091/p407-prospective-evaluation-of-clinical-efficacy-and-safety-of-golimumab-in-biologic-experienced-and-na%C3%A3-ve-patients-with-moderate-to-severe-ulcerative-colitis-experience-from-a-tertiary-referral-centre
#16
B Orlandini, G Dragoni, S Bagnoli, S Deiana, G Macrì, F Rogai
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28175026/p226-comparison-of-four-different-immunoassays-for-measuring-golimumab-and-anti-golimumab-antibody-concentration-in-patients-with-ulcerative-colitis
#17
S Paul, G Duru, A De Vries, J C Marini, D Aoucheta, F Cornillie, S Nancey, I Detrez, A-E Berger, A Gils, X Roblin
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172973/p621-efficacy-and-safety-of-golimumab-in-ulcerative-colitis-preliminary-data-from-a-multicenter-italian-study
#18
F Bossa, M R Valvano, G Costantino, E Vinci, A Rispo, M Mendolaro, M Patturelli, E Shaini, S Mazzuoli, C RIcciardelli, A Tursi, A Lauria, P Paese, A Azzarone, L Sebkova, G Pranzo, W Fries, F Castiglione, M Cappello, A Privitera, B Principi, A Andriulli
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172970/p446-characterization-of-ulcerative-colitis-patients-in-the-golimumab-pursuit-maintenance-study-post-hoc-analyses-of-patients-who-maintained-and-did-not-maintain-clinical-response-through-week-54
#19
W J Sandborn, P Rutgeerts, H Zhang, O J Adedokun, S Xu, R Shraim, C Marano
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172740/p686-application-of-dried-blood-spots-for-pharmacokinetic-profiling-of-golimumab-treated-patients-with-ulcerative-colitis
#20
I Detrez, V Ballet, G Van Assche, S Vermeire, M Ferrante, A Gils
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
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