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https://www.readbyqxmd.com/read/28435230/persistence-with-golimumab-in-immune-mediated-rheumatic-diseases-a-systematic-review-of-real-world-evidence-in-rheumatoid-arthritis-axial-spondyloarthritis-and-psoriatic-arthritis
#1
REVIEW
Axel Svedbom, Chiara Storck, Sumesh Kachroo, Marinella Govoni, Ahmed Khalifa
PURPOSE: In immune-mediated rheumatic diseases (IMRDs), persistence to treatment may be used as a surrogate marker for long-term treatment success. In previous comparisons of persistence to tumor necrosis factor α inhibitors (TNFis), a paucity of data for subcutaneous (SC) golimumab was identified. The aim of this study was to conduct a systematic review of persistence to SC golimumab in clinical practice and contextualize these data with five-year persistence estimates from long-term open-label extension (OLE) trials of SC TNFis in IMRDs...
2017: Patient Preference and Adherence
https://www.readbyqxmd.com/read/28431485/efficacy-of-golimumab-in-belgian-patients-with-active-rheumatoid-arthritis-despite-treatment-with-non-biologic-disease-modifying-anti-rheumatic-drugs-sub-analysis-of-the-go-more-study
#2
Patrick Durez, Marie Vanthuyne, Muhammad S Soyfoo, Ilse Hoffman, Michel Malaise, Piet Geusens
OBJECTIVES: The GO-MORE trial (NCT00975130) was a phase 3 study in 40 countries evaluating the efficacy and safety of golimumab as add-on therapy in biologic-naïve adults with active rheumatoid arthritis despite stable treatment with disease-modifying anti-rheumatic drugs. To inform local practice in Belgium and examine the role of baseline disease activity in treatment response, we compared the efficacy of golimumab in the Belgian subpopulation and the rest of the world. METHODS: Baseline disease activity and six-month efficacy rates in the GO-MORE trial were compared for the Belgian subpopulation and the rest of the world by t-tests and chi-squared tests...
April 21, 2017: Acta Clinica Belgica
https://www.readbyqxmd.com/read/28413099/second-line-biologic-therapy-optimization-in-rheumatoid-arthritis-psoriatic-arthritis-and-ankylosing-spondylitis
#3
REVIEW
Fabrizio Cantini, Laura Niccoli, Carlotta Nannini, Emanuele Cassarà, Olga Kaloudi, Ennio Giulio Favalli, Andrea Becciolini, Maurizio Benucci, Francesca Li Gobbi, Serena Guiducci, Rosario Foti, Marta Mosca, Delia Goletti
OBJECTIVE: The Italian board for the TAilored BIOlogic therapy (ITABIO) reviewed the most consistent literature to indicate the best strategy for the second-line biologic choice in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA). METHODS: Systematic review of the literature to identify English-language articles on efficacy of second-line biologic choice in RA, PsA, and ankylosing spondylitis (AS). Data were extracted from available randomized, controlled trials, national biologic registries, national healthcare databases, post-marketing surveys, and open-label observational studies...
March 22, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28410817/medication-adherence-and-persistence-over-time-with-self-administered-tnf-alpha-inhibitors-among-young-adult-middle-aged-and-older-patients-with-rheumatologic-conditions
#4
Gregory S Calip, Sruthi Adimadhyam, Shan Xing, Julian C Rincon, Wan-Ju Lee, Rebekah H Anguiano
OBJECTIVE: Self-injectable TNF inhibitors are increasingly used early in the chronic treatment of moderate to severe rheumatologic conditions. We estimated medication adherence/persistence over time following initiation in young adult and older adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis. METHODS: We conducted a retrospective cohort study of patients aged 18+ years newly initiating etanercept, adalimumab, certolizumab pegol, or golimumab using the Truven Health MarketScan Database between 2009 and 2013...
March 21, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28401434/long-term-efficacy-and-safety-of-golimumab-in-the-treatment-of-multirefractory-beh%C3%A3-et-s-disease
#5
Antonio Vitale, Giacomo Emmi, Giuseppe Lopalco, Claudia Fabiani, Stefano Gentileschi, Elena Silvestri, Di Scala Gerardo, Florenzo Iannone, Bruno Frediani, Mauro Galeazzi, Giovanni Lapadula, Donato Rigante, Luca Cantarini
Our aim was to retrospectively assess the role of golimumab as a treatment choice in patients with Behçet's disease (BD). Seventeen patients diagnosed with BD according to the international criteria were consecutively enrolled; the BD Current Activity Form (BDCAF) was used to evaluate disease activity. After having collected clinical data from patients, statistical analysis was performed to identify differences between the start of therapy and last visit; significance was defined as p < 0.05. The mean duration of golimumab treatment was 18...
April 11, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28374338/therapeutic-drug-monitoring-of-golimumab-in-the-treatment-of-ulcerative-colitis
#6
REVIEW
Niels Vande Casteele, Reena Khanna
Ulcerative colitis (UC) is a relapsing-remitting chronic inflammatory disorder affecting the mucosal surface in a continuous manner from the rectum through part of, or the entire, colon. Patients with severe disease and those who become refractory or intolerant to corticosteroids and/or immunosuppressants, require treatment with biologic agents that target tumor necrosis factor-α (TNF). Golimumab, a fully human monoclonal antibody, is the latest TNF antagonist to get approved for the treatment of moderate-to-severe UC...
April 3, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28371797/real-life-effectiveness-of-golimumab-in-biologic-na%C3%A3-ve-patients-with-rheumatoid-arthritis-data-from-the-rheumatic-diseases-portuguese-register-reuma-pt
#7
Ana Filipa Mourão, Célia Ribeiro, Joana Borges, Maria João Gonçalves, Miguel Bernardes, Susana Fernandes, Raquel Dezerto, Pedro Laires, Patrícia Machado, Mónica Eusébio, Maria José Santos, Helena Canhão
OBJECTIVES: To assess the effectiveness of subcutaneous Golimumab 50 mg/monthly combined with methotrexate (SC GLM + MTX) over 52 weeks of treatment, in biologic-naïve RA patients, in a multicentre nationwide cohort from the Rheumatic Diseases Portuguese Register (Reuma.pt). METHODS: Data for this observational study was collected from March 2011 to August 2015. Disease activity (DAS28), functional capacity (HAQ) and Patient Global Disease Assessment (PGDA) were measured at baseline and weeks 12, 24 and 52 of treatment...
February 18, 2017: Acta Reumatológica Portuguesa
https://www.readbyqxmd.com/read/28368383/oncostatin-m-drives-intestinal-inflammation-and-predicts-response-to-tumor-necrosis-factor-neutralizing-therapy-in-patients-with-inflammatory-bowel-disease
#8
Nathaniel R West, Ahmed N Hegazy, Benjamin M J Owens, Samuel J Bullers, Bryan Linggi, Sofia Buonocore, Margherita Coccia, Dieter Görtz, Sébastien This, Krista Stockenhuber, Johanna Pott, Matthias Friedrich, Grigory Ryzhakov, Frédéric Baribaud, Carrie Brodmerkel, Constanze Cieluch, Nahid Rahman, Gerhard Müller-Newen, Raymond J Owens, Anja A Kühl, Kevin J Maloy, Scott E Plevy, Satish Keshav, Simon P L Travis, Fiona Powrie
Inflammatory bowel diseases (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are complex chronic inflammatory conditions of the gastrointestinal tract that are driven by perturbed cytokine pathways. Anti-tumor necrosis factor-α (TNF) antibodies are mainstay therapies for IBD. However, up to 40% of patients are nonresponsive to anti-TNF agents, which makes the identification of alternative therapeutic targets a priority. Here we show that, relative to healthy controls, inflamed intestinal tissues from patients with IBD express high amounts of the cytokine oncostatin M (OSM) and its receptor (OSMR), which correlate closely with histopathological disease severity...
April 3, 2017: Nature Medicine
https://www.readbyqxmd.com/read/28337644/cns-demyelination-with-tnf-%C3%AE-blockers
#9
REVIEW
Elissavet Kemanetzoglou, Elisabeth Andreadou
Tumor necrosis factor-α (TNF-α) blockers are a popular therapeutic choice in a number of inflammatory diseases. Thus far, five TNF- α blockers have been approved for clinical use (etanercept, infliximab, adalimumab, golimumab. and certolizumab). Despite being considered relatively safe, serious side effects associated with immune suppression have been reported, including central and peripheral nervous system (CNS) demyelinating disorders. It is still elusive whether these events are mere coincidence or a side effect of anti-TNF-α use...
April 2017: Current Neurology and Neuroscience Reports
https://www.readbyqxmd.com/read/28336735/risk-of-tuberculosis-in-patients-treated-with-tnf-%C3%AE-antagonists-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#10
Zheng Zhang, Wei Fan, Gui Yang, Zhigao Xu, June Wang, Qingyuan Cheng, Mingxia Yu
OBJECTIVES: An increased risk of tuberculosis (TB) has been reported in patients treated with TNF-α antagonists, an issue that has been highlighted in a WHO black box warning. This review aimed to assess the risk of TB in patients undergoing TNF-α antagonists treatment. METHODS: A systematic literature search for randomised controlled trials (RCTs) was performed in MEDLINE, Embase and Cochrane library and studies selected for inclusion according to predefined criteria...
March 22, 2017: BMJ Open
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
REVIEW
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...
April 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28277444/bilateral-retrobulbar-optic-neuropathy-associated-with-golimumab
#17
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
#18
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...
May 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
#19
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
#20
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
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