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https://www.readbyqxmd.com/read/29329557/one-year-risk-of-serious-infection-in-patients-treated-with-certolizumab-pegol-as-compared-with-other-tnf-inhibitors-in-a-real-world-setting-data-from-a-national-u-s-rheumatoid-arthritis-registry
#1
Leslie R Harrold, Heather J Litman, Katherine C Saunders, Kimberly J Dandreo, Bernice Gershenson, Jeffrey D Greenberg, Robert Low, Jeffrey Stark, Robert Suruki, Srihari Jaganathan, Joel M Kremer, Mohamed Yassine
BACKGROUND: Registry studies provide a valuable source of comparative safety data for tumor necrosis factor inhibitors (TNFi) used in rheumatoid arthritis (RA), but they are subject to channeling bias. Comparing safety outcomes without accounting for channeling bias can lead to inaccurate comparisons between TNFi prescribed at different stages of the disease. In the present study, we examined the incidence of serious infection and other adverse events during certolizumab pegol (CZP) use vs other TNFi in a U...
January 2, 2018: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/29308279/the-real-world-use-of-different-anti-tumor-necrosis-factor-agents-in-a-northern-european-population-of-patients-with-beh%C3%A3-et-s-disease
#2
Fahd Adeeb, Wan Lin Ng, Maria Usman Khan, Joseph Devlin, Austin G Stack, Alexander Duncan Fraser
Objective: The aim of this study was to evaluate prescription practices, treatment responses, and serious adverse events of anti-tumor necrosis factor (anti-TNF) therapies in Behçet's disease (BD). Material and Methods: Patients with BD satisfying the International Study Group for Behçet's Disease or the International Criteria for Behçet's Disease criteria were recruited from a regional rheumatology program. The choice of anti-TNF, treatment response, and adverse events were specified...
December 2017: European Journal of Rheumatology
https://www.readbyqxmd.com/read/29303704/golimumab-in-refractory-uveitis-associated-to-juvenile-idiopathic-arthritis-multicentre-study-of-7-cases-and-literature-review
#3
REVIEW
Natalia Palmou-Fontana, Vanesa Calvo-Río, José Luis Martín-Varillas, Carlos Fernández-Díaz, Marina Mesquida, Alfredo Adán, María Victoria Hernández, Miguel Cordero-Coma, Olga Maiz Alonso, David Díaz-Valle, Carlos Fernández-Cid, Oscar Ruiz-Moreno, José Luis Hernández, Miguel Angel González-Gay, Ricardo Blanco
OBJECTIVES: To assess the efficacy of golimumab (GLM), a fully humanised anti-TNF-α monoclonal antibody, in refractory juvenile idiopathic arthritis (JIA)-associated uveitis. METHODS: This was a multicentre study of JIA-associated uveitis refractory to standard synthetic immunosuppressive drugs and in most cases to other anti-TNF-α agents. Results were expressed as mean±standard deviation or as median (range or interquartile range). The Wilcoxon signed-rank test was used to compare continuous variables...
December 15, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/29290076/risk-of-serious-infections-in-biological-treatment-of-patients-with-ankylosing-spondylitis-and-non-radiographic-axial-spondyloarthritis-a-meta-analysis
#4
Sen Wang, Qian He, Zongwen Shuai
The objective of the study is to quantitatively assess the risk of serious infections in patients with axial spondyloarthritis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) treated by biologics enrolled in randomized controlled trials (RCTs). A systematic literature searches of MEDLINE (via PubMed), EMBASE, the Cochrane Library and abstracts archives of the annual scientific meetings of both the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) was conducted through October 2015...
December 30, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/29287748/drug-associated-hyperpigmentation-of-the-oral-mucosa-report-of-four-cases
#5
REVIEW
Konstantinos I Tosios, Eleni-Marina Kalogirou, Alexandra Sklavounou
OBJECTIVE: The aim of this study was to describe 4 patients with oral mucosa hyperpigmentation associated with 4 drug classes and to review the relevant literature. STUDY DESIGN: Two patients under imatinib and hydroxychloroquine treatment exhibited diffuse palatal hyperpigmentation and 2 patients treated with minocycline and golimumab showed multifocal pigmented macules. In all cases, biopsy was performed. RESULTS: Microscopically, in all cases, there was no increase in the number of melanocytes in the epithelium, and pigment granules were present in the lamina propria...
November 3, 2017: Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
https://www.readbyqxmd.com/read/29278210/biologics-in-inflammatory-and-immunomediated-arthritis
#6
Michele Maria Luchetti, Devis Benfaremo, Armando Gabrielli
BACKGROUND: Biologic drugs, introduced in clinical practice almost twenty years ago, represent nowadays a prominent treatment option in patients with chronic inflammatory arthritis, such as Rheumatoid Arthritis, Psoriatic Arthritis and Spondyloarthritis, that include ankylosing spondylitis and non-radiographic axial spondyloarthritis. METHODS: Several compounds targeting different pathways have been marketed and approved for the treatment of inflammatory arthritis, with a significant impact on the clinical outcomes and the natural history of the diseases...
December 26, 2017: Current Pharmaceutical Biotechnology
https://www.readbyqxmd.com/read/29260508/a-systematic-review-of-the-cost-effectiveness-of-biologics-for-ulcerative-colitis
#7
REVIEW
Ewa Stawowczyk, Paweł Kawalec
BACKGROUND: Ulcerative colitis (UC) is a chronic autoimmune inflammation of the colon. The condition significantly decreases quality of life and generates a substantial economic burden for healthcare payers, patients and the society in which they live. Some patients require chronic pharmacotherapy, and access to novel biologic drugs might be crucial for long-term remission. The analyses of cost-effectiveness for biologic drugs are necessary to assess their efficiency and provide the best available drugs to patients...
December 19, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29247389/degree-of-prescriber-s-knowledge-about-variability-in-biological-drugs-innovators-in-manufacturing-process
#8
Lucía Jiménez-Pichardo, Rocío Gázquez-Pérez, Jesús Francisco Sierra-Sánchez
PURPOSE: The purpose of the study is to analyse the degree of prescribers' knowledge about the regulation and variability in manufacturing processes (MP) in bio-drugs "innovators" (BI). METHODS: For each selected drugs, the date of authorization by the European Medicines Agency, time elapsed until the first change, total number of changes and annual rate of change (ARC) were recorded. A survey was designed with 4 parts: (a) identifying the BI prescribed; (b) knowledge of the number and ARC of each BI during its MP; (c) knowledge of comparability requirement of BI before or after the MP; (d) evaluating the utility of the information in the survey...
December 15, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29247154/safety-and-efficacy-of-golimumab-administered-intravenously-in-adults-with-ankylosing-spondylitis-results-through-week-28-of-the-go-alive-study
#9
Atul Deodhar, John D Reveille, Diane D Harrison, Lilianne Kim, Kim-Hung Lo, Jocelyn H Leu, Elizabeth C Hsia
OBJECTIVE: To evaluate the safety and efficacy of intravenous golimumab (GOL) in patients with active ankylosing spondylitis (AS). METHODS: In a phase III, randomized, double-blind, placebo (PBO)-controlled trial, 208 patients were randomized (1:1) to intravenous (IV) infusions of GOL 2 mg/kg (n = 105) at weeks 0, 4, 12, and every 8 weeks, or PBO (n = 103) at weeks 0, 4, and 12, with crossover to GOL at Week 16. The primary endpoint was ≥ 20% improvement from baseline in the Assessment of Spondyloarthritis International Society Criteria (ASAS20) at Week 16...
December 15, 2017: Journal of Rheumatology
https://www.readbyqxmd.com/read/29219638/clinical-efficacy-radiographic-and-safety-results-of-golimumab-monotherapy-in-japanese-patients-with-active-rheumatoid-arthritis-despite-prior-therapy-with-disease-modifying-antirheumatic-drugs-final-results-of-the-go-mono-trial-through-week-120
#10
Tsutomu Takeuchi, Masayoshi Harigai, Yoshiya Tanaka, Hisashi Yamanaka, Naoki Ishiguro, Kazuhiko Yamamoto, Nobuyuki Miyasaka, Takao Koike, Yoshifumi Ukyo, Yutaka Ishii, Toru Yoshinari, Daniel Baker
OBJECTIVE: Evaluate the safety and efficacy of golimumab through week 120 in Japanese patients with active rheumatoid arthritis (RA) previously treated with DMARDs. METHODS: Japanese patients with active RA despite prior DMARDs were randomized to placebo (Group 1, n = 105), golimumab 50 mg (Group 2, n = 101), or golimumab 100 mg (Group 3, n = 102). At week 16, Group 1 patients crossed over to golimumab 50mg; after week 52, a one-time golimumab dose reduction from 100 to 50 mg was permitted...
December 8, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/29205904/dosing-down-and-then-discontinuing-biologic-therapy-in-rheumatoid-arthritis-a-review-of-the-literature
#11
REVIEW
Der-Yuan Chen, Chak Sing Lau, Bassel Elzorkany, Ping-Ning Hsu, Sonja Praprotnik, Radu Vasilescu, Lisa Marshall, Lyndon Llamado
AIM: To review the published studies that dose down and then discontinue biologic therapy in patients with rheumatoid arthritis (RA), particularly concerning the criteria for such dosing and the impact on clinical outcomes. METHODS: Published studies conducted in patients with RA that sequentially decreased the dose and then discontinued therapy were included if one or more of the following biologic disease modifying antirheumatic drugs (bDMARDs) was evaluated: abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab or tocilizumab...
December 4, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/29205421/systematic-review-with-network-meta-analysis-comparative-assessment-of-tofacitinib-and-biological-therapies-for-moderate-to-severe-ulcerative-colitis
#12
S Bonovas, T Lytras, G Nikolopoulos, L Peyrin-Biroulet, S Danese
BACKGROUND: Biological therapies have improved the care of patients with ulcerative colitis (UC). Tofacitinib, an oral small-molecule Janus kinase inhibitor, is potentially a new treatment option. AIM: To comparatively assess efficacy and harm of tofacitinib and biologics (infliximab, adalimumab, golimumab and vedolizumab) in adult patients not previously exposed to TNF antagonists. METHODS: We performed a comprehensive search of PubMed, Embase, Scopus, clinical trial registries, regulatory authorities' websites and major conference proceedings, through August 2017, to identify randomised, placebo-controlled or head-to-head trials assessing tofacitinib or biologics as induction and/or maintenance therapy in moderate-to-severe UC...
December 4, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29202535/-the-safety-and-efficacy-of-golimumab-in-treatment-of-25-patients-with-active-ankylosing-spondylitis
#13
H Ma, F Sun, Y M Zhang, H Zhang, J Zhu, X H Deng, J L Zhang, F Huang
Objective: To evaluate the efficacy and safety of golimumab in patients with active ankylosing spondylitis (AS). Methods: This was a randomized, double-blind, placebo-controlled trial. The subjects were randomized to receive either golimumab 50mg subcutaneously or placebo every 4 weeks. Patients in both groups received golimumab 50mg from week 24 to week 48. The primary endpoint was the proportion of at least 20% improvement in the Assessment of Spondyloarthritis International Society (ASAS20) at week 14. The secondary endpoints included at least 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40), ASAS partial-remission, Bath AS functional index, Bath AS disease activity index, Bath AS metrology index, enthesitis index and Jenkins sleep evaluation questionnaire...
December 1, 2017: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
https://www.readbyqxmd.com/read/29192530/cost-effectiveness-analysis-of-infliximab-adalimumab-golimumab-and-vedolizumab-for-moderate-to-severe-ulcerative-colitis-in-spain
#14
Cristina Trigo-Vicente, Vicente Gimeno-Ballester, Raquel Montoiro-Allué, Alejandro López-Del Val
OBJECTIVES: Assess the efficiency of biologic treatment for moderate to severe ulcerative colitis (UC) which are indicated and financed for this pathology by Spain. METHODS: A Markov model was constructed to simulate the progression in a cohort of patients with moderate to severe UC. The perspective chosen was National Health Service with an over 10 years of time horizon, with a discount rate of 3%, and established threshold of €30,000/quality-adjusted life-year (QALY)...
December 2, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/29148425/ex-vivo-inhibited-cytokine-profiling-explains-inferior-treatment-response-to-golimumab-after-adalimumab-failure-in-rheumatoid-arthritis
#15
Lieke Tweehuysen, Kiki Schraa, Mihai G Netea, Frank H J van den Hoogen, Leo A B Joosten, Alfons A den Broeder
OBJECTIVES: Clinical data suggest that the response of rheumatoid arthritis patients to treatment with golimumab is much lower among those who switched from adalimumab than among those who switched from etanercept. To elucidate the mechanism behind this difference in response to sequential biologic treatment, we examined the effect of TNF inhibitors on ex vivo cytokine production profiling. METHODS: In a prospective cohort study, blood samples were obtained from patients before the start of a biologic...
October 18, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/29148406/high-3-year-golimumab-survival-in-patients-with-rheumatoid-arthritis-ankylosing-spondylitis-and-psoriatic-arthritis-real-world-data-from-328-patients
#16
Konstantinos Thomas, Irini Flouri, Argiro Repa, Kalliopi Fragiadaki, Petros P Sfikakis, Christos Koutsianas, Evripidis Kaltsonoudis, Paraskevi V Voulgari, Alexandros A Drosos, Evangelia Petrikkou, Prodromos Sidiropoulos, Dimitrios Vassilopoulos
OBJECTIVES: Our primary objective was to study the long-term survival on drug (SOD) of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) treated with golimumab (GLM) in real life settings. METHODS: This was a retrospective, observational study of all patients treated with GLM in 4 Academic Centres in Greece during a 4-year period (09/2010-06/2014). SOD was analysed using Kaplan-Meier survival analysis, while Cox regression analysis estimating hazard ratios (HRs) for different baseline variables associated with drug discontinuation was performed for each disease...
November 9, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/29142035/the-sex-influence-on-response-to-tumor-necrosis-factor-%C3%AE-inhibitors-and-remission-in-axial-spondyloarthritis
#17
Ennio Lubrano, Fabio Massimo Perrotta, Maria Manara, Salvatore D'Angelo, Olga Addimanda, Roberta Ramonda, Leonardo Punzi, Ignazio Olivieri, Carlo Salvarani, Antonio Marchesoni
OBJECTIVE: The aim of this study was to evaluate the influence of sex on response to treatment and disease remission in patients with axial spondyloarthritis (axSpA). METHODS: In this retrospective multicenter study, patients with axSpA, according to the Assessment of Spondyloarthritis international Society (ASAS) criteria for axSpA, and treated with adalimumab, etanercept, golimumab, or infliximab, were studied. We compared clinical characteristics, patient-reported outcomes, disease activity, function, and response to treatment in male and female patients with this disease...
November 15, 2017: Journal of Rheumatology
https://www.readbyqxmd.com/read/29140944/subcutaneous-golimumab-in-pediatric-ulcerative-colitis-pharmacokinetics-and-clinical-benefit
#18
Jeffrey S Hyams, Daphne Chan, Omoniyi J Adedokun, Lakshmi Padgett, Dan Turner, Anne Griffiths, Genevieve Veereman, Melvin B Heyman, Joel R Rosh, Ghassan Wahbeh, Richard Strauss
BACKGROUND: Current treatments for pediatric ulcerative colitis (UC) are limited. We evaluated the pharmacokinetics and clinical benefits of subcutaneous golimumab, an anti-tumor necrosis factor agent, in moderately-to-severely active pediatric patients with UC refractory to conventional therapy. METHODS: We report a multicenter, open-label study of golimumab with a pharmacokinetics phase (week 0-14). Patients had moderately-to-severely active UC and were naive to anti-tumor necrosis factor treatment...
December 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29127626/impact-of-infliximab-and-etanercept-biosimilars-on-biological-disease-modifying-antirheumatic-drugs-utilisation-and-nhs-budget-in-the-uk
#19
Mohammed I Aladul, Raymond W Fitzpatrick, Stephen R Chapman
OBJECTIVE: Biological disease-modifying antirheumatic drugs (bDMARDs) are effective but expensive options for treating rheumatoid arthritis. The introduction of infliximab and etanercept biosimilars presents a significant potential cost saving in a financially constrained health system such as the National Health Service (NHS) in the UK. This study examines the impact of the introduction of infliximab and etanercept biosimilars on the utilisation of bDMARDs and subsequent budget impact...
December 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29082659/two-year-persistence-of-golimumab-as-second-line-biologic-agent-in-rheumatoid-arthritis-as-compared-to-other-subcutaneous-tumor-necrosis-factor-inhibitors-real-life-data-from-the-lorhen-registry
#20
Ennio G Favalli, Luigi Sinigaglia, Andrea Becciolini, Vittorio Grosso, Roberto Gorla, Chiara Bazzani, Fabiola Atzeni, Pier C Sarzi Puttini, Enrico Fusaro, Raffaele Pellerito, Roberto Caporali
OBJECTIVES: To evaluate the 2-year retention rate of golimumab compared with etanercept and adalimumab as second-line biologic agent in rheumatoid arthritis (RA) patients who failed a previous tumor necrosis factor inhibitor (TNFi). METHODS: Data on RA patients treated with a second-line subcutaneous TNFi were extracted from a multicentric Italian cohort (the LORHEN registry). The analysis was limited to etanercept, adalimumab and golimumab in the period when all were available in Italy (since October 2010)...
October 30, 2017: International Journal of Rheumatic Diseases
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