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Switching infliximab

Hiroaki Matsuno, Tsukasa Matsubara
OBJECTIVES: This study aimed to demonstrate the equivalence of NI-071, an infliximab biosimilar (BS), and the infliximab reference product (RP) for treating Japanese patients with active rheumatoid arthritis (RA) refractory to methotrexate. METHODS: In this multicenter two-period phase III study, patients were treated with BS or RP for 30 weeks (Period I) in a randomized double-blind manner and then with BS for the following 24 weeks (Period II). The efficacy and safety of BS and RP were compared...
October 5, 2018: Modern Rheumatology
Agnieszka Owczarczyk-Saczonek, Witold Owczarek, Agnieszka Osmola-Mańkowska, Zygmunt Adamski, Waldemar Placek, Adriana Rakowska
Tumour necrosis factor alpha (TNF-α) is a leading inflammatory cytokine that plays a pivotal role in the pathogenesis of psoriasis. In case of a severe course of psoriasis and moderate-to-severe disease in which traditional systemic treatments are ineffective or contraindicated, TNF-α inhibitors (iTNF-α) are used. This class of drugs includes monoclonal antibodies and a fusion protein (etanercept) and can induce a humoral or cell-mediated immune response, leading to formation of anti-drug antibodies (ADAs)...
October 4, 2018: Dermatologic Therapy
Zaina T Al-Salama
PF-06438179/GP1111 (Zessly® ; Ixifi® ) [hereafter referred to as GP1111] is a biosimilar of the reference monoclonal anti-TNF-α antibody infliximab, and is approved in the EU and USA for the same indications as the reference drug, including rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis (including paediatric ulcerative colitis in the EU), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis; GP1111 is also approved in Japan. GP1111 has similar physicochemical characteristics and pharmacodynamic properties to those of reference infliximab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate-to-severe RA despite methotrexate therapy...
October 4, 2018: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Jonathan P Segal, Lawrence Penez, Soad Mohsen Elkady, Guy H T Worley, Simon D McLaughlin, Benjamin H Mullish, Mohammed N Quraishi, Nik S Ding, Tamara Glyn, Kesavan Kandiah, Mark A Samaan, Peter M Irving, Omar D Faiz, Susan K Clark, Ailsa L Hart
BACKGROUND: Restorative proctocolectomy with ileal pouch-anal anastomosis is considered the procedure of choice in patients with ulcerative colitis refractory to medical therapy. Subsequent inflammation of the pouch is a common complication and in some cases, pouchitis fails to respond to antibiotics, the mainstay of treatment. In such cases, corticosteroids, immunomodulatory or biologic treatments are options. However, our understanding of the efficacy of anti-tumour necrosis factor medications in both chronic pouchitis and Crohn's-like inflammation is based on studies that include relatively small numbers of patients...
September 29, 2018: Scandinavian Journal of Gastroenterology
F Magro, C Rocha, A I Vieira, H T Sousa, I Rosa, S Lopes, J Carvalho, C C Dias, J Afonso
Background: The advent of Remicade® biosimilars, Remsima®, Inflectra® and, more recently, Flixabi®, has brought along the potential to decrease the costs associated with this therapy, therefore increasing its access to a larger group of patients. However, and in order to assure a soft transition, one must make sure the assays and algorithms previously developed and optimized for Remicade perform equally well with its biosimilars. This study aimed to: (a) validate the utilization of Remicade-optimized therapeutic drug monitoring assays for the quantification of Flixabi; and (b) determine the existence of Remicade, Remsima and Flixabi cross-immunogenicity...
2018: Therapeutic Advances in Gastroenterology
Yunsuek Kim, Suyeon Park, Hyun-Sook Kim
Tumor necrosis factor-α inhibitor (TNFi) therapy has shown to be remarkably effective for treating ankylosing spondylitis (AS); however, nearly 30% of AS patients every year either stop TNFi therapy or switch to a different TNFi due to inefficacy or adverse effects. The goal of this study was to identify predictors of TNFi treatment duration, including extra-articular manifestations, using a nationwide registry in Korea. Data obtained from the Korean College of Rheumatology Biologics (KOBIO) registry, a nationwide, multi-center database representing 58 tertiary care hospitals in Korea...
September 25, 2018: Clinical Rheumatology
Jiyeon Joy Park, Lauren Boutillier, Joseph E Cruz, GaEun Joung, Jeffrey Nemeth
BACKGROUND: Infliximab dose rounding is a commonly accepted practice at many institutions to contain costs. Currently, there is limited data on the clinical and financial implications of infliximab dose rounding standardization. OBJECTIVE: To determine whether standardized infliximab dose rounding is comparable with nonstandardized dosing in patients with Crohn's disease or ulcerative colitis in terms of cost and efficiency, using a cost comparison between the 2 dosing methods at an outpatient infusion center attached to a community teaching hospital...
October 2018: Journal of Managed Care & Specialty Pharmacy
Johlee S Odinet, Chelsea E Day, Jennifer L Cruz, Gregory A Heindel
BACKGROUND: Several authors have hypothesized that adverse drug events (ADEs) upon switching from reference biologics to biosimilar products are related to the nocebo effect. However, a thorough and current review of the existing literature has not been conducted. OBJECTIVE: To evaluate if patient and/or physician knowledge of a switch from a reference biologic product to a biosimilar product was associated with an increase in ADEs likely to be susceptible to the nocebo effect...
October 2018: Journal of Managed Care & Specialty Pharmacy
Spyridon Michopoulos, Gregorios Paspatis, Konstantinos Triantafyllou, Spyridon Potamianos, Vassiliki Nikolopoulou, Evangelos Akriviadis, John A Karagiannis, Spyridon Ladas, Maria Tampaki, Charalambos Tzathas
Background: Real-world data on management patterns and long-term outcomes of patients with inadequately controlled Crohn's disease (CD) in Greece are scarce. Methods: This was a multicenter, prospective observational study of 18-65-year-old CD patients whose physicians judged that their current therapy was inadequate to control their condition and therefore decided to switch treatment. Data were collected at enrollment (time of switch), and 30, 54 and 104 weeks post-enrollment...
September 2018: Annals of Gastroenterology: Quarterly Publication of the Hellenic Society of Gastroenterology
Martin Soubrier, Bruno Pereira, Angelique Fan, Thomas Frayssac, Marion Couderc, Sandrine Malochet-Guinamand, Sylvain Mathieu, Zuzana Tatar, Anne Tournadre, Jean-Jacques Dubost
OBJECTIVE: To compare, in real-life settings, the retention rates of initial anti-tumor-necrosis factor (TNF) treatments (etanercept [ETN], adalimumab [ADA] and infliximab [IFX]) used as first-line biotherapy for axial spondyloarthritis (axSpA), and evaluate treatment switches to another anti-TNF inhibitor in the event of treatment failure. METHODS: We analyzed the medical records of all SpA patients (Assessment in Ankylosing Spondylitis International Working Group axial criteria) treated with ETN, IFX or ADA between 2001 and February 2015...
August 30, 2018: International Journal of Rheumatic Diseases
Mohammed I Aladul, Raymond W Fitzpatrick, Stephen R Chapman
OBJECTIVES: To investigate knowledge and attitudes of different healthcare professionals in UK towards infliximab and insulin glargine biosimilars METHODS: UK medical consultants/registrars, nurses and pharmacists participated in anonymised, self-administered web-based survey distributed by professional associations. KEY FINDINGS: There were 234 respondents: medical consultants/registrars (150), nurses (58) and pharmacists (26). 76% of medical consultants/registrars, 84% of pharmacists and 53% of nurses understood what biosimilars were...
August 30, 2018: International Journal of Pharmacy Practice
Maya H Buch, Alyssa Johnsen, Michael Schiff
OBJECTIVES: To explore antinuclear autoantibody (ANA) and anti-double-stranded DNA (anti-dsDNA) autoantibody development during abatacept and tumour necrosis factor inhibitor (TNFi) treatment, and effects of switching from TNFi to abatacept in ANA/anti-dsDNA autoantibody-positive patients. METHODS: This was a post hoc analysis of biologic-naïve patients with active RA in ATTEST and AMPLE. In AMPLE, patients received subcutaneous abatacept or adalimumab (2 years)...
August 21, 2018: Clinical and Experimental Rheumatology
Alessandro Armuzzi, Gionata Fiorino, Angela Variola, Natalia Manetti, Walter Fries, Ambrogio Orlando, Giovanni Maconi, Fabrizio Bossa, Maria Cappello, Livia Biancone, Laura Cantoro, Francesco Costa, Renata D'Incà, Paolo Lionetti, Mariabeatrice Principi, Fabiana Castiglione, Maria L Annunziata, Antonio Di Sabatino, Maria Di Girolamo, Maria M Terpin, Claudio C Cortelezzi, Simone Saibeni, Arnaldo Amato, Sandro Ardizzone, Luisa Guidi, Silvio Danese, Arianna Massella, Agostino Ventra, Giulia Rizzuto, Alessandro Massari, Francesco Perri, Vito Annese
Background: We report a prospective, nationwide cohort evaluating the safety and effectiveness of CT-P13. Methods: A structured database was used to record serious adverse events (SAEs), clinical remission/response, inflammatory biomarkers (CRP and calprotectin), and endoscopic findings. Results: Eight hundred ten patients with inflammatory bowel disease (IBD) (452 Crohn's disease [CD]) were enrolled. Four hundred fifty-nine patients were naïve to anti-TNFα (group A), 196 had a previous exposure (group B), and the remaining 155 were switched to CT-P13 (group C)...
August 18, 2018: Inflammatory Bowel Diseases
Evripidis Kaltsonoudis, Eleftherios Pelechas, Paraskevi V Voulgari, Alexandros A Drosos
OBJECTIVES: To estimate the size of unmet needs in the treatment of early Rheumatoid Arthritis (eRA), using all the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and/or biological DMARDs (bDMARDs) in a long-term observational study. MATERIALS AND METHODS: 538 patients with eRA were evaluated. The 2010 ACR/EULAR classification criteria were used. All patients were csDMARDs and bDMARDs-naive with disease duration less than one year. They were treated according to EULAR and ACR recommendations for RA...
June 22, 2018: Seminars in Arthritis and Rheumatism
Akos Ilias, Lorant Gonczi, Zuszsanna Kurti, Peter L Lakatos
The introduction of biological agents has revolutionized the management of ulcerative colitis (UC). Biosimilars are considered to be equivalent to the reference biologic products in terms of pharmacokinetic properties, clinical effectiveness and safety and have now been approved in inflammatory bowel diseases (IBD). CT-P13 was the first biosimilar to infliximab that obtained regulatory approval by the EMA and US FDA. Accumulating data on biosimilars led to an increased acceptance amongst practicing gastroenterologists and their use can be associated with a potential reduction in healthcare costs...
February 2018: Best Practice & Research. Clinical Gastroenterology
Vance J Bray, Aaron Broadwell, Herbert S B Baraf, Shawn Black, Brenna L Brady, Joseph Tkacz, Lorraine Yarngo, Raphael J DeHoratius
PURPOSE: For patients with rheumatoid arthritis (RA) who do not respond or lose response to anti-tumor necrosis factor (TNF) biologics, switching to a different anti-TNF can be an effective means to manage symptoms and disease progression. This study examined the utilization and effectiveness of intravenous golimumab within a real-world population of patients with RA switching directly from infliximab, a potent anti-TNF. METHODS: Patient charts (n = 113) were collected from five US-based rheumatology practices...
September 2018: Drugs in R&D
Tao Gu, Alex Mutebi, Bradley S Stolshek, Hiangkiat Tan
OBJECTIVES: To estimate total costs among patients with rheumatoid arthritis (RA) who persisted on or switched from newly initiated biologic therapy. STUDY DESIGN: A retrospective claims database analysis. METHODS: This analysis included adults in the HealthCore Integrated Research Database with RA who initiated treatment with a biologic for RA (abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, or tocilizumab) between January 2009 and November 2014...
July 2018: American Journal of Managed Care
Bente Glintborg, Jan Sørensen, Merete Lund Hetland
Objectives: National Danish guidelines in May 2015 dictated a mandatory switch from originator infliximab (INX) to biosimilar CT-P13 in patients with inflammatory rheumatic disease. We investigated if this non-medical switch changed use of outpatient hospital resources. Methods: Observational cohort study. Switchers were identified in DANBIO. Rheumatic outpatient contacts, visits and services were identified in the National Patient Registry. The 6-month rate for (1) number of visits (or services) and (2) days with ≥1 visit (or service) were compared before/after switching (paired t-tests)...
2018: RMD Open
Elena Nikiphorou, Pekka Hannonen, Juha Asikainen, Jelena Borodina, Arto Kokko, Kirsi Paalanen, Tuomas Rannio, Tuulikki Sokka
OBJECTIVES: Reports to-date indicate similarity between infliximab biosimilar (IB) and infliximab bio-original (IO) in clinical efficacy and safety. This study examines the survival of IB and IO using routinely collected data over a 2-year period. METHODS: Routinely collected clinical data inputted directly in an electronic database at a large rheumatology centre were analysed. Adult patients taking IO or IB for any rheumatological diagnosis were included. Kaplan-Meier survival analyses were used to examine IB and IO survival, with a sub-group analysis among those starting infliximab from 2008 onwards...
June 7, 2018: Clinical and Experimental Rheumatology
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