388 results match your criteria Biologics[Journal]


Efficacy of adalimumab as second-line therapy in a pediatric cohort of Crohn's disease patients who failed infliximab therapy: the Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition experience.

Biologics 2019 3;13:13-21. Epub 2019 Jan 3.

Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy.

Background: Adalimumab (Ada) treatment is an available option for pediatric Crohn's disease (CD) and the published experience as rescue therapy is limited.

Objectives: We investigated Ada efficacy in a retrospective, pediatric CD cohort who had failed previous infliximab treatment, with a minimum follow-up of 6 months.

Methods: In this multicenter study, data on demographics, clinical activity, growth, laboratory values (CRP) and adverse events were collected from CD patients during follow-up. Read More

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http://dx.doi.org/10.2147/BTT.S183088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6322517PMC
January 2019
10 Reads

Spotlight on dinutuximab in the treatment of high-risk neuroblastoma: development and place in therapy.

Biologics 2019 21;13:1-12. Epub 2018 Dec 21.

Cancer Center,

Neuroblastoma (NB) is a pediatric cancer of the sympathetic nervous system which accounts for 8% of childhood cancers. Most NBs express high levels of the disialoganglioside GD2. Several antibodies have been developed to target GD2 on NB, including the human/mouse chimeric antibody ch14. Read More

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http://dx.doi.org/10.2147/BTT.S114530DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6306059PMC
December 2018
1 Read

The role of microfluidics in protein formulations with pre-programmed functional characteristics.

Biologics 2018 3;12:191-197. Epub 2018 Dec 3.

Institute for Tissue Engineering and Regenerative Medicine, The Chinese University of Hong Kong, Hong Kong, China,

Protein-based therapies hold great promise for treating many diseases. Nevertheless, the challenges of producing therapies with targeted attributes via standardized processes may hinder the development of protein formulations and clinical translation of the advanced therapies. Microfluidics represents a promising technology to develop protein formulations with pre-programmed functional characteristics, including size, morphology, and controlled drug release property. Read More

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https://www.dovepress.com/the-role-of-microfluidics-in-prote
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http://dx.doi.org/10.2147/BTT.S126725DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6284529PMC
December 2018
2 Reads

Infliximab dose adjustment can improve the clinical and radiographic outcomes of rheumatoid arthritis patients: REVIVE study results.

Biologics 2018 27;12:171-182. Epub 2018 Nov 27.

Department of Hematology and Rheumatology, Kindai University School of Medicine, Osaka, Japan,

Purpose: We evaluated the clinical responses and radiographic outcomes of 90 patients with rheumatoid arthritis (RA) undergoing continuous or dose-adjusted infliximab treatment over 104 weeks.

Patients And Methods: Patients received 3 mg/kg infliximab continuously (the contin group; n=50), or the dose escalation and de-escalation of infliximab (3, 6, and 10 mg/kg) from week 14 (the adjusted group; n=40) based on the patient's Disease Activity Score in 28 joints (DAS28). The retention rate, clinical response, and radiographic assessment were determined at week 104. Read More

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http://dx.doi.org/10.2147/BTT.S187998DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6267494PMC
November 2018

Combination of EGFR-TKIs with chemotherapy versus chemotherapy or EGFR-TKIs alone in advanced NSCLC patients with EGFR mutation.

Biologics 2018 30;12:183-190. Epub 2018 Nov 30.

Department of Thoracic Surgery, Tangdu Hospital, The Fourth Military Medical University, Xi'an 710038, Shaanxi, China,

Purpose: Both epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) and chemotherapy are widely applied for the treatment of advanced non-small-cell lung cancer (NSCLC) with EGFR mutations, and the combination of EGFR-TKIs and chemotherapy has been used for advanced NSCLC patients; however, little is known about the efficacy of the direct comparison among them.

Patients And Methods: The demographic and clinical characteristics of 92 patients harboring advanced NSCLC with EGFR mutation were retrospectively reviewed. We evaluated the effects of EGFR-TKIs, chemotherapy, and EGFR-TKIs plus chemotherapy on advanced NSCLC patients with EGFR mutations, and the efficacy of combination of chemotherapy and EGFR-TKIs vs chemotherapy or EGFR-TKIs alone in advanced NSCLC patients was evaluated. Read More

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http://dx.doi.org/10.2147/BTT.S169305DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6280904PMC
November 2018
1 Read

Structural and functional comparability study of anti-CD20 monoclonal antibody with reference product.

Biologics 2018 23;12:159-170. Epub 2018 Nov 23.

Sun Pharmaceutical Industries Limited, Tandalja, Vadodara 390 012, India,

Background: Cell surface protein, CD20, is extensively expressed on the surface of B cells. Antibodies targeting CD20 protein are being used to treat B-cell malignancies and B-cell mediated autoimmune diseases. Considering the cost of therapy with innovator monoclonal antibodies for these diseases, development of biosimilar products for the treatment of such diseases provides affordable solution to rising healthcare costs. Read More

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http://dx.doi.org/10.2147/BTT.S187744DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6257079PMC
November 2018
1 Read

Analysis of drug utilization and health care resource consumption in patients with psoriasis and psoriatic arthritis before and after treatment with biological therapies.

Biologics 2018 12;12:151-158. Epub 2018 Nov 12.

Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy.

Objectives: To describe the therapeutic pathways of patients with psoriasis (PSO) and psoriatic arthritis (PsA) before and after treatment with biological therapies in a real-world setting and to determine the relative consumption of health care resources.

Design: Retrospective observational study.

Setting: Real-life clinical setting in 5 Italian local health units. Read More

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http://dx.doi.org/10.2147/BTT.S168691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6237141PMC
November 2018
2 Reads

The effects of golimumab treatment on systolic and diastolic left ventricular function in ankylosing spondylitis.

Biologics 2018 8;12:143-149. Epub 2018 Nov 8.

Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Reade, Amsterdam, The Netherlands,

Background: Diastolic left ventricular (LV) dysfunction appears more prevalent in ankylosing spondylitis (AS). The effects of tumor necrosis factor alpha (TNF-α) blocking therapy, a strong and effective anti-inflammatory drug, on diastolic LV function in AS are unknown. The objective of the study was to find the effects of 1-year treatment with golimumab 50 mg subcutaneously once per month on systolic and diastolic LV dysfunction in AS patients. Read More

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https://www.dovepress.com/the-effects-of-golimumab-treatment
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http://dx.doi.org/10.2147/BTT.S176806DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6231442PMC
November 2018
9 Reads

Analysis of real-world treatment patterns in a matched rheumatology population that continued innovator infliximab therapy or switched to biosimilar infliximab.

Biologics 2018 25;12:127-134. Epub 2018 Oct 25.

Department of Rheumatology, Guven Hospital, Ankara, Turkey.

Purpose: This study compared treatment patterns of Turkish patients with a diagnosis of rheumatoid arthritis (RA) who were treated with innovator Remicade (infliximab [IFX]) and either continued IFX or switched to CT-P13.

Materials And Methods: Adult RA patients with ≥1 IFX claim were identified from the Turkish Ministry of Health database. Eligible patients initiated and continued IFX treatment (continuers cohort [CC]) or initiated IFX and switched to CT-P13 (switchers cohort [SC]) during the study period. Read More

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https://www.dovepress.com/analysis-of-real-world-treatment-p
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http://dx.doi.org/10.2147/BTT.S172337DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6207267PMC
October 2018
10 Reads

Two decades with omalizumab: what we still have to learn.

Biologics 2018 26;12:135-142. Epub 2018 Oct 26.

Department of Medicine and Surgery, University of Parma, Parma, Italy.

From its availability for clinical use nearly two decades ago for severe asthma, omalizumab has gained strong evidence of efficacy and safety in the treatment of severe asthma not controlled by standard-of-care therapy. It has been acknowledged by Global Initiative on Asthma guidelines as add-on therapy against severe uncontrolled asthma. Thanks to controlled trials supporting its efficacy, omalizumab has also been licensed for the treatment of chronic spontaneous urticaria. Read More

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http://dx.doi.org/10.2147/BTT.S180846DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6208531PMC
October 2018
9 Reads

Designing of CD8 and CD8-overlapped CD4 epitope vaccine by targeting late and early proteins of human papillomavirus.

Biologics 2018 2;12:107-125. Epub 2018 Oct 2.

Centre of Interdisciplinary Science - Computational Life Sciences, College of Food Science and Engineering, Henan University of Technology, Zhengzhou, China,

Background And Aim: Human papillomavirus (HPV) is an oncogenic agent that causes over 90% of cases of cervical cancer in the world. Currently available prophylactic vaccines are type specific and have less therapeutic efficiency. Therefore, we aimed to predict the potential species-specific and therapeutic epitopes from the protein sequences of HPV45 by using different immunoinformatics tools. Read More

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https://www.dovepress.com/designing-of-cd8-and-cd8-overlappe
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http://dx.doi.org/10.2147/BTT.S177901DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6174296PMC
October 2018
38 Reads

A descriptive analysis of real-world treatment patterns of innovator (Remicade) and biosimilar infliximab in an infliximab-naïve Turkish population.

Biologics 2018 2;12:97-106. Epub 2018 Oct 2.

Guven Hospital, Department of Rheumatology, Ankara, Turkey.

Purpose: Biosimilar IFX (CT-P13) received marketing approval in Turkey for treatment of rheumatologic diseases, including ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis (RA), inflammatory bowel disease (IBD), and psoriasis. Population data on real-world treatment patterns of CT-P13 following marketing approval in European countries are largely unreported. This study examined the prescribing and medication utilization patterns of innovator infliximab (IFX) and CT-P13 in Turkey for patients with RA or IBD naïve to either IFX. Read More

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https://www.dovepress.com/a-descriptive-analysis-of-real-wor
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http://dx.doi.org/10.2147/BTT.S172241DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6174299PMC
October 2018
11 Reads

Focus on biosimilar etanercept - bioequivalence and interchangeability.

Biologics 2018 30;12:87-95. Epub 2018 Aug 30.

Rheumatology Unit, Hospital S. Giovanni di Dio, Florence, Italy.

Background: The recent approval of reference etanercept (re-ETN) biosimilars SB4, GP2015, and HD203 produced relevant changes in the management of rheumatoid arthritis (RA), psoriatic arthritis, and ankylosing spondylitis due to the considerably lower cost of these products and the consequent savings.

Aims: To review the pharmacodynamics, pharmacokinetics, efficacy, and safety of ETN biosimilars when employed as first-line therapy or after transition from re-ETN. Patients' acceptability was also addressed. Read More

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http://dx.doi.org/10.2147/BTT.S126854DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6121755PMC
August 2018
2 Reads

Combined treatment with metformin and gefitinib overcomes primary resistance to EGFR-TKIs with EGFR mutation via targeting IGF-1R signaling pathway.

Biologics 2018 20;12:75-86. Epub 2018 Aug 20.

Department of Respiratory Disease, Daping Hospital, Third Military Medical University, Chongqing 400042, China,

Aim: Although EGFR tyrosine kinase inhibitors (TKIs) have shown dramatic effects against sensitizing EGFR mutations in non-small cell lung cancer (NSCLC), ~20%-30% of NSCLC patients with EGFR-sensitive mutation exhibit intrinsic resistance to EGFR-TKIs. The purpose of the current study was to investigate the enhanced antitumor effect of metformin (Met), a biguanide drug, in combination with gefitinib (Gef) in primary resistant human lung cancer cells and the associated molecular mechanism.

Experimental Design: H1975 cell line was treated with Met and/or Gef to examine the inhibition of cell growth and potential mechanism of action by using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT), Ki67 incorporation assay, flow cytometry analysis, small interfering RNA technology, Western blot analysis and xenograft implantation. Read More

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http://dx.doi.org/10.2147/BTT.S166867DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6108345PMC
August 2018
3 Reads

Efficacy of ustekinumab against infliximab-induced psoriasis and arthritis associated with Crohn's disease.

Biologics 2018 19;12:69-73. Epub 2018 Jul 19.

Department of Gastroenterology, Saitama Medical Center, Jichi Medical University, Saitama, Japan,

Anti-TNFα drugs have been shown to be effective for maintaining stable remission in patients with Crohn's disease. However, some problems have been identified during clinical use of this class of drugs, such as secondary treatment failure, in which the drugs become progressively less effective with time, and the development of paradoxical reactions such as psoriatic skin symptoms. Thus, while anti-TNFα drugs are used to treat psoriasis, they can sometimes also cause paradoxical psoriasis, characterized by the appearance of psoriasis-like eruptions, which has recently begun to attract attention. Read More

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http://dx.doi.org/10.2147/BTT.S169326DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6055910PMC
July 2018
1 Read

The conundrum of indeterminate QuantiFERON-TB Gold results before anti-tumor necrosis factor initiation.

Biologics 2018 27;12:61-67. Epub 2018 Feb 27.

Department of Medicine.

Background: Tumor necrosis factor alpha (TNFα) is a key cytokine in both the pathogenesis of inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) and the host defense against tuberculosis (TB). Consequently, anti-TNFα medications result in an increased risk of latent TB infection (LTBI) reactivation. Here, we sought to evaluate the factors affecting the results of QuantiFERON-TB Gold In-Tube (QFT-GIT) assay as a screening tool for LTBI. Read More

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http://dx.doi.org/10.2147/BTT.S150958DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5834167PMC
February 2018
4 Reads

New frontiers in oncolytic viruses: optimizing and selecting for virus strains with improved efficacy.

Biologics 2018 9;12:43-60. Epub 2018 Feb 9.

PanTherapeutics, Lutry, Switzerland.

Oncolytic viruses have demonstrated selective replication and killing of tumor cells. Different types of oncolytic viruses - adenoviruses, alphaviruses, herpes simplex viruses, Newcastle disease viruses, rhabdoviruses, Coxsackie viruses, and vaccinia viruses - have been applied as either naturally occurring or engineered vectors. Numerous studies in animal-tumor models have demonstrated substantial tumor regression and prolonged survival rates. Read More

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https://www.dovepress.com/new-frontiers-in-oncolytic-viruses
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http://dx.doi.org/10.2147/BTT.S140114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5810530PMC
February 2018
5 Reads

Correlation between HLA haplotypes and the development of antidrug antibodies in a cohort of patients with rheumatic diseases.

Biologics 2018 31;12:37-41. Epub 2018 Jan 31.

Immunology and Allergology Laboratory Unit, USL-Toscana Centro, Hospital S. Giovanni di Dio, Florence, Italy.

Introduction: The aim of this study was to investigate the correlation between human leukocyte antigen (HLA) haplotypes and the development of antidrug antibodies (ADAs) in a cohort of patients with rheumatic diseases.

Patients And Methods: We evaluated the presence of ADAs in 248 patients with inflammatory rheumatic diseases after 6 months of treatment with anti-TNF drugs: 26 patients were treated with infliximab (IFX; three with rheumatoid arthritis [RA], 13 with ankylosing spondylitis [AS], 10 with psoriatic arthritis [PsA]); 83 treated with adalimumab (ADA; 24 with RA, 36 with AS, 23 with PsA); 88 treated with etanercept (ETA; 35 with RA, 27 with AS, 26 with PsA); 32 treated with certolizumab (CERT; 25 with RA, two with AS, five with PsA); and 19 treated with golimumab (GOL; three with RA, seven with AS, nine with PsA). Serum drug and ADA levels were determined using Lisa-Tracker Duo, the ADA-positive samples underwent an inhibition test, and the true-positive samples underwent genetic HLA typing. Read More

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http://dx.doi.org/10.2147/BTT.S145941DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5797458PMC
January 2018
2 Reads

Analytical characterization of recombinant hCG and comparative studies with reference product.

Biologics 2018 30;12:23-35. Epub 2018 Jan 30.

Sun Pharmaceutical Industries Limited.

Introduction: Regulatory agencies recommend a stepwise approach for demonstrating biosimilarity between a proposed biosimilar and reference biological product emphasizing for functional and structural characterization to trace if there is any difference which may impact safety and efficacy. We studied the comparative structural and biological attributes of recombinant human chorionic gonadotropin (rhCG), SB005, with reference product, Ovidrel and Ovitrelle. Recombiant hCG was approved in 2000 by the US Food and Drug Administration for the induction of final follicular maturation, early luteinization in infertile women as part of assisted reproductive technology program. Read More

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https://www.dovepress.com/analytical-characterization-of-rec
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http://dx.doi.org/10.2147/BTT.S141203DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5796461PMC
January 2018
30 Reads

Bezlotoxumab: an emerging monoclonal antibody therapy for prevention of recurrent infection.

Biologics 2018 18;12:11-21. Epub 2018 Jan 18.

Internal Medicine and Infectious Diseases, Infection Prevention and Epidemiology, Detroit Medical Center, Wayne State University, Detroit, MI, USA.

infection (CDI) is the most common health care-acquired infection associated with high hospital expenditures. The incidence of subsequent recurrent CDI increases with prior episodes of CDI, 15%-35% risk after primary CDI to 35%-65% risk after the first recurrent episode. Recurrent CDI is one of the most challenging and a very difficult to treat infections. Read More

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http://dx.doi.org/10.2147/BTT.S127099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5779312PMC
January 2018

Tuberculosis and viral hepatitis infection in Eastern Europe, Asia, and Latin America: impact of tumor necrosis factor-α inhibitors in clinical practice.

Biologics 2018 12;12:1-9. Epub 2018 Jan 12.

Pfizer, Brussels, Belgium.

Tumor necrosis factor-α (TNF-α) inhibitors are increasingly becoming the standard of care for treating a number of inflammatory diseases. However, treatment with TNF-α inhibitors carries an inherent risk of compromising the immune system, resulting in an increased susceptibility to infections and malignancies. This increased risk of infection is of particular concern in Asia, Eastern Europe, and Latin America where tuberculosis (TB) and viral hepatitis are endemic. Read More

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http://dx.doi.org/10.2147/BTT.S148606DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5769557PMC
January 2018
12 Reads

Anti-angiogenic effects of biotechnological therapies in rheumatic diseases.

Biologics 2017 14;11:123-128. Epub 2017 Dec 14.

Department of Basic Medical Sciences, Neurosciences and Sensory Organs, University of Bari Medical School.

Introduction: Angiogenesis plays a key role in the pathogenesis of numerous rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, and vasculitides. Therefore, the inhibition of pathological angiogenesis may be considered a useful therapeutical approach in these rheumatic diseases.

Methods: This review article is based on a literature research about the role of biotechnological therapies in angiogenesis inhibition. Read More

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https://www.dovepress.com/anti-angiogenic-effects-of-biotech
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http://dx.doi.org/10.2147/BTT.S143674DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5733924PMC
December 2017
8 Reads

Octreotide long-acting repeatable in the treatment of neuroendocrine tumors: patient selection and perspectives.

Biologics 2017 6;11:115-122. Epub 2017 Dec 6.

Division of Endocrinology, Diabetes, and Metabolism, Orlando VA Medical Center, Orlando, FL, USA.

Over the past three decades, the incidence and prevalence of neuroendocrine tumors have gradually increased. Due to the slow-growing nature of these tumors, most cases are diagnosed at advanced stages. Prognosis and survival are associated with location of primary lesion, biochemical functional status, differentiation, initial staging, and response to therapy. Read More

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http://dx.doi.org/10.2147/BTT.S108818DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5723116PMC
December 2017
9 Reads

Anticholinesterase constituents from the leaves of L. (Anacardiaceae).

Biologics 2017 2;11:107-114. Epub 2017 Aug 2.

Department of Pharmacognosy, Faculty of Pharmacy, Obafemi Awolowo University, Ile Ife, Osun, Nigeria.

has been used in traditional medicine for the management of several diseases, including memory loss. This study aimed to evaluate the cholinesterase inhibitory activity of the methanol extract of the leaves and its derived fractions, as well as carry out detailed phytochemical investigations leading to the isolation and characterization of bioactive compounds from the plant. The acetyl cholinesterase (AChE) and butyryl cholinesterase (BUChE) inhibitory activities were evaluated by colorimetric and thin-layer chromatography bioautographic assay techniques. Read More

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http://dx.doi.org/10.2147/BTT.S136011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546590PMC
August 2017
3 Reads

Epigenetic memory of oxidative stress: does nephrilin exert its protective effects via Rac1?

Biologics 2017 17;11:97-106. Epub 2017 Jul 17.

Department of Pediatrics, Division of Pediatric Nephrology, University of Mississippi Medical Center, Jackson, MS, USA.

Aim: Nephrilin peptide, a designed inhibitor of Rictor complex (mTORC2), exerts pleiotropic protective effects in metabolic, xenobiotic and traumatic stress models. Stress can generate enduring epigenetic changes in gene function. In this work we examine the possibility that nephrilin treatment protects against acute and enduring global changes in oxidative metabolism, with a focus on the Rictor-complex-mediated activation of Rac1, a subunit of NADPH oxidase (Nox) via PKCs, Prex1 and p66shc. Read More

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http://dx.doi.org/10.2147/BTT.S136188DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5522666PMC
July 2017
6 Reads

Patient profiles and clinical utility of mepolizumab in severe eosinophilic asthma.

Biologics 2017 27;11:81-95. Epub 2017 Jun 27.

Respiratory Biomedical Research Unit, Glenfield Hospital, University of Leicester, Leicester, UK.

Mepolizumab (Nucala) is an effective and specific anti-eosinophil molecular therapy that has recently been approved as add-on therapy for the management of severe eosinophilic asthma by the US Food and Drug Administration (FDA), European Medicines Agency (EMA; European Union) and more recently National Institute for Health and Care Excellence (NICE; UK). It is one of several molecular therapies in development for this indication and is illustrative of the strategic trajectory for pharmaceutical drug development taken over the past decade in several disease areas. Molecular therapies offer the prospect of improved specificity and effectiveness of biological effect. Read More

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http://dx.doi.org/10.2147/BTT.S93954DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5498675PMC
June 2017
10 Reads

Autophagy regulates the stemness of cervical cancer stem cells.

Biologics 2017 21;11:71-79. Epub 2017 Jun 21.

Hubei Key Laboratory of Embryonic Stem Cell Research.

Cancer stem cells (CSCs) are a rare population of multipotent cells with the capacity to self-renew. It has been reported that there are CSCs in cervical cancer cells. Pluripotency-associated (PA) transcription factors such as Oct4, Sox2, Nanog and CD44 have been used to isolate CSCs subpopulations. Read More

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http://dx.doi.org/10.2147/BTT.S134920DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5484512PMC
June 2017
29 Reads

Paradoxical SAPHO syndrome observed during anti-TNFα therapy for Crohn's disease.

Biologics 2017 22;11:65-69. Epub 2017 May 22.

Department of Surgery, Fujisawa Shonandai Hospital, Fujisawa, Japan.

Currently, anti-TNFα antibodies are used to treat Crohn's disease. We report on a 45-year-old Japanese female with Crohn's disease developing SAPHO (synovitis, acne, pustulosis, hyperostosis, and osteitis) syndrome following exposure to the anti-TNFα antibody adalimumab. Initially, adalimumab induced remission, but the patient showed SAPHO syndrome 11 weeks following the start of adalimumab therapy for the first time. Read More

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http://dx.doi.org/10.2147/BTT.S134508DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5447692PMC
May 2017
11 Reads

Development of a potent invigorator of immune responses endowed with both preventive and therapeutic properties.

Biologics 2017 2;11:55-63. Epub 2017 May 2.

Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi, India.

This article reviews briefly the making of an immunoprophylactic-cum-immunotherapeutic vaccine against leprosy. The vaccine is based on cultivable, heat-killed atypical mycobacteria, whose gene sequence is now known. It has been named . Read More

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http://dx.doi.org/10.2147/BTT.S128308DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5422320PMC
May 2017
41 Reads

promotes cell invasion in gastric cancer by activating the NF-κB signaling pathway.

Biologics 2017 12;11:45-53. Epub 2017 Apr 12.

Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, People's Republic of China.

() overexpression has been reported to be involved in the carcinogenesis and progression of many malignant tumors. However, the role of in the progression of gastric cancer (GC) remains unclear. In this study, we explored whether and how regulates proinflammatory signaling to promote GC cell invasion. Read More

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http://dx.doi.org/10.2147/BTT.S127650DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5395274PMC
April 2017
15 Reads

New developments in the treatment of multiple myeloma - clinical utility of daratumumab.

Biologics 2017 11;11:31-43. Epub 2017 Apr 11.

Department of Hematology, University Hospital Galway.

Multiple myeloma is a clonal disorder of plasma cells that is currently considered incurable. CD38 is a 46 kDa type II transmembrane glycoprotein that is highly expressed on myeloma cells. Daratumumab is a first in-class human IgG1 monoclonal antibody that targets CD38, and has antimyeloma effects through several mechanisms. Read More

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http://dx.doi.org/10.2147/BTT.S97633DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5395289PMC
April 2017
6 Reads

Neutralizing activities against seasonal influenza viruses in human intravenous immunoglobulin.

Biologics 2017 10;11:23-30. Epub 2017 Mar 10.

Research and Development Division, Japan Blood Products Organization, Tokyo; Former Department of Virology, Research Institute for Microbial Diseases, Osaka University; Pathogenic Risk Evaluation, Graduate School of Veterinary Medicine, Rakuno Gakuen University, Hokkaido, Japan.

Influenza viruses A/H1N1, A/H3N2, and B are known seasonal viruses that undergo annual mutation. Intravenous immunoglobulin (IVIG) contains anti-seasonal influenza virus globulins. Although the virus-neutralizing (VN) titer is an indicator of protective antibodies, changes in this titer over extended time periods have yet to be examined. Read More

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http://dx.doi.org/10.2147/BTT.S123831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5354529PMC
March 2017
7 Reads

A practical guide about biosimilar data for health care providers treating inflammatory diseases.

Biologics 2017 24;11:13-21. Epub 2017 Feb 24.

Pfizer Inc, Chesterfield, MO, USA.

To make informed decisions about the safety, efficacy, and clinical utility of a biosimilar, health care providers should understand the types and be able to analyze data generated from a biosimilar development program. This article reviews the biosimilar guidelines, the biosimilar development process to provide education and context about biosimilarity, and uses examples from infliximab biosimilars to review the terminology and potential types of analyses that may be used to compare potential biosimilars to the originator biologic. A biosimilar is a biologic product that is highly similar to an approved (originator) biologic, notwithstanding minor differences in clinically inactive components, and with no clinically meaningful differences in terms of the safety, purity, and potency of the product. Read More

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http://dx.doi.org/10.2147/BTT.S122335DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5338847PMC
February 2017
3 Reads

Biosimilars and the extrapolation of indications for inflammatory conditions.

Biologics 2017 17;11:5-11. Epub 2017 Feb 17.

Pfizer Inc, New York, NY, USA.

Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indication for the biosimilar product to all the indications originally approved for the originator. Regulatory approval and marketing authorization of biosimilars in inflammatory indications are made on a case-by-case and agency-by-agency basis after evaluating the totality of evidence from the entire development program. Read More

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http://dx.doi.org/10.2147/BTT.S124476DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5322938PMC
February 2017
16 Reads

Centrosome - a promising anti-cancer target.

Biologics 2016 13;10:167-176. Epub 2016 Dec 13.

Department of Pharmacology, Ponce Health Sciences University-School of Medicine, Ponce Research Institute, Ponce, Puerto Rico.

The centrosome, an organelle discovered >100 years ago, is the main microtubule-organizing center in mammalian organisms. The centrosome is composed of a pair of centrioles surrounded by the pericentriolar material (PMC) and plays a major role in the regulation of cell cycle transitions (G1-S, G2-M, and metaphase-anaphase), ensuring the normality of cell division. Hundreds of proteins found in the centrosome exert a variety of roles, including microtubule dynamics, nucleation, and kinetochore-microtubule attachments that allow correct chromosome alignment and segregation. Read More

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http://dx.doi.org/10.2147/BTT.S87396DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5167523PMC
December 2016
3 Reads

Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimilars.

Biologics 2016 1;10:157-165. Epub 2016 Dec 1.

CliCon S.r.l., Health, Economics & Outcomes Research, Ravenna.

Aim: The purpose of this study was to assess the prescription of epoetins and consumption of health care resources (in terms of drug treatments) in naïve patients with hematological malignancies in a real-world setting; in particular, we compared the results between reference product and biosimilar products.

Methods: An observational retrospective study based on administrative and laboratory databases of three local health units was conducted. All adults diagnosed with hematological malignancies and who had received at least one epoetin (either reference product or biosimilars) prescription for the first time between 1 January 2010 and 30 April 2012 (enrollment period) were included. Read More

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http://dx.doi.org/10.2147/BTT.S114625DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5137929PMC
December 2016
10 Reads

Update on sepsis-associated acute kidney injury: emerging targeted therapies.

Biologics 2016 7;10:149-156. Epub 2016 Nov 7.

Department of Intensive Care, Medicine and Surrey Peri-Operative Anaesthesia and Critical Care Collaborative Research Group, Royal Surrey County Hospital NHS Foundation Trust; Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, UK.

Sepsis-associated acute kidney injury (SA-AKI) is an independent predictor of increased mortality and morbidity. It is essential that further advances in the treatment of sepsis should prioritize targeted therapies in SA-AKI in order to improve these bleak outcomes. As yet, a unique therapy that effectively reduces the impact of acute kidney injury has not been demonstrated. Read More

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http://dx.doi.org/10.2147/BTT.S87385DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5106183PMC
November 2016
7 Reads
3 Citations

Eag1 channels as potential early-stage biomarkers of hepatocellular carcinoma.

Biologics 2016 20;10:139-148. Epub 2016 Sep 20.

Department of Pharmacology, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional.

Hepatocellular carcinoma (HCC) is a major cause of cancer death worldwide. HCC is usually asymptomatic at potential curative stages, and it has very poor prognosis if detected later. Thus, the identification of early biomarkers and novel therapies is essential to improve HCC patient survival. Read More

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https://www.dovepress.com/eag1-channels-as-potential-early-s
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http://dx.doi.org/10.2147/BTT.S87402DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5036561PMC
September 2016
26 Reads

Therapeutic efficacy of monthly subcutaneous injection of daclizumab in relapsing multiple sclerosis.

Authors:
Stanley Cohan

Biologics 2016 12;10:119-38. Epub 2016 Sep 12.

Providence Multiple Sclerosis Center; Providence Brain and Spine Institute; Providence Health & Services, Portland, OR, USA.

Despite the availability of multiple disease-modifying therapies for relapsing multiple sclerosis (MS), there remains a need for highly efficacious targeted therapy with a favorable benefit-risk profile and attributes that encourage a high level of treatment adherence. Daclizumab is a humanized monoclonal antibody directed against CD25, the α subunit of the high-affinity interleukin 2 (IL-2) receptor, that reversibly modulates IL-2 signaling. Daclizumab treatment leads to antagonism of proinflammatory, activated T lymphocyte function and expansion of immunoregulatory CD56(bright) natural killer cells, and has the potential to, at least in part, rectify the imbalance between immune tolerance and autoimmunity in relapsing MS. Read More

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https://www.dovepress.com/therapeutic-efficacy-of-monthly-su
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http://dx.doi.org/10.2147/BTT.S89218DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5026217PMC
September 2016
9 Reads

New targeted treatments for non-small-cell lung cancer - role of nivolumab.

Biologics 2016 1;10:103-17. Epub 2016 Aug 1.

Department of Thoracic Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek (NKI-AvL), Amsterdam, the Netherlands.

Non-small-cell lung cancer (NSCLC) is often diagnosed at an advanced stage of disease, where it is no longer amenable to curative treatment. During the last decades, the survival has only improved significantly for lung cancer patients who have tumors harboring a driver mutation. Therefore, there is a clear unmet need for effective therapies for patients with no mutation. Read More

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http://dx.doi.org/10.2147/BTT.S87878DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4975160PMC
August 2016
3 Reads

Neutralizing activities of human immunoglobulin derived from donors in Japan against mosquito-borne flaviviruses, Japanese encephalitis virus, West Nile virus, and dengue virus.

Biologics 2016 7;10:99-102. Epub 2016 Jul 7.

Department of Virology, Research Institute for Microbial Diseases, Osaka University, Osaka; Research and Development Division, The Research Foundation for Microbial Diseases of Osaka University, Kagawa.

Japanese encephalitis virus (JEV), West Nile virus (WNV), and dengue virus (DenV) are causal agents of Japanese encephalitis, West Nile fever, and dengue fever, respectively. JEV is considered to be indigenized and widespread in Japan, whereas WNV and DenV are not indigenized in Japan. Globulin products seem to reflect the status of the donor population according to antivirus neutralization activity. Read More

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http://dx.doi.org/10.2147/BTT.S105650DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4940000PMC
July 2016
17 Reads

Guanine nucleotide exchange factor H1 can be a new biomarker of melanoma.

Biologics 2016 5;10:89-98. Epub 2016 Jul 5.

Reconstructive and Plastic Surgery, The General Hospital of Shenyang Military Region, Shenyang, People's Republic of China.

Guanine nucleotide exchange factor H1 (GEF-H1), which couples microtubule dynamics to RhoA activation, is a microtubule-regulated exchange factor. Studies have shown that GEF-H1 can be involved in various cancer pathways; however, the clinical significance of GEF-H1 expression and functions in melanoma has not been established. In this study, we investigated the relationship between clinical outcomes and GEF-H1 functions in melanoma. Read More

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http://dx.doi.org/10.2147/BTT.S109643DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4939981PMC
July 2016
11 Reads

Effects of fucoidan from Fucus vesiculosus in reducing symptoms of osteoarthritis: a randomized placebo-controlled trial.

Biologics 2016 26;10:81-8. Epub 2016 May 26.

Marinova Pty Ltd, Cambridge, TAS, Australia.

Purpose: Preliminary investigation of a fucoidan with demonstrated reduction in the symptoms of osteoarthritis (OA) of the hip and knee.

Patients And Methods: A double-blind randomized controlled trial was carried out to determine the safety and efficacy of a 300 mg dose of a Fucus vesiculosus extract (85% fucoidan) over a 12-week period in a population (n=122) with mild-to-moderate OA of the hip and knee as measured by the validated instrument "Comprehensive Osteoarthritis Test." Safety was measured by assessing cholesterol, liver function, renal function, and hematopoietic function, and closely monitoring adverse events. Read More

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http://dx.doi.org/10.2147/BTT.S95165DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4887044PMC
June 2016
2 Reads

Efficacy of anti-IL-1 treatment in familial Mediterranean fever: a systematic review of the literature.

Biologics 2016 4;10:75-80. Epub 2016 Apr 4.

KU Leuven, Laboratory of Clinical Infectious and Inflammatory Disorders, University Hospitals Leuven, Leuven, Belgium.

Introduction: In 5%-10% of patients with familial Mediterranean fever (FMF), colchicine is not effective in preventing inflammatory attacks. Another 5%-10% of patients are intolerant to effective doses of colchicine and experience serious side effects. Treatment with anti-interleukin-1 (IL-1) drugs may be an alternative for these patients, although it is not reimbursed for this indication in many countries. Read More

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http://dx.doi.org/10.2147/BTT.S102954DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4831592PMC
April 2016
4 Reads

Cost-effectiveness of routine measuring of serum drug concentrations and anti-drug antibodies in treatment of rheumatoid arthritis patients with TNF-α blockers.

Biologics 2016 1;10:67-73. Epub 2016 Apr 1.

Department of Medicine, South Karelia, Finland.

Monitoring of anti-drug antibodies (ADAbs) or serum concentrations of biologicals in treatment of rheumatoid arthritis could provide an explanation for a loss of efficacy and help in the choice of subsequent medication. Current clinical practices do not generally include such monitoring of tumor necrosis factor (TNF)-α blockers on a routine basis. The main aims of this study were to estimate the probabilities of optimal and nonoptimal treatment decisions if infliximab or adalimumab drug trough level (DL) and ADAbs are tested or not in rheumatoid arthritis, and to model cost-effectiveness of performing such monitoring on a routine basis. Read More

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http://dx.doi.org/10.2147/BTT.S96982DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4824281PMC
April 2016
2 Reads

Tocilizumab in refractory rheumatoid arthritis: long-term efficacy, safety, and tolerability beyond 2 years.

Biologics 2016 22;10:59-66. Epub 2016 Mar 22.

Department of Rheumatology, Charing Cross Hospital, London, UK.

Objectives: To evaluate the long-term efficacy and safety of tocilizumab (TCZ) in clinical patients with rheumatoid arthritis (RA) refractory to synthetic disease-modifying antirheumatic drugs, anti-tumor necrosis factor agents, and B-cell depletion therapy with rituximab (RTX).

Methods: We conducted a single-center retrospective study of 22 patients with RA treated with TCZ. We collected data including demographics and medication histories. Read More

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http://dx.doi.org/10.2147/BTT.S101289DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4818059PMC
April 2016
3 Reads

Correlations between immunogenicity, drug levels, and disease activity in an Italian cohort of rheumatoid arthritis patients treated with tocilizumab.

Biologics 2016 11;10:53-8. Epub 2016 Mar 11.

IRCCS Galeazzi Orthopedic Institute, Milan, Italy.

The aim of this study was to evaluate the real-life immunogenicity of anti-drug antibodies, drug levels, and disease activity in an Italian cohort of rheumatoid arthritis patients treated with tocilizumab (TCZ). We evaluated 126 TCZ-treated patients with rheumatoid arthritis (16 males and 110 females; mean age 59±12 years, range 26-83; mean disease duration 11±5 years) with inadequate 12-week response to any synthetic and biological disease-modifying anti-rheumatic drugs, in a retrospective analysis. One-hundred and seven patients were treated with methotrexate mean dose 12. Read More

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http://dx.doi.org/10.2147/BTT.S97234DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4795572PMC
April 2016
35 Reads

Selective biologics for ulcerative colitis and Crohn's disease - clinical utility of vedolizumab.

Biologics 2016 9;10:33-52. Epub 2016 Mar 9.

Snyder Institute for Chronic Diseases, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.

Inflammatory bowel disease (IBD) encompasses a cluster of different disease phenotypes which are broadly classified into ulcerative colitis and Crohn's disease. Disease pathogenesis is driven by abnormal host immune responses to their resident gut microbiome in genetically susceptible individuals. Clinical disease features and outcomes are heterogenous and not unexpected as over 163 genetic loci are associated with disease susceptibility, and there are great variability in environmental exposures. Read More

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http://dx.doi.org/10.2147/BTT.S71679DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4790488PMC
March 2016
1 Read

Update on the management of Philadelphia chromosome positive chronic myelogenous leukemia: role of nilotinib.

Biologics 2016 26;10:23-31. Epub 2016 Feb 26.

Department of Malignant Hematology, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.

Chronic myelogenous leukemia (CML) is a pluripotent stem cell disease characterized by the presence of the Philadelphia chromosome and the bcr-abl gene. The discovery of tyrosine kinase inhibitors (TKIs) revolutionized therapy for CML, such that durable response, increased overall survival, and increased progression-free survival of patients in chronic phase CML is now possible. Due to resistance and intolerance to imatinib, there was need for development of second- and third-generation TKIs for the treatment of CML. Read More

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http://dx.doi.org/10.2147/BTT.S67844DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4777272PMC
March 2016
2 Reads

Biosimilars in the management of neutropenia: focus on filgrastim.

Biologics 2016 18;10:17-22. Epub 2016 Feb 18.

Medical Department, Pediatric Unit, Azienda Sanitaria Provinciale Ragusa, Ragusa, Italy.

Advances in chemotherapy and surgery allows the majority of patients to survive cancer diseases. Yet, the price may be a proportion of patients dying of complications due to treatment-induced infectious complications, such as neutropenia. With the aim of decreasing morbidity and mortality related to infectious complications, recombinant human granulocyte colony-stimulating factor (G-CSF), filgrastim, and pegylated filgrastim have been used to reduce time and degree of neutropenia. Read More

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http://dx.doi.org/10.2147/BTT.S73580DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4762467PMC