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Biologics: Targets & Therapy

Patrizia Alvisi, Serena Arrigo, Salvatore Cucchiara, Paolo Lionetti, Erasmo Miele, Claudio Romano, Alberto Ravelli, Daniela Knafelz, Stefano Martelossi, Graziella Guariso, Salvatore Accomando, Giovanna Zuin, Costantino De Giacomo, Lucio Balzani, Monia Gennari, Marina Aloi
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...
2019: Biologics: Targets & Therapy
Michelle E Keyel, C Patrick Reynolds
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 ch14.18, known as dinutuximab. Dinutuximab used in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and isotretinoin (13- cis- retinoic acid) has a US Food and Drug Administration (FDA)-registered indication for treating high-risk NB patients who achieved at least a partial response to prior first-line multi-agent, multimodality therapy...
2019: Biologics: Targets & Therapy
Hu Meng, Shuai Deng, Yajing You, Hon Fai Chan
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. In this review, we discuss some examples of adopting microfluidics for fabricating particle- and fiber/tube-based formulations and highlight the advantages of microfluidics-assisted fabrication...
2018: Biologics: Targets & Therapy
Yuji Nozaki, Yasuaki Nagare, Chisato Ashida, Daisuke Tomita, Akinori Okada, Asuka Inoue, Koji Kinoshita, Masanori Funauchi, Itaru Matsumura
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)...
2018: Biologics: Targets & Therapy
Miaomiao Wen, Jinghua Xia, Ying Sun, Xuejiao Wang, Xianghui Fu, Yanning Zhang, Zhipei Zhang, Yongan Zhou, Xiaofei Li
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...
2018: Biologics: Targets & Therapy
Sanjay Kumar Singh, Santosh Pokalwar, Sandip Bose, Shivika Gupta, Suhani Almal, Ranjit Sudhakar Ranbhor
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. Materials and Methods: Reference products of rituximab (six batches) were procured and stored as per manufacturer's instructions...
2018: Biologics: Targets & Therapy
Luca Degli Esposti, Valentina Perrone, Diego Sangiorgi, Stefano Buda, Margherita Andretta, Maurizio Rossini, Giampiero Girolomoni
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. Participants: A total of 351 male and female patients with at least 1 prescription for a biological drug from January 1, 2010 to December 31, 2013; patients with concomitant rheumatoid arthritis, ankylosing spondylitis, or Crohn's disease were excluded...
2018: Biologics: Targets & Therapy
S C Heslinga, T C Konings, I E van der Horst-Bruinsma, O Kamp, V P van Halm, Hacm de Bruin-Bon, M J Peters, M T Nurmohamed
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. Methods: Forty consecutive AS patients were treated with TNF-α blocking therapy for 1 year...
2018: Biologics: Targets & Therapy
Yusuf Yazici, Lin Xie, Adesuwa Ogbomo, Lorie A Ellis, Kavitha Goyal, Amanda Teeple, Ismail Simsek
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...
2018: Biologics: Targets & Therapy
Cristoforo Incorvaia, Marina Mauro, Elena Makri, Gualtiero Leo, Erminia Ridolo
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. The optimal duration of treatment in either disease has not been established...
2018: Biologics: Targets & Therapy
Satyavani Kaliamurthi, Gurudeeban Selvaraj, Aman Chandra Kaushik, Ke-Ren Gu, Dong-Qing Wei
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. Methods: Initially, we determined the antigenic potential of late (L1 and L2) and early (E1, E2, E4, E5, E6, and E7) proteins...
2018: Biologics: Targets & Therapy
Yusuf Yazici, Lin Xie, Adesuwa Ogbomo, Lorie A Ellis, Kavitha Goyal, Amanda Teeple, Ece A Mutlu, Ismail Simsek
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...
2018: Biologics: Targets & Therapy
Fabrizio Cantini, Maurizio Benucci
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...
2018: Biologics: Targets & Therapy
Yong-Hong Pan, Lin Jiao, Cai-Yu Lin, Cong-Hua Lu, Li Li, Heng-Yi Chen, Yu-Bo Wang, Yong He
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...
2018: Biologics: Targets & Therapy
Satohiro Matsumoto, Hirosato Mashima
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...
2018: Biologics: Targets & Therapy
Shahrad Hakimian, Yevgeniy Popov, Abbas H Rupawala, Karen Salomon-Escoto, Steven Hatch, Randall Pellish
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. Methods: We conducted an observational, retrospective study in patients with IBD and RA who underwent LTBI screening using QFT-GIT at UMass Memorial Medical Center between 2008 and 2016 prior to initiation of anti-TNF medications...
2018: Biologics: Targets & Therapy
Kenneth Lundstrom
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. Moreover, clinical trials have confirmed good safety profiles and therapeutic efficacy for oncolytic viruses...
2018: Biologics: Targets & Therapy
Maurizio Benucci, Arianna Damiani, Francesca Li Gobbi, Francesca Bandinelli, Maria Infantino, Valentina Grossi, Mariangela Manfredi, Guillaume Noguier, Francesca Meacci
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)...
2018: Biologics: Targets & Therapy
Rajamannar Thennati, Sanjay Kumar Singh, Nitin Nage, Yena Patel, Sandip Kumar Bose, Vinod Burade, Ranjit Sudhakar Ranbhor
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...
2018: Biologics: Targets & Therapy
Bhagyashri D Navalkele, Teena Chopra
Clostridium difficile 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. Standard guidelines provide recommendations on treatment of primary CDI. However, treatment choices for recurrent CDI are limited. Recent research studies have focused on the discovery of newer alternatives for prevention of recurrent CDI targeting prime virulence factors involved in C...
2018: Biologics: Targets & Therapy
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