Expert opinion on biological therapy
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Cancer immunotherapy has made much progress in recent years. Clinical trials evaluating a variety of immunotherapeutic approaches are underway in patients with malignant gliomas. Thanks to recent advancements in cell engineering technologies, infusion of ex vivo prepared immune cells have emerged as promising strategies of cancer immunotherapy. ⋯ While some of the recent studies have shown promising results, the ultimate success of cellular immunotherapy in brain tumor patients would require improvements in the following areas: 1) feasibility in producing cellular therapeutics; 2) identification and characterization of targetable antigens given the paucity and heterogeneity of tumor specific antigens; 3) the development of strategies to promote effector T-cell trafficking; 4) overcoming local and systemic immune suppression, and 5) proper interpretation of imaging data for brain tumor patients receiving immunotherapy.
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Expert Opin Biol Ther · Oct 2016
ReviewRecent advances in the biologic therapy of lupus: the 10 most important areas to look for common pitfalls in clinical trials.
Systemic lupus erythematosus (SLE) is an autoimmune disease affecting different organs. The improved knowledge of the disease's pathogenesis has contributed to the emergence of immune targets and new biologic drugs directed at them. Although rheumatologists continue to use off-label biologics in SLE resistant to other immunosuppressants, only belimumab has been approved as a biological therapy since 2011. ⋯ Some drugs that have failed in previous drug trials have shown to be efficacious in the treatment of lupus in observational studies. Moreover, the post-hoc analyses of the data of negative drug trials have shown that results of the same trials could be altered with the modification of some pitfalls. For future clinical trials, the consideration of these pitfalls is crucial when designing clinical trials. This could potentially enhance the approval of novel drugs for SLE.
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Expert Opin Biol Ther · Oct 2016
ReviewImmune checkpoint blockade as a potential therapeutic target in non-small cell lung cancer.
The recent emergence of immune checkpoint blockade therapy and the progression of immunobiology in cancer have spurred an increasing interest in the immunotherapy for advanced non-small cell lung cancer (NSCLC). Immune checkpoint inhibitors (ICIs), designed to directly target immune inhibitory molecules, have demonstrated efficacy in the treatment of patients with advanced NSCLC. ⋯ Immunotherapies targeting the immune checkpoint pathways have shown potential to generate durable responses and improve survival for NSCLC patients. Although the toxicity profile of this immunotherapy is manageable, immune-related adverse events and drug resistance may cause therapeutic failure. Therefore, a better understanding of the mechanisms underpinning its function and the potential side effects of ICIs, as well as the identification of predictive biomarkers for patient selection are essential.
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Although anti-tumour necrosis factor (TNF) agents have caused a paradigm shift in the management of moderate-to-severe Crohn's, they are sometimes associated with diminished or absent response in a considerable proportion of patients. Hence agents targeting pathways other than TNF are needed. Ustekinumab is a monoclonal antibody directed against the p40 subunit of IL-12 and 23. ⋯ Current literature strongly supports the fact that ustekinumab is clinically efficacious and reasonably safe for induction and maintenance of remission in moderate-to-severe Crohn's disease.
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Axial spondyloarthritis (axSpA) is a chronic inflammatory disease of the spine and sacroiliac (SI) joints. The spectrum of axSpA includes ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA). Evidence has supported the use of TNF alpha inhibitors (TNFi) in treating these diseases, with good efficacy and tolerable safety profiles. Certolizumab pegol (CZP) is an anti-TNF alpha (TNFa) agent with data to support its use in both AS and nr-axSpA. ⋯ While there are several biologics with evidence for improved outcomes in AS, there is less evidence for biologic medications that have good efficacy in nr-axSpA. CZP has good evidence of improved outcomes in terms of clinical efficacy, patient reported outcomes and imaging outcomes in both conditions, with a tolerable safety profile.