Expert opinion on biological therapy
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Expert Opin Biol Ther · Sep 2018
ReviewIpilimumab in combination with nivolumab for the treatment of renal cell carcinoma.
Renal cell carcinoma (RCC) is a highly immunogenic neoplasm, and cytokine-based immunotherapies have been used for decades with limited success. In recent years, antibody-based immunotherapies targeting immune checkpoint receptors PD-1 and CTLA-4 have demonstrated clinical efficacy in metastatic RCC (mRCC) patients, leading to FDA approval of the combination of nivolumab and ipilimumab in treatment-naïve patients with intermediate- or poor-risk disease in April 2018. Areas covered: The pharmacodynamics and pharmacokinetics of nivolumab and ipilimumab are reviewed. ⋯ Ongoing clinical studies involving the combination of nivolumab plus ipilimumab in RCC are discussed. Expert opinion: The combination of nivolumab and ipilimumab has demonstrated superior efficacy for treatment-naïve patients with intermediate- and poor-risk mRCC with clear cell histology and is likely to replace anti-angiogenic therapies as the treatment-of-choice in this patient population in the United States. Development of additional combination strategies, novel trial designs, and predictive biomarkers of response will be important to further optimize therapeutic selection and clinical outcomes.
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Severe uncontrolled asthma is by definition refractory to traditional therapies or can be controlled only with therapies that have intolerable side effects. Monoclonal antibodies that target interleukin (IL)-5/IL-5Rα, IgE, and IL-4Rα have shown favorable results in clinical trials, including reductions in asthma exacerbations and other important clinical outcomes. These biological agents offer treatment alternatives to patients with uncontrolled severe eosinophilic asthma. ⋯ Biologic therapies targeting the IL-5, IgE, IL-4/IL-13 signaling pathways have been successful in clinical trials in subjects with severe eosinophilic asthma. Some of these agents have also been successful regardless of peripheral blood eosinophil counts. These treatments have shown a relatively favorable safety profile in clinical trials, although long-term safety data for some of these agents are limited. Due to the high costs associated with these medications, they should be reserved for select patients where they yield a therapeutic and pharmacoeconomic advantage.
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Expert Opin Biol Ther · Jun 2018
ReviewAn evaluation of nivolumab for the treatment of metastatic renal cell carcinoma.
The treatment paradigm for metastatic renal cell carcinoma (mRCC) has undergone a revolution with the rapid market approval of multiple agents over a three-year period. The immunogenicity of renal cell carcinoma (RCC) provided the biological rationale to assess the clinical efficacy of nivolumab, an immune checkpoint inhibitor. Nivolumab is approved for second-line treatment after failure of angiogenesis-targeted therapy and in combination therapy with ipilimumab for previously untreated intermediate- or poor-risk advanced RCC. ⋯ Nivolumab was recently approved in the first-line setting as part of combination therapy with another immune modulator. Moreover, nivolumab use may offer clinicians the option for treatment beyond progression as emerging data has indicated possible overall survival benefits in this setting. Ongoing clinical studies may result in nivolumab use in the first-line setting, as monotherapy or in combination therapy with antiangiogenesis agents.
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Expert Opin Biol Ther · Jun 2018
ReviewProgress with infliximab biosimilars for inflammatory bowel disease.
Biological therapies have revolutionized the treatment of inflammatory bowel diseases (IBD) in the last two decades. Though biological drugs are effective, their use is associated with high costs and access to biological agents varies among countries. As the patent for the reference products expired, the advent of biosimilar monoclonal antibodies has been expected. Biosimilars represent less expensive alternatives compared to the reference product. ⋯ The use of biosimilar infliximab in IBD is increasing worldwide. Its use may be associated with budget savings leading to better access to biological therapies and consequently improved health outcomes. Switching from the originator to a biosimilar in patients with IBD is acceptable, although scientific and clinical evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients.
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Expert Opin Biol Ther · May 2018
ReviewTreating childhood traumatic brain injury with autologous stem cell therapy.
Neonatal traumatic brain injury (TBI) is a significant cause of developmental disorders. Autologous stem cell therapy may enhance neonatal brain plasticity towards repair of the injured neonatal brain. ⋯ Combination treatments, such as with hypothermia, may enhance the therapeutic effects of stem cells. Stem cell therapy has immense potential as a stand-alone or adjunctive therapy for treating neuroinflammation associated with neonatal TBI acutely and for preventing further progression of the injury.