Expert opinion on biological therapy
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Patients with severe eosinophilic asthma have an unmet need for novel and efficacious treatments. Reslizumab is one of the three monoclonal antibodies targeting the IL-5 pathway and has been found in Phase IIIb clinical trials to reduce asthma exacerbations, control asthma-related symptoms and improve pulmonary function in patients with eosinophilic asthma. ⋯ Reslizumab and other anti-IL-5 therapies have seen success in recent trials through more stringent study participant selection targeting eosinophilic inflammation. This selection can now be based on simple blood counts. These drugs have shown a very good safety profile, but long-term safety data are not yet available. Approval for these drugs is eagerly awaited by clinicians and patients alike.
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Tremelimumab demonstrated therapeutic activity in different malignancies, including malignant pleural mesothelioma (MPM); however, continued research could improve the therapeutic index of this agent. ⋯ The use of immunotherapy has been extended from melanoma to thoracic malignancies or lung cancer and MPM. The first clinical trials for MPM with drugs modulating immune checkpoints have been tested or are currently being tested with the first results now under critical consideration. Among these drugs, tremelimumab has been attracting attention as a potential new treatment for MPM. Nevertheless, even though clinical efficacy has been preliminarily demonstrated, the cost/benefit ratio of this drug for this neoplasm is yet to be ascertained.
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Expert Opin Biol Ther · Jan 2015
ReviewBotulinum toxin in urology: a review of clinical potential in the treatment of urologic and sexual conditions.
In recent years, there has been an increased interest in the use of botulinum neurotoxin (BoNT) to treat medical conditions refractory to conventional treatment. The following article provides an overview of the clinical use and efficacy of BoNT in the treatment of various urologic and sexual conditions. ⋯ BoNT-A has received regulatory approval for use in neurogenic DO and overactive bladder, but its use remains unlicensed in other lower urinary tract conditions such as non-neurogenic lower urinary tract symptoms in men with benign prostatic hyperplasia, bladder pain syndrome and DSD. Published literature shows that BoNT can be effective in carefully selected patient groups, has minimal adverse event profile and is generally well tolerated by many patients. However, many questions remain unanswered and larger scale multi-institutional studies are required to determine the key factors in BoNT treatment success.
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Expert Opin Biol Ther · Jan 2015
Is there enough evidence with evolocumab and alirocumab (antibodies to proprotein convertase substilisin-kexin type, PCSK9) on cardiovascular outcomes to use them widely? Evaluation of Sabatine MS, Giugliano RP, Wiviott SD et al. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med 2015;372:1500-1509, and Robinson JG, Farnier M, Krempf M et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med 2015;372:1488-99.
Statins alone often do not reduce LDL cholesterol levels sufficiently to given maximum cardiovascular benefit. Thus, additional drugs are required to reduce the levels of LDL cholesterol. Monoclonal antibodies to PCSK9 have recently been shown to decrease LDL cholesterol, but it is not known whether they improve cardiovascular outcomes. ⋯ In OSLER and ODYSSEY LONG TERM, there were very few cardiovascular outcomes, but the trials do suggest that evolocumab and alirocumab may reduce these outcomes. However, there are also some safety concerns with both of these antibodies. Large clinical outcome trials are underway with both evolocumab and alirocumab, which will probably clarify both the safety concerns and any cardiovascular benefits with these antibodies. In our opinion, these antibodies may be suitable for use in subjects with familial hypercholesterolemia, who are uncontrolled with their present medications, provided intensive safety and cardiovascular monitoring is being undertaken. However, evolocumab and alirocumab should be used with caution in other subjects, until outcome studies in higher numbers of subjects have shown acceptable safety and cardiovascular profiles.
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Expert Opin Biol Ther · Jan 2015
The anti-IL-4 receptor alpha antibody dupilumab: facing a new era in treating atopic dermatitis.
Atopic dermatitis is the most common chronic inflammatory skin disease with high prevalence rates in adults and even higher among children. For the numerous patients suffering from moderate to severe disease, standard systemic treatment regimens such as cyclosporine A, methotrexate or azathioprine are not suited for long-term treatment due to their unfavorable safety profile. A promising alternative would be the newly developed IL-4 receptor alpha antibody dupilumab which has been investigated in several clinical trials during the last years. ⋯ First clinical data of treating AD with dupilumab provided strong evidence for a highly significant efficacy and safety. In the case, future phase III studies will confirm these findings, dupilumab has the potential to become a new first line standard treatment for patients with severe AD.