Expert review of clinical pharmacology
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In the EU, the EMA has been working with biosimilars since 1998. This experience is crystallized in the extensive set of guidelines, which range from basic principles to details of clinical trials. While the guidance may appear complicated, it has enabled the development of biosimilars, of which 21 have managed to get marketing authorization. ⋯ The most controversial issues with biosimilars are immunogenicity and extrapolation of therapeutic indications. The available data for these topics do not raise concerns among EU regulators. Interchangeability and substitution are regulated by individual EU member states.
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Expert Rev Clin Pharmacol · Jan 2015
ReviewKey findings from studies of methotrexate tapering and withdrawal in rheumatoid arthritis.
Methotrexate is the dominant initial drug in the management of rheumatoid arthritis (RA). Despite its widespread use, methotrexate is associated with a number of adverse effects. ⋯ This review examines studies of methotrexate tapering and withdrawal on RA outcomes. It covers three scenarios: tapering/withdrawing methotrexate monotherapy; tapering/withdrawing methotrexate as part of a 'step-down' combination disease-modifying anti-rheumatic drug regimen; and tapering/withdrawing methotrexate when it is being co-prescribed with biologic agents.
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Expert Rev Clin Pharmacol · Jan 2015
ReviewOlodaterol + tiotropium bromide for the treatment of chronic obstructive pulmonary disease.
A solid scientific rationale and an increasing body of clinical evidence for combining a β2-agonist with an antimuscarinic agent in COPD fully support the opinion that patients not controlled by a single bronchodilator should be given two bronchodilators with different mechanisms of action. Tiotropium is an established choice for the management of patients with stable COPD, and olodaterol is a new effective and safe once-daily long-acting β2-agonist. ⋯ The large ongoing TOviTO Phase III trial program is documenting the efficacy and safety of olodaterol/tiotropium fixed dose combination delivered via the Respimat Soft Mist Inhaler as maintenance therapy in patients with moderate to very severe COPD. However, we must still know whether this fixed-dose combination will affect exacerbations and hospitalizations, and ultimately death, and also the precise estimates of its relative cardiovascular safety.
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Expert Rev Clin Pharmacol · Jan 2015
EditorialFactors to consider in the choice of intrathecal drug in the treatment of neuropathic pain.
Medication selection for neuropathic pain follows a path of evidence, with respect to appreciating the patient's entry into the pain care algorithm. As we decide how to approach neuropathic pain, the considerations for intrathecal therapy medication selection are bound by catheter location, region of pain, and patient selection, to name a few. Future research and the 2016 polyanalgesic consensus conference may further provide patient care through a mindful eye on the improvement of patient safety and a reduction of the societal needs of opioids.
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Expert Rev Clin Pharmacol · Jan 2015
EditorialClinical trial design for rare cancers: why a less conventional route may be required.
Major recent advances in the diagnosis, treatment, prevention and screening of cancer have led to improvements in survival and other outcomes for cancer patients. When the 198 identified rare cancers are taken in aggregate, rare cancers account for 22% of all cancer diagnoses, higher than any single common cancer. ⋯ Overcoming the challenges inherent in the study of rare diseases is critical to achieve improvements in outcomes for patients. Combining a redesign of clinical trial protocols with the new paradigm for the treatment of all cancers, may lead to improvements in survival benefits for rare cancers in line with those achieved in the treatment of more common types.