Etanercept was the first tumour necrosis factor alpha antagonist approved in the USA for the treatment of rheumatoid arthritis, in 1998, and then for other diseases. With the etanercept patent set to expire in the EU in 2015, a number of etanercept copies have reached the production phase and are undergoing clinical trials, with the promise of being cheaper alternatives to the reference product. In a global scenario that is favourable to the entry of biosimilars, this article discusses the stage of development, manufacture, clinical trials and the regulatory process involved in the approval of etanercept biosimilars, compiling the literature data. Reducing treatment cost is the principal attraction for biosimilars to emerge in the global market. It is essential for the doctors’ decision on the prescription of these medications, as well as for payers, to have clearly defined studies of clinical equivalence, quality, and safety in order to better evaluate the various copies of etanercept. The authors discuss the need to harmonize different national regulations and the introduction of effective pharmacosurveillance systems for prompt recognition of adverse effects in copies of biopharmaceuticals that differ from those found in the reference products.

Hemifacial spasm (HFS) is a craniofacial movement disorder characterized by involuntary contractions of the muscles on one side of the face 1 . The most common site for the contractures is the orbicularis oculi muscle, but the corrugator supercilii, frontalis muscle, orbicularis oris, zygomaticus major and platysma can also be affected 2 . The condition is believed to be mainly due to a peripheral dysfunction of the facial nerve, occasionally associated with nerve compression by a blood vessel or tumor 3,4 . The pathophysiology, however, has yet to be fully elucidated as the condition can occur in the absence of structural alterations 3 . In a recent study, Wilkinson and Kaufmann 5 showed that HFS may be associated with central nervous system changes. Accordingly, one previous study from our group found similar profiles of obsessive and psychiatric symptoms in cases of HFS and blepharospasm, which is recognized as a movement disorders of A total of 550 BTX-A injections were administered to 100 HFS patients. Results: Mean duration of improvement following each injection session was 3.1 months, mean latency to detection of improvement was 7.1 days and mean success rate was 94.7%. Patients were evaluated at an interval of 5.8 months after each application. Adverse effects, which were mostly minor, were observed in 37% of the patients at least once during follow-up. The most frequent was ptosis (35.1%). Conclusion: Treatment of HFS with BTX-A was effective, sustainable and safe and had minimal, well-tolerated side effects.

Relapsing polychondritis (RP) is an autoimmune disease characterized by recurrent episodes of inflammation and progressive destruction of cartilaginous tissues, especially of the ears, nose, joints, and tracheobronchial tree. Its etiology is not well understood, but some studies have linked its pathophysiology with autoimmune disease and autoantibody production. We described a case of a 46-year-old male patient with ankylosing spondylitis who developed RP after the use of etanercept. Few similar cases have been described in the literature. However, they show a possible association between the use of biological inhibitors of tumor necrosis factor (anti-TNFα), which potentially produces autoantibodies, and the development of RP. The treatment was based on data in the literature and included the cessation of biological therapy and the addition of corticosteroids with substantial improvement.

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O caso clínico de uma mulher de 23 anos, com lúpus eritematoso sistêmico, que desenvolveu peritonite crônica e ascite como sua primeira manifestação clínica é descrito. Os principais achados que levaram ao diagnóstico foram plenitude e dor abdominal, hérnia umbilical e ascite. Houve boa resposta ao tratamento com prednisona e hidroxicloroquina.