The Portuguese Society of Rheumatology position paper on the use of biosimilars.

Biotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the first biosimilar monoclonal antibody to be authorized for use in the European Union. The current document is a position statement of the "Sociedade Portuguesa de Reumatologia" (Portuguese Society of Rheumatology) on the use of biosimilar drugs in rheumatic diseases. Two systematic literature reviews were performed, one concerning clinical trials and the other one concerning international position papers on biosimilars. The results were presented and discussed in a national meeting and a final position document was discussed, written and approved by Portuguese rheumatologists. Briefly, this position statement is contrary to automatic substitution of the originator by the biosimilar, defends either a different INN or the prescription by brand name, supports that switching between biosimilars and the originator molecule should be done after at least 6 months of treatment and based on the attending physician decision and after adequate patient information, recommends the registration of all biosimilar treated patients in Reuma.pt for efficacy, safety and immunogenicity surveillance, following the strategy already ongoing for originators, and opposes to extrapolation of indications approved to the originator to completely different diseases and/or age groups without adequate pre-clinical, safety or efficacy data.

[Non-traumatic osteonecrosis of the patella, a rare cause of knee pain]. / Osteonecrose não traumática da rótula, uma causa rara de gonalgia.

Non-traumatic osteonecrosis of the patella is a rare cause of knee pain that must be present in the diagnostic discussion of disability of the knee with subacute character. The author describes a case in which the characteristic images had an important role in defining the etiology of disabling knee pain, developing pathophysiological hypotheses that may have contributed to the clinical presentation, including situations of overuse of the joint.

[Osteomyelitis after septic trochanteric bursitis - clinical case]. / Osteomielite após bursite trocantérica infecciosa - a propósito de um caso clínico.

We report the clinical case of a 76 years-old woman with a subacute trochanteric inflammatory pain with low-grade fever and laboratory markers of acute inflammation, associated with the ultrasonographic evidence of bursitis and radiologic evidence of femoral erosions, that resolved after intravenous antibiotherapy. Although rare, the infectious etiology should be considered in patients with clinical manifestations of bursitis and signs of systemic involvement.

[Colonic acute pseudo-obstruction: uncommon manifestation of vertebral fracture]. / Pseudo-obstrução cólica aguda: uma apresentação pouco frequente da fractura vertebral.

We report the clinical case of a 73-years-old woman with sarcoidosis since 29 years-old, on long-term corticosteroid therapy, who presented with symptoms of abdominal pain after an episode of acute and severe low back pain associated with significant functional impairment, in the context of D11 fracture. Although infrequent, recent spine fractures should be considered in osteoporotic or osteoporotic risk patients presenting with pain and abdominal distension.

[Macrodystrophia lipomatosa. A rare disease with rheumatic manifestations]. / Macrodistrofia lipomatosa uma doença rara com manifestações reumatológicas.

The author presents the case of a 32-year-old woman with the diagnosis of Macrodystrophia Lipomatosa associated with carpal tunnel syndrome. Macrodystrophia Lipomatosa is a rare form of localized gigantism characterised by an abnormal overgrowth of the mesenchymal elements of one or more digits. For the rheumatologist this disease has interest due the possibility of musculoskeletal complaints, namely compression of the neurovascular structures and local degenerative articular disease.

Diabetes fosforada idiopática do adulto: a propósito de um caso clínico / Acquired hypophosphatemic osteomalacia: case report

O fósforo é elemento essencial e muitas vezes pouco valo rizado na prática clínica. A diabetes fosforada idiopática do adulto (DFIA) é causa de alteraçao da homeostase do fósforo, resultante de defeito da reabsorçao deste elemento no túbulo proximal, de causa nao conhecida. Caracteriza-se clinicamente por raquialgias, radiculalgias, fadiga, dores ósseas e articulares e sintomas neuropsiquiátricos. As características laboratoriais típicas sao: hipofos fatemia, hiperfosfatúria e índices de reabsorçao tubular do fósforo que demons tram diminuiçao da reabsorçao renal desse elemento. A hipofosfatemia moderada que se verifica na DFIA provoca alteraçao do metabolismo ósseo, que resulta em osteopenia. A terapeutica com fósforo e vitamina D leva a normalizaçao da fosfa temia e dos índices de reabsorçao renal de fósforo, a melhoria clínica e o aumento da densidade mineral óssea. Os autores escrevem o caso de paciente com DFIA e discutem alguns pontos de etiopatogenia, clínica e terapeutica dessa doença