Abstract Objectives: To compare the efficacy and safety of a new formulation of a fixed dose combination of glucosamine sulfate (GS; 1500 mg) and bovine chondroitin sulfate (CS; 1200 mg) versus the reference product (RP) in patients with knee osteoarthritis (OA). Methods: In this multicenter, randomized, single-blind trial, 627 patients with knee osteoarthritis (OA)—Kellgren-Lawrence grades 2 or 3 and mean score ≥ 40 mm in the WOMAC pain subscale—were randomized to receive GS/ CS or the RP for 24 weeks. The primary efficacy endpoint was the absolute change in WOMAC pain subscale score. The secondary endpoints included the following: WOMAC total and subscale scores, overall assessment of the disease by the patient and the investigator, SF-12 score, OMERACT-OARSI response rate to the treatment, and rescue medication use. Results: Mean reductions of WOMAC pain score were – 35.1 (sd = 23.2) mm in the GS/CS group and – 36.5 (sd = 24.9) mm in the RP group. The difference between the adjusted means of both treatments confirmed the noninferiority of GS/CS versus the RP. Improvement was observed in pain, stiffness, physical function and total WOMAC score, as well as in overall OA assessment by the patient and the investigator for both groups. No improvement was observed in SF-12. The rate of OMERACT-OARSI responders was 89.4% in GS/CS group and 87.9% in the RP group. Headache and changes in glucose tolerance were the most frequent treatment-related adverse events. Conclusions: The new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin sulfate was non-inferior to the RP in symptomatic treatment of knee OA, with a high responder rate and good tolerability profile. Trial registration: ClinicalTrials.gov; Registration number NCT02830919; Date of registration: July 13, 2016; First randomization date: December 05, 2016).

Abstract Objectives: To compare the efficacy and safety of a new fixed dose combination of glucosamine sulfate and chondroitin sulfate capsules (GS/CS) versus the fixed dose combination of glucosamine hydrochloride and chondroitin sulfate (Cosamin DS®) in capsules in patients with osteoarthritis (OA) of the knee. Methods: Multicenter, randomized, double-blind study. Participants with knee OA Kellgren-Lawrence grades 1 to 3 and VAS of symptoms ≥4 cm were randomized to receive GS/CS or Cosamin DS® over 12 weeks. The primary efficacy endpoint was the evaluation of the analgesic efficacy by the investigator. Secondary efficacy endpoints included: joint pain and swelling, investigator efficacy of the medication, and the use of rescue medication. Adverse events and drug tolerability were analyzed. Results: One hundred patients were randomized, and 50 patients were allocated to each group. The analgesic efficacy evaluated by the investigator in the GS/CS group was 88.9, 95%CI: 75.2, 95.8% and in the Cosamin DS® group was 85.4%; 95%CI: 70.1, 93.4%. The mean reduction in the pain intensity was significant in both groups (p < 0.001), with no difference between them. The primary efficacy analysis demonstrated the non-inferiority of the GS/CS group compared with the Cosamin DS® group; the lower limit of the 90% confidence interval (CI) between the two groups (− 8.39%) was higher than the established margin of non-inferiority of − 10.00%. Improvement in other efficacy outcomes was observed, again without differences between groups. Adverse events were similar between groups and both presented good tolerability. Conclusions: The new fixed-dose formulation of GS/CS is effective in treating knee OA, presenting a good safety and tolerability profile. Trial Registration: (https://clinicaltrials.gov/ct2/show/NCT00955552?term=NCT00955552&rank=1; ClinicalTrials.gov; register number NCT00955552; First randomized patient: 08/17/2010).

A doença de Castleman (DC) é uma desordem linfoproliferativa policlonal, também conhecida como hiperplasia nodular gigante ou hiperplasia angiofolicular linfoide. Esta é uma doença rara que está frequentemente associada ao vírus da imunodeficiência humana (HIV) e ao herpes vírus 8 (HHV-8). Os achados histopatológicos encontrados na DC sugerem uma intensa resposta aos estímulos antigênicos observada em várias doenças associadas com ativação imune, como a artrite reumatoide. Um fator importante implicado na patogênese da DC é a produção autônoma da interleucina-6 (IL-6). Nessa doença, as manifestações clínicas estão relacionadas aos níveis de IL-6, e a remoção cirúrgica dos linfonodos acometidos ou a utilização de anticorpos anti-IL-6 fazem regredir os sintomas. Descrevemos um caso da DC multicêntrica em uma mulher jovem, não associada à infecção pelo vírus HHV-8 ou à imunossupressão. Uma breve revisão da literatura se segue à descrição do caso clínico.

Castleman's disease (CD) is a polyclonal lymphoproliferative disorder also known as giant nodular hyperplasia or angiofollicular lymph node hyperplasia. It is a rare disease often associated to human immunodeficiency virus (HIV) and human herpes virus 8 (HHV-8). Histopathological findings in Castleman's disease suggest an exaggerated response to antigenic stimuli seen in other diseases associated with immune activation, such as rheumatoid arthritis. An important aspect of its pathogenesis is the autonomous production of interleukin-6 (IL-6). In this disease, the clinical manifestations are associated to IL-6 serum levels, and surgical removal of the compromised lymph nodes or use of anti-IL-6 antibodies can slow down the symptoms. We describe a multicentric Castleman's disease in a young woman not associated to HHV-8 virus infection or immunosuppression. A short review of the literature follows the description of this clinical case.

O lúpus cutâneo é a principal manifestação clínica do lúpus eritematoso sistêmico. Diferentes formas de apresentações clínicas e histopatológicas compõem o quadro cutâneo. A diferenciação de tais apresentações clínicas é de grande relevância para melhor abordagem terapêutica dos pacientes. Ampla variedade de intervenções terapêuticas está atualmente disponível para o tratamento do lúpus cutâneo. Nessa revisão, serão abordadas as principais opções terapêuticas, medicamentosas e não-medicamentosas, além das novas terapias ainda em estudo.

Cutaneous lupus is the most common systemic lupus erythematosus clinical manifestation. Skin lesions are classified according to the clinical and histopathologic features, which are of great relevancy for the management of the disease. Nowadays several therapeutic interventions are available to the treatment of cutaneous lupus. In this review we will approach the most widely used and also the new therapies which are under study.

O lúpus eritematoso sistêmico bolhoso é reconhecido como entidade distinta relacionada à auto-imunidade contra colágeno VII. Em alguns casos, a presença de doença bolhosa coincide com a exacerbação do lúpus eritematoso sistêmico, especialmente da nefrite lúpica. São descritos dois casos de mulheres jovens com erupção vésico-bolhosa em áreas expostas e não expostas ao sol associada à nefrite lúpica. O diagnóstico foi comprovado pela histopatologia e imunofluorescência direta características. O tratamento com corticosteróide e dapsona costuma ser eficiente.

Bullous systemic lupus erythematosus is recognized as a distinct entity related to autoimmunity to type VII collagen. In some cases, the flare of bullous disease coincides with the exacerbation of systemic lupus erythematosus, and especially lupus nephritis. Two cases of young female patients with vesiculobullous eruption on sun-exposed and non-exposed areas associated to lupus nephritis are described. Diagnosis was proved by characteristic histopathology and direct immunofluorescence. Corticosteroids and dapsone therapy may be effective.

Paciente de 34 anos, portadora de doença de Crohn (DC) havia oito anos, foi atendida queixando-se de dor torácica e febre, sem manifestações gastrointestinais. Testes laboratoriais mostraram atividade inflamatória (VHS = 45mm, PCR positivo). O exame físico revelou derrame pleural na base do hemitórax esquerdo, confirmado pela radiografia de tórax. A análise do líquido pleural mostrou 100% de linfócitos, com BAAR negativo. A biópsia pleural evidenciou granuloma não caseoso. Foi instituída terapia para tuberculose, sem sucesso, com regressão dos sintomas apenas após reintrodução de altas doses de corticosteróide, sugerindo atividade da DC como causa do derrame pleural.

A 34-year-old patient had had Crohn's disease (CD) for eight years; she was seen for complaints of thoracic pain and fever, without gastrointestinal manifestations. Initial laboratory exams were compatible with the presence of inflammatory activity (VHS = 45 mm for normal value of 20 mm and PCR+). The physical exam revealed signs of pleural effusion in the left hemithorax base, which was confirmed by thoracic RX. The pleural liquid analysis showed that the cells were 100% of lymphocytes, with negative BAAR research. The pleural biopsy evidenced non caseous granuloma. Despite the tuberculosis treatment, the patient only got better when corticotherapy was introduced in high doses, suggesting the activity of CD as the cause of the pleural effusion. This case establishes a connection between activity of CD and manifestations of lung disease.