Phase III/IV, Randomized, Fifty-Two-Week Study of the Efficacy and Safety of Belimumab in Patients of Black African Ancestry With Systemic Lupus Erythematosus.

OBJECTIVE: Enrollment of patients of Black African ancestry with systemic lupus erythematosus (SLE) in phase II and phase III of the belimumab trials was not reflective of the racial distribution observed in the lupus population. This study was undertaken to assess the efficacy and safety of intravenous (IV) belimumab plus standard therapy in patients of self-identified Black race. METHODS: EMBRACE (GSK Study BEL115471; ClinicalTrials.gov identifier: NCT01632241) was a 52-week multicenter, double-blind, placebo-controlled trial in adults of self-identified Black race with active SLE who received monthly belimumab 10 mg/kg IV, or placebo, plus standard therapy. The optional 26-week open-label extension phase included patients who completed the double-blind phase. The primary end point of the study was SLE Responder Index (SRI) response rate at week 52 with modified proteinuria scoring adapted from the SLE Disease Activity Index 2000 (SLEDAI-2K) (SRI-SLEDAI-2K). Key secondary end points included SRI response rate at week 52, time to first severe SLE flare, and reductions in prednisone dose. RESULTS: The modified intent-to-treat population comprised 448 patients, of whom 96.9% were women and the mean ± SD age was 38.8 ± 11.42 years. The primary end point (improvement in the SRI-SLEDAI-2K response rate at week 52) was not achieved (belimumab 48.7%, placebo 41.6%; odds ratio 1.40 [95% confidence interval 0.93, 2.11], P = 0.1068); however, numerical improvements favoring belimumab were observed, in which the SRI-SLEDAI-2K response rates were higher in those who received belimumab compared with those who received placebo, especially in patients with SLE who had high disease activity or renal manifestations at baseline. The safety profile of belimumab was generally consistent with that observed in previous SLE trials. Adverse events were the primary reasons for double-blind phase withdrawals (belimumab 5.4%, placebo 6.7%). CONCLUSION: The primary end point of this study was not achieved, but improvement with belimumab versus placebo was observed, suggesting that belimumab remains a suitable treatment option for SLE management in patients of Black African ancestry.

Leishmaniasis during anti-tumor necrosis factor therapy: report of 4 cases and review of the literature (additional 28 cases).

OBJECTIVE: To describe the development of 4 new cases of leishmaniasis in patients receiving anti-tumor necrosis factor-α (anti-TNF) agents and review the pertinent literature. METHODS: Chart review of the 4 cases and MEDLINE search for additional reported cases. RESULTS: All reported cases, including ours, came from endemic areas. The infection was detected on an average of 23.5 months after the initiation of anti-TNF therapy. The majority of cases had the classical clinical presentation. The biological therapy was suspended in 21 cases. The results were successful for leishmaniasis therapy in all cases. In 10 cases it was possible to reintroduce anti-TNF agents. On follow-up it was observed that there was an infection relapse in 3 cases. CONCLUSIONS: The present study shows that leishmaniasis, in its several clinical forms, should be included in the differential diagnosis of possible infections involving patients under use of aTNF therapy. Endemic disease under geographic expansion, easy international displacement and intense human migratory flows certainly represents a risk of this infection in an increasing universe of people which includes the immunosuppressed patients. Cutaneous lesions, prolonged fever, splenomegaly, and pancytopenias, the main clinical-laboratory findings of leishmaniasis, can also be present in autoimmune rheumatic disease, thus leading to delayed diagnosis and treatment of the parasitic disease. The diagnosis depends basically on a high suspicion index, being confirmed with the identification of the protozoan. The classic treatment of the infection when instituted is associated with complete recovery. It is important to point out that all cases reported so far had either originated from or been recently in regions regarded as endemic of leishmaniasis.

Anticitrulline peptide antibodies (CCP3) in leprosy sera: a negative association.

Anticyclic citrullinated peptide antibodies (anti-CCP) have been described almost exclusively in patients with rheumatoid arthritis. Recently, these autoantibodies have been found in patients with active tuberculosis. Leprosy is another mycobacterial disease where the presence of autoantibodies has been described by several authors. In this study, 64 patients with leprosy (32 paucibacillary and 32 multibacillary forms of the disease) were evaluated and only 2 patients were positive for the presence of anti-CCP. The low frequency of anti-CCP in leprosy sera demonstrated in our study illustrates the high specificity of anti-CCP for the diagnosis of rheumatoid arthritis.

Sacroiliíte bilateral por criptococos: relato de um caso e revisão de literatura / Bilateral cryptococcal sacroiliitis: case report and literature review

O envolvimento do sistema osteoarticular na criptococose ocorre, particularmente, nas formas disseminadas da infecção, afetando principalmente indivíduos imunodeprimidos. O sistema ósseo é acometido em 5 a 10 por cento dos casos e o sistema articular é raramente comprometido. Até o momento, há 31 casos de artrite criptocócica relatados na literatura médica e, nesta série, apenas 2 casos de sacroiliíte criptocócica. Os autores relatam o caso de um paciente com síndrome da imunodeficiência adquirida (AIDS), que desenvolveu criptococose disseminada, complicada com sacroiliíte bilateral. Este se constitui no primeiro caso de sacroiliíte criptocócica relatado na literatura médica brasileira e sul-americana.

The involvement of osseous and articular system in cryptococcosis occurs particularly in the disseminated forms of the infection, affecting mostly immunossupressed hosts. The bone system is compromised in 5 to 10 percent of the cases, and the articular system is rarely implicated. Until now, there are 31 related cases of cryptococcal arthritis in the medical literature, and in this serie, only 02 cases of criptococcal sacroiliitis. The authors discuss a case of a patient with AIDS that developed disseminated cryptococcosis, complicated with bilateral sacroiliitis. To our knowledge this is the first case of cryptococcal sacroiliitis related in the Brazilian and South-American medical literature.