Renato Sampaio Tavares

Safety and efficacy of ruxolitinib in an open-label, multicenter, single-arm phase 3b expanded-access study in patients with myelofibrosis: a snapshot of 1144 patients in the JUMP trial

JUMP is a phase 3b expanded-access trial for patients without access to ruxolitinib outside of a clinical study; it is the largest clinical trial to date in patients with myelofibrosis who have been treated with ruxolitinib. Here, we present safety and efficacy findings from an analysis of 1144 patients with intermediate- or high-risk myelofibrosis, as well as a separate analysis of 163 patients with intermediate-1-risk myelofibrosis – a population of patients not included in the phase 3 COMFORT studies. Consistent with ruxolitinib’s mechanism of action, the most common hematologic adverse events were anemia and thrombocytopenia, but these led to treatment discontinuation in only a few cases. The most common non-hematologic adverse events were primarily grade 1/2 and included diarrhea, pyrexia, fatigue, and asthenia. The rates of infections were low and primarily grade 1/2, and no new or unexpected infections were observed. The majority of patients achieved a ≥50% reduction from baseline in palpable spleen length. Improvements in symptoms were rapid, with approximately half of all patients experiencing clinically significant improvements, as assessed by various quality-of-life questionnaires. The safety and efficacy profile in intermediate-1-risk patients was consistent with that in the overall JUMP population and with that previously reported in intermediate-2- and high-risk patients. Overall, ruxolitinib provided clinically meaningful reductions in spleen length and symptoms in patients with myelofibrosis, including those with intermediate-1-risk disease, with a safety and efficacy profile consistent with that observed in the phase 3 COMFORT studies. This trial was registered as NCT01493414 at ClinicalTrials.gov.

Infecção pelo vírus da hepatite B em hemofílicos em Goiás: soroprevalência, fatores de risco associados e resposta vacinal

Objetivando determinar a prevalencia da infeccao pelo virus da hepatite B (HBV) em hemofilicos em Goias, analisar os fatores de risco associados e avaliar a resposta vacinal contra hepatite B, 102 pacientes foram entrevistados e amostras sanguineas coletadas para deteccao dos seguintes marcadores sorologicos: HBsAg, anti-HBs e anti-HBc. Uma prevalencia global de 43,7% (IC 95%: 33,5-54,2) para infeccao pelo HBV foi encontrada. A analise multivariada dos fatores de risco mostrou que o numero de episodios transfusionais e sorologia positiva para o virus da hepatite C estiveram significantemente associados a positividade ao HBV. Foram identificados 49 (48,1%) hemofilicos susceptiveis a esta infeccao, sendo imunizados 30 pacientes com a vacina recombinante Euvax-B. Destes, 28 (93,3%) individuos apresentaram titulos de anti-HBs maiores que 10 UI/L, o que mostra uma boa resposta a vacina. Os achados deste estudo ressaltam a importância das medidas de controle e prevencao da hepatite B nesta populacao.

Splenic marginal zone lymphoma: a literature review of diagnostic and therapeutic challenges

Splenic marginal zone lymphoma (SMZL) is a low-grade B-cell non-Hodgkins lymphoma characterized by massive splenomegaly, moderate lymphocytosis with or without villous lymphocytes, rare involvement of peripheral lymph nodes and indolent clinical course. As a rare disease, with no randomized prospective trials, there is no standard of care for SMZL so far. Splenectomy has been done for many years as an attempt to control disease, but nowadays it has not been encouraged as first line because of new advances in therapy as rituximab, that are as effective with minimal toxicity. Facing these controversies, this review highlights advances in the literature regarding diagnosis, prognostic factors, treatment indications and therapeutic options.