This systematic review and meta-analysis aimed to determine the effectiveness of brentuximab vedotin (BV) in relapsed/refractory classical Hodgkin lymphoma (R/R cHL) in the clinical practice setting using most recent results. A total of 32 observational studies reporting on treatment patterns, overall response rate (ORR), complete response (CR) rate, progression-free survival (PFS), overall survival (OS), and adverse events were found. After four cycles, a random-effect model yielded pooled ORR and CR rates of 62.6% (95% confidence interval (CI): 56.0-68.9; I 2 ¼ 9.7%) and 32.9% (95% CI, 20.8-46.3, I 2 ¼ 64.8%), respectively. Regarding survival, 1-year, 2-year, and 5year PFS ranged from 52.1% to 63.2%, 45.2% to 56.2%, and 31.9% to 33.0%, respectively. OS rates were 68.2-82.7%, 58.0-81.9%, and 58.0-62.0%, respectively. Most common adverse events were hematological toxicities (neutropenia: 13.3-23%, anemia: 8.8-39.0%, and thrombocytopenia: 4-4.6%), and grade 3 peripheral neuropathy (3.3-7.3%). This study supports the effectiveness and safety of BV in R/R cHL patients in the real-world setting.

Incidence and prevalence estimates for Gaucher disease (GD) are scarce for this rare disease and can be variable within the same region. This review provides a qualitative synthesis of global GD incidence and prevalence estimates, GD1–3 type-specific and overall, published in the last 10 years. A targeted literature search was conducted across multiple databases from January 2011 to September 2020, including web-based sources and congress proceedings to May 2021. Searches yielded 490 publications, with 31 analyzed: 20 cohort studies (15 prospective, 5 retrospective), 6 cross-sectional studies, 5 online reports (most from Europe (n = 11) or North America (n = 11); one multiregional). Across all GD types, incidence estimates ranged 0.45–25.0/100,000 live births (16 studies), lowest for Asia-Pacific. Incidence of GD1: 0.45–22.9/100,000 live births (Europe and North America) and GD3: 1.36/100,000 live births (Asia-Pacific only). GD type-specific prevalence estimates per 100,000 population were GD1: 0.26–0.63; GD2 and GD3: 0.02–0.08 (Europe only); estimates for GD type unspecified or overall ranged 0.11–139.0/100,000 inhabitants (17 studies), highest for North America. Generalizability was assessed as “adequate”or “intermediate” for all regions with data. GD incidence and prevalence estimates for the last 10 years varied considerably between regions and were poorly documented outside Europe and North America. Data for GD2 and GD3 were limited.

The ~10-fold higher reporting rate of therapeutic failure with the generic product relative to its reference product in the present Canadian study resembles findings with US-marketed generic products. While these results should be interpreted with caution due to the limitations of spontaneous adverse event reporting, which may confound comparisons across products, similar findings nonetheless led the US Food and Drug Administration to declare in 2014 that 2 methylphenidate ER generic products in the United States were neither bioequivalent nor interchangeable with OROS methylphenidate-their reference product. Our results indicate a potential safety issue with the Canadian-marketed generic and suggest a need for further investigation by Health Canada.

Findings from this study support the consideration of direct social issues as ADRs in the detection of drug safety signals.

Background: Drug utilization studies (DUSs) are increasingly being conducted in Latin America, especially in countries with a universal healthcare coverage, to inform policies and decision making. The need for an ethical framework specific to DUSs in Latin America has been recognized. Objectives: To describe the ethical and/or legal requirements applicable to DUSs in Latin American countries with universal healthcare coverage. Methods: We conducted a nonsystematic scoping review on DUSs in this region, covering the period from January 1, 2012, to July 1, 2017, and reviewed legislations and data protection requirements in each country. We also surveyed 45 ethics committees and 22 key informants to determine specific ethical requirements for various types of DUSs differing in data collection methods, study populations, and settings. Results: Local legislations on DUSs are highly heterogeneous across Latin America. In Chile and Guatemala, authorization from the national health authority must be obtained for accessing clinical records, whereas in Argentina, no authorization is required for the secondary use of existing data. In Argentina, Brazil, Costa Rica, Guatemala, and Peru, a national ethics committee approval is required in addition to a site-specific approval. Requirements for patient informed consent also vary across countries and depend on the type of DUS and study population. Conclusions: The lack of consensus in the legislative and ethical frameworks applicable to DUSs across Latin America leads to operational challenges for the implementation of multinational studies. In many countries, absence of a framework leads to precautionary stringent requirements, which restricts the feasibility of DUSs.