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.
84.6%) patients completed six cycles of therapy, 142 (66.6%) underwent interim PET2, of which 30.4% were positive, however few (n¼ 25, 17.6%) had PET-adapted modifications. A majority (89.1%) of patients received at least one supportive care product. AEs were more prevalent among older patients (>60 years). All grade neutropenia occurred in 47.1% of the patients receiving ABVD; the rate of febrile neutropenia was 6.8%. Other AEs included: infections (22.2%), anemia (27.6%), thrombocytopenia (2.7%). Cardiovascular or pulmonary complications occurred in 5 (2.3%) and 22 (10%) ABVD patients, respectively, 11 of whom had undergone PET2 assessment -3 with treatment de-escalation.Conclusions: Unmet needs exist with respect to the balance between therapeutic efficacy and safety risks of 1L chemotherapies in cHL. Even when PET2 scans are available to monitor tumour response, they are not always used to modify treatment management. Most patients continue to rely on supportive care products, or experience avoidable toxicities, underscoring the importance of new treatment combinations with novel agents.
Although relapse is an important outcome to measure the effectiveness of schizophrenia treatment, no standard definition exists. This review aimed at identifying definitions and measurements of schizophrenia relapse in observational studies of long‐acting injectables (LAIs) versus oral antipsychotics (OAPs) and at determining their impact on heterogeneity of comparative effectiveness estimates. A systematic review was conducted using MEDLINE and Embase (01 January 2010–11 November 2019 [date last searched]). Pragmatic searches of gray literature and snowballing were also conducted. Search outputs were screened independently by two assessors at first stage, and full‐text of potentially eligible sources at second stage. For each retained source, definition and measurement of relapse, study methods, and comparative effectiveness estimates were extracted. Heterogeneity of estimates was assessed using I2 statistic with a threshold of 50% for substantial heterogeneity. Literature search yielded 543 sources and pragmatic searches, 21, of which 35 were eligible. Twelve definitions of relapse were found based on hospitalization/emergency department (ED) data (28 studies) or clinical assessment (5 studies). No definition was provided in five studies. According to quantitative analyses, in studies defining relapse as schizophrenia‐related hospitalization and/or ED visits over 1‐year follow‐up, LAIs were significantly more effective than OAPs. For studies measuring relapse based on all‐cause hospitalization, heterogeneity was too high for pooling; yet this definition is the most frequently found in pooled estimates published in the literature. Schizophrenia relapse definitions led to substantial heterogeneity of comparative effectiveness estimates of LAIs versus OAPs. Creating study subgroups based on relapse definition effectively reduces statistical heterogeneity.
Background The coronavirus disease 2019 (COVID-19) pandemic has led to disruptions of healthcare delivery and may thus have impacted patterns of prescription opioid use, including risk factors for long-term use. Objective We aimed to describe changes in patterns of prescription opioid use due to the COVID-19 pandemic in community-dwelling adults without a cancer diagnosis. Methods Using administrative claims data of the province of Quebec, Canada, a random sample of adults (aged ≥18 years) was selected. These were members of the public drug plan without a cancer diagnosis who initiated a prescription opioid in the outpatient setting between 1 January, 2018 and 28 December, 2020. We assessed the daily dose of initial prescription opioids, the number of days’ supply of initial dispensing, and the total duration of opioid use over the first 6 months following initiation. We applied interrupted autoregressive integrated moving average models to examine weekly patterns of prescription opioids before and during the pandemic (starting at the lockdown). Our models included a step intervention function (immediate change) and a ramp intervention function (slope change). Results There were 112,650 and 34,261 patients who initiated opioid therapy, respectively, in the 115-week pre-pandemic period and in the 41-week pandemic period. At the start of the lockdown, there was a significant immediate decrease in opioid treatment initiation (−326; 95% confidence interval [CI] −419 to −234) and initial daily dose (−1.7 morphine milligram equivalents; 95% CI −2.7 to −0.7). Conversely, there was a significant immediate increase in the number of days’ supply of initial dispensing (1.4 days; 95% CI 1.0 to 1.8) and the total duration of opioid use over 6 months (5.7 days; 95% CI 4.6 to 6.8). All these weekly measures returned to values close to those of the pre-pandemic period 10 weeks after the start of lockdown. Conclusions Our findings showed that the COVID-19 lockdown had an impact on initial number of days’ supply, which is a risk factor for long-term use and ultimately opioid-related harm. However, over time, prescription practices and use reverted to those observed in the pre-pandemic period. Supplementary Information The online version contains supplementary material available at 10.1007/s40801-022-00329-z.
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