Antibody-drug conjugates (ADCs) are new treatment options for certain cancers, especially those in advanced states with limited treatment options. Their unique design provides targeted therapy with toxins that otherwise would not be available, but they manifest toxicities that require risk minimization interventions to optimize their tolerability. We summarize selected toxicities for ADCs that have been approved through the end of 2020 and three investigational ADCs, which include both payload and linker, as described in the US Prescribing Information, the European Summary of Product Characteristics, and study protocols.
View Article and Find Full Text PDFObjectives: To quantify patient preferences for endometriosis-associated pain treatments and risk tolerance in exchange for pain reduction and to explore whether preferences vary on the basis of patient characteristics.
Methods: US women with a self-reported physician diagnosis of endometriosis and moderate to severe dysmenorrhea and nonmenstrual pelvic pain (NMPP) completed an online discrete choice experiment survey. Each choice question had a pair of hypothetical treatments characterized by attributes with varying levels: improvements in severe dysmenorrhea, severe NMPP, and severe dyspareunia; mode of administration; and treatment-related risks of pregnancy-related problems, bone fracture later in life, and moderate to severe hot flashes.
Background: The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established.
Methods: We enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects).
Background: Adalimumab is a therapeutic monoclonal antibody for SC administration by 2 single-use injection devices providing bioequivalent amounts of adalimumab: a ready-to-use, prefilled syringe and an integrated, disposable delivery system, the autoinjection Pen. Although pens have been shown to be preferred over syringes by patients requiring long-term SC administration of medications, there are no data on preference and pain in the use of biologics in patients with chronic inflammatory diseases.
Objective: The aim of this study was to assess injection-site pain, tolerability, and patient preference of 2 delivery systems of adalimumab.
Background: Increased prevalence of adolescent obesity requires effective treatment options beyond behavior therapy.
Objective: To see whether sibutramine reduced weight more than placebo in obese adolescents who were receiving a behavior therapy program.
Design: 12-month, 3:1 randomized, double-blind trial conducted from July 2000 to February 2002.
Background: Lopinavir/ritonavir has demonstrated antiviral activity in the HIV-infected adult.
Subjects: The objective of this study was to investigate a liquid coformulation of lopinavir/ritonavir, in combination with reverse transcriptase inhibitors, in HIV-infected children.
Methods: One hundred antiretroviral (ARV)-naive and ARV-experienced, nonnucleoside reverse transcriptase inhibitor-naive children between 6 months and 12 years of age participated in this Phase I/II, open label, multicenter trial.