Project description:Introduction/objectivesMultiple modes of administration are available for systemic lupus erythematosus (SLE) treatments. This study examined patient and physician characteristics associated with the choice of weekly subcutaneous (SC) injection or monthly intravenous (IV) infusion for an unspecified SLE treatment.MethodsThis was a cross-sectional, US web-based survey using a direct elicitation, stated-preference methodology (HO-16-16706). Two hundred patients and 200 physicians were asked to choose between IV or SC administration in a hypothetical scenario. Pairwise and multivariate analyses estimated the odds ratio (OR) for the likelihood of choosing SC over IV for respondent characteristics.ResultsAmong patients, taking non-steroidal anti-inflammatory drugs increased the likelihood of choosing SC injection (OR 3.884), whilst having SLE-related skin problems, a fear of needles or self-injection, and never needing help around the house decreased the likelihood (OR 0.28, 0.13, 0.12, respectively; all p ≤ 0.05). Among physicians, > 95% recommended SC injection for patients who live or work far from an infusion center, prefer SC administration, and never or rarely miss medication doses. Physician characteristics including age and treatment practice also influenced choice.ConclusionsPatient and physician characteristics influence choice of SC versus IV therapy for SLE. These findings might inform shared decision-making, which could lead to improved patient outcomes. Key Points • Data regarding patient and physician preference for different modes of administration of SLE therapy are sparse. • This cross-sectional, US web-based study showed that patient and physician characteristics influence choice of SC versus IV therapy for SLE. • A degree of disconnect exists between how factors influence patients' choice and how those characteristics influence physicians' choice of SLE treatment mode of administration. • The findings from this study might inform shared decision-making, which could improve alignment between treatment choice and patient preferences, treatment satisfaction, adherence, and improved patient outcomes.

Project description:BackgroundGranisetron extended-release subcutaneous (SC) injection is a novel formulation of granisetron for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Palonosetron is administered intravenously and is indicated for CINV prevention in acute and delayed phases after the use of moderately emetogenic chemotherapy (MEC) and in the acute phase after highly emetogenic chemotherapy (HEC). No data are available regarding the impact of SC granisetron on the cost of unscheduled hydration compared with other antiemetic drugs, specifically the older-generation palonosetron.ObjectiveTo compare the costs of unscheduled hydration associated with breakthrough CINV after SC granisetron versus palonosetron administration in patients receiving MEC or HEC.MethodsThis retrospective analysis was based on electronic medical records data from a single multicenter, community-based practice involving patients receiving MEC or HEC with a 3-drug antiemetic regimen, including a neurokinin-1 receptor antagonist, dexamethasone, and either SC granisetron or palonosetron. A cost-of-care analysis for SC granisetron and palonosetron was based on the maximum per-unit Medicare reimbursement amounts for the use of unscheduled hydration, administration of rescue antiemetic drugs, laboratory tests, and patient office evaluations.ResultsA total of 182 patient records were evaluated, 91 for patients receiving SC granisetron and 91 receiving palonosetron. The mean per-patient cost of care related to unscheduled hydration in patients receiving HEC or MEC was significantly lower with SC granisetron ($296) than palonosetron ($837; P <.0001), including subset analysis of patients requiring additional care (SC granisetron [$691], N = 39; palonosetron [$1058], N = 72; P = .0260). The mean hydration costs per patient receiving HEC or MEC were lower with SC granisetron ($62) than with palonosetron ($253; P <.0001). The hydration costs per patient receiving only HEC were lower with SC granisetron ($66) than palonosetron ($280; P <.0001). The per-patient costs were lower when SC granisetron was administered than when palonosetron was administered as part of the antiemetic regimen, except for the cost of rescue antiemetic drug in patients receiving MEC. Fewer median unscheduled hydration therapies per patient were used with SC granisetron versus palonosetron (HEC, 3 vs 5; MEC, 2 vs 3).ConclusionThe use of SC granisetron reduced the total per-patient costs of care associated with unscheduled hydration compared with palonosetron in patients receiving HEC or MEC for breakthrough CINV events.

Project description:The CD20-specific monoclonal antibody rituximab (MabThera(®), Rituxan(®)) is widely used as the backbone of treatment for patients with hematologic disorders. Intravenous administration of rituximab is associated with infusion times of 4-6 hours, and can be associated with infusion-related reactions. Subcutaneous administration of rituximab may reduce this and facilitate administration without infusion-related reactions. We sought to determine the feasibility of achieving equivalent efficacy (measured by endogenous B-cell depletion) and long-term durability of CD20 target coverage for subcutaneously administered rituximab compared with intravenous dosing. In these preclinical studies, male cynomolgus monkeys were treated with either intravenous rituximab or novel subcutaneous formulation of rituximab containing human recombinant DNA-derived hyaluronidase enzyme. Peripheral blood samples were analyzed for serum rituximab concentrations, peripheral B-cell depletion, and CD20 target coverage, including subset analysis according to CD21+ status. Distal lymph node B-cell depletion and CD20 target coverage were also measured. Initial peak serum concentrations of rituximab were significantly higher following intravenous administration than subcutaneous. However, the mean serum rituximab trough concentrations were comparable at 2 and 7 days post-first dose and 9 and 14 days post-second dose. Efficacy of B-cell depletion in both peripheral blood and distal lymph nodes was comparable for both methods. In lymph nodes, 9 days after the second dose with subcutaneous and intravenous rituximab, B-cell levels were decreased by 57% and 42% respectively. Similarly, levels of peripheral blood B cells were depleted by >94% for both subcutaneous and intravenous dosing at all time points. Long-term recovery of free unbound surface CD20 levels was similar, and the duration of B-cell depletion was equally sustained over 2 months for both methods. These results demonstrate that, despite initial peak serum drug level differences, subcutaneous rituximab has similar durability, pharmacodynamics, and efficacy compared with intravenous rituximab.

Dataset Information

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries.

Publications

Time Savings with Rituximab Subcutaneous Injection versus Rituximab Intravenous Infusion: A Time and Motion Study in Eight Countries.

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