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

Abstract

BackgroundRituximab is a standard treatment for non-Hodgkin lymphoma. The SABRINA trial (NCT01200758) showed that a subcutaneous (SC) rituximab formulation did not compromise efficacy or safety compared with intravenous (IV) infusion. We aimed to quantify active healthcare professional (HCP) time and patient chair time for rituximab SC and IV, including potential time savings.MethodsThis non-interventional time and motion study was run in eight countries and 30 day oncology units. Rituximab SC data were collected alongside the MabCute trial (NCT01461928); IV data were collected per routine real-world practice. Trained observers recorded active HCP time for pre-specified tasks (stopwatch) and chair time (time of day). A random intercept model was used to analyze active HCP time (by task and for all tasks combined) in the treatment room and drug preparation area, drug administration duration, chair time and patient treatment room time by country and/or across countries. Active HCP and chair time were extrapolated to a patient’s first year of treatment (11 rituximab sessions).ResultsMean active HCP time was 35.0 and 23.7 minutes for IV and SC process, respectively (-32%, p <0.0001). By country, relative reduction in time was 27–58%. Absolute reduction in extrapolated active HCP time (first year of treatment) was 1.1–5.2 hours. Mean chair time was 262.1 minutes for IV, including 180.9 minutes infusion duration, vs. 67.3 minutes for SC, including 8.3 minutes SC injection administration (-74%, p <0.0001). By country, relative reduction was 53–91%. Absolute reduction in extrapolated chair time for the first year of treatment was 3.1–5.5 eight-hour days.ConclusionsCompared with rituximab IV, rituximab SC was associated with reduced chair time and active HCP time. The latter could be invested in other activities, whereas the former may lead to more available appointments, reducing waiting lists and increasing the efficiency of day oncology units.Trial RegistrationClinicalTrials.gov NCT01200758

Safety of switching from intravenous to subcutaneous rituximab during first‐line treatment of patients with non‐Hodgkin lymphoma: the Spanish population of the MabRella study

“…Indeed, recent studies have reported that subcutaneous rituximab entails considerable reductions in administration, chair/bed use, active healthcare professional and overall hospital times (De Cock et al , ; Lugtenburg et al , ), without affecting the patients’ perception of their treatment and the time they had to talk to healthcare providers (Lugtenburg et al , ). Data from subcutaneous rituximab administration showed it to be a preferable treatment formulation for patients (Rummel et al , ), with improved treatment convenience, satisfaction and effect on daily living (De Cock et al , ; Rummel et al , ). Based on the accumulated clinical data, subcutaneous rituximab was approved and is currently available for the treatment of patients with DLBCL and FL (http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000165/human_med_000897.jsp&mxml:id=WC0b01ac058001d124; https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761064).…”

A Canadian Perspective on the Subcutaneous Administration of Rituximab in Non-Hodgkin Lymphoma

“…To date, studies have shown that the safety profiles of the sc and IV formulations of rituximab are similar (Table i) 6,[9][10][11]13,14,16,17 ; however, studies have reported greater rates of gastrointestinal toxicities with the IV formulation (55% vs. 31%) 14 and of local administration-related reactions (arrs) with the sc formulation 6,9-11,13,14,17 . Of patients given the sc formulation, arrs were reported by 31%-50%; of those given the IV formulation, 4% -32% reported such reactions.…”

“…A second ongoing trial, mabcute, is examining induction with sc rituximab (IV cycle 1; sc cycles 2-8) plus chemotherapy, followed by maintenance with sc rituximab at standard doses in patients with relapsed or refractory indolent nhl 9 . Upon completion of standard maintenance, responding patients will be randomized to receive additional maintenance or observation 9,10 . Preliminary data from the mabcute study presented at the American Society of Hematology meeting in 2013 showed a reduction in chair time of 64%-91% and a savings in physician time of 6.8-38.4 minutes, resulting in an expected annual chair time savings of 105.1-233.4 eight-hour days.…”

Rituximab for subcutaneous delivery: Clinical management principles from a nursing perspective

“…Further, the potential benefits of the reduction in administration time are appreciable. It simplifies the treatment experience for both patients and health‐care professionals, reduces the burden on health‐care resources and is likely to improve patient quality of life and treatment adherence . One multinational study demonstrated reductions of between 64% and 91% in patient chair time following a switch from IV to SC administration of rituximab, which translated to a reduction of 17–33 h of chair time per patient over the first year of treatment.…”

“…Furthermore, health‐care professional time was substantially reduced, by between 7 and 38 min per session, equating to 0.9–5.1 h less resource input per patient over the first year of treatment. Patient throughput, waiting list times and hospital efficiency were greatly improved …”