Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab)

Abstract

NCT01724021 (ClinicalTrials.gov).

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

“…In addition, most of these ARRs resolved spontaneously, as drug delay was only reported in one patient and no treatment discontinuation was required. These safety results, including the 48Á6% of ARRs and the 7Á9% presentation of injection site erythema, are in line with the acceptable safety profile reported in clinical trials that assessed subcutaneous rituximab administration (Salar et al, 2014;Davies et al, 2014Davies et al, , 2017bRummel et al, 2017;Lugtenburg et al, 2017). The SABRINA (FL) and MabEase (DLBCL) trials showed the occurrence of ARRs in 20Á9-48Á2% of patients during up to 7 cycles of subcutaneous rituximab for the first-line induction treatment of FL and DLBCL, mainly manageable mild to moderate events À only reaching grade 3 in 2Á7-3Á1% of patientsÀ, which most frequently included injection-site reactions (≥5%), such as erythema, pruritus, rash, pain, bruising, discoloration, haematoma, hypertrophy, induration or inflammation/swelling (Lugtenburg et al, 2017;Davies et al, 2017b).…”

“…The SABRINA (FL) and MabEase (DLBCL) trials showed the occurrence of ARRs in 20·9–48·2% of patients during up to 7 cycles of subcutaneous rituximab for the first‐line induction treatment of FL and DLBCL, mainly manageable mild to moderate events − only reaching grade 3 in 2·7–3·1% of patients−, which most frequently included injection‐site reactions (≥5%), such as erythema, pruritus, rash, pain, bruising, discoloration, haematoma, hypertrophy, induration or inflammation/swelling (Lugtenburg et al , ; Davies et al , ). Although the PrefMab (FL and DLBCL) trial reported lower rates of ARRs, ranging from 10·4% to 21·1% and with few overall cases of erythema (1·8%) or injection site erythema (1·5%), the differences in trial design should be noted, as this trial used a crossover approach of intravenous and subcutaneous rituximab administration with the latter being administered for up to 3–4 cycles (Rummel et al , ). With regard to maintenance treatment for FL, the SparkThera trial also supported an acceptable and manageable safety profile, with 31% of patients experiencing ARRs after subcutaneous rituximab injection for up to 2 years, which were mainly mild to moderate, rarely required treatment, and most commonly included erythema (13%), injection site erythema (5%) and myalgia (5%) (Salar et al , ).…”

“…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).…”

The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States

“…Other recent examples of the FDA using patient preferences to inform regulatory decisions are a recent FDA advisory committee approval of a subcutaneous formulation of rituximab in the treatment of blood cancers, supported in part by a patient preference study conducted within the trial [21,22], and the release of an FDA draft guidance [23] on developing treatments for Duchenne muscular dystrophy, in part informed by a proposed draft guidance developed by the patient group Parent Project Muscular Dystrophy, which conducted a patient preference study to support their draft [24].…”

“…Although some examples of the application of patient preference data to regulatory decisions exist [4,22,29], many questions remain about how to incorporate patient preference data in regulatory decisions and the standards that should be applied to these data. A number of organizations, including, but not limited to, patient groups, such as the National Health Council and FasterCures, industry associations, such as the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization, and public-private partnerships, such as the Medical Device Innovation Consortium in the USA and the Innovative Medicines Initiative in Europe, have suggested or are evaluating frameworks for systematically incorporating patient preference information in regulatory benefit-risk assessments.…”