Comparison of rituximab originator (MabThera®) to biosimilar (Truxima®) in patients with multiple sclerosis.

BACKGROUND: Rituximab's originator MabThera® or Rituxan® has demonstrated high efficacy in multiple sclerosis (MS). Because of the patent expiration, rituximab biosimilars have been developed. However, because a biosimilar is not the exact copy of the originator, the efficacy and safety of a biosimilar may significantly differ. OBJECTIVES: To compare the efficacy and safety of the biosimilar Truxima® and the originator MabThera® in MS. METHODS: Consecutive MS patients receiving MabThera® or Truxima® were prospectively followed during 1 year after treatment introduction. Allocation to each treatment depended on the period of introduction and not the physician's choice. Lymphocyte count, clinical and magnetic resonance imaging (MRI) activity, Expanded Disability Status Scale (EDSS), and adverse events were compared. RESULTS: In total, 105 and 40 patients received MabThera® and Truxima®, respectively. The two groups did not differ in baseline characteristics. Effect on CD19+ lymphocytes and disease activity were similar during follow-up. EDSS remained stable, with no difference between groups. Adverse events were similar between groups. CONCLUSION: The efficacy and safety of the rituximab biosimilar Truxima® seem equivalent to the originator MabThera® in MS patients. Truxima® could represent a relatively cheap and safe therapeutic alternative to MabThera® and could improve access to highly efficient therapy for MS in low- or middle-income countries.

Interventions to reduce nurses' medication administration errors in inpatient settings: A systematic review and meta-analysis.

BACKGROUND AND OBJECTIVES: Serious medication administration errors are common in hospitals. Various interventions, including barcode-based technologies, have been developed to help prevent such errors. This systematic review and this meta-analysis focus on the efficacy of interventions for reducing medication administration errors. The types of error and their gravity were also studied. METHODS: MEDLINE, EMBASE, the Cochrane Library and reference lists of relevant articles published between January 1975 and August 2014 were searched, without language restriction. Randomized controlled trials, interrupted time-series studies, non-randomized controlled trials and controlled before-and-after studies were included. Studies evaluating interventions for decreasing administration errors based on total opportunity for error method were included. Nurses administering medications to adult or child inpatients were considered eligible as participants. Two reviewers independently assessed studies for eligibility, extracted data and assessed the risk of bias. The main outcome was the error rate without wrong-time errors measured at study level. A random effects model was used to evaluate the effects of interventions on administration errors. RESULTS: 5312 records from electronic database searches were identified. Seven studies were included: five were randomized controlled trials (including one crossover trial) and two were non-randomized controlled trials. Interventions were training-related (n=4; dedicated medication nurses, interactive CD-ROM program, simulation-based learning, pharmacist-led training program), and technology-related (n=3; computerized prescribing and automated medication dispensing systems). All studies were subject to a high risk of bias, mostly due to a lack of blinding to outcome assessment and a risk of contamination. No difference between the control group and the intervention group was found (OR=0.72 [0.39; 1.34], p=0.3). No fatal error was observed in the three studies evaluating the gravity of errors. CONCLUSIONS: This review did not find evidence that interventions can effectively decrease administration errors. In addition, most studies had a high risk of bias. More evaluation studies with stronger designs are required.