A new study shows that the clinical status of patients who have either rheumatoid arthritis or axial spondyloarthritis, can be successfully maintained when switching from the biologic originator etanercept to a biosimilar called SB4.
Using real-world evidence collated from four countries in the European Union, the “BENEFIT” Pan-European Observational Study elucidates the efficacy and safety profile of the transition from the original biological drug etanercept to a biosimilar in populations of patients who have rheumatoid arthritis or axial spondyloarthritis.
The biosimilar, SB4, received marketing approval from the EU based on the data presented derived from pre-clinical, phase I and phase III studies in 2016. According to the data in these studies, SB4 exhibited efficacy and bioequivalence as well as comparable safety and immunogenicity profiles of similar measures to etanercept.
The study's authors emphasized the significance of collecting real-world data by transcending the controlled environment of a randomized clinical trial. By investigating outcomes in a real-world setting, investigators were able to gain insight into the practice perspective regarding transition logistics and outcomes associated with switching therapies in a standard clinical practice setting.
The observational study followed 557 patients, 358 with rheumatoid arthritis and 199 with axial spondyloarthritis in a real-world setting. Of these patients, rheumatoid arthritis patients averaged 60.9% (SD 11.09) years of age, while the mean of axial spondyloarthritis patients was 39.9 (13.3) years. Nearly three-fourths of the patients followed who had rheumatoid arthritis were women, averaging 73.3% or 264 of the population; slightly more than one-fourth of the patients in the axial spondyloarthritis arm (27.1%) were women.
Among the inclusion criteria were having rheumatoid arthritis or axial spondyloarthritis and having initiated SB4 therapy after having been reached a stable dose of etanercept within a period of six months.
Researchers retrieved data from clinical records both retrospectively dating back six months prior and prospectively and/or retrospectively six months for a six-month period following the etanercept to SB4 switch. The following endpoints were followed: disease score (noted as disease activity score calculator for rheumatoid arthritis (DAS-28)) for rheumatoid arthritis, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for axSpA) over time, clinical characteristics and management, and serious adverse events.
Rheumatoid Arthritis patients averaged a DAS-28 score of 2.0 (SD 0.84) six months prior to transition to SB4, while axial spondyloarthritis averaged 2.5 (SD 1.93). Disease score values at six months post-transition to SB4 individual changes in disease scores from baseline to six months post-transition were negligible (0.0 (SD 0.81 for RA patients) and (2.3 (1.81) for axial spondyloarthritis patients)).
Only one adverse event—pneumonia—was reported as a serious adverse event and linked to SB4. The other six adverse events reported were not related to SB4. These were uveitis, chronic obstructive pulmonary disease, umbilical hernia, lithium overdose, and relapsing pancreatitis.
REFERENCE: ABSTRACT NUMBER 542 "‘BENEFIT’ Pan-European Observational Study to Evaluate the Real-world Effectiveness of SB4 Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis or Axial Spondyloarthritis: A Switch Success Story. ACR/ARP Annual Meeting, November 8-13, Georgia World Congress Center, Atlanta, GA