What the trial was testing
The trial enrolled 455 patients with rheumatoid arthritis. The study was sponsored by Pfizer and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Switching between biosimilar and original Humira three times showed no difference in drug levels or safety.
The Lancet. Rheumatology · 2023 · NCT04230213
These findings — that patients switched three times between versions with identical safety and drug levels — were published in the The Lancet. Rheumatology and represent the headline result of the study.
Researchers tracked outcomes across 455 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with rheumatoid arthritis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This biosimilar is FDA-approved and available now. The study shows that switching between the biosimilar and original Humira multiple times is safe and works just as well. If your insurance or doctor suggests switching to save costs, this research supports that it's a reasonable option. Talk to your rheumatologist about whether a biosimilar makes sense for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open rheumatoid arthritis trials
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.
Twenty-four Hour Movement Behaviors and Atherosclerotic Risk
This observational study aims to investigate how 24-hour movement behaviors are associated with atherosclerotic risk in adults with rheumatoid arthritis. These behaviors include physical activity, sedentary behavior, and sleep. The main questions it aims to answer are: * Are 24-hour movement behaviors, both individually and in combination, associated with indicators of atherosclerotic risk in adults with RA? * Do changes in 24-hour movement behaviors over 12 months relate to changes in indicators of atherosclerotic risk? Participants will: * Wear activity monitors (accelerometers) continuously for 7 days to measure physical activity, sedentary behavior, and sleep. * Answer questionnaires about their health and lifestyle. * Undergo cardiovascular assessments, body composition measurements, physical fitness tests, and blood tests to measure lipid and inflammatory profile. * Return 12 months later for follow-up assessments. The researchers hope this study will improve understanding of how daily movement behaviors influence cardiovascular health in people with rheumatoid arthritis. The findings may help inform future recommendations to promote healthier movement behaviors and improve cardiovascular risk management in this population.