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
B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome
The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)
Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis
This study will test the safety and effects of SBT777101 when given as a single dose to subjects with rheumatoid arthritis. It is the first study of this treatment being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Following completion of the initial single ascending dose cohorts, the study may evaluate alternative administration regimens of SBT777101, including split-dose administration. In the split-dose cohort, participants may receive two intravenous infusions of SBT777101 derived from a single manufacturing process, administered approximately 6 weeks apart. The study will continue to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.