The Study
TSH receptor specific monoclonal autoantibody K1‐70TM targeting of the TSH receptor in subjects with Graves' disease and Graves' orbitopathy—Results from a phase I clinical trial
This study watched 18 people take a new medicine and noted what happened to them—like whether they felt better or had side effects. But since no one else took a fake pill or nothing, we can't be sure the medicine actually caused the improvements. It’s like noticing your headache went away after drinking tea—you don’t know if the tea helped or if it just went away on its own.
Analysis score
Maximum 45 for a randomized controlled trial.
Where the score came from
Scientists gave a single antibody injection to people with Graves' disease — a condition where the immune system accidentally makes the thyroid produce too much hormone.
Where does this study sit?
Reviews of RCTs (Meta-analyses)
Max 100Randomized Trials
Max 90Reviews of Cohort Studies
Max 85Cohort Studies
Max 72Reviews of Case-Control Studies
Max 63Case-Control Studies
Max 58Cross-Sectional & Case Series
Max 50Expert Opinion
Max 539 / 100
Quality score
Participants are randomly assigned to treatment or control groups, minimizing bias. The gold standard for testing whether an intervention causes an effect.
Key takeaways
Summary
Based on the study abstract and findings.
- 1Yes — patients felt significantly better, could stop wearing sunglasses indoors, and even applied for jobs, suggesting real-life improvement beyond lab numbers.
- 2All 9 patients who got 50 mg or 150 mg IV doses became hypothyroid within 4 weeks; eye bulging improved by 2–5 mm; eye pain, redness, and fatigue got better; no serious side effects.
Score breakdown, methodology, conflicts of interest, evidence analysis & raw study data
Publication
Journal
Clinical Endocrinology
Year
2022
Authors
J. Furmaniak, J. Sanders, P. Sanders, Yang Li, B. R. Smith
Related Content
Claims (5)
In adults with Graves' disease, a single intravenous injection of 50 mg or 150 mg of K1-70TM is associated with a measurable decrease in bulging eyes by 2–5 mm within two to six weeks, along with reduced eye pain, redness, and sensitivity to light.
A single intravenous injection of K1-70TM at 50 mg or 150 mg in adults with Graves' disease reduces free triiodothyronine and free thyroxine, increases thyroid-stimulating hormone, and results in hypothyroidism in all treated individuals within 28 days by directly blocking the thyroid-stimulating hormone receptor.
A single dose of K1-70TM up to 150 mg given by injection into a vein or muscle is not associated with serious side effects, immune reactions in 83% of adults with Graves' disease, or significant reactions at the injection site.
When K1-70TM is given through an IV, it stays in the bloodstream longer and at higher levels than when it is injected into muscle, with a half-life of about 22 days at a 150 mg dose.
Graves' disease is a condition where the immune system produces antibodies that bind to the thyroid gland and cause it to produce too much thyroid hormone.
Not medical advice. For informational purposes only. Always consult a qualified healthcare professional before making health decisions.