What the trial was testing
The trial enrolled 99 patients with lupus. The study was sponsored by State University of New York - Upstate Medical University and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was an early-stage trial — researchers are still confirming safety and getting an early look at how well the treatment works. 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
Disease activity scores dropped significantly, and patients cut their daily steroid dose from 24 mg to 7 mg on average.
Lancet (London, England) · 2018 · NCT00779194
These findings — that more than half of participants showed reduced disease activity after a year of treatment — were published in the Lancet (London, England) and represent the headline result of the study.
Researchers tracked outcomes across 99 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 lupus, 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 was an early-stage study and sirolimus is not yet FDA-approved specifically for lupus. The medication is already approved for other conditions, so some doctors may prescribe it off-label. Ask your rheumatologist whether sirolimus or similar treatments might be appropriate for your situation.
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 lupus trials
Creating Health Course Study for People With Rheumatological Conditions and Mood Disorders
The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), anxiety disorders, depressive disorders and moderate depression. Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.
Intervention to Improve Communication and Medication Adherence in Lupus
CO-LEAD is an intervention to improve patient-provider communication and medication adherence among patients with systemic lupus erythematosus (SLE). The purpose of this study is to optimize the culturally appropriate delivery and test the effect of the CO-LEAD intervention, which includes the following: 1. clinicians will be provided with a program to teach them to use effective communication strategies with patients to review real-time pharmacy refill date, engage and formulate solutions to adherence barriers, and collaboratively overcome adherence barriers. 2. use of a reliable and valid patient-reported measure of the extent of and reasons for nonadherence that helps patients identify and communicate their adherence barriers with clinicians proactively, efficiently, and comprehensively.