The TULIP Study: What is It?
TULIP stands for: Treatment of Uncontrolled Lupus via the Interferon Pathway. It is made up of two Phase III clinical trials, TULIP 1 and TULIP 2.
The medication being tested in these studies is called anifrolumab. Anifrolumab is a monoclonal (derived from a single ancestral cell) antibody that binds to a specific subunit of the type I interferon receptor. This blocks the activity of type I interferons including IFN-α, IFN-β and IFN-ω. Research suggests that these proteins are involved in the immune system response to viral infections.
TULIP 1 Results
Clinical trials measure success by identifying a primary endpoint before beginning the trial. The primary endpoint is the target, set before beginning the research, that determines if the intervention (in this case, the medication) causes a significant and measurable change.
The primary endpoint for the TULIP study was a statistically significant decrease in disease activity for people with SLE measured by the SLE Responder Index 4 (SRI4) 12 months after starting the medication. Unfortunately, the TULIP study did not achieve this result.
TULIP 1 Study Methods
The TULIP 1 study was a 52-week long study. 460 people with lupus (SLE) participated in the trial. Participants were assigned to one of three groups:
- 150mg anifrolumab
- 300mg anifrolumab
For all groups, the medication or placebo was delivered intravenously every 4 weeks during the trial.