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:

1. 150mg anifrolumab
2. 300mg anifrolumab
3. Placebo

For all groups, the medication or placebo was delivered intravenously every 4 weeks during the trial.

Type I Interferon: What is it?

Even though this trial did not return a positive result, there is still hope for treatments designed using type I interferons. Type I interferons are cytokines involved in the inflammatory pathways. That means that they are involved in the signalling process in the immune system.

Up to 80% of adult Lupus Warriors have an increased type I interferon gene signature. This variation has been shown to correlate with lupus disease activity.

Interferon proteins work to regulate the body’s immune system. These proteins are critical in creating a strong immune reaction within the body; essentially, they are released at sites of viral infection and abnormal cell growth. Interferons (IFNs) have three roles:

1. Limiting the spread of infectious agents to neighboring cells
2. Restraining inflammatory pathways and cytokine production
3. Activating the adaptive immune system. (The adaptive immune system is specifically designed to eliminate pathogens)

The Future of Lupus Treatment

Sandra C. Raymond, the CEO of the Lupus Foundation of America, had this to say on the subject of new treatments for lupus: “Despite results announced [recently], people with lupus can remain optimistic that new therapies may soon become available due to the outstanding interest and investment by pharmaceutical and biotech industries. We are also encouraged that several additional promising treatments remain in the near-term pipeline.”