TULIP 2 Phase III and Type 1 Interferon Lupus Treatments
Anifrolumab, a promising type 1 interferon medication, passed its second Phase III trial. The new treatment is now eligible for approval for the treatment of lupus.
Type 1 interferon medications are promising candidates for treating lupus because they reduce inflammation and temper the immune response. This helps manage the physical aspects that are responsible for most symptoms of lupus. However, unlike immunosuppressant drugs, type 1 interferons don’t leave your body vulnerable to pathogens.
Interferons stop the inflammation response and block cytokine production in the body. Adding man-made interferons to the body helps Lupus Warriors' immune system function. It protects the body while also stopping it from attacking itself.
AstraZeneca and MedImmune are the developers of anifrolumab, one of the better-known type 1 interferon drugs and the particular medication in this study. TULIP 2 is the second such study. On August 29, 2019, AstraZeneca announced that the study had succeeded in meeting its endpoint – the goal for it to be considered a success.
What is the TULIP 2 Trial?
TULIP stands for “Treatment of Uncontrolled Lupus via the Interferon Pathway.” It was the second of the two scheduled phase III trials for anifrolumab. TULIP 2 was designed after assessing the strengths and shortcomings of the TULIP 1 trial. Based on data from the earlier studies, the researchers made updates to the trial design to better understand the potential benefits of the treatment.
373 people participated in the study and were randomized into groups. TULIP 2 had fewer participant groups than TULIP 1, and only used a single treatment group. It also used a different measurement, BICLA, as the primary endpoint.
Group 1
300 mg anifrolumab
Given every 4 weeks
Group 2
Placebo
Given every 4 weeks
Looking Deeper at TULIP 2
The use of different endpoints is not uncommon in lupus research. The tools for measuring lupus disease activity are not identical and can reflect different benefits.
TULIP 2 used the BICLA, or British Isles Lupus Assessment Group based Composite Lupus Assessment. BICLA requires partial recovery in all organs and no new flares for a treatment to be considered a success. This disease activity measure is well-regarded and linked to good results.
Phase III clinical trials take years to complete and are a crucial part of the drug development process. Earlier phases assess the safety of products; phase III studies have to show clinically significant improvements to pass. This data is then submitted to the FDA for evaluation and approval before a new drug can be sold in the United States.
For more information on the clinical trial process, click here.
Mene Pangalos, the Executive Vice President, BioPharmaceuticals R&D as AstraZeneca said, "Only one new treatment has been approved [for lupus] in the last 60 years. These are important results and we will now review the full data set and explore pathways to bring this potential new treatment to patients."
What Happened with TULIP 1?
TULIP 1 was also a phase III trial that did not reach its primary endpoint. You can read more about the study here.
460 adult patients with clinically diagnosed SLE participated in the study. The participants were randomized into three groups and given treatments on a 4-week cycle as follows:
Group 1
Fixed-dose intravenous infusion
150mg of anifrolumab
Group 2
300mg of anifrolumab
Group 3
Placebo
The primary endpoint for the TULIP 1 study was a “statistically significant decrease in disease activity” for the patients in the study, as measured by the SLE Responder Index 4, or the SRI4. This measurement is a measure of how well lupus symptoms respond to a treatment.
SRI4 combines SLEDAI scores, blood tests, and reported severity of symptoms to evaluate disease activity. It is associated with good results in moderate to severe SLE. Symptom improvement is measured as “Full improvement” in most of the organ systems affected by SLE. SRI4 is considered to be a good measure of disease activity.