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Medications

TULIP 2 Phase III and Type 1 Interferon Lupus Treatments

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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.

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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
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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.”

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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.

 

Comments (19)

19 thoughts on “TULIP 2 Phase III and Type 1 Interferon Lupus Treatments

  1. I am doing well on Benlysta infusions every four weeks, but it will be wonderful to have another drug option that works a little differently in the body. I do worry about my increased susceptibility to infection with Benlysta.

  2. I’m on Benlysta infusion every four weeks, they do help, but it is like it doesn’t stay long in my system, I don’t like the fact that the week before I’m due to have my infusion, my body works against me hands, feet swell up every-joint aches, my body starts cramping that’s the only way I can explain it. I’m so fatigued hurting will this help

  3. I am 30 I was on Plaquenil everyday for 10 months. I went into the hospital cuz I thought maybe I had a kidney infection and found out I was in late-stage liver failure. After over two weeks being in the hospital my liver kept getting worse and the only thing they could say it was from was from the plaquenil. Without it I can’t take care of my kids or four and six. I get flare-ups constantly and I don’t have control of my mind anymore. But now I’ll go to worried about my liver to treat the lupus

  4. Won’t these medications be very limited when released to the public? And how will the average person ever be able to even afford them. I have SLE and would love a shot, but thinking about how much this will cost literally breaks my heart

  5. I have lupus that attacks mainly my nervous system, I tried Benlysta for 3+ yrs at 1st it made me feel better but I had to stop taking it. Was making me not think straight and I was not acting like myself. Would this drug work for people who have nervous system Lupus?

  6. I have been diagnosed with SLE and Lupus Nephritis and have already had chemo which was not effective. Please let me know if this would work for my diagnosis. Thank you.

  7. I also was on Benlysta infusions for over 3+ years, I tried the auto injector and had a severe allergic reaction to it. I can say that although I was always very sensitive to benlysta, and had to stop the infusions because I started not feeling like myself. Was doing crazy things, not like myself..I am now feeling pretty good. But having been diagnosed over 18 years ago, who knows how long this will last? I am interested in anything else that could help with nervous system lupus

  8. When will this be available? i was on Benlysta for 5 years, but developed cavitary pneumonia and cannot restart due to the risk for reinfection.

  9. I tried Benlysta, Rituxan and the host of other “standard” therapies for SLE, but none offered any benefit or improvement. Some actually complicated my situation with adverse reactions. This mechanism of action is intriguing. I’ve been of all therapies for 5 miserable years…so I’m glad to come across this information!

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