TULIP 2 Phase III and Type 1 Interferon Lupus Treatments - LupusCorner (2024)

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 hadsucceeded in meeting its endpoint – the goal for it to be considered a success.

TULIP 2 Phase III and Type 1 Interferon Lupus Treatments - LupusCorner (1)

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 1300 mg anifrolumab
Given every 4 weeks
Group 2Placebo
Given every 4 weeks
TULIP 2 Phase III and Type 1 Interferon Lupus Treatments - LupusCorner (2)

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.”

TULIP 2 Phase III and Type 1 Interferon Lupus Treatments - LupusCorner (3)

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 1Fixed-dose intravenous infusion
150mg of anifrolumab
Group 2300mg of anifrolumab
Group 3Placebo

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 (20)
  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.

    Reply

  2. This new drug sounds interesting; however, will it work on Lupus patients that have Lupus Nephritis?

    Reply

    1. Hi Edie,
      Thanks for reading and being part of the LupusCorner community! According the AstraZeneca press release there is also a Phase II trial on anifrolumab for lupus nephritis in the TULIP program. We will share those results when they are available
      -Brett

      1. Please let us know my daughter has lupus nephritis also

        Reply

        1. I also have SLE with lupus nephritis. Please let me know.

          Reply

    2. Good question Eddie. That’s what I was wanting to know as well.

      Reply

  3. 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

    Reply

    1. Would it be possible to switch to weekly subcutaneous injections?

      Reply

  4. Will organs need to be affected to use treatment?

    Reply

  5. Interested

    Reply

  6. 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

    Reply

  7. Will this help with hemolytic anemia ?

    Reply

  8. 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

    Reply

  9. 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?

    Reply

  10. I also have SLE with lupus nephritis. Please let me know.

    Reply

  11. 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.

    Reply

  12. 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

    Reply

  13. 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.

    Reply

  14. 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!

    Reply

  15. What potentially will the criteria be to use this drug?

    Reply

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TULIP 2 Phase III and Type 1 Interferon Lupus Treatments - LupusCorner (2024)

FAQs

What is the most serious type of lupus? ›

What are the different types of lupus? There are several different types of lupus: Systemic lupus erythematosus (SLE) is the most common and most serious type of lupus. SLE affects all parts of the body.

What organ does lupus affect first? ›

Certain cells and processes of the immune system have been identified as playing a role in lupus. Kidneys About one half of people with lupus experience kidney involvement, and the kidney has become the most extensively studied organ affected by lupus.

How long can you have lupus without knowing? ›

Lupus is known as "the great imitator" because its symptoms mimic many other illnesses. Lupus symptoms can also be unclear, can come and go, and can change. On average, it takes nearly six years for people with lupus to be diagnosed, from the time they first notice their lupus symptoms.

What foods make lupus worse? ›

Foods that seem to trigger a flare vary greatly from person to person. So a food that causes problems for one person may have no effect on you. Some foods that have been said to make lupus worse include nightshade vegetables, and animal protein. Nightshade vegetables include potatoes, tomatoes, eggplant, and peppers.

What is the life expectancy of a person with lupus? ›

Early diagnosis, careful treatment, and constant monitoring may help 85–90% of people with lupus live a typical lifespan. According to a 2021 review , almost all global studies that included participants who started after 1990 report a 90% 10-year survival rate.

Is Coffee bad for lupus? ›

Researchers of one study found that those with lupus who had a daily caffeine intake between 154 mg – 377 mg/day experienced a lower prevalence of “lupus nephritis, neuropsychiatric involvement, hematological manifestations, hypocomplementemia, and anti-DNA positivity.” These individuals also had lower blood levels of ...

What should lupus patients avoid? ›

5 Things to Avoid if You Have Lupus
  • (1) Sunlight. People with lupus should avoid the sun, since sunlight can cause rashes and flares. ...
  • (2) Bactrim and Septra (sulfamethoxazole and trimethoprim) Bactrim and Septra are antibiotics that contain sulfamethoxazole and trimethoprim. ...
  • (3) Garlic. ...
  • (4) Alfalfa Sprouts. ...
  • (5) Echinacea.

What does lupus do to your face? ›

Thick, scaly patch of skin (discoid lupus)

People who have discoid lupus develop these patches. Most patches appear on the face, scalp, or ears, but patches can develop elsewhere on the skin. Without prompt treatment, these patches tend to stay on the skin for a long time — sometimes for years.

What disease is often misdiagnosed as lupus? ›

Sjogren's syndrome, another autoimmune disease, can often be mistaken for lupus. It primarily causes dry eyes and dry mouth but can also cause fatigue and joint pain similar to lupus.

What is a common misdiagnosis of lupus? ›

As a result, people with lupus are frequently misdiagnosed with rheumatoid arthritis, fibromyalgia, chronic fatigue, skin disorders, psychological disorders such as anxiety and depression or receive no answers at all.

What is the hardest autoimmune disease to diagnose? ›

Some common autoimmune diseases, including Type 1 diabetes mellitus, are relatively easy to diagnose, while others, such as vasculitis, Addison's disease, lupus, and other rheumatic diseases, are more difficult.

What is stage 5 lupus? ›

Class 5, or membranous lupus nephritis

This classification involves thickening and scarring of the important structures within the kidney. A person will have high levels of blood, protein, or both in their urine as well as high blood pressure. They may also require dialysis or a kidney transplant.

Does lupus make you pee a lot? ›

Between 30-50% of those diagnosed with SLE develop kidney disease or lupus nephritis. Symptoms and signs of lupus nephritis can include swelling or puffiness of the feet, legs and eyes; high protein levels in the urine; frothy or frequent urination; blood in the urine; and high blood pressure.

What are three triggers of lupus? ›

Common triggers include:
  • Overwork and not enough rest.
  • Being out in the sun or having close exposure to fluorescent or halogen light.
  • Infection.
  • Injury.
  • Stopping your lupus medicines.
  • Other types of medicines.

What are the top 5 worst autoimmune diseases? ›

There are some worst autoimmune disease conditions that may affect life expectancy.
  • Autoimmune myocarditis.
  • Multiple sclerosis.
  • Lupus.
  • Type 1 diabetes.
  • Vasculitis.
  • Myasthenia gravis.
  • Rheumatoid arthritis.
  • Psoriasis.
Mar 30, 2023

Is lupus a terminally ill disease? ›

In most cases, lupus is not fatal. In fact, 80% to 90% of people who have this autoimmune disease will likely live a normal life span. Still, some people do die from the disease, in which your immune system attacks your body's organs and tissues.

Is lupus considered a severe disability? ›

How much it will impact your life will depend on the severity, which can range from mild to severe. Lupus is also a hidden disability in many ways as often the symptoms are not obvious. Extreme Fatigue / tiredness.

Is lupus worse than rheumatoid? ›

Lupus and rheumatoid arthritis (RA) are both chronic autoimmune disorders that can have significant impacts on a person's health and quality of life. However, it is difficult to say which one is worse as they affect people differently and have different symptoms.

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