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US FDA approves Stelara for ulcerative colitis

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This past October, the U.S. Food and Drug Administration approved ustekinumab (Stelara by Janssen), a human IL-12 and IL-23 antagonist.

This is based on data from a phase 3 UNIFI trial, which demonstrated that ustekinumab induced and maintained clinical remission in a significantly greater proportion of adults with moderately to severely active UC compared with placebo.

Trial And Study Results

Janssen said at the time the UNIFI data was released that at Week 8, the trial data showed Stelara hit some of its major secondary endpoints, which includes the proportion of patients in clinical response, endoscopic healing, as well as health-related quality of life scores. In addition, Janssen said that at least 50 percent of study participants were considered biologically refractory, and 17 percent had a history of inadequate response or intolerance to any anti-TNF antibody and Takeda’s Entyvio (vedolizumab). It is unknown if diet and lifestyle were tracked in these studies.

Stelara, Janssen said, is the first and only approved biologic therapy for UC that targets the interleukin (IL)-12 and IL-23 cytokines. The IL-12 and IL-23 cytokines have been shown to play an important role in inflammatory and immune responses.

The UNIFI trial includes an initial induction study and was followed by a maintenance study eight weeks later where patients received subcutaneous injections of Stelara every 8 weeks for 44 weeks. In the Induction study, 19% of patients receiving Stelara achieved clinical remission in 8 weeks. Janssen also noted that Stelara provided rapid relief of symptoms as 58 percent of patients experienced a clinical response at Week 8. It is not known what diet or lifestyle factors were being implemented by the patients during the study

In the maintenance study, 45% of patients who received Stelara remained in remission after one year. Stelara also helped patients achieve clinical remission without the use of corticosteroids, the company noted. At the end of the first year, 43% of patients treated with Stelara were in clinical remission and not receiving steroids, Janssen said. At the risk of sounding repetitive, it is not known what diet or lifestyle factors were being implemented by the patients during the study. Not the downplay the efficacy and results of these studies and trials, we know from both the Crohn’s And Colitis Summit and One Great Gut Collection that Diet and Lifestyle alone can induce long term remission, deep mucosal healing sometimes confirmed by visual examination via Colononsocopy per the patient request, sometimes simply confirmed by a high Quality of Life, Thriving lifestyle, and lack of debilitating symptoms

In addition to the latest approval from the FDA, Stelara has been approved as a treatment for adults living with moderate to severe plaque psoriasis, adolescent patients with moderate to severe plaque psoriasis, adults with active psoriatic arthritis and adults with moderately to severely active Crohn’s disease. The drug brings in about $4 billion in annual sales which shows the need for this drug in today’s current environment and the additional need for Dietary and Lifestyle guidance.

If you’re unsure which pro inflamantroy markers are high in your body, consider your options here: IBD Crohn’s Colitis test you can order from home. Doctor approval is direct from the companies listed, you do not need to obtain prior approval from your personal Doctor, which can lead to unwanted delays, or being denied to have the blood test you wish to see the results of for your body to make the most educated decision for your health.

Monitoring your health. The Crohn’s Disease Activity Index (CDAI) and  Simple Clinical Colitis Activity Index (SCCAI) are useful tools to consider using.  They access disease activity in Crohn’s and Ulcerative Colitis. For children, consider the Pediatric Crohn’s Disease Activity Index(PCDAI ) or Pediatric Ulcerative Colitis Activity Index (PUCAI).

Lab Tests to Consider

TH1 TH2 Cytokine Test – Basic
For those with a confirmed autoimmune condition, the Th1 Th2 test is possibly the most important test. The test points out imbalances in the immune system by looking at cytokines, proteins that the immune system relies on to communicate. Bad communication results in complications for those with autoimmune conditions. The information this test provides helps your doctor develop a strong and effective treatment plan for you, especially when seeking alternative medicine support.

The immune system works like a seesaw. On one side you have Th1 cytokines that initiate the first line of defense. On the other side, you have Th2 cytokines that help produce antibodies to protect you from future invasions. However, when one side goes up, the other side goes down. This can contribute to a weak immune system and potentially promote autoimmune issues. Running this test will help to understand where the imbalance is. Because certain botanicals used in natural medicine can boost Th1 cytokines and Th2 cytokines, this test can help you and your doctor develop an effective plan to help balance a weak immune system and turn the volume down on autoimmune attacks.

TH1 TH2 TH17 Cytokine Test – Advanced aka CytoDX
This test is more detailed than the above with readings including

  • Inflammatory Cytokines- Th1
    • INF Gamma: Th1
    • IL-1 beta: Th1
    • IL-2: Th1
    • IL-6: Th1 and Th2
    • IL-7: Weak Th1
    • IL-8: Weak Th1
    • IL-12 p70: Th1
    • IL-17A: Th17
    • IL-18: Weak Th1
    • TNF alpha- Th1
  • Anti-Inflammatory Cytokines- Th2
    • IL-4: Th2
    • IL-5: Th2
    • IL-10: T-regulatory cells
    • IL-13: Th2
    • IL-15: Weak Th2

TH17 Test
New studies show that an increase in a particular type of white blood cell, called Th17 cells, can trigger and determine the severity of autoimmune conditions. Monitoring Th17 levels can help you and your doctor better treat the condition.

Basic CD4 CD8 Ratio Test
The CD4 CD8 ratio profile helps assess the immune system in detail. This test is crucial for patients who are suspected of having a compromised immune system as seen in autoimmune conditions and HIV.

Any purchase from the lab test companies above using the above links will allow the One Great Gut Foundation to get closer to curing IBD Crohn’s and Colitis. So you can invest in your health and build a healthier world through our initiatives, at the same time.

Stelara Efficacy and Frequency

Many of us are already familiar with the efficacy and safety of ustekinumab in Crohn’s disease given that it has been commercially available for more than 3 years now,” Edward V. Loftus Jr., MD, Chief Medical Editor of Healio Gastroenterology and Liver Disease, said in an interview. The approval was based on the UNIFI induction and maintenance trials, which was published late last month in The New England Journal of Medicine. Along with the usual endpoints, ustekinumab was found to be significantly more effective than a placebo at inducing and maintaining a combined endpoint of both endoscopic and histologic improvement.”

The first dose of ustekinumab will be administered intravenously in a health care facility. After that, the remaining doses will be given subcutaneously 8 weeks after the first dose and then every 8 weeks thereafter. Sometimes varying frequencies outside of the 8-week window is needed. I know of patients who are approved to take ustekinumab every 6 or 7 weeks to manage their symptoms.

Lifestyle and Diet

In many patients, diet and lifestyle changes have increased the success of ustekinumab and decreased unwanted side effects. To learn about the most effective dietary and lifestyle techniques that worked for other’s who found full remission, some claiming they are cured, with evidence-backed by Colonoscopy which showed no sign of IBD, ever. As a matter of fact the Gastroentrolgist stated that if the patient had not let him know that they previously had a challenging case of Crohn’s or Colitis, they would never have known. ref: Crohn’s And Colitis Summit and One Great Gut Collection

Remember, what works for one may not work for another. I recommend that you allow Science to be your map, and intuition to be your compass. We’ve noticed that healing is accelerated when the patient heals themselves not just Physically, but also Emotionally, Mentally and Spiritually.  As a matter of fact I’ve interviewed some who claim to be cured, simply by doing the work mentally(Paul), or spiritually(Joshua).

Look, You didn’t get into this alone, and you aren’t getting out of it that way, either. Join this community and your poops will soon shine. Friends don’t let friends suffer alone.

I’ve been Thriving with IBD since 2019

Are you looking for more information on how you too can Thrive with IBD? Join our email list(No Spam, No nonsense, no longer daily, just useful updates) and follow us on Instagram(@onegreatgut) Twitter and Facebook. I’m also on TikTok and Snapchat but don’t post there often and have no idea what I’m doing there except enjoying the creativity of the next generation. Does anyone want to help me out there?

Do you find these articles hgelpful?  Please donate today so we may continue this service so humanity may prosper in a peaceful world with a peaceful microbiome

Note: Originally published in December 2019, this article has been revised and updated for accuracy and thoroughness.

Healio Gastroenterology and Liver Disease
Biospace – Janssen’s Stelara Wins FDA Approval for Ulcerative Colitis




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