C-reactive protein (CRP)

Accidental Fear or Valid reporting? Risk of New IBD Rises for Patients Treated With Etanercept

The Center for Biosimilars today published an article that concluded that there is a fearful risk of being diagnosed with IBD Crohn’s or Colitis for those currently being treated with Etanercept.

Respectfully, I believe this study is incomplete and does not tell the full story. Though I don’t currently have access to the full study, just the Wiley Online Library Summary and the Center for Biosimilars article, until Lifestyle and Diet are factored into these studies I believe they do not tell the complete story. 20 years of clinical and cost outcomes from Integrative Medicine* have demonstrated the following results:

60% Decrease in hospital admissions
59% Reduction in hospital days
62% Savings in Outpatient surgeries and procedures
85% Reduction in Pharmaceutical costs
*Data provided by Patient-centered integrative medicine Independent Practice Association (IPA) per Advanced Medicine Integration Group, L.P. (AMI)

With the efficacy of leverage of using Integrative Medicine Lifestyle and Dietary changes, and the rise of it’s usage I believe a study like this is incomplete and may be unintentionally promoting accidental fear. What do you think?

Combined with the recent news that the United States Congress is grappling with tainted Chinese drugs, baffled by lack of FDA oversight in the U.S. pharmaceutical supply chain*. Remember when lead paint in children’s toys were a problem? That’s nothing compared to my concern to FDA Approved drugs potentially containing unwanted excipients.

As shown by the patients I interviewed during the Crohn’s And Colitis Summit who believe they are now cured of IBD Crohn’s and Colitis it’s becoming increasingly apparent for all of us to pay attention to our Physical, Mental, Emotional and Spiritual healing and growth.

Etanercept is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor by acting as a TNF inhibitor. It has U.S. F.D.A. approval to treat rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

They state that while anti-tumor necrosis factor (anti-TNF) drugs are effective at treating a range of inflammatory diseases, some limited data suggest that they may, paradoxically, result in a higher risk of developing other de novo inflammatory conditions.

It’s worth mentioning that anti-TNF drugs are not the only drugs available to those with inflammatory diseases. Recently the United States FDA approved Stelara for ulcerative colitis. It’s also important to note that there are different inflammatory markers in the body. TNFa is only one of those markers. When my TNFa was low, I failed Remicade. Though this was the recommendation of my then specialist Doctors, it seemed apparent to me that I would fail Remicade, and subsequently, I did. This resulted in a horrific QOL(Quality of Life) and a very small regretful view of the world and shitty symptoms. In hindsight, I should never have tried Remicade knowing that my TNFa was within the normal range. If you are wondering what your inflammatory markers look like I recommend ordering a test from this page: IBD Crohn’s Colitis test you can order from home.

Recently, Danish researchers sought to assess whether there is a link between anti-TNF therapy and the development of inflammatory bowel disease (IBD).¹ Using nationwide Danish registries, the group examined data for all patients with rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, pemphigus, alopecia areata, and vitiligo who were enrolled between 1994 and 2017. Anti-TNF agents were introduced in Denmark in 2004, and there were 17,018 individuals who had been exposed to anti-TNF drugs and 63,308 who had not been exposed.

Overall, 7344 patients were treated with infliximab, 9072 were treated with etanercept, and 8355 were treated with adalimumab. Fewer patients were treated with golimumab (n = 1973) or certolizumab pegol (n = 2503). Overall, 34.1% of patients were exposed to 2 anti-TNF drugs, and 16.7% were exposed to 3 or more.

The researchers found that patients treated with etanercept had a significant increase in the risk of developing new Crohn disease (CD), with an adjusted hazard ratio (HR) of 2.0 (95% CI, 0.8-2.2). The adjusted HRs for developing CD were 1.3 (95% CI, 0.8-2.22) for infliximab and 1.2 (95% CI, 0.8-1.8) for adalimumab. There was no statistically significant increased risk for new CD with golimumab or certolizumab pegol.

Additionally, patients treated with etanercept had a significant increase in the risk for developing new ulcerative colitis (UC), with an adjusted HR of 2.0 (95% CI, 1.5-2.8). The adjusted HRs for developing new UC were 1.0 (95% CI, 0.6-1.6) for infliximab and 0.6 (95% CI, 0.3-1.0) for adalimumab. Again, there was no statistically significant increased risk for new UC with golimumab or certolizumab pegol.

According to the authors, “This study firmly establishes the risk of developing de novo IBD while on anti‐TNFα agents, particularly with etanercept.”

In a letter linked to the publication, a separate group of authors from the centers in China noted that a different TNF binding pattern may be responsible for the increased risk of new IBD with etanercept versus other anti-TNFs.²

Etanercept binds to 2 of 3 sites of the TNF molecule, while infliximab binds to all 3, they explain. Additionally, unlike infliximab or adalimumab, etanercept does not bind to peripheral blood cells and lamina propria mononuclear cells derived from patients with IBD. Infliximab and etanercept also have different effects on cytokine production of T lymphocytes, “possibly inducing IBD in genetically predisposed patients,” say the authors, adding that more research into IBD-triggering pathways is warranted.

Lessons Learned:

If you’re unsure which pro-inflammatory 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.

Any purchase from the lab test companies on that page, or the below links will allow the One Great Gut Foundation to get closer to meeting our initiatives which help you Thrive with IBD Crohn’s and Colitis. So you can invest in your health and build a healthier world through our initiatives, at the same time. Thrive Physically, Mentally, Emotionally and Spiritually.

Monitoring your health. The Crohn’s Disease Activity Index (CDAI) and the 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 meeting our initiatives which help you Thrive with IBD Crohn’s and Colitis. So you can invest in your health and build a healthier world through our initiatives, at the same time. Thrive Physically, Mentally, Emotionally and Spiritually.

References
1. Korzenik J, Larsen MD, Nielsen J, Kjeldsen J, Norgard BM. Increased risk of developing Crohn’s disease or ulcerative colitis in 17,018 patients while under treatment with anti‐TNFα agents, particularly etanercept, for autoimmune diseases other than inflammatory bowel disease. Aliment Pharmacol Ther. 2019;50(3):289-294. doi: 10.1111/apt.15370.

2. Dai C, Jian M, Sun MJ. Letter: increased risk of developing Crohn’s disease or ulcerative colitis in 17 018 patients while under treatment with anti‐TNFα agents, particularly etanercept, for autoimmune diseases other than IBD. Aliment Pharmacol Ther. 2019;50(7):834-835. doi: 10.1111/apt.15460.

3. AP&T – Alimentary Pharmacology and Therapeutics – Increased risk of developing Crohn’s disease or ulcerative colitis in 17 018 patients while under treatment with anti‐TNFα agents, particularly etanercept, for autoimmune diseases other than inflammatory bowel disease – Joshua Korzenik Michael Due Larsen Jan Nielsen Jens Kjeldsen Bente Mertz Nørgård First published: 02 July 2019 https://doi.org/10.1111/apt.15370 The Handling Editor for the article was Professor Richard Gearry, and it was accepted for publication after full peer‐review. Funding information: University of Odense Hospital Free Research Foundation.

* Newsweek October 2019 Congress grappling with tainted Chinese Drugs, is baffled by lack of FDA oversight in U.S. Pharmaceutical supply chain by Blake Dodge
https://www.newsweek.com/congress-spooked-tainted-chinese-drugs-eyeing-pharmaceutical-supply-chain-1468753?fbclid

* Newsweek December 2019 U.S. DRUG PRICES TO RISE IN 2020 AS COMPANIES PREPARE TO CHARGE MORE FOR IBRANCE, XELJANZ, 200 OTHERS by Jeffrey Martin
https://www.newsweek.com/us-drug-prices-rise-2020-companies-prepare-charge-more-ibrance-xeljanz-200-others-1479939

US FDA approves Stelara for ulcerative colitis

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

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 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

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.

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