My Take On Biologics

I have had another article published on inflammatoryboweldisease.net about taking a biologic with Crohn's. 

Come read it here:

My Take On Biologics

Visit inflammatoryboweldisease.net for more articles regarding IBD. 

Are Clinical Trials Necessary? *Updated Repost*

The simple answer?  Yes.

First of all, what ARE "clinical trials" anyway? Again, simply put, is where people volunteer for tests to help researchers investigate new treatments for a wide variety of diseases or medical conditions.
They could be looking for how people respond to a new drug or maybe the side effects.
It also could be they are comparing existing drugs to new factors in a patient's life. Clinical trials cover a wide variety of situations from new drugs or vaccines, or maybe surgical or even behavioral changes.

The World Health Organization (WHO) defines a clinical trial as:

‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’ 

Think of where we would be without clinical trials. Without the volunteers. Animals, labs and computer simulations can only go so far. Nothing compares to testing with the human body itself. Imagine diseases or conditions like, heart disease, cancer, Alzheimer's, Parkinson's, Crohn's/colitis and now Covid-19 WITHOUT those clinical trials. More people are alive today, or living better lives, not only because of those scientists and researchers working hard behind the scenes to bring new treatments forward, but also those volunteering for clinical trials.

Let's take me for example. I was on Remicade (800 mg) every 6 weeks. Recommended dosage is 5 mg/kg, meaning 5 milligrams of Remicade for every kilogram of the patient's weight. So I was at about 10 mg/kg because I had an ongoing problem with fistulating perianal disease. My body eventually developed antibodies to the medication and was taken off it after 8 years.  I was put on Humira for two years until a forced Government non-medical switch to the Humira biosimilar.

I remember back in early 2000/2001, my gastroenterologist telling me about Remicade and asking if I wanted to be part of possible clinical trials. After discussing it in length about it, I declined. My Crohn's at the time was 'manageable' and to be honest, I was scared, even though my doctor said that from what she'd heard and read, the drug looked promising. I was worried about possible side effects, but that was more than 20 years ago.

In hindsight, I wish I had taken her advice and done it. I eventually made the decision to get the Remicade infusions many years later. I was on Remicade for 8 years and it was a "godsend", for me. I regret my decision so many years ago. I could have been part of the initial study and had the benefits from it earlier.

Researchers and scientists are constantly trying to improve life for crohn's/colitis sufferers. Whether that be by improving on current treatments or coming up with new ones. Clinical trials are happening all the time. Your doctor would know of any current trials going on or coming up but also search your country's Crohn's and colitis foundations. Many will have links on their websites to pre-screening. You might get declined, but it just means you don't meet their criteria, don't let this discourage you. I've been declined numerous times for various reasons.

The more patients who are willing to participate in clinical trials, the better the research

IBD Global Network

I had my first Zoom meeting with the IBD Global Patient and HCP Network today.  The first of many meetings over the next year with other patient advocates and health care professionals to discuss the relevance and need for clinical trials when it comes to IBD. More importantly, how to improve the clinical trial process from how to get patients to sign up to helping the healthcare professionals doing the trials with better resources, research, etc.

I have always been an advocate for the clinical trial process because without them, we may not have the amazing IBD drugs we have now.

I had the chance to be part of the Remicade trials in Canada more than 20 years ago but turned it down. I only wish I had agreed to take part back then. Remicade was amazing for me when I finally decided to go on it in 2012 until my body developed antibodies to it just 8 years later. I still think about those who were part of the clinical trials that ended up helping me with my Crohn's and I thank them for it.

There are many places to look for IBD clinical trials, here are a few:

Crohns and Colitis Canada

CISCRP

Crohns and Colitis Foundation (USA)

Crohns and Colitis UK

Clinical Trials (worldwide)

Sure, you might be in the placebo group but I think that IF there is a chance for a better life with a new medication, it's worth a try. I have tried to get into several clinical trials over the years but my main problem with not being accepted is that I have had bowel resections, too many for that matter, and do not qualify.

...but you might.

 

The Perspective of a Crohn's "Veteran"

I have had another article published on inflammatoryboweldisease.net about being a Crohn's veteran with 34 years "experience".

Come read it here:

The Perspective of a Crohn's "Veteran"

Visit inflammatoryboweldisease.net for more articles regarding IBD.

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COVID 19 3rd Dose Booster

Crohn's and Colitis Canada has recommended that people who have IBD on medications that suppress the immune system be included with other immunocompromised people getting the 3rd booster shot in the fight against COVID 19.  See here:

COVID 19 BOOSTER

As does the Crohns Colitis Foundation:

COVID 19 BOOSTER

And Crohns and Colitis UK:

COVID 19 BOOSTER

Please contact your local governments to push adding immunosuppressed IBD patients to their 3rd dose lists.  With the Delta variant becoming more and more prevalent, and with the millions of people NOT vaccinated (for whatever reason) the risk of catching COVID is still there.

Hadlima (adalimumab)

Today was my first injection of Hadlima, the biosimilar to Humira.

The injection pen was easy but it hurt more than the Humira. Only lasted a few seconds, but it definitely let me know it was there that's for sure.  It's only been an hour and so far so good.  Not that I'm expecting anything to go wrong.

I'm still not happy with the government forced-switching from a biologic to a biosimilar, but I have no choice and have to make the best of it.

Let's see where this goes shall we.

To Bag Or Not To Bag

That is the question.

It may come one day.  The decision to choose to have ostomy surgery.  Some might not have that decision as it may be an emergency.  When I had my first (of many) bowel resections starting in 1989, it was an emergency and my doctor and surgeon said to be prepared for the possibility of waking up with a pouch. In the end, it wasn't needed. Every resection I've had since there was always the chance of waking with the pouch attached.

Fast forward to around 10 years ago. My gastroenterologist strongly suggested I have ostomy surgery mainly because of my ongoing perianal disease. I had been doing "OK" with my Crohn's symptoms and frankly, I had gotten used to the perianal disease and how to "live" with it.  I had learned over the decades what to do and what not to do.  Sure it was a pain in the ass (literally), but the thought of yet another major surgery just wasn't what I wanted to do. I had just started Remicade and wanted to see how this new medication would work for me and fingers crossed, rid me of the abscesses, fistulas, and fissures.

8 years with the biologics Remicade and a year on Humira didn't seem to work for the perianal disease.  It worked wonders on my other Crohn's symptoms though. (Unfortunately, I am starting a biosimilar, Hadlima, tomorrow.)  A colonoscopy confirmed the fissures and stricturing about 6 inches inside. I made the decision to go through with the ostomy surgery along with the proctectomy with the hope to finally rid myself of the pain.  There is no guarantee of course because Crohn's is unpredictable, but after 33 years, maybe the pain will subside.

So, in September 2020 I had a temporary loop ostomy so the perianal disease can heal. It went well, but I was back in November 2020 with acute renal failure due to the amount of water I was losing. Two weeks later I had my permanent ostomy and proctectomy.  A month and a half in the hospital to maybe eliminate future hospital visits.

We are now 7 months post-op and I'm glad to have made the decision.  The only regret is I didn't make the decision sooner.  Oh sure, it's taking a long time to get used to having the pouch and I still am having some skin issues around it, and I am able to sit finally, but I wouldn't take it back. It's freeing in a way, not having to worry all the time about where a bathroom is.  There is no sudden rush anymore. The main problem right now is trying to keep hydrated in the current heatwave we are having. I am drinking about 5 liters a day, along with electrolyte drinks, and keeping out of the sun and heat. I still got dehydrated I think as I have shortness of breath, headaches, muscle cramps, fatigue, and nausea. Trial and error I guess.

So, to bag or not to bag? For me..... yes.

Hadlima Biosimilar

 I live in Canada and while my country is great for universal health care, the money from the Federal government is dispursed amongst the provinces and territories for their own needs.  

MY provincial government, the NDP of British Columbia, in their "wisdom" has decided to forcibly switch my medication for the sole reason of money.  No consideration to me as the patient.  A non-medical switch from my biosimilar, Humira (adalimumab), to a biosimilar, Hadlima. Crohns and Colitis Canada, doctors and practitioners have been advocating on behalf of patients since 2019, falling on deaf ears at the government level.  They did this a couple years back when I was on Remicade. Back in April, I wrote a letter to our provincial government, the Health Minister and the Premier, as well as news agencies, and the ONLY response I received was a note from a general entity within the government, with a link to biosimilars.  I don't need more information on biosimilars and biologics, I'm pretty sure I have done way more research on the meds than the government ever did.  I asked for proof that switching patients who are long-term users of biologics, to biosimilars has no side effects.  I also asked where were all these "savings" being directed to.  No surprise I received zero response.

I am not saying that biosimilars don't work, I see plenty of evidence they do.  That's not in question.  What I am asking those who are in charge, to prove to me that forcibly switching patients for nonmedical reasons, is better than leaving them on medications that are working for them.  The decision to switch should be between the patient and the doctor and not the government. 

I have had Crohns disease for 33 years and the past 10 of those have been on biologics.  The ONLY drug that has worked for me and believe me, I've tried many.  I understand using biosimilars, but it should be for patients who have not tried biologics and keep those who are on them, ON THEM.  When, and if, the biologic stops working for them, THEN switch to the biosimilar.  Not say, "too bad, we're switching you" end of story.

I guess we'll find out what happens to me after June 2 when I am supposed to start Hadlima.  Hopefully, it works and keeps my Crohn's at bay. 

No one ever said there were ethics in government. They are proving it now.

****UPDATE****  My Hadlima starts July and not June 2