Would you take this drug?

[nofun]

I have a decision to make. Most people just follow their doctor's recommendation, but I like to actually read the drug information before making a decision.

I will not mention the drug name so we can concentrate on the numbers:

Percentage of patients in clinical remission after one year:

Placebo: 36%
Taking the drug: 53%

Serious adverse events & infections after one year:

Placebo: 17.4%
Taking the drug: 17.9%

Lets ignore the cost of the drug as I will most likely get it paid by insurance.

The drug seems to be safe with the reported adverse events being almost the same as in the placebo group. But the efficacy? Only 17% better than the control group taking placebo. Is it worth the trouble, going for injections, risking adverse reactions only for the 17% chance of improvement?

 

[Adam1971]

Did your doctor explain the rationale for choosing this drug over others? Can you talk with your doctor about your concerns about efficacy? You are well within your rights as a patient to ask these questions and receive honest and informative answers. Just my opinion.

 

[emmaaaargh]

Unfortunately a lot of IBD drugs have similar remission rates! None of them are a certainty to work for anyone, and most are no better at effectiveness than this one. It's not the best of odds, but when you're desperate to fix a flare that's all but destroyed your guts, you'll go for the drug. Especially if you've been in the 47%, and other drugs haven't worked.

 

[nofun]

This question is about STELARA and I took the data directly from their website.

Can you talk with your doctor about your concerns about efficacy?

The doctor dismissed my concerns saying that the clinical studies are usually done on patients with worse than average condition. I am not sure this is true. I actually have heard about the opposite. Anyway, he works with what is available.

I am surprised that drugs less than 20% better than placebo are approved and marketed as a solution. I understand there is nothing else available, but this is not good.

More on the philosophical side, if you had similar ratio of success in other areas of life, would you bother? Would you start a school knowing that you have 17% chance of graduating? or a business?

 

[emmaaaargh]

Where did you hear that clinical trials are conducted on healthier patients? From my experience, that tends not to be true, unless a patient specifically requests to join a trial. I myself have only started to have clinical trials mentioned to me as I have approached the end of the list of medication currently available, which is incredibly depressing. In either case, the study you are referring to was carried out in patients who had tried conventional therapy and had it fail them - so it's incredibly likely they did have aggressive disease. Furthermore, the difference between the adverse effect rates in both groups is statistically insignificant - in other words, it's essentially the same. I would call that an incredibly good safety profile.

Attaching the same percentage to other areas of life isn't really a good comparison, because dealing with medicine is quite literally a dice roll, unlike things like attending university or starting a business. You can influence factors affecting your success in those areas, but you can't in medicine. We aren't far enough in the field of personalised medicine yet to be able to tailor drugs to each individual exactly, so unfortunately prescribing for chronic conditions tends to rely on a lot of "try X and see if it works, if not, we'll try Y". It does suck that we have nothing with a better response rate, yes. But that doesn't mean we shouldn't take the drug. As I mentioned before, people can and do die from this disease. When you're nearing that cliff face, you'd probably (certainly I would, and have) grab at any rope you can that might pull you back from it.

 

[nofun]

Where did you hear that clinical trials are conducted on healthier patients?

I was referring to bias in clinical studies related to the funding sources. Most studies are funded by pharmaceutical companies with huge financial stakes in having a positive result. I have no idea if this played a role in the STELARA studies. It was just a thought when I have heard my doctor arguing the opposite.

Industry-funded clinical trials and cost-effectiveness analyses, for instance, yield positive results far more often than studies that are funded or conducted by other entities.15-18 This may reflect bias caused by enrollment of relatively healthy patients, insufficient selection or dosage of comparator drug, inadequate sample size, or inappropriate length of patient follow-up.

https://jamanetwork.com/journals/jama/fullarticle/196846

 

[aypues]

Is this your first biologic? Remicade is the gold standard and is 1st line biologic therapy for most patients.

 

[my little penguin]

Study or no study
Stelara isn’t used as a first line drug for the large majority of ibd patients
A patient typically has to fail multiple cheaper drugs and biologics first before they are permitted to try Stelara or entyvio

would I let Ds take the drug
The simple answer for my kiddo is yes
He was dx at age 7 which means a disease burden for 70-80 years
He was on remicade - allergic reaction
Humira for over five years work great till it stopped
And now Stelara for 2.5 years so far
Despite the low success rates in trials
Humira gave Ds pink healthy intestines no signs or f disease
And Stelara so far a non detectable fecal cal with normal bloodwork etc...
So for him it works great

The important thing is does the drug work for you with the least amount of side effects

also keep in mind that at least drug companies are sponsoring studies for new drug development for crohns
Rare diseases that have few patients have NO drug studies - docs must do off label prescribing as a single patient case study and hope for the best

 

[nofun]

Is this your first biologic?

Yes it would be my first one. Penguin is right that Stelara is usually not the first drug prescribed. My doctor went around it by asking me to fill up a prescription for Imuran, and just report side effects without actually taking it. I am still on the fence regarding Stelara. My condition is bad, but I manage. Some days are worse, some days are better.

As for Remicade, I quickly looked at their website:

REMISSION
Nearly 4 out of 10 patients achieved remission with REMICADE® at Week 30 compared with nearly 3 out of 10 patients not given REMICADE®.

I don't know, but it just looks like the drugs that are available are not very good. I know there is nothing better, but I just can't convince myself to take it knowing the odds. There are also lots of people reporting that most biologics only work for the first few years, and then the symptoms return.

 

[my little penguin]

Ask your doc BRAND
B enefits - what are the benefits for your situation?
R isks ?
A lernatives ?
N othing - what happens if you do nothing
This is huge - small bowel affected could mean surgery or short bowel syndrome , obstruction fistulas etc.... what does your doc see happening if you do nothing - not symptoms on the outside but based

D ecision - then you decide.

We don’t decide to take drugs because the odds are good or even great
The drugs are taken to stop the inflammation cycle
Inflammation that is not controlled can cause devastating problems
Controlling it for years can save a lot

prior to these drugs 20 years ago or so
Your only option was prednisone
Which has its only issues

 

[aypues]

Stelara is not a good first choice at all. Just based on this I would move doctors to an IBD specialist.
regarding efficacy, yes, they are not high...but better than steroids And way less harmful!
what is your resistance? I don’t understand why you are only highlighting the negative. What is the real issue?

 

[Scipio]

Yes it would be my first one. Penguin is right that Stelara is usually not the first drug prescribed. My doctor went around it by asking me to fill up a prescription for Imuran, and just report side effects without actually taking it. I am still on the fence regarding Stelara. My condition is bad, but I manage. Some days are worse, some days are better.

I don't know, but it just looks like the drugs that are available are not very good. I know there is nothing better, but I just can't convince myself to take it knowing the odds. There are also lots of people reporting that most biologics only work for the first few years, and then the symptoms return.

If your condition is "bad" you need to be doing something. Simply "managing" will not be good enough in the long run.

As I've said before, the biggest threat to the health of Crohn's patients is not side effects of the drugs. By far the biggest threat to our health is uncontrolled or poorly controlled Crohn's disease.

Stelara was not the first Crohn's drug I took; budesonide was. But it was the first and so far only biologic I've taken. And after more than 2 years, it's still working well for me. IBD docs are increasingly starting patients on Stelara as the first biologic, since it has a lower rate of inducing drug-inactivating antibodies and a lower rate of side effects compared to the older anti-TNF drugs such as Remicade and Humira. That's what it looks like your doc wants to do. Try Stelara first.

My advice is to either take the Stelara or don't, but please take something - a real Crohn's drug. If you continue with "managing" active Crohn's disease with no real treatment, you will almost certainly come to regret it.

 

[Delta_hippo]

When you say 17% chance of improvement, it depends what the consequences of do nothing are. For me, do nothing means rapidly very ill and back in hospital for more surgery or worst case death. So I look at it as how do I reduce risk of that happening and hope that the little percentages I get from biologics, diet changes, vitamin d, working less all add up to reduce the risk of that happening. But for others Crohn’s is not so aggressive and the do nothing scenario not so deadly. I would caution that symptoms don’t necessarily reflect internal damage so if you don’t take the drugs then proceed with extreme caution in monitoring progress. There are many on here who thought all was well and end up in hospital having diseased intestines cut out and that is not fun.