Side Effects of Enbrel and Humira

So many people here say that they are afraid of the side effects of Enbrel and Humira. Let's get specific and talk about them. Both medicines have been on the market for a long time. Millions of people have used them. The incidence of side effects has been observed and the risks are well known.

Let's talk about them.

Report post

92 replies. Join the discussion

Thank you for posting that link. I found it before on the NPF website and I was alluding to it in my post. To me, that story is good news. If/when Enbrel runs it's course, we can take other meds.

I've heard from more than one doctor that you can increase your chances of keeping the medicine effective if you remain very regular in your dosing. I take mine on the same day each week and at the same time each day. I'm even leary of increasng my time between doses as my doctor says some patients have done. That's probably OK, except I don't think I'm organized enough to go on a 10 day schedule. Once a week is perfect for me.

FYI, once injected, Enbrel has a average half-life of 122 hours.

Report post

I have been on enbrel, humira and now stelera. I have had no side effects. Enbrel was not that effective for me. humira worked great for two years. Now stelera is outstanding. I have just received only my second shot and I am virtually cleared. Stelera surpresses only certain t cells not all of them like enbrel and humira. As such the risks from infection is reduced. I also take fish oils which are great, Lovasa.

Report post

Am pretty sure Humira has been @ for over 10 years - as I checked a lot online before I started taking it. I go to Mass Gnrl in Boston for 6 yrs now where they do a considerable amt of biologic testing and think I am getting the correct info from the nurses and other support people I talk to. - Beside the derms themselves. My experience with Humira has been mixed over 8+ months... no real symptoms to speak of but it started losing it's effectiveness after the 1st couple of months...so following a thread here (plus something my derm said) I experimented with diet.

It could be the Humira, or it could be the gluten free diet I am on but it's almost totally gone again. I do recognize we are guinea pigs in a way. How it will effect us in 20 years is not known...I do however see a better quality of life. Each person has to make that decision...I will say I have 'talked privately' with a biological engineer I met online who has ps. I asked him quite frankly if he would take the drug his company manufactured. His response was he hoped his disease never got to the point he had to make that decision.

Report post

By the way, I am a cancer survivor as I had testicular cancer in 1975 and a node dissection and two years of chemotherapy. I was stage 1 and today I would not have had all the surgery or chemotherapy, but 35 years ago and I thank the good Lord every day for life and great doctors. I also had TB as an infant. So biologics were a big decision for me. I spoke with all my doctors who have treated me for years. I wanted to try the biologic route and I am delighted I did. I am far better off and now the stelera. What is crazy is that today I received my extensive blood tests results checking me out as I just took my second shot of stelera. I have had high lipids and triglycerides for many many years. I have tried everything but taking statins as I was border line high in cholesterol as my good cholesterol was high which was a good thing. My triglycerides are my issue. Well my lipid profile improved dramatically and the only new thing for men in the last month is stelera !? And my psoraisis coverage went from 30% to less than 5%. I feel great.

Report post

I also had testicular cancer, about 17 years ago. That now makes two sports stars I've shared a disease with. I like biking, I don't think I'll take up golfing though.

Report post

What a great thread. All kinds of ideas and viewpoints!

There are roughly 2 million patients who have taken TNF antagonists:
Enbrel: > 500,000
Humira: > 500,000
Remicade: > 1,000,000

There are a wide variety of disease states that are indicated:
Rheumatoid Arthritis
Psoriatic Arthritis
Crohn's Disease
Ulcerative Colitis
Juvenile Idiopathic (Rheumatoid) Arthritis

Enbrel has approval for treating children with JIA down to Age 2
Humira is approved for children with JIA to age 4.
Remicade is approved for children with Crohn's Disease down to Age 8.

This class of therapy is not new. It is a seasoned, tried and tested group of medications with extensive experience in trials, in the market, in adults and in children. In general, the TNF antagonists are not for patients with limited disease (eg., elbows, knees). They are used in patients with widespread, difficult-to-treat skin. In many cases (at least in the US), you must have tried other systemic medications before the insurance industry will approve the use of the biologics.

There is no question that the biologics are spectacularly expensive and very difficult to receive if you do not have good insurance. That fact is unlikely to change very much over the next 5 years, even with the advent of biosimilars (generics).

Lastly, every single medical decision usually involves a risk-benefit analysis. This analysis is overwhelmingly in favor of patients who have widespread psoriasis, need a systemic treatment and choose a biologic drug. Your dermatologist is the person to explain these issues to you!

Report post

I thought it is Humira with over 1,000,000 patients.

Report post

Nice post Craig.
One thing though, I don't think this class of drugs can be truly considered seasoned.

All of these have committed to postmarket studies and some are still ongoing from each biologic.
The main questions surrounds its use for children and effect on offspring of women exposed to biologics.
And there are other safety studies that are ongoing.
But there are still unanswered questions.

You can search for the studies they have committed/required to do here:
http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm

Report post

Lots of good discussion. Hopefully everyone in this forum are sharing their real expereince, instead of biased/marketing any one specific drug.

Craig

Where do you get # of patients count?

For example Enbrel assuming 500K patients and average cost per year 15K, total revenue comes around 7.5 billion. But amgen reported only 3.5 billion revenue last year.

One thing is very clear, if these drug companies know that their biologic drugs continuosly worked for 5 or 10 years then they will claim that as part of their marketing material.

By not doing that, either they don't know or they know it is not a long term solution.

Report post

I was on Humira and Enbrel for less than a year each and although I had no physical side effects from either and although they kept my PsA in remission, they both did nothing for my Psoriasis so I switched to Remicade and have been on this for over 6 years now.
You might say I did sometimes have a sort of mental side effect from Humira and Enbrel though--I got 90 day supplies through my BC/BS mail order plan that had to be refrigerated all the time and, during storms, I was often nervous about a power outage that could ruin thousands of dollars of the med, something I never fear with Remicade since I do not need to handle it at all.

Report post

Psorry and Andrew,
I'm sorry that you both had to go through the Cancer. I can only imagine how it would effect me.
I'm so glad that both of you came through it ok.
Joel

Report post

Va12,
I agree with you about the drug companies not tooting their horn about LONG TERM effectiveness. Enbrel as been around since 1998 and they do only a two and a half year study, come on I don't buy it. It wouldn't make sense to do just one study for 2.5 years. You know that they have done a lot of studies and research.

With this train of thought,
my Rheumy is going to push me to add MTX to Enbrel in a few months. After reading posts on here and other places. At this point I don't think that I want to go on it. There is a real possibility of it damaging your liver. That is why your Dr. has to keep a close eye on it and your not suppose to drink while on it. On top of that, I belong to a support group for auto-immune disease and several of the member's of the group complained about vomiting, upset stomach's taking it orally. Some of them asked their Dr. to Rx them the injection form of it to stop that from happening. I may totally be wrong on this, but my train of thought is this: if it is going to make you vomit and make you feel sick, then that tells me that your body doesn't want it. And if there is a good chance that it doesn't work after a few years, why even go on that drug, if after a few years you may be moving on to another drug anyways. I think I will skip this drug and move on to the next one to begin with.
Joel

Report post

Joel, MTX is a form of chemotherapy , thus the nausea and why I have not taken it, although mybdoctor wanted me to take it with enbrel. Instead I went onto humira and now stelera.

Report post

Been on Enbrel for almost 5 years. works great only side effect is a dry nose and I used to have sinus infections, but since I switched jobs, that has stopped.

Report post

I shouldn't even call mine cancer as it was stage I, and we treated it with simple surgery and then just monitoring. I didn't go through radiation or chemo. After I recovered from the surgery (8 weeks!), I was fully better.

As for MTX, yes it can damage your liver, and yes in high doses it's a chemotherapy drug. It also gives you significantly more risk of getting an infection. That said, if the doctor watches you, your liver will be fine. You will be taking it in doses much less than for chemo. And even with the higher risk of infection, if you're otherwise healthy, you should be fine, especially short term.

Report post

Andrew, I was stage 1as well. In 1975 they
treated all testicular cancers as stage 4. Thank goodness we both caught it early!

Report post

Joel - In case you do have to start MTX, I haven't had any of the side effects you listed above. And I was pretty nervous about those because I have a history of peptic ulcers and crohns, so my stomach isn't always stellar to begin with. ;-) My only side effect from the MTX is I'm just pretty tired the day after I take it. So far my liver's been fine, I just get blood work done every 6 weeks or so. I don't drink much to begin with but since my liver tests have been good, I may have a drink or two a month. In the end though, it hasn't done much to help my PsA though so I've started Humira in addition to the MTX. I just wanted to chime in because I know MTX has really helped many people and I don't want people thinking the side effects are always horrible.

Report post

Joel - sorry, I did have one other side effect early on from the MTX and that was mouth sores. But since my rheumy upped my folic acid to 3mg/day those are few and far between now. Forgot about that since I haven't had one in awhile.

Report post

Correct! As I have posted many times before on this site, I personally know friends of mine who have been on Enbrel with excellent results for more than 10 years. One of them has stayed on Enbrel since the Phase III clinical trials. The potential side effects of any drug (in the 1-3 percent risk range) needs to be assessed against the current side effects of the disease itself (a few of them in the 100% incidence range)--depression, extreme discomfort, pain in joints, loss of relationships, anxiety, inability to go to the beach or the pool--need I go on?

Report post

va12: The "number of pts treated estimate" comes from sources in Pharma, in Insurance companies and in the reports to the FDA.
It is a good attempt to estimate that number based on earnings reports and cost of treatment, BUT rest assured that no insurance carrier pays retail prices on any drug. There is a world of wheeling-dealing that takes place behind the scenes that none of us can see.

MajorFlake: I don't get your point about Enbrel having only been tested for 2.5 years. There have been many phase 2, phase 3 and phase 4 studies conducted by Amgen in psoriasis involving thousands of patients. All of this experience adds up in the eyes of the regulatory authorities and in the physicians who prescribe the drugs. The biologic studies, having been conducted in the last 10 years, have involved the longest and largest trials for any of the psoriasis drugs (including the traditional drugs such as MTX, cyclosporine and acitretin). The Stelara phase 3 trials were 1 year long with a 4 year extension. Those 5 year trials currently set the standard for length of time involving a large population of study patients. You would be surprised to find that MTX, Cyclosporine and Acitretin were approved with short studies involving only a few hundred patients.

At some point, you have to stop running trials of this nature (for a variety of practical and technical reasons) and rely on other sources of data. Registries are the most reasonable next step. A registry is usually a real world observational experience ... with a large number of patients on therapy followed over a long period of time. Because the rheumatologists were involved in the biologic drugs first, they have the largest and longest running registries. The largest psoriasis registry is sponsored by Janssen (the makers of Stelara). It is called Psolar. They allow patients on many different systemic treatments into the registry and not just those on Remicade or Stelara. Recently, the number of patients hit 10,000 and they have been drawn from all over the world.

With regards to safety, data from the rheumatology registries have been very reassuring. The Psolar registry is relatively young but has many patients. Data will flow out of it starting this year and because it is psoriasis-specific, it will be of prime interest to dermatologists and psoriasis pts.

Report post

This discussion is closed to replies. We close all discussions after 90 days.

If there's something you'd like to discuss, click below to start a new discussion.

Things you can do

Support the National Psoriasis Foundation

Help the National Psoriasis Foundation reach its goals and support people like yourself by making a donation today.

Donate to the National Psoriasis Foundation

Discussion topics

Additional resources

Community leaders