Medications - Biologic Drugs

[PsA_Mod_Squad]

Biologic medications target molecules on cells of the immune system, joints, and the products that are secreted in the joints, all of which can cause inflammation and joint destruction. Unlike other medications that treat PsA after it has occurred, biologics attempt to stop it from happening. There are several types of biologics, each of which targets a specific type of molecule involved in this process.

Biologics that bind tumor necrosis factor (TNF) include etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), certolizumab pegol (Cimzia), and golimumab (simponi). These are called anti-TNF agents or TNF inhibitors. There are newer biologics that target other molecules instead of TNF..

Biologics like all the “good meds” put you in the “gap” Some folks start to get immediate results, especially with skin, others take several months. Biologics may be used alone or in combination with other DMARDs (eg, methotrexate), NSAIDs, and/orglucocorticoids (steroids).

All biologic agents must be injected. Some can be injected under the skin by the patient, a family member, or nurse. There are others that must be injected into a vein, which is typically done in a doctor's office or clinic; this takes between one and three hours to complete.

Biologics are perhaps the most controversial medications we take. While most of us who have been around awhile prefer them and frankly as the “gap process” Look forward to the day we can start them because they are so much more pleasant to take with fewer side effects, the internet would lead you to believe otherwise.

When the “right to know” laws were passed back in the 80’s one of the more fortunate or less fortunate depending on your reference outcomes was that every “occurrence” with a medication during clinical trials had to be listed. With the biologics one of those occurrences was an very slight increase over the placebo group in certain types of cancers. Statistically these occurrences could have been classified as “outliers” because of the right to know laws they had to be listed anyway. In 10 years of post market studies, they still have not been able to establish any evidence that the biologics were the cause. These are immuno-suppresent drugs as are many of the meds we take. The best person to discuss these issues with is your physician. He is far more reliable than strangers on the Internet. Millions are taking them and benefiting from them. They simply are too busy enjoying life to spend time in Internet chat rooms informing the world of their “problems”

The US numbers are much higher for use of biologics but as a point of reference: only 26%of patients use Bios Patients who initiated biologics both as monotherapy (30%) and in combination with methotrexate (36%) dropped the therapy with in 12 mos and 50% dropped all therapy.

So no matter how you cut it basically only 1 in 5-10 patients use Biologics. As was said earlier people in this community generally have severe disease or more complications from their disease so their experiences are not typical.

[tntlamb]

Enbrel:

If your doctor is considering Enbrel start here: http://www.enbrel.com/index.jspx As hard as it is to believe the information is correct – all of it. It is verified checked and rechecked by several dozen groups. I dare to say the ONLY websites on the entire internet you can trust are those of the pharmaceutical manufacturers.

Enbrel is the oldest of the biological drugs and it is the only one that is fully human DNA, as a result it has the fewest side effects and is the least likely to develop actual antibodies requiring a change to another biological. There are folks who have been using Enbrel for 12 years.

ENBREL is a protein similar to one your body naturally produces. It works with the immune system to help regulate the body's natural TNF balance. TNF refers to Tumor Necrosis Factor. TNF is one of the chemical messengers (proteins) that help to regulate the inflammatory process. During a normal immune response, TNF attaches to special cells throughout the body. This, in turn, "switches on" immune cells, causing them to release chemicals that can contribute to inflammation. When people produce too much TNF, it overwhelms the immune system's ability to control inflammation leading to diseases like psoriatic arthritis.

ENBREL reduces the amount of TNFalpha- it binds and deactivates some TNFalpha molecules before they can trigger inflammation. By interrupting the chain of events that leads to inflammation, ENBREL can work with your immune system to help reduce inflammatory symptoms. Contrary to what many folks believe Enbrel does not suppress your entire immune system.

All biologicals use a similar process to be produced whether they are “humanized” DNA (actual DNA from a living thing modified to act like human DNA) or fully synthetic attached to other living matter. That process is part of the reason Biological medication is so expensive. In the case of Enbrel the Human DNA is implanted into the ovary of a Chinese Hamster to produce the base for the new protein. Needless to say it takes a lot of hamsters to produce the proteins necessary to make a single dose of Enbrel.

So what should you expect when you start Enbrel.. The simple answer is NOTHING. Reactions to the actual medication are extremely rare. Side effects while using the medication are also rare. If you have been using a DMARD, prednisone, or NSAIDS starting a Biologic is almost a non-event. There are a few things however that you should know.

Enbrel is injected. It uses a needle smaller than what most diabetics use 6 times a day. You can get your Enbrel in a “sure click” pen which you hold to your skin and push a button and it does the rest or in pre loaded syringes. Everybody has an opinion which is best.

The sure click has latex with it causing more site reactions. It also has no flow control so you get it as fast as the spring pushes it in. However if you just can’t poke yourself it’s a great way to go. The regular syringes are just that poke it in push the plunger at comfortable rate. (on personal note if you DO have needle phobia you should go to work on overcoming it, the itty bitty enbrel needles are a great way to go. PsA involves LOTS of needles meds tests, more meds there is always another needle waiting somewhere)

However you go for injection, take the med out of the fridge at least a ½ hour before you shoot to warm it up. It takes most of the sting away. Most on this site inject in their belly, but there are a few leg shooters. (I’m one, but that’s because of some nerve damage, I have a large numb spot on my leg and haven’t felt a needle in years) Don’t pre ice where you are going to shoot. It actually increases the pain because the dispersal of the medicine is slowed down and it’s the flow of the med that hurts. This is one of the reasons I prefer pre-loaded syringes. I can slow the rate down to the point I have no sense of the dispersion

Some have a “site reaction” This red circle varies in size from quarter size to much larger. It is rarely the medication causing it. Sometimes you get it sometimes you don’t. It generally goes away. A benedryl type ointment or oral usually takes away the itch. As you become a better shot the site reactions usually go away. If it’s a problem ask your doc.

So when does it work? Some of us have had results (especially with the “P” part of this disease) in 24 hours. Most of us take a few months (Remember the Gap?) Your response is slow, you may not even know its happening. I didn’t realize how much it was helping me until my wife mentioned me tying my own shoes.

Now, just a couple of personal notes from my experience. The docs are more frequently laying out several meds and allowing the patient to choose. So how do you? I have been at war with Consumer Reports for years speaking of bias, but it is interesting to me that as a whole Consumers like Enbrel the best.

I like it for an entirely different reason. First we have the most information about it. As a result we know of all the meds we take for PsA it is likely the safest with fewest side effects. My plan is to live a long time with PsA so the other reason is that although I have been on it for a very long time, I know I will have to change at some point. Every bio we take will have to be changed at some point. I have been very fortunate that what little eye involvement I have had has easily been handled by some drops. There are a few bios that are very effective for uvitis - Enbrel is not one of them. IF I am going to burn through a bio, I don’t want it to be one that I may need later on and have no alternative.

As always, have the best of luck on your journey. And as much as I hate to end on a negative note, I do need to remind you, no matter how well you respond to Enbrel or any other biologic you will still have a flare from time to time. DO NOT panic. Your first thought should be getting through the day and the next day not panic that your medication is failing. Just as it starts slow, it almost always gives up slowly. A flare is just that.

[Seenie]

Here's a link that from the American College of Rheumatology which is a good summary.