How Medication Decisions are Made in RA Treatment

November 4, 2004

a, this is a great article and should probably be posted where it

can be read by every newcomer to RA and this site. I see so many

questions about how much pain do I have to just deal with, is my dr

doing all he can do for me, should my doctor be more aggressive in

treating the disease and not just the pain, etc. To me, this is a

very realistic picture of what we should be able to expect from our

doctors--complete information about the medications we take, an

ongoing dialog about how the medication is working, and a goal

of " complete remission. "

> How Medication Decisions are Made in RA Treatment

>

> Summary of a presentation at the Living with RA Workshop

>

> A. Paget, MD, FACP, FACR

> Physician-in-Chief and Chairman of the Division of Rheumatology

> Hospital for Special Surgery

> The ph P. Routh Professor of Medicine

> Weill Medical College of Cornell University

>

> Research has profoundly changed the treatment of rheumatoid

arthritis (RA)

> in the past decade on two fronts.

>

> First, we now understand that the " personality " of RA is that is

can damage

> joints within a few years. This provides a window of opportunity

for us to

> control the disease. So it's important to make the diagnosis early -

and for

> the primary care doctor and rheumatologist to work in partnership

to start

> treatment immediately. Early treatment is particularly important in

RA.

>

> Second, new and effective medications for rheumatoid arthritis (RA)

are now

> available. More are coming to market soon. They have profoundly

changed the

> treatment of RA. The early use of these medications have made a

major dent

> in this disorder and what it does to people. Do we have a ways to

go? Yes.

> Are we much better off than we were in the past? Unbelievably so.

So things

> have changed.

>

> The Doctor-Patient Relationship: A Partnership

>

> You need to become an informed consumer to work as a partner with

your

> physician in making decisions about your medications. You need

trust and

> good communication to make the best decisions. You need to educate

yourself,

> and your physician needs to educate you. When you have questions,

it's your

> responsibility to ask them. Constant communication and feedback is

vital. An

> open relationship and communication are mandatory. If you don't

have it, you

> should demand it. If you don't get it, you should find it.

Decisions must be

> made together. You have to be an informed consumer of medical care.

>

> The Process

>

> When I recommend a medication, here's the way I think about it. I'm

going to

> tell you why I've chosen this medication that I think is best for

you. I'll

> tell you the facts that we use. And then you tell me whether you

think that

> they're best for you. You play a big role in the final decision.

>

> When we start on a medication, I assume that, on a scale of 0 to 10

with 10

> being the worst, you score a 10 on pain, stiffness, functional

limitation,

> and fatigue. My goal is that within two months you will be 70%

better. My

> goal is to bring down the thermostat of inflammation. Every week, I

want to

> hear from you about how it's working - either by email, fax, phone,

or

> visits. Is it working? Are there side effects? I will tell you what

to

> expect and in what time period. If it doesn't work, I will discuss

it with

> you. I will either change medicines or add medicines.

>

> Facts Used in Making RA Therapeutic Decisions

>

> * Does the patient have RA? Other conditions masquerade as RA -

such as

> thyroid problems and infections. So the diagnosis must be confirmed.

> * How active or severe is the RA? No two people have exactly

the same

> RA. They have different genetics, different environmental exposures

and

> triggers. Depending on the severity, you may need a " machine gun "

medicine

> or a " cruise missile " medicine.

> * What is the " personality " of the RA? Again, this relates to

your

> individual RA and helps the doctor decide what type of medication

to use.

> * What are the goals of treatment? Although we all want a cure,

that's

> not here yet. Short of that, there are goals to aim for.

> * What medications have already been used? What have you been

on before

> - at what dose - with what benefit - and what side effects? If you

only got

> a 3 or 4% improvement, it's not worth the money nor the potential

side

> effects.

> * What medical problems other than RA do you have? These are

called

> comorbidities. You are not just a disease - you are a whole person.

For

> example, if you have high blood pressure, your doctor has to make

sure not

> to give you an arthritis drug that will cause fluid retention and

raise your

> pressure. If you have a history of ulcers, your doctor will be

cautious

> about giving you an NSAID - either choosing a COX-2 or adding

another drug

> to reduce acid output in your stomach. If you have diabetes, that

also

> affects prescribing. Do you have any allergies?

> * What is your age? Children and older adults need different

doses.

> * What is your insurance coverage? Some health insurers do not

cover

> certain medications, for example Medicare only covers intravenously

injected

> medications at this time, not medications injected under the skin.

> * What is your capacity to take medication? For example, if you

have

> hand problems, you may not be able to use some self-injected

medications -

> so you may need to come to the hospital for that medication or find

a friend

> or family member to inject you.

>

> The Goals of Therapy in RA in 2003

>

> * Complete remission - This means no evidence of disease (NED),

a term

> borrowed from oncology (cancer medicine). It does not mean a cure -

just

> that all the symptoms are gone. That is, complete suppression of:

> - joint redness, warmth and swelling (inflammation);

> - joint stiffness, particularly in the morning;

> - often profound fatigue (pooping out in the middle of the

day).

> * Back to work and normal function as you know it.

> * Avoidance of joint damage and healing of old erosions.

>

> Treatment Options in RA

>

> We have two general classes of drugs - nonsteroidal-anti-

inflammatory drugs

> (NSAIDs for short, including COX-2s) and disease-modifying anti-

rheumatic

> drugs (DMARDs for short)

>

> Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), including COX-2s

>

> NSAIDs and COX-2s control inflammation and pain, but they can

irritate the

> intestine, liver and kidney. NSAIDs and COX-2s are not disease-

modifying.

> The COX-2s, compared to the traditional or older NSAIDs, give you

less

> gastrointestinal irritation. However, there is no difference in

their

> anti-inflammatory effectiveness.

>

> * Traditional NSAIDs: aspirin, naproxen (brand-named Naprosyn,

Aleve),

> ibuprofen (Motrin, Advil, etc.), diclofenac (Voltaren) and many

others.

> * COX-2s: celecoxib (Celebrex), rofecoxib (Vioxx), valdecoxib

(Bextra)

> meloxicam (Mobic). (See Guidelines to Help Reduce the Side-Effects

of COX-2

> Selective Drugs)

>

> Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

>

> These drugs have been shown to decrease the development of erosions

and

> joint-space narrowing and deformities - either significantly or

completely.

> They vary greatly with regard to side effects and cost.

>

> * methotrexate (Rheumatrex, Trexall)

> * leflunomide (Arava)

> * sulfasalazine (Azulfidine)

> * hydroxychloroquine (Plaquenil)

> * etanercept (Enbrel)

> * infliximab (Remicade)

> * adalimumab (Humira)

> * anakinra (Kineret)

>

> Potential Side Effects from RA Medications

>

> This is only a partial list of problems that may arise as side

effects from

> your medications. Not all people get side effects, and they may

vary from

> mild to severe. All side effects should be reported to your doctor

promptly.

> Because of the increased risk of some of these side effects, such

as liver

> irritation, you will need to have regular blood tests - and you

need to know

> how often those tests should be done and when to check on those test

> results.

>

> * NSAIDs: stomach upset, indigestion, stomach pain, rash,

swelling of

> the legs due to fluid and salt retention;

> * methotrexate: liver irritation, nausea, infections;

> * leflunomide: diarrhea, infections, liver irritation;

> * sulfasalazine: rash, nausea;

> * hydroxychloroquine: rash, diarrhea, eye (retinal)

inflammation or

> damage (rare);

> * etanercept, infliximab, adalimumab: infections, skin rashes

at the

> site of injections.

>

> Facts to Consider When You Make Final Decisions

>

> * Do I understand:

> - what this drug is for?

> - how it works?

> - how it is monitored?

> - how I will know that it is working?

> * How do I take the drug:

> - by pill, injection, IV?

> - daily or weekly? (methotrexate is weekly)

> * How much does it cost?

> - Does my insurance pay for it?

>

> Studies show that 40 to 50% of people with various types of

arthritis don't

> take their medication the way the doctor prescribed. People don't

want to

> take medicine because of side effects, costs and other reasons. But

if the

> doctor thinks you're taking them and you're not, the doctor makes

decisions

> thinking you're taking them. And that's not good.

>

> Remember, your doctor needs to know not just about your prescription

> medications but also about over-the-counter medications, vitamins,

herbals,

> alternative therapies, health foods, all of it. Just because you

get it in a

> health food store doesn't mean it's going to be safe in your

situation. For

> example, some health food store products can thin your blood; if

you take

> them with Coumadin, a blood thinner, you can have a problem. So

anything you

> take, has to be factored into the situation.

>

> Anti-TNF Medications

>

> Tumor Necrosis Factor was discovered here at Hospital for Special

Surgery.

> Our third surgeon-in-chief realized that lung tumor patients who

developed

> pneumonia had a decrease in their tumor size. He thought the

infection might

> be producing a chemical that was shrinking the tumor. That's why the

> chemical is called tumor necrosis factor, i.e. a protein that kills

> (necroses) tumors.

>

> This TNF protein is made by immune cells in your joints. It's what

causes

> the inflammation - the redness, warmth and swelling - in your

joints and

> causes joint damage. It's what make you feels tired. It's what

makes you

> lose weight.

>

> Over the past few years, we have developed amazing biological

medications.

> These are the most sophisticated medications that exist today. They

actually

> block these TNF proteins.

>

> But everything is a balance. TNF not only blocks tumor growth, but

it

> protects us from infection. Remember the worst flu you ever had?

And then

> you feel better. One of the factors in your body that helped stop

that

> infection was TNF. But you do have other warriors in your body to

stop

> infection. So given how powerful these medicines are in fighting

RA, we

> accept the fact that you are at higher risk when we block TNF. It's

not a

> common risk, and we watch you carefully. If you develop an

infection - such

> as bronchitis or a urinary tract infection - we give you an

antibiotic and

> stop the anti-TNF medication temporarily until the infection is

cured.

> Always report fever, chills, night sweats and others signs of

infections

> such as cough, diarrhea, abdominal pain, and urine symptoms to your

doctor

> immediately.

>

> Typical Anti-TNF Medications

>

> Here are three of the different anti-TNF medications that help make

people

> with RA better. Consider some of the similarities and differences.

>

> * Etanercept (Enbrel)

> - subcutaneous injection twice a week, stays in the body for

four

> days;

> - no Medicare coverage.

> - most health insurers will not cover etanercept until you

have been

> on full doses of methotrexate without adequate improvement.

> - no Medicare coverage. The company that makes this, in some

> situations, will give the drug free to patients who cannot afford

it or

> where the insurance company will not pay for it. Ask your doctor

about this.

> * Adalimumab (Humira)

> - subcutaneous injection every other week, stays in the body

for 14

> days;

> - no Medicare coverage; The company that makes this, in some

> situations, will give the drug free to patients who cannot afford

it or

> where the insurance company will not pay for it. Ask your doctor

about this.

> - most health insurers will not cover adalimumab until you

have been

> on full doses of methotrexate without adequate improvement.

> * Infliximab (Remicade)

> - intravenous infusion (in doctor's office, clinic or

hospital) every

> 8 weeks;

> - stays in the body for 8 days;

> - paid for by Medicare.

> - needs to be taken along with weekly doses of methotrexate

>

> Another new biologic agent

>

> * Anakinra (Kineret), which blocks the action of another

protein that

> stimulates inflammation that causes inflammation called IL-1.

> - subcutaneous injection daily

> - stays in the body for only 6 hours

> - not paid for my Medicare

>

> A Final Note On Medication Decisions

>

> Note the differences in how long these drugs stay in the body. The

longer a

> drug stays in the body, the longer you can wait between doses -

which is

> good. But the longer it stays in the body, the longer it stays

around -

> which can be a problem if you develop an infection.

>

> All the new anti-TNF drugs cost about $13,000 a year, but most

health

> insurers cover them. However, two are not covered by Medicare. The

one drug

> that is covered by Medicare is given as an intravenous infusion;

sometimes

> allergic reactions occur, which require treatment with

diphenhydramine

> (Benadryl) or acetaminophen (Tylenol).

>

> About 40% of our patients with RA develop the disease after 60

years of age.

> Because of their age, they are more apt to have other medical

problems that

> predispose them to other medical problems. Thus, I might prefer to

treat

> them with a drug that stays around for a shorter period of time -

but their

> Medicare coverage relegates them to a drug that might not be my

first

> choice.

>

> This example demonstrates that some medication decisions are

personal

> decisions, some are professional decisions, but some decisions are

imposed

> by health insurers. But nonetheless, these are extraordinary

medications

> that have made a profound improvement in people's lives.

>

> http://www.hss.edu/Conditions/Rheumatoid-Arthritis/How-Decisions-

Are-Made-In

> -Ra-Treatment

November 4, 2004