The truth about living with Rheumatoid Arthritis

Medications

Rheumatoid Arthritis – Should I take my biological when I’m sick?

One of the most common questions people ask is whether or not they should take their biological when they are sick.

As you probably know, treatment for Rheumatoid Arthritis and many other Autoimmune diseases is based around suppressing a haywire immune system which, left unchecked, is mistakenly attacking healthy tissue.  By suppressing the immune system, the disease process is slowed or even halted completely.  Unfortunately suppressing your immune system comes with risks, the most common of which is making you more susceptible to every bug going around.

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Humira (adalimumab) – Medications for Rheumatoid Arthritis

humiraHumira is a biological DMARD (Disease Modifying Anti-Rheumatic Drug). Humira is an Anti-TNF (Tumour necrosis factor) and it is self injected once every fortnight.  Humira is prescribed for moderate to severe Rheumatoid Arthritis, in cases where cheaper medications (such as methotrexate, arava or sulfasalazine) have failed to provide benefit.

How does it work?

Tumour necrosis factor is a protein that promotes inflammation and is found in the synovial fluid and blood of patients suffering inflammatory arthritis.  Humira is a human antibody that blocks this protein, thereby reducing the inflammation and the signs and symptoms associated with it (swelling, pain, tenderness)

Humira Dose

Humira is available in pre-filled syringes and a pen auto injector.  The usual dose is 40mg self-injected fortnightly.

Humira Side effects

The most common side effects are injection site reactions – redness, swelling, itching and bruising.  This is usually mild, but if it lasts for more than 5 days or is severe, a doctor should be consulted.

Also common are nausea, headache, rash and abdominal pain and bloating.

Humira suppresses the immune system, so infections are common, as are minor infections becoming more serious.  Humira has also been associated with serious infections such as tuberculosis, sepsis and fungal infections. Though rare, these infections can be fatal.  Humira may also cause or worsen diseases of the nervous system, such as Multiple Sclerosis.  Humira also raises the risk of some cancers.

A full list of side effects is available here.

Monitoring

No special monitoring is necessary. Humira should be discontinued if an infection develops (e.g. fever) until all signs of infection are gone.

Contraindications

Patients much be tested for tuberculosis before starting Humira.  Humira is an immune system supressant, and patients suffering serious infections should not receive Humira.  Invasive fungal infections (such as histoplasmosis) and other opportunistic infections may be worsened by Humira and in some instances have been fatal.

Patients with pre-existing disease of hte nervous system, such as Multiple Sclerosis should not take Humira.

Advice in pregnancy/breastfeeding

Humira has not been studies in pregnancy or breast feeding women, and therefore is avoided.

Enbrel (etanercept) – Medications for Rheumatoid Arthritis

enbrelEnbrel is a biological DMARD.  Enbrel is an injectable drug that works by blocking Tumor necrosis factor alpha (TNF alpha), a cytokine implicated in inflammatory arthritis.  TNF alpha promotes inflammation in the body and its associated symptoms – pain, swelling and tenderness.

How does it work?

TNF alpha is produced by the body when there is inflammation.  Enbrel is a synthetic man-made protein that binds to the TNF-alpha, and so it acts like a sponge to remove most of it from the blood and the joints.

 Enbrel Dose

Enbrel is available in pre-filled syringes and a pen auto injector.  The usual dose if 50mg, self injected once weekly

Enbrel Side effects

The most common side effects are injection side reactions – itching, pain, redness, swelling and bruising at the site of the injection.  Headache, dizziness and nasal and throat infections can occur.

Serious side effects can occur.  Enbrel raises the risk of some cancers, especially lymphoma. , Multiple sclerosis, myelitis, optic neuritis and other diseases of the nervous system have been reported. Low blood counts have been seen with Enbrel and other TNF blockers.  Congestive heart failure is also a risk.  Lupus-like syndrome has also occurred.

The medication should always be discontinued if there are any signs of infection, including fever.

A complete list of side effects is available here

Monitoring

No special monitoring is necessary.

Contraindications

Patients must be checked for tuberculosis before treatment commences.  Enbrel is an immune system suppressant, and patients with serious infections should not receive Enbrel, and it should be discontinued if an infection develops.  Invasive fungal infections (such as histoplasmosis),  bacterial sepsis and other opportunistic infections may be worsened by Enbrel, and in some cases have been fatal.

Enbrel is not recommended for patients with pre existing disease of the nervous system, such as MS.

Advice in pregnancy/breast feeding

No studies have been conducted.  Animal studies did not reveal toxicity to the fetus, however as animal studies are not always predictive of human response, enbrel is avoided in pregnancy.

Rheumatoid Arthritis – Qualifying for Biological DMARDS (bDMARDS) in Australia

rheumatoid arthritis infusions

image from http://www.texasneurology.com/infusioncenter/

Ok, bear with me. This is going to get confusing. Why?  Because I am going to try and explain why some people with severe RA cannot access expensive biological medications in Australia.

Why is it hard to get these drugs?  Because they are expensive.  I would think that the cost of supporting the disability that Rheumatoid Arthritis causes is more expensive than these treatments… treatments that offer hope of remission and a normal or near normal life…But hey, I don’t make the rules….

In Australia, eight biological medications are available under the Pharmaceutical Benefits Scheme (PBS) which means their cost is subsidised by the government.  IF you qualify.

I have been told that the cost of unsubsidised treatment with these drugs is between $1200 to $2000 per month.  Obviously out of reach of the mere mortal.

The medications are abatacept (Orencia), adalimumab (Humira), etanercept (Enbrel), golimumab (Simponi) and tocilizumab (Actemra),certolizumab pegol (Cimzia), infliximab (Remicade), rituximab (Rituxan/mabthera).

Over the course of your life you are allowed subsidised treatment with FIVE biologicals.  If the first five you try don’t help, you’ll have to pay for the others yourself.  As previously stated, pretty much impossible for the average person.

Additionally, methotrexate at a dosage of at least 7.5mg per week must be taken with abatacept (Orencia) , golimumab (simponi), infliximab (remicade) and rituximab (rituxan) therapy.  So too bad if you can’t tolerate methotrexate.  You’re down to four options now.

That’s if you even qualify for treatment.

As stated before, conclusive blood tests for rheumatoid arthritis don’t exist.  Blood tests are indicative and interpreted in context with other results.  See Rheumatoid Arthritis diagnosis for more info.

For me, the only ‘proof’ I have that I actually DO have rheumatoid arthritis is in my scans.  Synovitis is visible on nuclear bone scans and ultrasound.  Positive, physical evidence. Indisputable.  Relevant in the current diagnostic criteria for Rheuamtoid Arthritis.  But it’s not part of the qualifying criteria for biologics in Australia.

I clearly have rheumatoid arthritis, or at least a form of inflammatory arthritis, but the criteria only take blood work into consideration, not physical evidence.

Previously you needed a positive RF (Rheumatoid Factor).  This criteria was removed in 2005, possibly in deference to the fact that 30% of people with active and obvious rheumatoid arthritis do not have a positive RF.  This is often referred to as “Seronegative Rheumatod Arthritis”.

Seronegative Rheumatoid Arthritis is considered to be a milder, less serious form of the disease.  I have met enough people with severe Seronegative Rheumatoid Arthritis to realise this is not the case.  Equally I have met people with a positive RF who have no signs of disease whatsoever.

So removing RF from the disease criteria was a positive step.  Gives me hope – criteria can be changed!

So, the criteria for treatment are a count of tender and swollen joints – determined by the rheumatologist squeezing your joints and seeing how much you flinch.  I don’t flinch.  You can put a cigarette out on my hand and I won’t flinch.  I know someone that you could brush their hand lightly with a feather and they would flinch.  They would even cry on cue if you asked them to.  Pretty flawed test I think.

Then you need to submit a blood test.  Your CRP (C-reactive protein) or ESR (erythrocite sedimentation rate) are both indicators of inflammation in the body.

Sounds fine, right?  Except that they are not very accurate tests.  Something as simple as the common cold can cause an elevated ESR or CRP.  Conversely some people with severe and active inflammatory arthritis *always* have ESR and CRP in the normal range.  Mine is mildly elevated from time to time.

Also a pretty flawed test I think!

In addition to all of this you MUST have been on methotrexate for 3-6 months at the maximum dose of 20mg per week.  Except in the case of intolerance or toxicity.  Methotrexate can cause liver damage and lower your white cell count. This is considered toxicity.  Intolerance is experiencing severe side effects.  Again, there is a criteria and points system. Medicine is like that.  All about criteria and points.  Not at all about people and pain.

Severe depression is not considered a bad enough side effect to class as intolerance.  It is classed instead as non-compliance.

In addition to having failed methotrexate you need to have failed two other DMARDs – sulfasalazine, leflunomide, azathioprine, plaquenil or intra muscular gold.

Do all of that and then you win the prize – a new medication with a whole host of dangerous side effects that *might* put you in remission.  If that one fails you can try four more.  Then what?  Five strikes and you’re out, apparently.

Too bad if one of the other three was the magic combination for you.

Now I’m not 100% sure that all of the above is completely correct.  Try googling – you will find not a lot of information.  Try asking a rheumatologist..they will likely um and ahh…they will not discuss it.  I have heard other RA patients say that the criteria is so complicated that even most doctors don’t understand them.

This is the best information I have been able to get.  The actual application form is here.

http://www.medicareaustralia.gov.au/provider/pbs/drugs1/files/4139-rheumatoid-arthritis-pbs-authority-application-initial.pdf

 

On reading through this, I think I have qualified.  I have failed methotrexate and another DMARD after 3 months of treatment (sulfasalazine).  I can explain my normal CRP with my prednisone use.

It could be done.  Some rheumatologists do it.  I love my rheumatologist – he has been great to me.  And his registrar has done her best.  But I now have an appointment booked with someone else.  A rheumatologist who is known for fudging the system.  Cheating?  Maybe.

Sometimes you have to.

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Corticosteroids / Prednisone – Medications for Rheumatoid Arthritis (RA)

Corticosteroids like prednisone have powerful anti-inflammatory effects.  In the 1950s, when they were first introduced as a treatment for Rheumatoid Arthritis (RA) they were hailed as ‘a cure’.  Unfortunately this conclusion was seriously premature, as it became very apparent, very quickly, that prednisone causes serious adverse events and side effects, especially with prolonged use and/or high dosages.

Corticosteroids are usually given orally, however they can also be injected directly into the joint.

The current thinking on prednisone use is to use the lowest dose that provides symptomatic relief, for the shortest possible time.  Having said this, in some cases of severe rheumatoid arthritis, some patients still require long term therapy and/or high dose therapy to achieve any kind of relief. Each patient must be assessed individually to weight the potential side effects against the benefits.

How does prednisone work?

Corticosteroids have a wide range of biological activities including anti-inflammatory and immunosuppressive effects, which is why they are so useful in Rheumatoid Arthritis.  Because prednisone weakens the immune system, however, it can make it easier for the patient to get an infection or worsen an existing infection.  When taking prednisone, patients should take care to avoid being near people who are sick.

Prednisone dose

From Australian Prescriber “In patients who cannot tolerate NSAIDs or in whom the use of DMARDs has proven to be problematic, e.g. adverse effects, monitoring difficulties or poor compliance, the use of a low-dose corticosteroid e.g. prednisolone 5-10 mg/day, may provide good control of symptoms and improved function.” It’s common to start patients with moderate to severe Rheumatoid Arthritis on a higher dose – 20 – 25mg per day to get symptoms under control initially and improve pain levels and ability to function.  This dose is gradually tapered down to reach the lowest dose that will control symptoms. After a week of treatment, prednisone will interfere with the body’s ability to produce corticosteroids (especially cortisol), so the drug cannot be stopped suddenly.  Corticosteroids/prednisone need to be tapered down very gradually to allow the body’s own ability to manufacture cortisol to recover.  The tapering may be quick (over the course of days) if the treatment was short, but will be much slower if treatment was long term.

Prednisone side effects

Short term side effects include high blood glucose levels, especially in diabetic patients.  Common short term side effects are headache, insomnia, increased appetite, euphoria, and rarely , mania (particularly in patients with Bipolar Disorder.  Prednisone has been known to induce a patient’s first bipolar episode)  It can also cause anxiety, and depression, especially when tapering off. Long term side effects include Cushings syndrome,  weight gain especially around the mid riff and face, osteoporosis, glaucoma and cataracts, type II diabetes mellitus and major depression.  Prednisone also lowers the body’s ability to heal, and can also cause avascular necrosis (bone death).

Contraindications

If the patient has a current infection, prednisone will worsen this, and therefore should not be prescribed.  Patients with diabetes mellitus may not be able to take prednisone.  Patients with bi-polar disorder should not take prednisone.

Pregnancy/Breastfeeding

Prednisone may be used in pregnancy, but each case is individual and needs and risks to the fetus vs benefits need to be weighed up. Prednisone does pass into breast milk in small quantities.