A Dfferent Route To a New Treatment

My road to a biologic drug was different than most I think. Building on my experience as an active patient who often searched for information online, I found an educational resource for doctors online years ago. They are also called CMEs which stands for Continuing Medical Education and have changed in format now.

Though they are meant for doctors, anyone could participate and the format was great. After every few pages there was a quiz, so I could check that I was absorbing the information.

That was the way I learned about the results of the Premier Trial and others that were similar. The conclusions that stuck with me, were those that said anti-TNF drugs improved disease activity and physical function.  What appealed to me most was that biologic drugs were said to give an increased sense of well-being, better physical function, and to decrease erosions and joint damage. I had already seen what joint damage could do and knew I wanted as little as possible. 

After reading these conclusions it seemed to me that my life could be better with more aggressive treatment. With physical symptoms of fatigue and inability to expend energy my life was limited. After working all day I had no energy left for any other aspects of life and I spent my weekends resting and visiting sick relatives. I felt like a doll lying in a room in a dollhouse when there were no kids at home.

Well-being is not something that my doctor ever asked about in his surveys that included the Rapid 5 ( a quick way for doctors to judge disease activity) and HRQL (Health Related Quality of Life)  measurements. Fatigue was not part of them.

Now we see Patient Related Outcomes (the results patients think are important) becoming far more important in treatment decisions and clinical trials for chronic diseases like rheumatoid arthritis. This change is recent and similar to 'treat to target' which is another phrase you may have seen online, far more than in doctor's offices.

I was convinced, but next I had to convince my doctor to take another look at my health. In my experience if you show up looking presentable and a bit perky at the Dr's office they think you are doing fine. Getting that re-assessment is difficult if you seem to be coping adequately. As my first GP (who missed my diagnosis) used to day "If it's not broke, don't fix it."

It took a few appointments to do this, which in RA terms translates to more than a year.  I had to "fail" on another DMARD so that the insurance company would be satisfied. If the new DMARD had worked it would have been great but it didn't. 

Now I am on a biologic. With it I have more tolerance for exercise and I can do more in a normal day. It did give me a better sense of well-being so I am happier and I think I am healthier too.

For an interesting read have a look at this paper that discusses the qualitative or narrative responses that show the outlook of patients - that is the experiences, attitudes and expectations of people like us about the information they receive before they start anti-TNF therapy

I really liked the paper - it sounded like me

This post is part of RA Blog Week. For more on this topic click here

Patient View of Humira

When I first developed RA the treatment plan given by my Family Doctor was to take a maximum dose of aspirin (12  pills a day) for a three months to see if that would have a beneficial effect. Over those months damage continued to occur. Since this treatment did not seem to make a difference I found another doctor. His treatment was NSAIDs, specifically Indomethacin: That resulted in gastro problems added to the pain, swollen joints, weight loss and fatigue.                     

                                   

When I finally saw a specialist over a year later he outlined the possibilities  The most aggressive treatment was in his Pyramid of Possibilities was immune suppressant drugs.  I was prescribed gold injections and then transitioned to methotrexate.  Over the years the methotrexate was combined with almost every other DMARD (disease modifying anti rheumatic drug) possible.  I kept trying all the combinations hopefully over the years until I became more involved and informed about treatments and possible choices. 

Once I was aware that methotrexate does not actually stop damage to the joints and found out there were other choices that did stop joint damage I campaigned for treatment with a biologic drug. In my reading I had learned that biologics produced a greater sense of well-being and a better quality of life at the same time as they stopped progression of damage. 

I saw the info above in online CME (Continuing Medical Education) courses during the time that pharmaceutical companies were the major sponsors of many of them. Reports of drug trials like the PREMIER Study and ARMADA were a further influence on my desire for biologics.

I combined this knowledge with the facts of my life.  I was working full time but all other areas of my life were neglected because of  pain and fatigue.  Most of the time I was not at work was spent resting up to be able to continue to work. My exercise tolerance was very poor. It used to take me two days to recover from any efforts beyond isometrics. Now with Humira my recovery time from exercise seems normal and I am able to do more in a day than just work.

There has been great progress in the treatment of RA over the past years. Prior to 15 years ago there were only 7 new treatments found in 70 years. Now it is hard to keep track of all the new alternatives. The improvement in treatment is noticeable even by the look of the people waiting at the rheumatology clinic. No wheelchairs and very little visible damage can be seen now.

Some of my friends in online groups have had moderate or serious adverse effects that have led them to discontinue biologic drugs. However at least as many have said that a biologic has given them their lives back. That is important!  Even if my improvement on a biologic is not remission and amounts to me feeling 20% better it’s a welcome change.  

Progression is the major factor in my choice. I can’t afford to have any new joint damage. While only one active joint may sound like good control to many, when that one joint fuses it’s useless for good and the disease moves on to another one. There are no miracles in RA that unwind joint damage.

Over the past 7 years that I have been taking Humira I have been sick 4 to 5 times with colds and flu and the severity has seemed worse but not the frequency. 

I did express concern about the price before I started to use adalimumab. The “payment specialist” with the organization that Abbott uses to distribute the drug looked into methods of payment to lessen the financial impact. That organization paid my deductible for the first year to make the  transition easier.  It was a good investment for them seeing that I am still taking it after seven years.

I have been influenced by this great talk by Dr Edward Keystone called The Most Exciting Time Ever In The History of Arthritis and by Dr Shashank Akerkar's blog post called Time, tide and inflammation waits for nobody.

The choice of Humira as my biologic was mine. The Dr. I was seeing gave me a choice of the 3 major anti-TNFs. I had concerns about one and chose Humira based on the ease of use and my schedule.

Despite my enthusiasm for effective treatment I am anxious to see full disclosure of significant risks through the release of data from clinical trials. The legal action blocking disclosure of trial data by pharma companies Abbvie and InterMune is a step backwards for patient safety. There is a petition here against the lawsuit.

Their lawsuit has shut down the whole public access program of the European Medicines Agency.  Patient safety is not a trade secret! To paraphrase @ePatientDave "Give us our damn data."

If we are choosing to take these budget busting drugs we should have access to data about them.

Progression of Damage and Why It matters

Damage to your joints sounds so academic and unlikely when you first get a diagnosis of inflammatory arthritis (or Rheumatoid Arthritis Disease). Even though joints are painful and swollen it's hard to believe that your bones will be affected.  I developed RA at 32 and took having good health for granted then.  There was no time to be sick with two boys 10 and 11 and a job.

                                       Anetto archive

You start off as normal healthy person and Rheumatoid Arthritis comes sneaking up on you gradually in most cases.  You start to notice pain and fatigue.  Your joints hurt and you feel so awful, and yet you still wonder  if you're sick or is it just life catching up with you? But now the effects are hitting you like a ton of bricks. My doctor thought I was dramatizing and hysterical so the process of finding the problem took longer.

                                www.cropthornehouse.co.uk

But finally you have a diagnosis and start on methotrexate, the "gold standard" drug. You have to wait to feel the effects and they creep up on the RAD just like it crept up on you.  Finally you start to feel the drug is working. The pain and fatigue ease up and you can function better bit by bit, even though nausea and gastro effects may make you feel like crap. (And this is a good result) 

(note: injecting MTX is easier on the stomach than pills)

And you are happy that your joints are not swollen and there is less pain and fatigue.  Your normal/old life is hard to remember but you feel better and that's some relief.  However from my reading and the evidence of my own joints after years on MTX, damage to your joints may still be occurring. 

If you were to look at X Rays it is easy to see the difference between a normal joint and one seriously affected by RAD

                                     www.paincaredirect.com

Normal joints have space between them and you can see 8 separate bones in the healthy wrist.

I was shocked to find out after years with RA and MTX and assorted other Dmards that MTX does not stop damage to bones from occurring.  Your symptoms may improve with that treatment but it is no guarantee that your bones are not being eroded and that your joint space is not narrowing.

For years I thought that I was on the best treatment and did not think I needed a biologic drug.  That was before I saw information about new clinical trials and read that with a biologic there is a lot less joint destruction.

As an example the Premier Trial concluded that   "ADA+MTX (adalimumab + methotrexate) inhibited both JE (joint erosions) and JSN (joint space narrowing) progression independently of disease activity. JSN played a more prominent role in patient-reported outcomes than JE. Preventing the onset or worsening of JSN probably represents a critical aspect of effective disease management of early rheumatoid arthritis patients"

And here "Early intervention with combination therapy also offered substantial protection from radiographic damage compared with methotrexate monotherapy." 

                                  MTX Right/Folic acid Left

Dr Haraoui says this in an editorial from Annals of the Rheumatic Diseases
"Indeed regardless of the therapy used, approximately 50% of patients will not show radiographic progression over 2–3 years; This percentage increases up to 75–85% of patients receiving combination therapy, and those who do progress, progress less than patients on methotrexate alone."

There are many reasons that I have a lot of damage to my joints. Some is due to late diagnosis of course, but 20 years on MTX, even with other associated Dmards, was not enough to stop the joint damage.  By the time I had a wrist fusion the Dr could not distinguish the eight separate  bones and said there was no cartilage at all in the joint.

When you end up with this much damage there are many things that are difficult or painful for you to do and some things are just not possible anymore. Damage leads to disability. "The association between joint damage and disability in rheumatoid arthritis (RA), especially in the later stages of disease, is a main reason why radiographic joint damage is a common and valid outcome measure in RA clinical trials"

                             Structural Damage www.ehow.com

Here is one of the main goals of rheumatology treatment:
"The primary goal of treating the patient with rheumatoid arthritis is to maximise long-term health-related quality of life through control of symptoms, prevention of structural damage, normalisation of function and social participation." 

The treatment is now much better and the levels of damage to joints have decreased over each decade. The level of disability is decreasing over time with good treatment.  That's the good news

Help Your Bones - Types of Exercise

If you you are planning to exercise to improve your bone density and strength, avoiding the movements that may harm your spine is important. You want to solve a problem, not create a new one. Pool exercises are good for keeping you limber and extending your range of motion and endurance, but for strong bones You need to supplement swimming with activity that will increase your strength.

                                         Publicis Dumocalcin Campaign

We need to work on making our muscles and core stronger. If Rheumatoid Disease has affected your hands and feet, and walking or  lifting is more difficult it's good to know that working on your core strength is still possible, as long as the fatigue is not a barrier. 

When I started to exercise I felt like my muscles consisted of limp spaghetti the day after.  Thank goodness for timely biologics that let me do more. Starting slow and building up strength gradually also helped.

                                                                  scomotle.org
                                                                                                   Muscles Like Spaghetti


Pilates sounded like a good match for what I wanted to achieve and I found a story in Chatelaine magazine about Lori Weisbrod, who teaches Arthro-Pilates in Toronto  http://www.arthro-pilates.com/  Since she has autoimmune arthritis herself she knows about the pain and issues arising from damaged joints and fatigue.  I've been working on improving strength with her for 4 years through good times and less good times with my body resulting in more strength and muscle.

                                        Lori Weisbrod ArthroPilates

I have also read a lot on the TheraPilates website.  Sherri Betz is a well known speaker and teacher in the area of Pilates and osteoporosis and she has a great collection of articles on her website http://www.therapilates.com/PDF/modifyingpilates.pdf  in particular her article "Modifying Pilates for Clients With Osteoporosis"  If you are planning to do Pilates you should read it.  If you are already doing Pilates it would be a good read for your instructor. If you're in California you could takes classes with her. Below is an example of a back strengthening exercise.

                                                           Extension Exercise

Here is the rationale behind avoiding the flexion (forward bending) and doing the extension movements.  It's one of many papers by Dr Mersheed Sinaki, who studies the effect of muscle strength and exercise on bone mineral density and back pain.

She mentions a correlation between muscle mass and bone mass - so that's why you need to get stronger with inflammatory arthritis.

I am not sure if we could become as strong as these two ladies below but they are great examples.  I am a lot younger than they are and they have me beat by miles.

                                     Ernestine Shepperd,74  - oldest competitive female bodybuilder

                                                                Richard Lautens Toronto Star

                  Ida Herbert 96 -  Guinness World Record World’s oldest yoga teacher.
                                                          
                                        
There are more actions you can take for your bones you can do for your bones so this is the topic for the next post also.
Here's a link to Post #1 about RA and bones.