Anti-T cell Antibody Abatacept/Orencia

Abatacept / Orencia Patient Decision Aid

Should I take Abatacept / Orencia blocker for my rheumatoid arthritis?

What is a                 Patient Decision Aid?

This decision aid gives you information about RA, the medications used to treat it, details about Orencia and some questions to help you think through what is important to you.




You have 4 options to choose from

Your Options

This decision aid should help you feel more confident about the reasons for your decision. When planning your treatment in the future, your doctor will find it useful to know these reasons too.

1. Continue

2. Start Orencia

3. Discuss options other than Orencia with your doctor

4. Defer your choice for now


Information about RA

Information About RA

RA is a disease where your body’s natural defense (immune) system is over active and can affect your whole body. It results in inflammation of the joint lining – particularly the hands, wrists and feet. This can affect you by causing general feelings of sickness like fatigue, fever, or loss of appetite in addition to swelling, pain and stiffness of the joints. Together these symptoms reduce your ability or interest to do important activities at home, work and leisure. It is usually a chronic disease which means that it typically cannot be cured but needs regular treatment over many years to control symptoms and minimize complications.

If no treatment is chosen the symptoms of RA will vary but continue for years. In addition, most people will have at least some damage to the joints. This can lead to disability and may even shorten your life. Recent research suggests people with RA, especially if poorly controlled, have a higher risk for heart attack and stroke.


Treatments for RA

Goals of RA Threatment

The main goals of RA treatment are to suppress joint inflammation, reduce pain and swelling, and slow or prevent joint damage.

To reach these goals, there are three types of medication used: Non-steroidal anti-inflammatory drugs (NSAIDs), prednisone and disease modifying anti-rheumatic drugs (DMARD). Often all three types are prescribed together to control joint inflammation. DMARDs are usually started soon after the diagnosis of RA and continued for as long as the disease continues.

The table below shows these three types of medication and where Orencia fit.  

Information about Orencia Therapy

Information about Orencia 

As you saw in the table, there are two types of DMARDs: synthetic drugs and biological agents.  Synthetic drugs (like methotrexate, MTX) are chemicals that improve RA by directly ‘quieting’ the overactive inflammatory cells.  The second class of DMARDs is the bioogical agents.  These are not chemicals, but are proteins.  They also work to reduce inflammation, but do it differently than the synthetic drugs.  The proteins are targeted against one of the body’s overactive defense cells, called T-cells.  T-cells have many functions in your body.  One of their tasks is to help fight off infection by recruiting and directing the other defense cells.  Unfortunately, they also advance the RA process.


To better understand this, imagine that your RA is like a football team.  In football, the quarterback’s task is to direct the other players and throw the ball down the field.  Imagine that something were to attach to the quarterback’s arm and prevent him from passing the ball to the other players.  The game would not advance.  In the RA process, T-cells are similar to the quarterback.



Orencia helps reduce the progression of RA by hindering T-cells.  This prevents t-cells from being able to recruit and direct the other cells involved in the RA process.  (T-cells are not depleted; they just cannot do their job.)

Proteins cannot be taken orally because they would be broken down in your stomach before they could do their job.  Instead, they are given either as an injection in the skin (subcutaneous, or SC) or intravenously (drip into the vein, or IV).  Orencia is given either through an IV, which usually takes about 30 minutes followed by a treatment every two weeks.  After a month of being on Orencia, you will have a treatment every 4 weeks.  Alternatively Orencia can be taken as a injection into the skin one a week.

Orencia was approved by the FDA in 2005.  It’s used in combination with methotrexate (MTX) and is typically prescribed if MTX and another treatment (i.e. TNF blocker like Enbrel) did not work.


Understanding the Benefits

There are many benefits that come from taking biologic agents.  In terms or reducing symptoms and joint damage, biologic agents are the most powerful group of DMARDs.  While synthetic DMARDs work more slowly, you may feel some benefits of biologics after just 2-6 weeks.  The full benefit will be felt after 3-6 months.  Another benefit is that proteins are not broken down by the liver.  Unlike other DMARDs, these don’t typically cause liver irritation.

One goal of taking Orencia is to improve your RA symptoms.  If you improve you should expect less pain and stiffness.  Gripping, reaching and daily activities should also be easier.  You also may have more interest in taking on physical activity.

It is common for doctors to prescribe Orencia in combination with another DMARD, like methotrexate (MTX).  For example, if you add Orencia to your current MTX program, then you have about a 68% chance of your RA symptoms improving.  Another way to look at this is to see what happens if 100 patients add Orencia to their MTX program.

The outcomes of 100 patients treated with Orencia and MTX

Some patients improve more than others with a new treatment. After starting Orencia and MTX, about 40% of patients will have major improvement and about 20% will have their RA completely suppressed.

If you have taken a TNF blocker in the past and did not have much improvement, your chance of having improvement with Orencia might be a little less than the numbers above.

Improvements from the combination of MTX and Orencia are usually sustained, which allows many patients to continue on it for 5 years or more.

How RA Joint Damage Progresses Without Treatment

How RA joint damage progresses without treatment 

The diagram below shows the course that RA may follow if no treatment is used. The top pictures show what the progression looks like on the outside, while the bottom pictures show what is happening to the joints under the skin.

One of the major problems of RA is that joint damage can begin in the first year of the disease and build up over time if the disease is not controlled. These pictures show how swelling of the joint lining can break down bone and cause “erosions” to form where the support ligaments attach. This weakens the joint and over time allows the joints to move out of line and deform.


How RA Joint Damage Is Slowed with Orencia Treatment

One benefit of adding Orencia to your treatment is its power to slow further joint damage.  Research has shown that the use of Orencia along with MTX can notably reduce the rate of RA joint damage in most patients (compared to using MTX alone).  Although the exact numbers are not known, the information below is from another biologic agent, a TNF blocker, that’s similar to Orencia.

To see that different DMARD programs can give different results, look at the table and ‘Joint Damage Speedometer’ below.

Another way to look at this is to consider:

  • If you take no treatment you will have the expected amount of added joint damage (100%).
  • If you take MTX + Orencia less damage will occur – about 5% or less of what would have been expected if no treatment was taken.

Orenica Slows             Joint Damage


Understanding Side Effects

Understanding            Side Effects

All drugs have the potential for benefit and harm. In the next few pages we have listed the most common, as well as some less common but serious, side effects. Part of being informed is having an idea of how often these events happen. This booklet is not meant to replace talking with your medical provider. Rather, its goal is to inform you and support your decision making.

Costs

The cost of Orencia is not a side effect, but can be a burden and barrier to use.  Orencia costs about $1500/month.  Though this might seem like a staggering amount of money, it’s important to collect all of the facts about costs before making a decision.

For example, IV treatments may be covered more fully than other drugs by some insurance companies, including Medicare.  Also, there are private foundations and company co-pay cards that markedly reduce costs.  You should talk with your medical team about payment options for these advanced treatment.  In most cases there are ways to make these types of treatments accessible to nearly all patients.

Conception

The safety of taking Orencia during pregnancy is not known.  Sexually active men and women using Orencia must use a medically approved form of birth control.

Infusion reactions

Agents given through vein can cause infusion reactions.  Very few patients who have an Orencia infusion develop a reaction.  These can be mild, with slight itching or a warm feeling.  More severe reactions can include headaches, low blood pressure, swelling or chest pains.  It is possible that an infusion reaction could be severe enough to cause death.

Because the reactions are varied, IV treatments are given at infusion centers or hospitals where doctors supervise the treatment.  If a person has an infusion reaction, the nurse must recognize this quickly.  He or she will then stop the treatment and give fluids, antihistamines, steroids, or other care as necessary.  Your doctor will then decide if it is safe to restart the infusion or if the treatment must be stopped.  Infusion reactions can often be prevented with a small adjustment in medications.  Occasionally the medication will need to be completely discontinued.

Serious Infection

Types of Serious Infection 

Because TNF blockers reduce the activity of the hyperactive immune cells in RA, it can also reduce your ability to fight off infections.  There are three types of infections:  acute, chronic, and latent/ “sleeping”.

Acute infections

Acute Serious Infection 

These are infections that begin rapidly.  They have a known cause and can be cured if given the proper treatment.  The most common types of acute infections people on Orencia might have are bronchitis or sinusitis.   These are not serious and can be easily treated.

orencia also makes it more likely that you will have  serious acute infections like pneumonia, kidney, or skin infections.  When we refer to serious infections, we mean infections sever enough that you would need to be admitted to the hospital for one or more days to receive antibiotics through the vein and/or other care like IV fluids and oxygen.  

If you are >65 years old, have other diseases such as diabetes or chronic lung disease, or take prednisone, your risk may be higher.  If you are young and healthy your risk may be lower.  Orencia should not be taken by persons with HIV (Human Immunodeficiency Virus).

If you choose to take Orencia you have an added chance of about 2-3% each year of having a serious infections.  Another way to look at this is to see if 100 patients take Orencia. 


The outcomes of 100 patients treated with Orencia for 1 year


Chronic Infections

Chronic Infection

 Orencia can also lead to worsening of chronic infections.  Chronic infections are infections that begin slowly and can last for many years.  If Orencia is used in a person with a chronic infection, the body’s ability to control this infections can be reduced, resulting in the spread of the infections throughout the body.

Hepatitis B and C viruses are two examples of chronic infections.  These liver infections can occur for years, with very small amounts of virus present.  The safety of Orencia for people with hepatitis B or C is not fully known.  If you have hepatitis B or C, you and your doctor should decide together whether or not you should use Orencia.

Other chronic infections also make it unsafe to use Orencia.  If you have chronic skin ulcers, bone infections or another ongoing chronic infections, it is important that your doctor knows this.  These types of infections must be completely removed from your body before treatment with Orencia is safe.

Latent Infections

Latent Infection

Latent infections are inactive (or sleeping) infections that can be awakened by RA therapy.  A person with a latent infections probably does not have any symptoms of infections.  An example of a latent infection is tuberculosis, or TB.  Latent TB “sleeps” in a person;e lungs, walled off by your body’s immune system.  The TB bacteria can awake if someone is given treatments (like TNF blockers) that reduce the activity of the immune system.  If TB wakes up, it becomes active and can spread to other parts of the body.  This can be a danger to you and others.  You could infect people around you- like your family or co-workers- because TB is spread through the air.

Orencia has not been known to awaken latent/sleeping TB.  But because other biologics (TNF blockers) have been reported to awaken TB, the American College of Rheumatology suggests all people who take Orencia get screened for TB before starting a while taking Orencia.

If you have a positive TB skin test and you choose to take Orencia and you do not take a preventative therapy, it is possible the chance of TB becoming active is increased.  If you do take a preventative therapy, the chance of TB becoming active is very small.


The two fungal infections, coccidioidomycosis (or Valley Fever) and histoplasma, also ‘sleep’ in your body and can be awoken if you take TNF blockers.  Histoplasma is a common infection in the Indiana/Ohio river valleys, but is can also occur in surrounding states, like parts of MIchigan.  Valley Fever is common in Arizona and southern California.  You can get these infections if you inhale dust from the soil of areas where these fungi live.  If you inhale the fungi, it enters your lungs.

Immune Reactions

Although Orencia can be used to treat diseases like RA rarely, protein treatments- like TNF blockers or Orencia - activate the body’s defense (immune) system.  A reaction like this can become a serious problem.  It is not known how often this occurs, but it appears this is less frequent with Orencia than TNF blockers.  This is still being studied by doctors.  For more information about specific TNF blockers see the manufacturers’ medication guide.


Other Side Effects

People with RA have an increased risk of developing lymphoma.  It is not known what effect Orencia has on this risk.  In clinical trials of Orencia, there were unexpected cases of lung cancer.  The Federal Drug Association (FDA) has been monitoring this drug since its approval in 2005.  Throughout the monitoring process, the FDA has not expressed any increased concern about Orencia causing lung cancer.  Research is still being done to help understand the relationship between Orencia and cancers.

Orencia can interfere with the readings of some blood glucose monitors.  If you use a blood glucose monitor you should check with your doctor about what types of monitors should not be used.

Be sure to let your doctor know if you have chronic lung disease, or COPD.  Orencia has been known to cause worsening of COPD and/or pneumonia in patients with COPD.


Advice for Reducing Serious Side Effects

Suggestions for the safe monitoring of Orencia have been made by the College of Rheumatology.  While this will not prevent all problems, if you follow these guidelines you will likely detect problems earlier.  This should help your doctor to make adjustments and reduce serious side effects.


Sorting it Out

Sorting It Out

This is a good time to think back about what you know about your options and what is most important to you. While you might think the choice you face is simply whether or not to take Orencia, there are at least 5 options available.


How do you make hard decisions?

How do you make hard decisions?

When making hard decisions it is sometimes helpful to see how others went about choosing what was best for them. 

Consider the people below. Do any of them approach decision making like you? When making hard decisions it is sometimes helpful to see how others went about choosing what was best for them. 


Weighing the Facts

Earlier we outlined possible benefits and side effects from taking LEF.

Possible Benefits

Possible Benefits

  •   Less pain, stiffness and fatigue
  •   Improve physical function
  •   Reduce progression of joint damage
  •   Prevent complications of active RA
  •   Use less prednisone (steroids)


Possible Side Effects

Possible Side Effects

  • Infusion or injection site reactions
  • Serious infection
  • Immune reactions
  • Worse COPD - emphysema if you already have it
  • Unknowns about lung cancer

Are any of these especially important to you?

What matters most to Me? 

What Matters Most to Me?

Of the risks and benefits, are you clear what are most important to you?  While is it possible that you will not experience any of the side effects in this brochure, it is important to think about how you would feel if you did.

The table below lists some of the benefits and risks  of therapy.  In your mind rate how much each of these matter to you if they were to occur.


Moving Towards              a Decision

Moving Towards a Decision 

Now that you know more about TNF and have considered what is most important to you about the decision, are you leaning towards a particular choice? 

Some people find listing the pros and cons makes the decision clearer. Try creating a table like the one below and filling it out to sort out what matters most to you.

Conclusion 

Conclusion

Orencia is a powerful medicines that can help control RA, but there are risks taking it.  Because RA is a chronic disease, you may need to take a Orencia for years.  This will mean that is you choose to take a Orencia you will have to be committed to taking the medicine and monitoring its safety.  Fortunately rheumatologists have of experience using Orencia in RA, and it can be used safely in most people.



Reflecting on your decision

Reflecting on your decision

As you work towards making a decision about TNF, decide whether these statements are true for you

  • I know the options
  • I am informed about the benefits and harms of treatment.
  • The doctor gave me a chance to be involved in the decision.
  • I feel an informed choice was made.
  • I will have the support I need to get, take and monitor the safety of the new medicine.

If most or all of these statements are true for you, you are on your way to a good decision. 

If not, you may want to talk further with your doctor, nurse, family or other important support persons.


Check what you know about Orencia with these questions

Where can I get more information?



Facts and numbers behind this decision aid

Sources of data

  1. Donahue KE. Systematic Review: Comparative Effectiveness and Harms of Disease-Modifying Medications for Rheumatoid Arthritis. Annals Intern Med 2008;148:124-134.
  2. Maxwell L, Singh JA. Abatacept for rheumatoid arthritis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD007277.
  3. Singh JA et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis.  Arthritis Care Res (Hoboken). 2012 May;64(5):625-39    
  4. Clinical experts such as rheumatology physicians and nurses when published sources were absent or conflicting. 

Reading level: SMOG: 9.9

Content Editor: Richard W. Martin, M.D., M.A. Professor of Medicine, Rheumatology. Michigan State University, College of Human Medicine. Author disclosure: No conflict to report.


Co-investigators: P Gallagher BS, A Head MD, A Eggebeen MD, J Birmingham MD.  

Technical and creative consultants:  R. Jelsema, Brennan Martin, Josh Quinn.

Acknowledgments:  The development of this patient decision was inspired by the work of a number influential basic and applied decision scientists.  We wish to acknowledge: Annette O’Connor PhD, John Wennberg, MD, Margaret Holmes-Rovner, PhD, Hillary Bekker, PhD, Gerd Giggerenzer, PhD, Timothy Wilson, PhD, Peter Ubel, MD, Adrian Edwards, MD and Glyn Elwyn, MD.


Funding:  This decision aid was developed, evaluated and published solely with private funds.  


Year of last update or review: 2012.


Copyright 2012 

West Michigan Rheumatology, PLLC 

1155 East Paris Ave. SE, Suite #100
Grand Rapids, MI 49546 

616-459-8088

www.mi-arthritis.com

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