ORENCIA is indicated for moderate to severe rheumatoid arthritis (RA):

ORENCIA has a heritage you can trust

When your doctor prescribes ORENCIA, you will receive an established moderate to severe RA treatment backed by clinical and real-world experience. Although every patient is unique, ORENCIA has a legacy of treating patients like you. You are not alone.

More than 20 years of treating RA

More than
500,000 people
treated in the US

14 clinical trials

#1 prescribed IV
RA treatment
in the US

Portrait of Betsy, a real patient taking ORENCIA®.

I’ve had RA since 1997 and had a hip replacement before there were biologic treatments. I struggled with RA before starting ORENCIA years ago. Since then, I've done all sorts of things that I couldn't do before because of my symptoms.

Betsy: a real patient taking ORENCIA for moderate to severe RA

Patients shown were compensated for their time. Your results may vary.

About ORENCIA: How it works

How ORENCIA® affects T cells to help treat rheumatoid arthritis (RA) by blocking signals that lead to joint damage.

Still nothing similar: ORENCIA was the first and is the only treatment of its kind in moderate to severe RA

There are different drug classes in RA, including other biologic drugs, but ORENCIA works differently than these other treatments by preventing T cells, at a key point in the immune cycle, from sending harmful signals to your joints.

No biosimilar available*

Unlike some RA treatments, ORENCIA does not have an approved biosimilar. When your doctor prescribes ORENCIA, you'll get exactly what they prescribed.

How it works

RA is a vicious cycle, but ORENCIA can help break the cycle early by targeting the T cells directly

T cells are important because they tell your immune system to react when there is an outside invader in your body. In RA, your own cells are seen as invaders. Once identified, your body activates your T cells to attack your cells, resulting in inflammation in your body.

ORENCIA disrupts T cell activation and prevents sending 2 kinds of signals (autoantibodies and cytokines) that act in different ways to trigger a response in your joints. It is not known how blocking T cells helps with moderate to severe RA symptoms.

Some RA treatments focus only on cytokines or autoantibodies. If you are taking ORENCIA, you know you are being treated with a different approach.

*	According to the Food and Drug Administration (FDA) Biosimilar Product Information page. Valid as of November 27, 2024.

ORENCIA clinical study results

Proven to reduce moderate to severe RA symptoms and joint swelling

ORENCIA at 1 and 5 years

This study showed how well ORENCIA IV worked in adults with moderate to severe RA who weren’t helped enough by methotrexate alone. In the 1-year portion of the study, 424 people with moderate to severe RA took ORENCIA with methotrexate and their results were compared to 214 people who took methotrexate alone. These data were included in the ORENCIA Prescribing Information.

Those who continued in a 4-year extension study (539 people) all took ORENCIA. Patients and physicians were aware of ORENCIA treatment, which may have influenced their results.

At 6 months

Reduced symptoms

Most people saw at least a 20% reduction in RA symptoms^†
- 68% of people taking ORENCIA and methotrexate hit this treatment goal
- 40% of people taking methotrexate alone reached this treatment goal

Reduced pain^‡

Pain was reduced by 40 points on a 100-point scale in people who took ORENCIA with methotrexate (from 67 to 27)
Pain was reduced by 20 points on a 100-point scale in people who took methotrexate alone (from 70 to 50)

At 1 year

Reduced further joint damage

ORENCIA and methotrexate reduced further joint damage by 56% compared to methotrexate alone, based on X-ray scores (1.07 vs 2.43)

Improved symptoms enough to impact the ability to perform everyday activities

64% of people saw an improvement in physical function at 1 year*

with ORENCIA and methotrexate compared with 39% of people taking methotrexate alone, based on activity scores.

31.4% of people (116/369) taking ORENCIA met the study’s goal for physical function at 1 year

and 74.2% of those people (66/89) continued to meet that physical function goal at 5 years.

Results were based on a survey of people assessing their own abilities:

Dressing & grooming

Getting out of bed

Grip

Walking

Eating

Hygiene

Common daily activities

Reaching

In patients for whom health factor data was available,

38% of people in this study had at least 1 other health factor

The most common was high blood pressure (22%).

*	Physical function was assessed using a questionnaire about dressing and grooming, arising, eating, walking, hygiene, grip, and common daily activities.
^†	Based on an improvement score that combined multiple scores for: joint swelling and tenderness, pain, disability, inflammation, and both patient and doctor assessments.
^‡	Based on a 100-point scale with 0 indicating the least amount of pain and 100 indicating the worst amount of pain.

Dive into more study details

To join this study, participants needed to meet the following criteria:

At least 18 years old
Diagnosed with RA at least 1 year ago
Living with active and persistent RA, despite treatment with methotrexate
Treated with methotrexate for at least 3 months
10 or more swollen joints, 12 or more tender joints

Here are some facts about the people taking ORENCIA  in this trial:

Average age of 52 years
Had RA for an average of 8 ½ years

In patients for whom health factor data were available:

40% of people taking ORENCIA had other health conditions
The most common other health condition was high blood pressure (22%)

Did they take other medications with ORENCIA?

All people continued taking methotrexate, but stopped taking other disease-modifying anti-rheumatic drugs (DMARDs) before beginning the study. The people were randomly assigned into 2 groups. In the study, 424 participants originally received ORENCIA IV with methotrexate and 214 participants received methotrexate only. Neither group of people knew which of the groups they were placed in. Their doctors did not know either. After 1 year, if people wished to continue in the long-term study they were all moved into the ORENCIA with methotrexate group. In the long-term study, 539 people received ORENCIA IV with methotrexate. Patients and physicians were aware of ORENCIA treatment, which may have influenced their results.

Safety data from this trial were consistent with results included in the combined safety profile for ORENCIA shown below.

Shown to deliver results in people who weren’t helped enough by TNF blockers

This study compared ORENCIA IV and DMARDs* to DMARDs alone in adults with moderate to severe RA who weren’t helped enough by a different type of RA treatment called TNF blockers. In the study, 256 people with moderate to severe RA took ORENCIA and non-biologic DMARDs, and 133 people took non-biologic DMARDs alone. Previous treatment with TNF blockers included Humira^® (adalimumab), Enbrel^® (etanercept), and Remicade^® (infliximab).

*	DMARDs are disease-modifying anti-rheumatic drugs that doctors usually try before prescribing ORENCIA and could choose to continue as background therapy.

At 6 months

Reduced symptoms

Most people saw at least a 20% reduction in RA symptoms^†
- 50% of people felt symptom relief with ORENCIA and DMARDs compared with 20% of people taking DMARDs alone, a difference of 30%

Reduced pain

30% pain reduction with ORENCIA and DMARDs
That's triple the pain reduction of DMARDs alone (10%)

Improved physical function^‡

47% of people saw an improvement in physical function with ORENCIA and DMARDs compared with 23% of people taking DMARDs alone based on activity scores.

In patients for whom health factor data was available,

55% of people in this study had at least 1 other health factor

The most common was high blood pressure (36%).

^†	Based on an improvement score that combined multiple scores for: joint swelling and tenderness, pain, disability, inflammation, and both patient and doctor assessments.
^‡	Physical function was assessed using a questionnaire about dressing and grooming, arising, eating, walking, hygiene, grip, and common daily activities.

Dive into more study details

To join this study, participants needed to meet the following criteria:

At least 18 years old
Diagnosed with RA at least 1 year ago
Living with active RA
Weren’t helped enough by TNF blockers after at least 3 months of treatment
10 or more swollen joints, 12 or more tender joints

Here are some facts about the people taking ORENCIA in this trial:

Average age of 53 years
12.2 years average time since RA diagnosis in people taking ORENCIA
55% of people taking ORENCIA had other health conditions
- The most common other health condition was high blood  pressure (38%)

The 389 people in this study were randomly placed into 2 groups to compare their responses to treatment. One group of 256 people received ORENCIA with DMARDs, and the other group of 133 people received DMARDs alone.

Safety data from this trial were consistent with results included in the combined safety profile for ORENCIA shown below.

Be patient. Many ORENCIA patients started having symptom improvement in about 6 months.

It's important to know that it may take time to see if the treatment is working within your immune system, and for symptom improvement to become noticeable. While some people taking ORENCIA saw a response within 15 or 29 days, most people began to feel their symptoms improving at 6 months (68%) compared to 40% of placebo patients.

Remember that ORENCIA works on your joints by targeting your immune system.

ORENCIA Side Effects & Safety Profile

The safety of intravenous (IV) treatment with ORENCIA in people with moderate to severe RA was compared to a placebo control group across:

6	key clinical trials

A broad group
of nearly

3000

people

Most common side effects

This chart shows side effects reported by at least 3% of people, out of a total of 1955 who received ORENCIA and 989 who received a placebo, and that occurred more than 1% more frequently in people taking ORENCIA at 6 months or 1 year. This is not a complete list of ORENCIA side effects. Serious side effects may occur. Call your rheumatologist for medical advice. You may report side effects to the FDA at 1-800-FDA-1088.

In some of these studies, doctors could choose to use disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate, as background therapy along with ORENCIA or placebo.

*	A placebo is a pill with no medicine.

Frequently asked questions (FAQs) about the safety of ORENCIA

Is routine lab monitoring required with ORENCIA?

No. Taking ORENCIA does not require regular lab tests. However, if you have diabetes and already use a blood glucose monitor to check your blood sugar (blood glucose) levels, and you are prescribed the IV (intravenous) form of ORENCIA, your healthcare provider may tell you to use a different way to monitor your levels. This is because the IV version of ORENCIA contains maltose, a type of sugar, that may give a false high blood sugar reading with certain types of monitors.

What are the most common side effects in RA?

The most common side effects of ORENCIA include:

Headache
Upper respiratory tract infection
Sore throat (nasopharyngitis)
Nausea

These are not all of the possible side effects of ORENCIA. If you have any questions or want more information about side effects, ask your rheumatologist or healthcare provider.

If you experience any side effects and would like to report them to the FDA, you can call 1-800-FDA-1088.

What is considered a serious side effect?

Serious side effects are those that may require medical treatment or hospitalization, cause permanent damage, or be life-threatening or sometimes even fatal. Talk to your healthcare provider about any concerns you may have.

How can I tell if I have an infection?

ORENCIA can make you more likely to get infections or make the infections that you have worse. In some cases, these infections have been fatal. Symptoms of an infection include:

Fever
Cough
Warm, red, or painful skin
Feeling very tired
Flu-like symptoms

Call your healthcare provider right away if you feel sick or have any of the symptoms of an infection.

How can I tell if I'm having an allergic reaction?

Allergic reactions can happen with ORENCIA. Symptoms of an allergic reaction may include:

Hives
Swollen face, eyelids, lips, or tongue
Trouble breathing

Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction.

What should I do if I am a carrier of the hepatitis B virus?

Talk to your healthcare provider as hepatitis B can become an active infection while you use ORENCIA. Your healthcare provider may do a blood test before treatment with ORENCIA.

Is it OK to receive vaccinations while taking ORENCIA?

It is important to know that:

You should not receive live vaccines while taking ORENCIA
You can receive non-live vaccines, such as pneumococcal and inactivated influenza (flu) vaccines
ORENCIA may also cause some other vaccinations to be less effective

Talk to your healthcare provider about your vaccination plans.

Should I take any extra precautions if I have chronic obstructive pulmonary disease (COPD)?

You may experience breathing problems more often while taking ORENCIA. Symptoms may include:

Worsened COPD
Cough
Trouble breathing

Call your healthcare provider if you experience any of these symptoms.

Does ORENCIA have a boxed warning?

ORENCIA does not have a required “Boxed Warning,” which is the strongest warning the FDA requires, although ORENCIA has Warnings and Precautions. Talk to your healthcare provider about all of your medical conditions, including if:

You have any kind of infection, as you may have a higher chance of getting serious side effects from an infection while taking ORENCIA. Infections include:
- Small infections (such as an open cut or sore) to whole body infections (such as the flu)
- Any infection that will not go away or a history of infections that keep coming back
- Viral hepatitis, a viral infection that affects the liver. Tell your healthcare provider if you have or have ever had viral hepatitis. Before starting ORENCIA, your healthcare provider may examine you for hepatitis
- Tuberculosis (TB), a type of lung infection. Tell your healthcare provider if you have ever had TB or a positive skin test for TB, or have recently been in close contact with someone who has ever had TB. Before starting ORENCIA, your healthcare provider may check you for TB or do a skin test. Call your healthcare provider if you notice any symptoms of TB, including: a cough that does not go away, weight loss, fever, or night sweats
You have allergies to the ingredients of ORENCIA. For a list of ingredients, see What are the ingredients in ORENCIA? in the Patient Information section of the Full Prescribing Information
You have Chronic Obstructive Pulmonary Disease (COPD), a type of lung disease
You have diabetes and use a blood glucose monitor to check your blood sugar (blood glucose) levels
- ORENCIA for IV (given through a needle placed in a vein) contains maltose, a type of sugar, that can give false high blood sugar readings with certain types of blood glucose monitors on the day of ORENCIA infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels
- ORENCIA for SC injection (injected under the skin) does not contain maltose. You do not need to change your blood sugar monitoring if you are using ORENCIA subcutaneously
You have a family or personal history of skin cancer, or see any growths or changes in the appearance of your skin during or after treatment with ORENCIA. Some people treated with ORENCIA have developed skin cancer

Is there a link between ORENCIA and cancer?

When people in clinical trials develop serious conditions, such as cancer, it is reported so investigators can look out for other cases.

Certain kinds of cancer (malignancies) have been reported in people using ORENCIA. It is not known if ORENCIA increases your chances of developing certain kinds of cancer.

Your time is now
Don’t wait to talk to your doctor

If you aren’t sure that your current treatment is right for you, now is the time to talk to your doctor about ORENCIA. Make sure to talk about your moderate to severe RA, your other health conditions, and your individual treatment goals.

Support at every step

You don’t have to go through treatment alone, because ORENCIA On Call^™ is here to help.

ORENCIA® On Call™ can help patients pay as little as $5 per month for Orencia® medication.