Clinical Results

Clinical Study Results for Moderate to Severe Rheumatoid Arthritis Patients Taking CIMZIA

When your rheumatoid arthritis (RA) is active, inflammation is occurring, causing joint pain and stiffness. Ongoing inflammation can also cause damage to your joints. Inflammation is caused by excess tumor necrosis factor (TNF), a protein produced by the immune system. CIMZIA is a prescription medication that is injected under the skin and targets TNF, providing noticeable relief from the joint pain and stiffness of moderate to severe RA.

Results varied from patient to patient, but in clinical trials with CIMZIA, many patients with moderate to severe rheumatoid arthritis experienced noticeable relief of their RA symptoms compared to patients taking a placebo.

  • Noticeable RA relief: In clinical trials, about six out of every 10 patients who received CIMZIA experienced noticeable RA symptom relief including improvement in pain, swelling, and tenderness.
  • The majority of patients noticed results within 24 weeks, with some patients reporting improvement in as fast as one to two weeks.
  • Stopped further joint damage for most patients as shown by their X-rays at both six months and one year in a clinical trial versus patients in a control group.
  • Improvement in common everyday activities: In clinical trials, patients on CIMZIA reported improvement in everyday activities such as showering, getting dressed, doing chores, walking short distances, and running simple errands.

The results from these clinical trials were based on patients who received the recommended starter and maintenance doses of CIMZIA.

Every patient is different and responds differently to therapy—so your results may vary. Talk to your doctor to see if CIMZIA may be right for you.

Clinical Study Results for Psoriatic Arthritis Patients Taking CIMZIA

When your psoriatic arthritis (PsA) is active, inflammation is occurring, which can cause joint pain, stiffness, and skin lesions. Ongoing inflammation can also cause damage to your joints. CIMZIA works by blocking the action of tumor necrosis factor (TNF), a protein produced by the immune system that causes inflammation. CIMZIA is a prescription medication that is injected under the skin and targets TNF, providing noticeable relief from the joint pain, stiffness, and skin symptoms of PsA.

Results vary from patient to patient, but in a clinical trial, the majority of patients taking CIMZIA with active psoriatic arthritis experienced noticeable relief of their PsA symptoms compared to patients taking a placebo.

  • Noticeable PsA relief: In a clinical trial, most people who took CIMZIA experienced relief from the joint pain and tenderness of PsA within 12 weeks and some in as fast as one to two weeks after their first dose versus placebo.
    • Skin improvement: The majority of patients who had active skin involvement reported 75% skin improvement by 24 weeks.
  • Improvement in everyday activities: In the same clinical trial, CIMZIA made it easier to perform many common daily activities, such as running errands, getting dressed, and getting in and out of a car.

The results from the clinical trial were based on patients who received the recommended starter and maintenance doses of CIMZIA.

Every patient is different and responds differently to therapy—so your results may vary. Talk to your doctor to see if CIMZIA may be right for you.

Clinical Study Results for Ankylosing Spondylitis Patients Taking CIMZIA

When your ankylosing spondylitis (AS) is active, inflammation is occurring, which may cause damage to the joints of the spine and, in some patients, other parts of the body. While the root cause of AS is unknown, too much of a protein called tumor necrosis factor (TNF) can contribute to the inflammation that occurs. CIMZIA works by blocking the action of TNF.

Results vary from patient to patient, but in a clinical trial with CIMZIA, the majority of patients with active ankylosing spondylitis experienced relief of their AS symptoms compared to patients taking a placebo.

  • Noticeable AS relief: In a clinical trial, CIMZIA was proven versus placebo to provide noticeable AS symptom relief, including improvements in morning stiffness, tenderness, and inflammatory back pain, for the majority of patients after 12 weeks and for some in as fast as one to two weeks.
  • Reduced AS disease activity: In the same clinical trial, CIMZIA reduced AS disease activity after 12 weeks, including improvements in pain, stiffness, tenderness, and fatigue, versus placebo.
  • Improvement in common activities: In the same clinical trial, patients on CIMZIA after 12 weeks reported improvement in doing certain common activities, such as looking over the shoulder without turning the body, putting on socks without help, bending from the waist to pick up a pen from the floor without help, or gardening.

The clinical study results above were based on patients who received the recommended starter and maintenance doses of CIMZIA.

Every patient is different and responds differently to therapy—so your results may vary. Talk to your doctor to see if CIMZIA may be right for you.

Clinical Study Results for Crohn’s Disease Patients Taking CIMZIA

When your moderate to severe Crohn’s disease (CD) is active, inflammation occurs in the digestive tract, causing symptoms such as diarrhea and stomach pain. CIMZIA works by blocking the action of tumor necrosis factor (TNF), a protein produced by the immune system that causes inflammation. CIMZIA may be right for you when other conventional treatments have not worked.

In a clinical trial, CIMZIA was proven versus placebo to provide noticeable symptom relief for the majority of patients who continued to take CIMZIA for 26 weeks of treatment versus placebo. In another clinical trial, some patients experienced noticeable symptom relief in as fast as six weeks.

The clinical study results above were based on patients who received the recommended starter and maintenance doses of CIMZIA.

Every patient is different and responds differently to therapy—so your results may vary. Talk to your doctor to see if CIMZIA may be right for you.

Your safety is important to us. Learn about our Important Safety Information.

Important Safety Information You Should Know About CIMZIA® (certolizumab pegol)

What is the most important information I should know about CIMZIA?

CIMZIA is a medicine that affects your immune system. CIMZIA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking CIMZIA, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections.

  • Your healthcare provider should test you for TB before starting CIMZIA.
  • Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with CIMZIA.

You should not start receiving CIMZIA if you have any kind of infection unless your healthcare provider says it is okay.

Before you receive CIMZIA, tell your healthcare provider if you:

  • think you have an infection, flu-like symptoms, or have any other symptoms of an infection such as: 
    • fever, sweat, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinate more often than normal
    • feeling very tired 
  • are being treated for an infection, or get a lot of infections or have infections that keep coming back
  • have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • have tuberculosis (TB), or have been in close contact with someone with TB
  • were born in, lived in, or traveled to countries where there is more risk of getting TB. Ask your healthcare provider if you are not sure.
  • live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may develop or become more severe if you take CIMZIA. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your healthcare provider.
  • have or have had hepatitis B
  • use the medicine Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), or Tysabri® (natalizumab)

After starting CIMZIA, if you get an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your healthcare provider right away. CIMZIA can make you more likely to get infections or make any infection that you may have worse.

Cancer

  • For people taking TNF-blocker medicines, including CIMZIA, the chances of getting lymphoma or other cancers may increase.
  • There have been cases of cancers in children, teenagers, and young adults who received TNF-blocker medicine that do not usually happen in people this age. CIMZIA is not approved for use in pediatric patients. People with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
  • Some people receiving TNF-blocker medicines, including CIMZIA, have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers and young males with Crohn’s disease or ulcerative colitis. Also, most of these people had been treated with both a TNF-blocker medicine and another medicine called IMURAN® (azathioprine) or PURINETHOL® (6-mercaptopurine, 6-MP).
  • If you use TNF-blocker medicine, including CIMZIA, your chance of developing certain kinds of skin cancer may increase. Tell your healthcare provider if any changes in the appearance of your skin, including growths on your skin, happen during or after your treatment.

What is CIMZIA?

CIMZIA is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. CIMZIA is used in adult patients to:

  • Lessen the signs and symptoms of moderately to severely active Crohn’s disease (CD) in patients who have not been helped enough by usual treatments.
  • Treat moderately to severely active rheumatoid arthritis (RA).
  • Treat active psoriatic arthritis (PsA).
  • Treat active ankylosing spondylitis (AS).

What should I tell my healthcare provider before starting treatment with CIMZIA?

CIMZIA may not be right for you. Before starting CIMZIA, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection
  • have or have had any type of cancer
  • have congestive heart failure
  • have seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis
  • are scheduled to receive a vaccine. Do not receive a live vaccine while taking CIMZIA.
  • are allergic to any of the ingredients in CIMZIA.
  • are pregnant or planning to become pregnant. It is not known if CIMZIA will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving CIMZIA.
    Pregnancy Registry: If you become pregnant while taking CIMZIA, talk to your healthcare provider about registering in the pregnancy exposure registry for CIMZIA. You can enroll in this registry by calling 1-877-311-8972. The purpose of this registry is to collect information about the safety of CIMZIA during pregnancy.
  • are breastfeeding or plan to breastfeed. It is not known if CIMZIA passes into your breast milk. You and your healthcare provider should decide if you will receive CIMZIA or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take the following medicines due to a higher chance for serious infections:

  • Kineret® (anakinra), Orencia® (abatacept), Rituxan® (rituximab), or Tysabri® (natalizumab)
  • medicines called Tumor Necrosis Factor (TNF) blockers, such as Remicade® (infliximab), Humira® (adalimumab), Enbrel® (etanercept), or Simponi® (golimumab)

Ask your healthcare provider if you are not sure. You should not take CIMZIA while you take any of these medicines.

How should I receive CIMZIA?

CIMZIA comes as a lyophilized powder or a solution in a prefilled syringe for injection. If your healthcare provider prescribes the CIMZIA powder, CIMZIA should be injected by a healthcare provider. If your healthcare provider prescribes the prefilled syringe, you will be trained on how to inject CIMZIA. See the booklet called “Instructions for Use” packaged in your CIMZIA prefilled syringe kit for complete instructions for use. Do not give yourself an injection of CIMZIA unless you have been shown by your healthcare provider, or they can train someone you know to help you with your injection. CIMZIA is given by an injection under the skin. Your healthcare provider will tell you how much and how often to inject CIMZIA. Do not use more CIMZIA or inject more often than prescribed.

What are the possible side effects of CIMZIA? CIMZIA can cause serious side effects including:

  • Heart Failure including new heart failure or worsening of heart failure you already have. Symptoms include shortness of breath, swelling of your ankles or feet, or sudden weight gain.
  • Allergic Reactions. Signs of an allergic reaction include a skin rash, swelling or itching of the face, tongue, lips, or throat, or trouble breathing.
  • Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your healthcare provider should monitor you carefully before and during treatment with CIMZIA to see if you carry the hepatitis B virus in your blood. Tell your healthcare provider if you have any of the following symptoms:
    • feel unwell
    • skin or eyes look yellow
    • tiredness (fatigue)
    • poor appetite or vomiting
    • pain on the right side of your stomach (abdomen)
  • New or worsening nervous system problems, such as multiple sclerosis (MS), Guillain-Barre syndrome, seizures, or inflammation of the nerves of the eyes. Symptoms may include:
    • dizziness
    • numbness or tingling
    • problems with your vision
    • weakness in your arms or legs
  • Blood Problems. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
  • Immune reactions including a lupus-like syndrome. Symptoms include shortness of breath, joint pain, or a rash on the cheeks or arms that worsens with sun exposure.

Call your healthcare provider right away if you have any side effects listed above.

The most common side effects of CIMZIA include: upper respiratory infections (flu, cold), rash, and urinary tract infections (bladder infections).

Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all of the possible side effects of CIMZIA. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the Medication Guide for CIMZIA and discuss it with your healthcare provider.