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Symptoms of humira. Understanding HUMIRA for Crohn’s Disease: Efficacy, Safety, and Treatment Guidelines

by alexxlab

What is HUMIRA and how does it treat Crohn’s disease. What are the potential side effects of HUMIRA. Who should consider HUMIRA as a treatment option. How is HUMIRA administered for Crohn’s disease. What precautions should be taken when using HUMIRA. How effective is HUMIRA in managing Crohn’s disease symptoms. What are the long-term considerations for HUMIRA use.

Содержание

What is HUMIRA and Its Role in Treating Crohn’s Disease?

HUMIRA (adalimumab) is a prescription medication used to treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older. As a TNF blocker, HUMIRA works by targeting specific components of the immune system that contribute to inflammation in Crohn’s disease.

HUMIRA’s efficacy in managing CD symptoms has made it a valuable treatment option for many patients. By reducing inflammation in the digestive tract, it can help alleviate common CD symptoms such as abdominal pain, diarrhea, and weight loss.

How does HUMIRA work?

HUMIRA functions by blocking tumor necrosis factor-alpha (TNF-α), a protein involved in the inflammatory process. By inhibiting TNF-α, HUMIRA helps reduce inflammation in the gastrointestinal tract, potentially leading to symptom relief and improved quality of life for CD patients.

Safety Considerations and Potential Side Effects of HUMIRA

While HUMIRA can be effective in treating Crohn’s disease, it’s crucial to understand the potential risks and side effects associated with its use. The most important safety information relates to the increased risk of infections and certain types of cancer.

Infection risks

Patients should not start HUMIRA if they have any kind of active infection unless their doctor approves. Serious infections, including tuberculosis (TB) and infections caused by viruses, fungi, or bacteria, have been reported in people taking HUMIRA. Some of these infections have been fatal.

  • TB screening is required before starting HUMIRA
  • Doctors should monitor patients closely for signs and symptoms of TB during treatment
  • Preventive treatment for TB may be necessary for some patients

Cancer risks

For both children and adults taking TNF blockers like HUMIRA, there may be an increased chance of developing lymphoma or other cancers. Rare cases of unusual cancers have been reported in children, teenagers, and young adults using TNF blockers.

A rare and often fatal type of cancer called hepatosplenic T-cell lymphoma has been observed in some patients using TNF blockers. Additionally, the risk of certain skin cancers (basal cell and squamous cell carcinoma) may increase with HUMIRA use.

Who Should Consider HUMIRA for Crohn’s Disease Treatment?

HUMIRA is typically prescribed for patients with moderate to severe Crohn’s disease who have not responded adequately to other treatments or who have lost response to previous therapies. The decision to use HUMIRA should be made in consultation with a gastroenterologist, taking into account the patient’s individual circumstances, disease severity, and potential risks.

Ideal candidates for HUMIRA treatment

  • Patients with moderate to severe CD not responding to conventional therapies
  • Individuals who have experienced a loss of response to other biologics
  • Patients without active infections or a history of recurrent infections
  • Those without a personal or family history of certain cancers

It’s essential for patients to have a thorough discussion with their healthcare provider about their medical history, current health status, and potential risks before starting HUMIRA treatment.

HUMIRA Administration and Treatment Protocol for Crohn’s Disease

HUMIRA is typically administered via subcutaneous injection. The treatment protocol for Crohn’s disease usually involves an initial loading dose followed by regular maintenance doses.

Typical HUMIRA dosing schedule for CD

  1. Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days)
  2. Second dose (Day 15): 80 mg
  3. Maintenance dose (starting at Day 29): 40 mg every other week

Some patients may require dose escalation to 40 mg every week if they do not respond adequately to the standard maintenance dose. The exact dosing schedule may vary based on individual patient needs and should be determined by the prescribing physician.

Self-administration of HUMIRA

Many patients can learn to self-administer HUMIRA injections at home after proper training from a healthcare professional. This can provide greater convenience and flexibility in managing their treatment regimen.

Precautions and Considerations When Using HUMIRA

Before starting HUMIRA, patients should inform their doctor about all health conditions, especially:

  • Current infections or history of recurrent infections
  • Diabetes
  • Tuberculosis (TB) or close contact with someone who has TB
  • Living in or having traveled to areas with increased risk of certain fungal infections
  • Nervous system problems like multiple sclerosis or Guillain-Barré syndrome
  • Heart failure or other heart conditions
  • Recent or scheduled vaccines
  • Pregnancy or plans to become pregnant
  • Breastfeeding or plans to breastfeed

Patients should also disclose all medications, including over-the-counter drugs, vitamins, and herbal supplements, as some may interact with HUMIRA.

Efficacy of HUMIRA in Managing Crohn’s Disease Symptoms

Clinical studies have demonstrated the effectiveness of HUMIRA in inducing and maintaining remission in patients with moderate to severe Crohn’s disease. Many patients experience significant improvement in symptoms and quality of life with HUMIRA treatment.

Key efficacy findings

  • Induction of clinical remission in a significant proportion of patients
  • Maintenance of remission in long-term studies
  • Reduction in corticosteroid use for many patients
  • Improved mucosal healing in some patients
  • Enhanced quality of life scores in clinical trials

Individual responses to HUMIRA can vary, and some patients may experience better results than others. Regular follow-ups with a healthcare provider are essential to monitor treatment efficacy and adjust the regimen if necessary.

Long-term Considerations for HUMIRA Use in Crohn’s Disease

While HUMIRA can be an effective long-term treatment option for many Crohn’s disease patients, there are several factors to consider for extended use:

Ongoing monitoring

Regular check-ups and lab tests are crucial to monitor for potential side effects and ensure continued treatment efficacy. This may include:

  • Routine blood tests to check liver function and blood cell counts
  • Periodic screening for tuberculosis
  • Skin examinations to check for potential skin cancers
  • Monitoring for signs of infection or other adverse effects

Potential for loss of response

Some patients may experience a diminished response to HUMIRA over time. This can be due to the development of antibodies against the medication or other factors. In such cases, dose adjustments or switching to alternative treatments may be necessary.

Pregnancy and breastfeeding considerations

Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the potential risks and benefits of HUMIRA use with their healthcare provider. While limited data suggest that HUMIRA may be safe during pregnancy, individual circumstances must be carefully evaluated.

Combining HUMIRA with Other Crohn’s Disease Treatments

HUMIRA may be used alone or in combination with other medications to manage Crohn’s disease. The optimal treatment approach can vary depending on individual patient factors and disease characteristics.

Common combination therapies

  • HUMIRA with immunomodulators (e.g., azathioprine, 6-mercaptopurine)
  • HUMIRA with corticosteroids (typically during the induction phase)
  • HUMIRA with topical treatments for perianal disease

The decision to use combination therapy should be made in consultation with a gastroenterologist, considering the potential benefits and risks for each patient.

Monitoring combination therapy

When using HUMIRA in combination with other medications, closer monitoring may be required to assess for potential drug interactions and cumulative side effects. Regular communication between the patient and healthcare team is crucial to optimize treatment outcomes and minimize risks.

Patient Education and Support for HUMIRA Users

Proper education and support are essential for patients using HUMIRA to manage their Crohn’s disease. This includes:

  • Comprehensive training on self-administration techniques
  • Education about potential side effects and when to seek medical attention
  • Information on proper storage and handling of HUMIRA
  • Guidance on lifestyle modifications to support overall health with CD
  • Resources for emotional and psychological support

Many pharmaceutical companies offer patient support programs that provide educational materials, nurse support, and assistance with insurance and financial concerns related to HUMIRA treatment.

Importance of adherence

Adherence to the prescribed HUMIRA regimen is crucial for achieving and maintaining symptom control in Crohn’s disease. Patients should be educated about the importance of consistent treatment and strategies to maintain adherence, such as setting reminders and incorporating the injections into their routine.

Alternative Biologics and Treatment Options for Crohn’s Disease

While HUMIRA is an effective treatment for many Crohn’s disease patients, it may not be suitable or effective for everyone. There are several other biologic medications and treatment options available for managing CD:

Other TNF inhibitors

  • Infliximab (Remicade)
  • Certolizumab pegol (Cimzia)
  • Golimumab (Simponi)

Integrin receptor antagonists

  • Vedolizumab (Entyvio)
  • Natalizumab (Tysabri)

Interleukin inhibitors

  • Ustekinumab (Stelara)
  • Risankizumab (Skyrizi)

The choice of treatment depends on various factors, including disease severity, location of inflammation, previous treatment response, and individual patient characteristics. A gastroenterologist can help determine the most appropriate treatment option for each patient.

Future Developments in Crohn’s Disease Treatment

Research in Crohn’s disease treatment is ongoing, with several promising developments on the horizon:

Emerging therapies

  • New biologics targeting different inflammatory pathways
  • Small molecule drugs with potential oral administration
  • Stem cell therapies for severe or refractory cases
  • Microbiome-based treatments

Personalized medicine approaches

Advances in genetic testing and biomarker identification may lead to more personalized treatment strategies, allowing doctors to predict which patients are most likely to respond to specific therapies like HUMIRA.

As research progresses, patients with Crohn’s disease can look forward to potentially more effective and targeted treatment options in the future. However, HUMIRA remains an important and effective treatment option for many patients with moderate to severe Crohn’s disease.

Crohn’s Disease (CD) & HUMIRA® (adalimumab)

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.

IMPORTANT SAFETY INFORMATION1

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.

IMPORTANT SAFETY INFORMATION1

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.

IMPORTANT SAFETY INFORMATION1

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.

IMPORTANT SAFETY INFORMATION1

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.

HUMIRA Use

1

HUMIRA is a prescription medicine used to treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.

IMPORTANT SAFETY INFORMATION 

ABOUT HUMIRA® (adalimumab)1

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

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

  • Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
  • Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

  • Have an infection, are being treated for infection, or have symptoms of an infection
  • Get a lot of infections or infections that keep coming back
  • Have diabetes
  • Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
  • Have or have had hepatitis B
  • Are scheduled for major surgery
  • Have or have had cancer
  • Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
  • Have or had heart failure
  • Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA
  • Are allergic to rubber, latex, or any HUMIRA ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
  • Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

  • Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
  • Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
  • Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
  • Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

  • Fever, sweats, 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
  • Urinating more often than normal
  • Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

  • To reduce the signs and symptoms of:
    • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
    • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Ankylosing spondylitis (AS) in adults.
    • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
  • To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
  • To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186

HUMIRA® (adalimumab) Injection Training Videos

IMPORTANT SAFETY INFORMATION

1

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

IMPORTANT SAFETY INFORMATION

1

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include

IMPORTANT SAFETY INFORMATION

1

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of

unusual

IMPORTANT SAFETY INFORMATION

1

You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.

IMPORTANT SAFETY INFORMATION 

ABOUT HUMIRA® (adalimumab)1

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

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

  • Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
  • Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

  • Have an infection, are being treated for infection, or have symptoms of an infection
  • Get a lot of infections or infections that keep coming back
  • Have diabetes
  • Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
  • Have or have had hepatitis B
  • Are scheduled for major surgery
  • Have or have had cancer
  • Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
  • Have or had heart failure
  • Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HUMIRA
  • Are allergic to rubber, latex, or any HUMIRA ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
  • Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

  • Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
  • Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
  • Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
  • Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

  • Fever, sweats, 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
  • Urinating more often than normal
  • Feeling very tired

HUMIRA is given by injection under the skin.

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

Uses

HUMIRA is a prescription medicine used:

  • To reduce the signs and symptoms of:
    • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone or with methotrexate.
    • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Ankylosing spondylitis (AS) in adults.
    • Moderate to severe hidradenitis suppurativa (HS) in people 12 years and older.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
  • To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
  • To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186

Patients with non-infectious uveitis (inflammation of the choroid) receive new treatment options thanks to a genetically engineered biological drug

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– A registered biological drug for the treatment of a number of immune-mediated diseases HUMIRA® (adalimumab) has been approved by the Ministry of Health of the Russian Federation for a new indication: non-infectious uveitis (middle, posterior) and panuveitis in adults

– This disease is the 5th most common cause of vision loss in developed countries[1]

With non-infectious uveitis, up to 10% of patients lose their vision completely[2]

MOSCOW, August 9, 2017 – Global biopharmaceutical company AbbVie announces that that the Ministry of Health of the Russian Federation has approved a new indication for the use of a drug for the treatment of a number of immune-mediated diseases HUMIRA® (adalimumab): treatment of non-infectious uveitis (middle, posterior) and panuveitis in adults with an inadequate response to corticosteroid therapy, in situations where dose reduction or withdrawal is necessary corticosteroids, as well as when corticosteroid therapy is contraindicated.

Uveitis is the name of a group of diseases that are associated with inflammation of the choroid (in Greek, uvea). They can develop at any age, but most often occur in people of working age between 20 and 50 years of age1. Among the complications of the disease are the development of a secondary, postveal form of glaucoma, cataracts, cystic macular edema, retinal vascular occlusion, retinal detachment, and others. Moreover, patients with uveitis in 50% partially, and in 10% completely lose their vision[3],[4],[5], becoming a serious burden for health care, the economy and society as a whole.

“Due to the lack of standardized approaches in the diagnosis and treatment of uveitis, as well as the rather complex problem of differential diagnosis and selection of adequate therapy, inflammatory diseases of the uvea often lead to a persistent decrease in vision and even to its complete loss. It must be remembered that a sufficiently large proportion of uveitis is occupied by uveitis in systemic and syndromic diseases that require the appointment of systemic therapy. Therefore, the emergence of biological therapy drugs that have proven themselves in other therapeutic areas for the treatment of non-infectious uveitis is extremely important for both ophthalmologists and patients. Now our patients will receive a new therapeutic opportunity to preserve their vision,” comments Tatyana Igorevna Kuznetsova, doctor of the Department of Ophthalmology with the clinic of the St. Petersburg State Medical University named after. Academician I. P. Pavlov, a specialist in the treatment of uveitis.

Non-infectious uveitis, the development of which is not associated with a bacterial or other infection, in more than 50% of cases occurs against the background of systemic autoimmune diseases such as systemic lupus erythematosus, ulcerative colitis, ankylosing spondylitis, Crohn’s disease and other similar diseases [6]. Risk factors also include genetic predisposition, infectious diseases, eye trauma in the past, and smoking[7],[8],[9].

This ophthalmic indication for HUMIRA® was approved for use by the FDA at the end of June 2016. The efficacy and safety of HUMIRA® in the treatment of non-infectious panuveitis, posterior uveitis and intermediate (intermediary) uveitis in adults was studied in two large clinical trials.

“AbbVie Russia is committed to ensuring that patients have access to cutting-edge therapies that have been proven to be effective and safe in international clinical trials and practices, are changing the therapy paradigm and benefiting patients and the healthcare system as a whole. We are pleased that the expansion of the indication for the use of our biological drug HUMIRA®, which has been proving effective for the treatment of a number of immune-mediated diseases for many years, will now improve the health of patients with non-infectious forms of uveitis who are in need of innovative biological therapy,” comments Anthony Wong , regional vice president of AbbVie in Russia, Ukraine and the CIS.

Use of HUMIRA® for the indication “treatment of non-infectious uveitis (middle, posterior) and panuveitis in adults with an inadequate response to corticosteroid therapy, in situations where dose reduction or withdrawal of corticosteroids is necessary, and when corticosteroid therapy is contraindicated” is possible from the date of approval given indication by the Ministry of Health of Russia on May 24, 2017.

The biological preparation HUMIRA® is also approved for use in Russia for the following indications: treatment of rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, Crohn’s disease, ulcerative colitis, chronic plaque psoriasis, axial spondyloarthritis, suppurative hydradenitis, juvenile idiopathic arthritis in children, including active enthesitis-associated arthritis.

Press release

[1] Durrani Om et al. Br J Ophthalmol 2004; 88 (9): 1159-62

[2] Brault MW et al. MMWR 2009; 58 (16): 421-6

[3] Miserocchi et al. Eur J Ophthalmol 2013; 23 (5): 705-17

[4] Rothova A et al. Br J Ophthalmol 1996; 80 (4): 332–6

[5] Vavvas D and Foster CS Int Ophthalmol Clin 2004; 44(3): 187-203

6 Prete M, Guerriero S, Dammacco R, et al. Autoimmune uveitis: a retrospectrive analysis of 104 patients from a tertiary reference center. J Ophthalmic Inflammable Infect . 2014; 4:17.

7 Yang MM, Lai TY, Luk FO, Pang CP. The roles of genetic factors in uveitis and their clinical significance. retina. 2014;34(1):1-11.

8 Caspi RR. A look at autoimmunity and inflammation in the eye. J Clin Invest. 2010;120(9):3073-3083.

9 Lin P, Loh AR, Margolis TP, Acharya NR. Cigarette Smoking as a Risk Factor for Uveitis. Ophthalmology. 2010;117(3):585-590.

ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)

Crohn’s disease – treatment and diagnosis in Israeli clinics

Crohn’s disease is an inflammatory bowel disease (VZK). Some areas of the gastrointestinal mucosa swell and become covered with wounds – ulcers. The process is most often localized in the last segment of the small intestine and in the first segment of the large intestine.

Treatment of Crohn’s disease in Israel is carried out using modern drugs, including monoclonal antibodies. If necessary, organ-preserving minimally invasive surgical operations are performed. After such treatment, the patient achieves a long-term remission and returns to a normal lifestyle. This is evidenced by numerous reviews of patients who have successfully undergone surgery.

Israeli Clinics statistics for 2022:

In Israeli clinics 100% accuracy of obtaining the correct diagnosis of Crohn’s disease.

Israel is developing new drugs and modern treatments for Crohn’s disease.

90% of Israeli gastroenterologists have been trained in European and American clinics.

Contents:

  • 1 Causes of Crohn’s disease
  • 2 Symptoms of Crohn’s disease
  • 3 Diagnosis of Crohn’s disease in Israel
  • 4 Benefits of treating Crohn’s disease in Israel
  • 5 Best clinics for the treatment of Crohn’s disease in Israel
    • 5.1 Ichilov Clinic
    • 5.2 Meir Medical Center

      • 9 0096 5. 3 Assuta Clinic

  • 6 Methods of treatment of Crohn’s disease in Israel
  • 7 How is the diagnosis and treatment of Crohn’s disease in Israel
  • 8 Cost of treatment of Crohn’s disease in Israel

Causes of Crohn’s disease

Doctors do not know why the disease develops. Perhaps the immune system reacts abnormally to normal bacteria that live in the intestines. Other bacteria and viruses can also contribute to the development of the disease.

Sometimes Crohn’s disease, like other inflammatory diseases of the gastrointestinal tract, is inherited. If your relative has this disorder, you are at risk. People of Eastern European, Jewish origin (Ashkenazi) are more likely to suffer from this disease.

Symptoms of Crohn’s disease

The main symptoms of the disease are abdominal pain and diarrhea (sometimes with blood). Sometimes bouts of diarrhea occur 10 to 20 times a day. Unmotivated weight loss also indicates pathology. Less common symptoms include mouth ulcers, intestinal obstruction, anal fissures (tears) and fistulas (fistulas) between organs.

Get medical help right away if you have:

  • faintness or fast but weak pulse;
  • severe stomach pain;
  • high fever or terrific chills;
  • incessant bouts of vomiting.

Diagnosis of Crohn’s disease in Israel

Your doctor will ask you about your symptoms and perform a physical examination. You may also be ordered x-rays and lab tests. The cost of the diagnostic program will depend on what tests will be shown to you.

Methods for diagnosing Crohn’s disease in Israeli clinics include:

  • contrast radiography of the small or large intestine;
  • colonoscopy or flexible sigmoidoscopy – examination of the colon using an endoscope with a light source;
  • biopsy – taking a piece of mucous for examination;
  • stool test – a test that detects blood and traces of infection in a stool sample;
  • imaging tests, including CT and MRI.

Benefits of treating Crohn’s disease in Israel

  • contrast radiography of the small or large intestine;
  • colonoscopy or flexible sigmoidoscopy – examination of the colon using an endoscope with a light source;
  • Use of modern methods of therapy. These methods include biological treatment with Remicade, Humira and others. Israeli specialists have been working with these drugs for many years and have accumulated a lot of experience in their use.
  • Performing organ-preserving operations. Whenever possible, Israeli doctors perform such sparing operations as strictureplasty. If it is necessary to remove part of the intestine, surgeons perform operations without a colostomy. The most common disease Krona is treated with medicines. If you are suffering from mild symptoms of the disorder, your doctor will recommend over-the-counter medications to help you manage diarrhea. If you decide to purchase these drugs yourself, check with your doctor before using them, as all drugs have side effects.

    Prescription drugs can also be used. They inhibit the inflammatory process in the intestines and prevent the onset of symptoms. These medicines also help heal damaged tissue and delay surgery.

    The operations performed in Israel for Crohn’s disease include:

    • strictureplasty – expansion of pathologically narrowed sections of the intestine;
    • resection – removal of part of the intestine with ulcers;
    • colectomy – complete or partial removal of the intestine.

    How is Crohn’s disease diagnosed and treated in Israel? He conducts a physical examination, takes a medical history and refers the patient for research.

    Second day – diagnostic measures

    The patient undergoes the necessary examinations:

    • laboratory tests;
    • colonoscopy.

    Third day – final diagnosis and prescription of therapy

    Gastroenterologist gives the patient a final diagnosis based on the test results and prescribes treatment.