Adalimumab

Inflammatory Conditions

Adalimumab is a medication used to manage symptoms and reduce the progression of several long-term inflammatory diseases. It is often prescribed when other treatments have not provided sufficient relief.

Joint and Bone Disorders

• Rheumatoid arthritis: Used in adults to decrease pain and swelling and slow joint damage.
• Juvenile idiopathic arthritis: Used in children 2 years and older to treat polyarticular JIA.
• Psoriatic arthritis: Used to treat joint symptoms and improve physical movement.
• Ankylosing spondylitis: Used to reduce inflammation in the spine and joints.

Gastrointestinal Disorders

• Crohn's disease: Used in adults and children 6 years and older to reduce symptoms and maintain remission.
• Ulcerative colitis: Used in adults and children 5 years and older to manage inflammation of the colon.

Skin and Eye Disorders

• Plaque psoriasis: Used for adults with moderate to severe chronic plaque psoriasis who may benefit from systemic therapy.
• Hidradenitis suppurativa: Used for adults and adolescents 12 years and older to treat this chronic skin condition.
• Uveitis: Used to treat non-infectious inflammation in the middle layer of the eye for adults and children 2 years and older.

Mechanism of Action

Adalimumab belongs to a class of medications known as tumor necrosis factor (TNF) blockers. TNF is a protein naturally produced by the immune system that helps regulate the body's inflammatory response. In people with certain autoimmune diseases, the body produces an excess of this protein, which leads to chronic inflammation and tissue damage.

This medication works by targeting and binding to TNF-alpha molecules. By attaching to these proteins, adalimumab prevents them from interacting with receptors on the surface of cells. This process helps to:

• Reduce the overall inflammatory response in the body.
• Decrease swelling, pain, and stiffness in affected areas, such as the joints, skin, or digestive tract.
• Slow the progression of structural damage caused by chronic inflammation.

Because adalimumab specifically targets a component of the immune system to manage disease activity, it is classified as a biologic medication.

Common Side Effects

Many people using adalimumab experience mild side effects. These often include:

• Pain, redness, itching, or swelling where the injection was given
• Headache
• Rash
• Nausea
• Back pain
• Cold or sinus symptoms

Serious Side Effects

Contact a healthcare provider immediately if you experience serious symptoms, such as:

• Signs of infection: Fever, chills, night sweats, constant fatigue, or a cough that does not go away.
• Neurological issues: Numbness, tingling, dizziness, vision changes, or weakness in the legs.
• Liver problems: Yellowing of the skin or eyes, dark urine, or pain on the right side of the stomach.
• Heart failure symptoms: Shortness of breath, sudden weight gain, or swelling in the ankles and feet.
• Lupus-like syndrome: Joint pain or a rash on the cheeks or arms that worsens in the sun.
• Blood disorders: Easy bruising, bleeding, or looking very pale.

Seek emergency medical care if you have signs of a severe allergic reaction, including hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Serious Infections

Adalimumab can lower the ability of the immune system to fight infections. This may increase the risk of serious infections caused by viruses, fungi, or bacteria, which can lead to hospitalization or death. Healthcare providers typically test for tuberculosis (TB) before starting treatment and monitor for signs of infection during therapy.

Cancer Risk

There is an increased risk of developing certain types of cancer, including lymphoma and skin cancers. A rare and serious type of cancer called hepatosplenic T-cell lymphoma has been reported in some patients, particularly in children and young adults with certain inflammatory conditions who were also using other specific medications.

Neurological and Heart Problems

This medication may cause or worsen conditions affecting the nervous system, such as multiple sclerosis or Guillain-Barré syndrome. It may also cause new or worsening heart failure. Signs to watch for include persistent numbness, tingling, vision changes, or swelling in the feet and ankles.

Additional Precautions

• Hepatitis B Reactivation: The hepatitis B virus can become active again in people who carry the virus in their blood.
• Blood Disorders: Adalimumab may cause a decrease in blood cells that help the body fight infections or stop bleeding.
• Vaccinations: People using this medication should not receive live vaccines.
• Latex Sensitivity: The needle cover of some prefilled syringes or pens may contain natural rubber latex, which can cause allergic reactions in sensitive individuals.

Pregnancy

Adalimumab should be used during pregnancy only if clearly needed. While it is not expected to be harmful to an unborn baby, the medication can cross the placenta during the third trimester. This exposure may affect the immune system of the newborn.

If adalimumab was used during pregnancy, healthcare providers usually recommend waiting at least five months after the last dose before giving the infant any live vaccines. It is important to discuss your pregnancy or plans to become pregnant with your doctor to manage your condition safely.

Breastfeeding

Limited information is available regarding the use of adalimumab while breastfeeding. Because it is a large protein, it is likely that only small amounts pass into breast milk and even smaller amounts are absorbed by the infant's stomach. However, you should consult with your healthcare provider to determine if breastfeeding is appropriate for your situation while using this medication.

Available Forms

Adalimumab is provided as a sterile, preservative-free solution for subcutaneous injection. It is available in several delivery systems designed for either self-administration or use by a healthcare professional:

• Single-dose pre-filled pens: These devices are designed for ease of use during self-injection.
• Single-dose pre-filled syringes: These allow for manual administration by the patient, a caregiver, or a provider.
• Single-dose vials: These are typically used in clinical settings where the dose is drawn into a syringe by a healthcare professional.

The medication is a clear, colorless solution. Some formulations are produced without citrate, which may help reduce pain or irritation at the injection site.

FDA Approval and Indications

Adalimumab was first approved by the U.S. Food and Drug Administration (FDA) in 2002. It is a tumor necrosis factor (TNF) blocker indicated for the treatment of several autoimmune and inflammatory diseases in adults and, for certain conditions, pediatric patients. Approved indications include:

• Rheumatoid arthritis
• Juvenile idiopathic arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis
• Hidradenitis suppurativa
• Uveitis

Boxed Warning

The FDA requires a boxed warning for adalimumab because it may increase the risk of serious, life-threatening safety issues.

Serious Infections

Patients treated with adalimumab are at increased risk for developing serious infections that may lead to hospitalization or death. These include tuberculosis (TB), bacterial sepsis, and invasive fungal infections (such as histoplasmosis, coccidioidomycosis, or blastomycosis). Healthcare providers are required to test patients for latent TB before starting treatment and monitor them for signs of infection during therapy.

Malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers. Cases of a rare and often fatal cancer called hepatosplenic T-cell lymphoma have occurred, primarily in adolescent and young adult males with inflammatory bowel disease who were also using other immunosuppressive medications.

Biosimilar Availability

The FDA has approved several biosimilar versions of adalimumab. A biosimilar is a biological product that is highly similar to an already approved reference biologic, with no clinically meaningful differences in terms of safety, purity, and potency. Some biosimilars may be designated as interchangeable, meaning they may be substituted for the reference product by a pharmacist depending on state laws.

Factors Affecting Cost

The cost of adalimumab can vary significantly based on several factors, including the specific version prescribed, the dosage required, and insurance coverage. As a biologic medication, it is typically more expensive than many other types of drugs.

Biosimilars

There are several biosimilar versions of adalimumab available. These medications are designed to be highly similar to the original biologic and may be available at a lower cost. Availability and coverage for these versions often depend on the specific insurance provider's formulary.

Insurance and Financial Assistance

Insurance companies often require prior authorization for adalimumab, meaning the insurer must approve the treatment before they will cover the cost. Patients may also find the following resources helpful:

• Specialty Pharmacies: This medication is usually obtained through a specialty pharmacy that handles high-cost biologic drugs and provides specific storage and delivery services.
• Patient Assistance Programs: Many drug manufacturers offer financial assistance or co-pay savings cards to help eligible patients manage out-of-pocket expenses.
• Insurance Formularies: Costs can vary depending on which tier the medication occupies within an insurance plan's list of covered drugs.