Skyrizi

Approved Uses

Skyrizi is approved by the FDA for use in adults to treat the following conditions:

• Plaque Psoriasis: It is used for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy (medications taken by mouth or injection that work throughout the body) or phototherapy (light treatment).
• Psoriatic Arthritis: It is used to treat adults with active psoriatic arthritis, a condition that causes joint pain, stiffness, and swelling.
• Crohn's Disease: It is used for adults with moderately to severely active Crohn's disease, which is a type of inflammatory bowel disease.
• Ulcerative Colitis: It is used for adults with moderately to severely active ulcerative colitis, a chronic condition that causes inflammation and sores in the digestive tract.

Doctors typically prescribe Skyrizi when these conditions are moderate to severe and require a systemic approach to manage inflammation and improve symptoms.

Mechanism of Action

Skyrizi is a monoclonal antibody that belongs to a class of medications known as interleukin-23 (IL-23) inhibitors. It is designed to target and block the activity of IL-23, a protein in the body that plays a key role in the inflammatory process.

Targeting Inflammation

In people with conditions such as plaque psoriasis, psoriatic arthritis, or Crohn's disease, the immune system produces excessive amounts of IL-23. This overproduction acts as a signal that triggers inflammation and other symptoms. Skyrizi works by binding specifically to the p19 subunit of the IL-23 protein, which prevents it from interacting with its receptors on the surface of cells.

Effects on the Body

By interfering with the IL-23 signaling pathway, Skyrizi helps to:

• Reduce skin cell growth: In plaque psoriasis, it slows down the rapid production of skin cells, which helps clear the skin of thick, red, or scaly patches.
• Lower inflammation: It decreases the inflammatory response that can cause joint pain and swelling in psoriatic arthritis or intestinal damage in Crohn's disease.
• Regulate the immune system: Because it targets a specific protein rather than the entire immune system, it provides a more focused approach to managing autoimmune symptoms.

Common Side Effects

The most frequently reported side effects of Skyrizi are generally mild and may include:

• Upper respiratory tract infections, such as the common cold or sinus infections
• Headache
• Feeling tired (fatigue)
• Injection site reactions, including redness, itching, or pain
• Fungal skin infections
• Stomach pain

Serious Side Effects

Skyrizi can cause serious side effects that require immediate medical attention. These include:

• Serious Infections: Skyrizi may lower the ability of your immune system to fight infections. Watch for symptoms like fever, sweats, chills, cough, or warm, red, or painful skin sores.
• Allergic Reactions: Symptoms of a severe allergic reaction may include hives, trouble breathing, or swelling of the face, lips, mouth, or tongue.
• Liver Problems: In people being treated for Crohn's disease or ulcerative colitis, Skyrizi may cause liver injury. Symptoms can include yellowing of the skin or eyes, dark urine, or pain in the upper right stomach area.

Infection Risk

Skyrizi affects the immune system, which may increase the risk of developing infections or worsening existing ones. Treatment is typically not initiated in individuals with an active, clinically important infection until the condition is resolved or properly treated. Healthcare providers usually monitor for signs of infection during and after treatment.

Tuberculosis Testing

Patients must be evaluated for tuberculosis (TB) before starting Skyrizi. If a TB infection is present, treatment for TB is usually completed before the first dose of Skyrizi is administered.

Liver Health

For patients with Crohn's disease or ulcerative colitis, healthcare providers monitor liver function. Blood tests to check liver enzymes and bilirubin levels are typically performed before starting treatment and during the induction period to watch for signs of liver injury.

Vaccinations

It is recommended to stay up to date with all required immunizations before beginning therapy. Live vaccines should not be given while a person is receiving Skyrizi.

Hypersensitivity Reactions

Serious allergic reactions, including anaphylaxis, can occur. Medical help is needed if symptoms such as fainting, swelling of the face or throat, or trouble breathing develop.

Pregnancy

There are no adequate and well-controlled studies of Skyrizi in pregnant women. While animal studies using monkeys did not show evidence of harm to the fetus at doses significantly higher than the human dose, these results do not always predict human response. Because Skyrizi is a monoclonal antibody, it is expected to be transported across the placenta during the third trimester.

If you are pregnant or planning to become pregnant, talk to your doctor. They will help determine if the benefits of using this medication outweigh the potential risks to the unborn baby.

Breastfeeding

It is not known if Skyrizi is present in human breast milk or if it has any effect on a breastfed infant or milk production. Although many monoclonal antibodies are large molecules that may not be absorbed well by an infant's digestive system, the safety profile for breastfeeding has not been established.

You should discuss the risks and benefits of breastfeeding while using Skyrizi with your healthcare provider to determine the best course of action for you and your child.

Available Forms

Skyrizi is administered as an injection. The specific form used depends on the medical condition and whether the dose is for starting treatment or maintenance.

• Subcutaneous Injection: This form is injected into the fatty tissue under the skin. It is available as a single-dose prefilled syringe or a single-dose prefilled pen. For some conditions, it is also available as a prefilled cartridge used with an on-body injector.
• Intravenous Infusion: For certain conditions, such as Crohn's disease, the initial doses are given through a vein in the arm by a healthcare professional in a clinical setting.

Strengths

Skyrizi is supplied in various strengths and concentrations tailored to specific dosing requirements. These include single-use vials for infusion, as well as syringes, pens, and cartridges for injection under the skin.

FDA Approval and Indications

Skyrizi was first approved by the U.S. Food and Drug Administration (FDA) in 2019. It is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that works as an interleukin-23 inhibitor. The FDA has approved Skyrizi for use in adults for the following indications:

• Plaque Psoriasis: For the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
• Psoriatic Arthritis: For the treatment of active psoriatic arthritis in adults.
• Crohn's Disease: For the treatment of moderately to severely active Crohn's disease in adults.
• Ulcerative Colitis: For the treatment of moderately to severely active ulcerative colitis in adults.

Regulatory Requirements and Safety Monitoring

The FDA requires specific screening before a patient begins treatment with Skyrizi. Healthcare providers must evaluate patients for tuberculosis (TB) infection prior to initiating therapy. Treatment should not be started in patients with an active TB infection.

While Skyrizi does not currently have a boxed warning, the FDA-approved labeling includes warnings regarding the risk of infections. Because the medication affects the immune system, it may increase the risk of infections or reactivate latent infections. Patients are monitored for signs and symptoms of infection during and after treatment.

There is no Risk Evaluation and Mitigation Strategy (REMS) program required for Skyrizi at this time.

Factors Influencing Cost

The out-of-pocket cost for Skyrizi is not fixed and depends on several variables related to your healthcare coverage and treatment plan:

• Insurance Coverage: Your specific health insurance plan, including its formulary, deductible, and copayment or coinsurance requirements, will significantly impact the final price.
• Pharmacy Choice: Skyrizi is a biologic medication and is typically dispensed through a specialty pharmacy rather than a standard retail pharmacy, which can affect the cost.
• Treatment Dosage: The cost may vary based on the dosage and frequency of administration required for your specific condition, such as plaque psoriasis, psoriatic arthritis, or Crohn's disease.

To determine the exact cost, it is recommended to contact your insurance provider. You may also speak with your healthcare provider about potential financial assistance programs that may be available for eligible patients.