Spevigo

Generalized Pustular Psoriasis (GPP)

Spevigo is used to manage generalized pustular psoriasis (GPP), a rare and serious inflammatory skin disease. GPP is distinct from other forms of psoriasis and is characterized by sudden outbreaks, or flares, of painful, pus-filled blisters (pustules) that can cover large areas of the body. These flares are often accompanied by systemic symptoms such as fever, chills, and intense fatigue.

Approved Uses

This medication is used in two ways for the management of GPP:

• Treating active flares: It is used to treat the symptoms of a GPP flare when one occurs.
• Preventing future flares: It is used as a maintenance treatment to help prevent new GPP flares from starting.

Patient Eligibility

Spevigo is approved for use in the following populations:

• Adults.
• Children 12 years of age and older who weigh at least 88 pounds (40 kilograms).

Mechanism of Action

Spevigo (spesolimab-sbzo) belongs to a class of drugs called monoclonal antibodies. It works by targeting and binding to the interleukin-36 (IL-36) receptor, a protein found on the surface of various immune cells.

In a healthy immune system, the IL-36 pathway helps the body respond to perceived threats. However, in people with generalized pustular psoriasis (GPP), this pathway becomes overactive. This overstimulation triggers a cascade of inflammation and causes the body to send too many white blood cells, known as neutrophils, to the skin.

How It Reduces Symptoms

By blocking the IL-36 receptor, Spevigo prevents inflammatory signals from being delivered. This action helps to:

• Stop the inflammatory cycle: It prevents IL-36 proteins from activating the receptor, which slows down the immune system's overreaction.
• Reduce skin damage: By limiting the accumulation of neutrophils, it helps decrease the formation of painful, pus-filled blisters and skin redness.
• Manage flares: The medication is designed to address the underlying cause of GPP symptoms during an active flare or to help prevent future flares.

Common Side Effects

The most common side effects reported by people using Spevigo include:

• Feeling tired or weak
• Nausea or vomiting
• Headache
• Itching
• Pain, redness, or bruising at the injection site
• Urinary tract infection

Serious Side Effects

While less common, some side effects can be serious. Seek medical attention immediately if you experience any of the following:

• Allergic reactions: Symptoms may include hives, rash, swelling of the face, lips, or tongue, and difficulty breathing.
• Infections: Spevigo may lower the ability of your immune system to fight infections. Watch for fever, chills, cough, shortness of breath, or pain during urination.
• Infusion or injection reactions: Some people may experience dizziness, flushing, or a skin rash during or shortly after receiving the medication.
• Severe skin reactions: Contact a doctor if you develop a widespread rash along with fever, swollen lymph nodes, or flu-like symptoms.

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, can occur with Spevigo. If a severe reaction is suspected, the medication must be discontinued immediately. Symptoms of a reaction may include respiratory distress, swelling, or skin changes.

Infections

Spevigo may increase the risk of infections. It is generally not started in patients with active, clinically important infections. Healthcare providers monitor patients for signs of infection during and after treatment. If a serious infection develops, treatment may need to be paused until the infection is resolved.

Tuberculosis Evaluation

Patients should be screened for tuberculosis (TB) before beginning treatment. Those with latent or active TB may require treatment for the infection before starting Spevigo.

Vaccinations

Live vaccines should be avoided during treatment and for a period of time after the last dose. Patients are encouraged to complete all required immunizations before starting this medication.

Pregnancy

Data on the use of Spevigo in pregnant women are limited, and there is not enough evidence to determine if the medication increases the risk of birth defects, miscarriage, or other developmental issues. Because Spevigo is a monoclonal antibody, it is expected to cross the placental barrier and may be transmitted from the mother to the developing fetus.

Individuals who are pregnant or planning to become pregnant should discuss the potential benefits and risks of treatment with their healthcare provider.

Breastfeeding

It is currently unknown if Spevigo passes into human breast milk, how it might affect a nursing infant, or if it impacts the production of breast milk. While other similar antibodies are known to be present in human milk, specific studies on Spevigo have not been conducted.

When deciding whether to breastfeed while using this medication, it is important to consider the mother's clinical need for the drug alongside the potential risks to the infant and the benefits of breastfeeding.

Available Forms

Spevigo is supplied as a sterile, preservative-free solution in the following forms:

• Injection for Intravenous Infusion: This form is provided in a single-dose vial and is administered into a vein by a healthcare professional.
• Injection for Subcutaneous Use: This form is provided in a single-dose prefilled syringe for injection under the skin.

FDA Approval History

Spevigo (spesolimab-sbzo) received its initial FDA approval in September 2022 for the treatment of generalized pustular psoriasis (GPP) flares in adults. In March 2024, the FDA expanded this approval to include the treatment of GPP in adults and pediatric patients aged 12 and older (weighing at least 40 kg) to prevent flares.

Approved Indications

The FDA has approved Spevigo for the following uses:

• Treatment of GPP flares in adults (administered intravenously).
• Treatment of GPP in adults and pediatric patients 12 years of age and older weighing at least 40 kg (administered subcutaneously).

Regulatory Safety Information

The FDA has not issued a boxed warning for Spevigo, and there is no Risk Evaluation and Mitigation Strategy (REMS) required for its use. Regulatory labeling includes precautions for the following:

• Infections: Spevigo may increase the risk of infections. Treatment should not be started in patients with a clinically important active infection.
• Hypersensitivity: Serious hypersensitivity reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported.
• Immunizations: Patients should avoid receiving live vaccines while being treated with Spevigo.
• Tuberculosis: Patients should be evaluated for tuberculosis infection prior to starting therapy.

Factors Affecting Cost

The price of Spevigo can vary significantly based on several factors:

• Insurance Plan: Your out-of-pocket costs, such as copays or coinsurance, are determined by your specific health insurance provider and pharmacy benefit tier.
• Administration Site: Costs may differ depending on whether the medication is administered in a hospital, an outpatient clinic, or at home.
• Treatment Type: Spevigo is available as an intravenous infusion for flares and as a subcutaneous injection for maintenance, which may be billed differently under medical or pharmacy benefits.

Financial Assistance

Because Spevigo is a specialized biologic medication, the manufacturer may offer support programs. These can include co-pay savings cards for commercially insured patients or patient assistance programs for those who are uninsured or underinsured. Eligibility for these programs is typically based on income and insurance status.

Generic Availability

There is currently no generic or biosimilar version of Spevigo available. It is a brand-name medication, which generally means it has a higher cost than generic alternatives.

Prior Authorization

Most insurance companies require prior authorization for Spevigo. This process requires your healthcare provider to submit documentation to your insurer to confirm the medication is medically necessary before coverage is approved.