GPP Signs & Symptoms | SPEVIGO® (spesolimab-sbzo)

What is GPP?

GPP, also known as generalized pustular psoriasis, is a chronic, rare, lifelong disease that occurs when a part of your immune system is out of balance.

What are the symptoms of GPP?

GPP symptoms can be unpredictable and include:

Pus-filled blisters called “pustules”

Painful skin that can swell and burn

Red, dry, itchy, or scaly skin

Fever or chills

Extreme fatigue

Joint pain

What do GPP flares look like?

GPP “flares” describe sudden symptoms that can intensify quickly and may become life-threatening. For many people, experiencing their first flare is how they learn they have GPP. Symptoms also continue between flares, though they may be less severe.

Symptoms on the skin can impact even a very small area and have a range of appearances:

First image: SPEVIGO clinical trial. Second image: original image from Choon SE, et al, in American Journal of Clinical Dermatology; 2022. Last 2 images: original images from Choon SE, et al, in Experimental Dermatology; 2023.

It’s important to talk to your doctor about any symptoms you experience, no matter how severe.

If you think you may have GPP, this symptom tracker can help you document your experience so you can share with your doctor.

IL-36 Pathway.

GPP is caused by a part of the immune system called the IL-36 pathway

The IL-36 pathway helps protect the body from injury and infection. When this system is out of balance, it causes inflammation throughout the body. This inflammation then leads to GPP symptoms, both on and beneath the skin.

GPP is not the same as plaque psoriasis

While both diseases share some symptoms (like large areas of red, itchy, very dry, scaly, or cracked skin), they are different diseases caused by different pathways in the body.

GPP is a
rare
form of psoraisis

Plaque psoriasis is the
most common
form of psoraisis

GPP is more common in
women
than men

Plaque psoriasis impacts
men & women
equally

GPP is primarily
driven by the
IL-36
pathway

Plaque psoriasis
is primarily driven by the
IL-23 and IL-17
pathways

Hallmark symptoms
of GPP include
pustules and symptoms of inflammation
throughout
the body,

like fever and joint pain

Hallmark symptoms of
plaque psoriasis
include
patches of raised, inflamed,

red skin covered with

silvery-white scales

GPP flares can be
life-threatening
and require hospitalization

Plaque psoriasis
rarely requires
hospitalization

Many people may live with both diseases. It’s important to get an accurate diagnosis so your doctor can recommend the best treatment plan for your GPP.

GPP and plaque psoriasis have different causes

Hear Dr Chovatiya explain the different systems involved in the 2 diseases.

Dr Chovatiya has been compensated for his participation.

SPEVIGO is the only treatment to help address a primary cause of GPP

Starting a conversation with your doctor.

Support for your next steps

This guide can help you prepare for a conversation with your doctor, including common questions to consider.

What is SPEVIGO?

SPEVIGO is a prescription medicine used to treat generalized pustular psoriasis (GPP) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). It is not known if SPEVIGO is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40 kg).

Please see the Medication Guide and Instructions for Use.

Important Safety Information
and Indication

Do not receive SPEVIGO if you or your child have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO.

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

SPEVIGO may cause serious side effects, including:

Infections. SPEVIGO may lower the ability of your or your child’s immune system to fight infections and may increase your or your child’s risk of infections. Your healthcare provider should check you or your child for infections and tuberculosis (TB) before starting treatment with SPEVIGO and may treat you or your child for TB before you begin treatment with SPEVIGO if you have a history of TB or have active TB. Your healthcare provider should watch you or your child closely for signs and symptoms of TB during or after treatment with SPEVIGO. Tell your healthcare provider right away if you or your child have an infection or have symptoms of an infection during or after treatment with SPEVIGO, including:
- fevers, chills, or sweats
- muscle aches
- cough
- shortness of breath
- blood in your phlegm (mucus)
- burning when you urinate
- urinating more often than normal
Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your or your child’s SPEVIGO injection. If you or your child have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO. If you or your child are given SPEVIGO in a vein (intravenously) and have an infusion-related reaction, your healthcare provider will stop your or your child’s SPEVIGO infusion and treat your or your child’s symptoms and may restart SPEVIGO at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you or your child get any of the following symptoms during or after your or your child’s SPEVIGO injection:
- feeling faint, dizzy, or lightheaded
- swelling of your face, eyelids, lips, mouth, tongue, or throat
- trouble breathing or throat tightness
- fever
- mouth sores
- chest tightness
- hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP)
- itching
- swollen lymph nodes

Before you or your child receive SPEVIGO, tell your healthcare provider about all of your medical conditions, including if you or your child:

have an infection that does not go away or that keeps coming back.
have TB or have been in close contact with someone with TB.
have recently received or are scheduled to receive an immunization (vaccine). You or your child should not receive live vaccines during and for at least 16 weeks after treatment with SPEVIGO. You or your child should be brought up to date with all vaccines before starting SPEVIGO.
are pregnant or plan to become pregnant. It is not known if SPEVIGO can harm your or your child’s unborn baby.
are breastfeeding or plan to breastfeed. It is not known if SPEVIGO passes into your breast milk. Talk to your healthcare provider about the best way to feed your or your child’s baby during treatment with SPEVIGO.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SPEVIGO?

The most common side effects of SPEVIGO given in a vein (intravenously) for GPP flare treatment include:

feeling tired or weak
headache
nausea
itching or itchy bumps
a collection of blood under the skin at the infusion site or bruising
urinary tract infection

The most common side effects of SPEVIGO when given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare include:

redness, pain, swelling, hardening, hives, or warmth at the injection site
joint pain
urinary tract infection
itching

These are not all of the possible side effects of SPEVIGO. Call your doctor for medical advice about side effects.

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 and Instructions for Use.

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