FAQ - Cibinqo (Abrocitinib)

Cibinqo (abrocitinib) is an oral JAK1 inhibitor approved by the FDA for adults and adolescents aged 12+ years with refractory moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. The FDA approved Cibinqo in January 2022.

Moderate to severe atopic dermatitis is generally determined by skin involvement (how much of your body surface is affected) and severity of symptoms such as itch and rash that cannot be controlled by topical medications alone. However, atopic dermatitis can be considered moderate or severe if the disease has a significant negative impact on your quality of life, even if the body surface affected is more limited. It’s important to talk to your doctor about how atopic dermatitis affects not just your skin but also other aspects of your life.

Together, you and your healthcare provider can determine if Cibinqo is an appropriate treatment option.

The inflammation of atopic dermatitis (AD) is caused in part by immune system messengers called cytokines that are increased in the blood and the skin.  Several of these inflammatory cytokines exert their effects through a chemical signal pathway inside cells known as the JAK-STAT pathway (Janus Kinase-Signal transducer and activators of transcription).

The JAK family has four members – JAK inhibitors can target one or more of these family members to block these immune signals and inhibit the inflammatory effect of key cytokines involved in AD.

Cibinqo works by selectively blocking JAK1, which is a JAK family member associated with several cytokines and other pathways that drive inflammation and itch in AD.  You can find a more complete explanation here.

A biologic is a type of medicine made from living organisms or components from living organisms (like proteins).  They have a unique protein structure and must be injected to be effective.  An oral JAK inhibitor like Cibinqo can be taken in pill form as its effects are not dependent on a complex protein structure.

Similar to biologics, JAK inhibitors, like Cibinqo can help combat signs and symptoms of atopic dermatitis at the immune system level.  A biologic has a specific target in the immune system on the outside of cells, whereas a JAK inhibitor such as Cibinqo can inhibit an immune system target inside of cells.

Cibinqo is taken as pill by mouth once daily as a 50mg, 100mg or 200mg tablet.

The recommended dosage of Cibinqo is 100mg once daily.  A 200mg dose once daily is recommended for those patients who do not respond to the 100mg dose. Lower doses may be recommended by your doctor if you have other health conditions, such as issues with kidney functions.

In the JADE MONO-1 and -2 monotherapy clinical trials for Cibinqo (i.e. Cibinqo used as a single therapy taken daily), after 12 weeks on either 100mg or 200mg of Cibinqo^1-3:

• Primary Clinical Trial Endpoints:

• Eczema Area and Severity Index (EASI)-75

• Key secondary reported endpoints:

• Improvements in disease- and health-related quality of life were also reported in addition to the decreases in depression and anxiety severity scores and fatigue scores.

Comparable primary and secondary endpoint efficacy was also demonstrated in a 3rd randomized controlled trial, JADE-COMPARE, at 12 and 16 weeks of once daily 100mg or 200mg dosing.⁴

In phase 3 clinical trials^1,2, the most common side effects (i.e. reported in >1%) of those taking 100mg or 200mg doses were common cold, nausea, headache, herpes simplex including cold sores, increased blood level of creatinine phosphokinase, dizziness, urinary tract infection, tiredness, acne, vomiting, mouth and throat pain, flu, stomach flu, bacterial skin infection, high blood pressure, allergic skin rash to something you contacted, stomach pain, shingles, and low platelet count.

A boxed warning, more commonly referred to a ‘black box’ warning, can be found on prescription drug labelling and package inserts, depending on the type of side effects the drug may have as determined by the FDA, which regulates all drugs in the United States.

While some drugs have minimal side effects, others can have the risk of more serious ones.  An FDA-issued black box warning draws attention to a drug with the potential for more serious or in some cases, life threatening risks, to alert healthcare providers and their patients to these considerations.

For Cibinqo, and other oral JAK inhibitors (i.e. Rinvoq [upadacitinib]), the boxed warning includes information about the risk for serious infections, mortality, cancer, cardiovascular events and clotting (thrombosis).

A conversation with your healthcare provider is the best way to determine if the benefits of Cibinqo outweigh the potential risk, as well as the need for any baseline and/or monitoring.

Yes. In addition to Cibinqo, Rinvoq (upadacitinib) is an oral JAK inhibitor FDA-approved for moderate to severe atopic dermatitis.  Read more about upadacitinib here.

Clinical trials for other JAK inhibitors (both oral and topical) for AD are currently underway.  Head-to-head comparative clinical trials of the different oral JAK inhibitors are not yet available.

Atopic dermatitis is a chronic skin disease that can affect everyone differently.  The length of therapy with Cibinqo should be discussed with your healthcare provider. Different treatment approaches are currently being investigated in clinical trials.⁵

Yes. Cibinqo is FDA-approved for children ages 12 years and older.

Cibinqo is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

Cibinqo is being studied in clinical trials in combination with topical corticosteroids.⁶

Talk to your healthcare provider about using Cibinqo with other prescription and over the counter therapies for atopic dermatitis and other medical conditions.

The cost for Cibinqo depends on your health insurance coverage for prescriptions. Pfizer, the company that makes Cibinqo, has programs that may help with your copay costs if needed. You can learn more at 833-956-DERM (833-956-3376) or www.cibinqo.com.

It’s important to talk to your doctor about how atopic dermatitis affects your skin and other aspects of your life.  Together, you and your healthcare provider can determine if Cibinqo is an appropriate treatment option.

Cibinqo is available by prescription only. Talk to your health care provider and visit www.cibinqo.com to learn more.