FAQ - Cibinqo (Abrocitinib)
What is Cibinqo?
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.
How does Cibinqo work?
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.
How is Cibinqo different from a biologic?
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.
How do you take Cibinqo?
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.
How effective is Cibinqo for atopic dermatitis?
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 Cibinqo1-3:
- Primary Clinical Trial Endpoints:
- Investigator Global Assessment (IGA)
- A tool used to provide a clinical trial investigator rating of overall disease severity at a particular time point.
- 24% and 28.4% of patients (100mg dose); 44% and 38.1% of patients (200mg dose) had an IGA score of clear to almost clear (IGA 0 or 1) compared to 8% and 9.1% on placebo.
- Investigator Global Assessment (IGA)
- Eczema Area and Severity Index (EASI)-75
- An investigator tool used to measure the extent (area) and severity of atopic dermatitis. EASI-75 is a 75% improvement in this score from the start of the trial.
- 40% and 44.5% of patients (100mg dose); 63% and 61% of patients (200mg dose) achieved an EASI-75 compared to 12% and 10.4% on placebo.
- Key secondary reported endpoints:
- Proportion of patients with a reduction in itch severity (PP-NRS; at least a 4-point decrease on an 11-point (0-10) numeric rating scale)
- 38% and 45.2% of patients (100mg dose); 57% and 55.3% of patients (200mg dose) achieved this level of itch reduction compared to 15% and 11.5% on placebo.
- Reductions in itch were observed within 1 day of the first treatment dose.
- Significant improvements in nighttime itch were also reported for both Cibinqo doses compared to placebo.
- 38% and 45.2% of patients (100mg dose); 57% and 55.3% of patients (200mg dose) achieved this level of itch reduction compared to 15% and 11.5% on placebo.
- Proportion of patients with a reduction in itch severity (PP-NRS; at least a 4-point decrease on an 11-point (0-10) numeric rating scale)
- 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
What are the most common side effects of Cibinqo?
In phase 3 clinical trials1,2, 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.
What is a ‘black box’ warning, and why does Cibinqo have one?
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.
Are there other oral JAK inhibitors FDA-approved for atopic dermatitis?
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.
How long do I have to take Cibinqo?
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
Can children use Cibinqo?
Yes. Cibinqo is FDA-approved for children ages 12 years and older.
Can I use Cibinqo with other prescription atopic dermatitis therapies?
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.
How much does Cibinqo cost?
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.
How do I know if Cibinqo is right for me?
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.
How can I get Cibinqo?
Cibinqo is available by prescription only. Talk to your health care provider and visit www.cibinqo.com to learn more.
References:
1 Simpson EL, Sinclair R, Forman S et al. Efficacy and safety of abrocitinib in adults and adolescents with moderate-to-severe atopic dermatitis (JADE MONO-1): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2020 Jul 25;396(10246):255-266.
2 Silverberg JI, Simpson EL, Thyssen JP et al. Efficacy and Safety of abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2020 Aug 1;156(8):863-873.
3 Silverberg JI, Thyssen JP, Simpson EL et al. Impact of Oral abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes. Am J Clin Dermatol. 2021 Jul;22(4):541-554.
4 Bieber T, Simpson EL, Silverberg JI et al. Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis. N Engl J Med. 2021 Mar 25;384(12):1101-1112.
5Blauvelt A, Silverberg JI, Lynde CW et al. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial. J Am Acad Dermatol. 2022 Jan;86(1):104-112. doi: 10.1016/j.jaad.2021.05.075. Epub 2021 Aug 17.
6 Eichenfield LF, Flohr C, Sidbury R et al. Efficacy and Safety of Abrocitinib in Combination With Topical Therapy in Adolescents With Moderate-to-Severe Atopic Dermatitis: The JADE TEEN Randomized Clinical Trial. JAMA Dermatol. 2021 Oct 1;157(10):1165-1173. doi: 10.1001/jamadermatol.2021.2830.
