FAQ – Rinvoq (Upadacitinib)
What is Rinvoq?
Rinvoq (upadacitinib) is an oral JAK1 inhibitor approved by the FDA for adults and adolescents aged 12+ years with 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 Rinvoq for atopic dermatitis 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 upadacitinib is an appropriate treatment option.
How does Rinvoq 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.
Rinvoq 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 Rinvoq 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 Rinvoq can be taken in pill form as its effects are not dependent on a complex protein structure.
Similar to biologics, JAK inhibitors, like Rinvoq 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 Rinvoq can inhibit an immune system target inside of cells.
How do you take Rinvoq?
Rinvoq is taken as pill by mouth once daily as either a 15mg or 30mg tablet.
The recommended dosage of Rinvoq is 15mg once daily. A 30mg daily dose can be considered for adolescents 12 years+ and adults less than 65 years old who do not adequately respond to the 15mg dose.
How effective is Rinvoq for atopic dermatitis?
In the Measure UP-1 and -2 monotherapy clinical trials for upadacitinib (i.e. upadacitinib used as a single therapy taken daily), after 16 weeks on either 15mg or 30mg of upadacitinib1:
- 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.
- 48.1% and 38.8% of patients (15mg dose); 62% and 52% of patients (30mg dose) had an IGA score of clear to almost clear (IGA 0 or 1) compared to 8.4% and 4.7% 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.
- 69.6% and 60.1% of patients (15mg dose); 79.7% and 72.9% of patients (30mg dose) achieved an EASI-75 compared to 16.3% and 13.3% on placebo.
- Key secondary reported endpoints:
- Proportion of patients with a reduction in itch severity (WP-NRS; at least a 4-point decrease on an 11-point (0-10) numeric rating scale)
- 52.2% and 41.9% of patients (15mg dose); 60% and 59.6% of patients (4mg dose) achieved this level of itch reduction compared to 11.8% and 9.1% on placebo.
- Reductions in itch were observed by day 2 after beginning treatment.
- Significant reductions in skin pain ratings and improvements in sleep quality scores compared to placebo were also observed for both doses.
- 52.2% and 41.9% of patients (15mg dose); 60% and 59.6% of patients (4mg dose) achieved this level of itch reduction compared to 11.8% and 9.1% on placebo.
- Proportion of patients with a reduction in itch severity (WP-NRS; at least a 4-point decrease on an 11-point (0-10) numeric rating scale)
- Significant improvements in health-related quality of life were also reported in addition to the decreases in depression and anxiety severity scores.
What are the most common side effects of Rinvoq in people treated for atopic dermatitis?
In phase 3 clinical trials1, the most common side effects (i.e reported in >1%) were upper respiratory tract infections, acne, herpes simplex (cold sores), headache, increased blood creatine phosphokinase, cough, hypersensitivity, folliculitis, nausea, abdominal pain, fever, increased weight, herpes zoster, influenza, fatigue, decreased blood neutrophils, muscles aches, and influenza like illness.
What is a ‘black box’ warning, and why does upadacitinib 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 Rinvoq, and other oral JAK inhibitors (i.e. Cibinqo [abrocitinib]), 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 Rinvoq outweigh the potential risk, as well as the need for any baseline and/or ongoing monitoring.
Are there other oral JAK inhibitors FDA-approved for atopic dermatitis?
Yes. In addition to Rinvoq, Cibinqo (abrocitinib) is an oral JAK inhibitor FDA-approved for moderate to severe atopic dermatitis. Read more about abrocitinib 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 Rinvoq?
Atopic dermatitis is a chronic skin disease that can affect everyone differently. The length of therapy with Rinvoq should be discussed with your healthcare provider.
Can children use Rinvoq?
Yes. Rinvoq is FDA-approved for children ages 12 years and older.
Can I use Rinvoq with other prescription atopic dermatitis therapies?
Rinvoq is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Rinvoq is being studied in clinical trials in combination with topical corticosteroids.2-3
Talk to your healthcare provider about using Rinvoq with other prescription and over the counter therapies for atopic dermatitis and other medical conditions.
How much does Rinvoq cost?
The cost for Rinvoq depends on your health insurance coverage for prescriptions. Abbvie, the company that makes Rinvoq, has programs that may help with your copay costs if needed. You can learn more at www.AbbVie.com/myAbbvieAssist or call 800-222-6885
How do I know if Rinvoq 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 Rinvoq is an appropriate treatment option.
How can I get Rinvoq?
Rinvoq is available by prescription only. Talk to your health care provider and visit www.rinvoq.com to learn more.
1 Guttman-Yassky E, Teixeira HD, Simpson EL et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate double-blind, randomised controlled phase 3 trials. Lancet. 2021 Jun 5;397(10290):2151-2168.
2 Reich K, Teixeira HD, de Bruin-Weller M et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2021 Jun 5;397(10290):2169-2181.
3 Silverberg JI, de Bruin-Weller M, Bieber T et al. Upadacitinib plus topical corticosteroids in atopic dermatitis: Week 52 AD Up study results. J Allergy Clin Immunol. 2021 Aug 14:S0091-6749(21)01212-4. doi: 10.1016/j.jaci.2021.07.036. Online ahead of print.
