A ONCE-DAILY ORAL JAK inhibitor indicated for the treatment of adults and pediatric patients 12+ years of age 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 are inadvisable.1
RINVOQ is indicated for the treatment of1:
- Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.
- Active psoriatic arthritis in adults who have had an inadequate response or intolerance to one or more TNF blockers.
Limitations of Use: Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.1
- Refractory, moderate to severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
Limitations of Use: RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.1
RINVOQ was evaluated in moderate to severe atopic dermatitis patients who1,2:
- were between the ages of 12 and 75
- had ≥10% body surface area involvement
- had a vIGA score of 3 or 4
- had an EASI score ≥16
- had baseline worst pruritus NRS ≥4
- had inadequate response to TCS/TCI or documented systemic treatment for AD within 6 months prior to baseline
RINVOQ is indicated for adults and pediatric patients 12 years of age and older 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 are inadvisable.1
In clinical trials, RINVOQ met co-primary endpoints of EASI 75 and vIGA 0/1 at Week 16. Additionally, many patients improved worst pruritus NRS by at least 4 points at Week 16.1
In pivotal trials, many patients achieved co-primary endpoints EASI 75 and vIGA 0/1 at Week 16.1
At Week 52 in a blinded to dose extension study, skin clearance rates, including vIGA 0/1, EASI 75, EASI 90 and itch reduction rates, were observed.2,3
DATA LIMITATIONS: Data through Week 52 were prespecified, non-ranked endpoints, not controlled for multiplicity; treatment effects could represent chance findings. There is the potential for enrichment as patients who are unable to tolerate or do not respond to drug may drop out. Awareness of active treatment may cause bias related to overall treatment effect. Patients may have used topical medications, which were no longer considered rescue.
Serious Infections: Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death. These infections include tuberculosis (TB), invasive fungal, bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.
Mortality: A higher rate of all-cause mortality, including sudden cardiovascular (CV) death, was observed with a Janus kinase (JAK) inhibitor in a study comparing another JAK inhibitor with tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients ≥50 years of age with at least one CV risk factor.
Malignancies: Lymphoma and other malignancies have been observed in RINVOQ-treated patients. A higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]), lymphomas, and lung cancer (in current or past smokers) was observed with another JAK inhibitor when compared with TNF blockers in RA patients. Patients who are current or past smokers are at additional increased risk.
Major Adverse Cardiovascular Events: A higher rate of CV death, myocardial infarction, and stroke was observed with a JAK inhibitor in a study comparing another JAK inhibitor with TNF blockers in RA patients ≥50 years of age with at least one CV risk factor. Current or past smokers are at additional increased risk.
Thrombosis: Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. A higher rate of thrombosis was observed with another JAK inhibitor when compared with TNF blockers in RA patients.
Hypersensitivity: RINVOQ is contraindicated in patients with known hypersensitivity to upadacitinib or any of its excipients.
Other Serious Adverse Reactions: Hypersensitivity Reactions (anaphylaxis and angioedema), Gastrointestinal Perforations, Laboratory Abnormalities (neutropenia, lymphopenia, anemia, lipid elevations, liver enzyme elevations), and Embryo-Fetal Toxicity.
Common side effects reported in ≥1% of patients with RINVOQ in atopic dermatitis include: upper respiratory tract infection, acne, herpes simplex, headache, increased blood creatine phosphokinase, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness.1
These are not all the possible side effects of RINVOQ.1
In the placebo-controlled portion of pivotal trials, 2% of patients on placebo (n=902), 10% of patients on RINVOQ 15 mg (N=899), and 16% of patients on RINVOQ 30 mg (N=906) experienced adverse events of acne.4
99% of cases were mild or moderate in severity. Two events led to study discontinuation (1 each in the 15 mg and 30 mg groups).4
RINVOQ is indicated for the treatment of adults and pediatric patients 12 years of age and older 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 are inadvisable.1
RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.1
For adults <65 years and pediatric patients 12+ years weighing at least 40 kg (88 lb), initiate treatment with RINVOQ 15 mg once-daily in pediatric patients (≥12 years, ≥40 kg) and adults <65 years of age. If an adequate response is not achieved, consider increasing the dosage to 30 mg once-daily. Discontinue RINVOQ if an adequate response is not achieved with the 30 mg dose. Use the lowest effective dose needed to maintain response. For patients ≥65 years, patients receiving strong CYP3A4 inhibitors, and patients with severe renal impairment, the recommended dose of RINVOQ is 15 mg once-daily.1
RINVOQ is an oral tablet, taken as 1 pill with or without food. RINVOQ is an extended-release tablet so patients should not split, break, crush, or chew the tablets. Ensure tablet is taken whole.1
For moderate to severe atopic dermatitis, the recommended dose for patients with severe renal impairment is 15 mg. No dose adjustment is needed for mild or moderate renal impairment. No dose adjustment is needed for mild or moderate hepatic impairment. RINVOQ is not recommended for use in patients with severe hepatic impairment.1
SUPPORT & ACCESS
RINVOQ® Complete may be able to help eligible commercially insured patients experiencing initial coverage delays or denials access their prescribed therapy.
Help may be available to commercially insured patients.
If eligible, the bridge is available for 24 months (rolling) or until the product is covered by the patient’s insurance, whichever is sooner. The bridge requires patient and HCP to attempt resolution for the insurance delay or denial once the patient’s plan has made a formulary decision and established a review process for coverage requests, including:
- Submitting a PA
- Submitting an appeal within 180 days if that PA is denied
(Full terms and conditions can be found on the RINVOQ Complete Enrollment Form)
You can request samples from a Rep.