RINVOQ is an oral selective and reversible JAK inhibitor indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). RINVOQ may be used as monotherapy or in combination with methotrexate.
RINVOQ, the new once-daily oral selective JAK inhibitor1
RINVOQ + MTX demonstrated significantly greater remission rates* vs placebo + MTX and adalimumab + MTX1,2
• | Remission rate:* 29% for RINVOQ + MTX vs 6% with placebo + MTX (primary endpoint)† and 18% for adalimumab + MTX‡ at Week 12 (P≤0.001 for both comparisons) |
See remission data
RINVOQ + MTX was superior to adalimumab + MTX at Week 12 on ACR50, pain, and HAQ-DI2
• | ACR50 response rate: 45% for RINVOQ + MTX vs 15% with placebo + MTX and 29% for adalimumab + MTX§ at Week 12 (P≤0.001 for both comparisons) |
• | Patient-reported pain: –32.1 change from baseline (VAS) for RINVOQ + MTX vs –15.7 with placebo + MTX and –25.6 for adalimumab + MTX§ at Week 12 (P≤0.001 for both comparisons) |
• | Physical function: –0.60 change from baseline in HAQ-DI for RINVOQ + MTX vs –0.28 with placebo + MTX|| and –0.49 for adalimumab + MTX§ at Week 12 (P≤0.001 vs placebo + MTX, P≤0.01 vs adalimumab + MTX) |
See efficacy data
RINVOQ’s safety has been established across 5 robust Phase 3 clinical trials involving more than 4,000 patients and more than 5,000 patient-years of exposure3
See safety profile
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*Remission: DAS28 (CRP) <2.6.
†Indicates multiplicity-controlled comparison of RINVOQ + MTX vs placebo + MTX.
‡Unranked endpoint of RINVOQ + MTX vs adalimumab + MTX not controlled for multiplicity; nominal P value provided.
§Superiority for ACR50, Δ pain, and Δ HAQ-DI for RINVOQ + MTX vs adalimumab + MTX at Week 12 were FDA ranked key secondary multiplicity-controlled endpoints.
||Δ HAQ-DI for RINVOQ + MTX vs placebo + MTX at Week 12 was an EMA ranked key secondary multiplicity-controlled endpoint.
ACR50: improvement of at least 50% in the American College of Rheumatology core criteria; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); EMA: European Medicines Agency; FDA: Food and Drug Administration; HAQ-DI: Health Assessment Questionnaire-Disability Index; JAK: Janus kinase; MTX: methotrexate.
SELECT-COMPARE: 48-week, double-blind, active comparator–controlled study of 1,629 adult patients with moderate to severe active RA and an inadequate response to MTX. Patients on stable background MTX were randomized 2:2:1 to RINVOQ 15 mg QD (n=651), placebo (n=651), or adalimumab 40 mg EOW (n=327). The primary endpoint was the proportion of patients achieving clinical remission (DAS28 [CRP] <2.6) for RINVOQ + MTX vs placebo + MTX at Week 12. The proportion of patients achieving low disease activity (DAS28 [CRP] ≤3.2) was a ranked secondary endpoint for RINVOQ + MTX vs placebo + MTX and vs adalimumab + MTX at Week 12.
Safety Information1
RINVOQ is contraindicated in patients hypersensitive to the active substance or to any of the excipients, in patients with active tuberculosis (TB) or active serious infections, in patients with severe hepatic impairment, and during pregnancy.
Use in combination with other potent immunosuppressants is not recommended.
Serious and sometimes fatal infections have been reported in patients receiving upadacitinib. The most frequent serious infections reported included pneumonia and cellulitis. Cases of bacterial meningitis have been reported. Among opportunistic infections, TB, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis have been reported with upadacitinib. Prior to initiating upadacitinib, consider the risks and benefits of treatment in patients with chronic or recurrent infection or with a history of a serious or opportunistic infection, in patients who have been exposed to TB or have resided or traveled in areas of endemic TB or endemic mycoses, and in patients with underlying conditions that may predispose them to infection. Upadacitinib therapy should be interrupted if a patient develops a serious or opportunistic infection. As there is a higher incidence of infections in patients ≥75 years of age, caution should be used when treating this population.
Patients should be screened for TB before starting upadacitinib therapy. Anti-TB therapy should be considered prior to initiation of upadacitinib in patients with previously untreated latent TB or in patients with risk factors for TB infection.
Viral reactivation, including cases of herpes zoster, were reported in clinical studies. Consider interruption of therapy if a patient develops herpes zoster until the episode resolves. Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.
The use of live, attenuated vaccines during or immediately prior to therapy is not recommended. It is recommended that patients be brought up to date with all immunizations, including prophylactic zoster vaccinations, prior to initiating upadacitinib, in agreement with current immunization guidelines.
The risk of malignancies, including lymphoma is increased in patients with rheumatoid arthritis (RA). Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma. The clinical data are currently limited and long-term studies are ongoing. Malignancies, including nonmelanoma skin cancer (NMSC), have been reported in patients treated with upadacitinib. Consider the risks and benefits of upadacitinib treatment prior to initiating therapy in patients with a known malignancy other than a successfully treated NMSC or when considering continuing upadacitinib therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Absolute neutrophil count <1000 cells/mm3, absolute lymphocyte count <500 cells/mm3, or hemoglobin levels <8 g/dL were reported in ≤1% of patients in clinical trials. Treatment should not be initiated, or should be temporarily interrupted, in patients with these hematological abnormalities observed during routine patient management.
RA patients have an increased risk for cardiovascular disorders. Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidemia) managed as part of usual standard of care.
Upadacitinib treatment was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.
Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo. If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.
Events of deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors, including upadacitinib. Upadacitinib should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient’s risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilization. If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
The most commonly reported adverse drug reactions are upper respiratory tract infections (13.5%), nausea (3.5%), increased blood creatine phosphokinase (2.5%), and cough (2.2%). The most common serious adverse reactions were serious infections.
Please see the RINVOQ Summary of Product Characteristics for complete Prescribing Information.
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References
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; [MM,YYYY].
- Fleischmann R, Pangan AL, Song IH, et al. Upadacitinib versus placebo or adalimumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase 3, double-blind, randomized controlled trial [published online July 9, 2019]. Arthritis Rheumatol. doi:10.1002/art.41032
- European Medicines Agency. RINVOQ medicine overview. https://www.ema.europa.eu/en/documents/overview/rinvoq-epar-medicine-overview_en.pdf. Updated XXXXXX. Accessed XXXXXX.