Last reviewed 2026-04-20 · How we verify

Rinvoq (upadacitinib)

JAK inhibitor that prevents STAT phosphorylation and activation in cytokine signaling pathways.

Upadacitinib (RINVOQ/RINVOQ LQ) is a JAK inhibitor indicated for moderately to severely active rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and giant cell arteritis in patients with inadequate response or intolerance to TNF blockers. The drug demonstrates dose-proportional plasma exposures with steady-state achieved within 4 days and a half-life of 8-14 hours, primarily metabolized by CYP3A4. Strong CYP3A4 inhibitors increase upadacitinib exposure requiring dose adjustments or close monitoring, while strong CYP3A4 inducers are not recommended due to reduced efficacy. RINVOQ is not recommended for combination use with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants.

At a glance

Mechanism of action

Upadacitinib is a Janus kinase (JAK) inhibitor that modulates intracellular signaling pathways. JAKs are intracellular enzymes that transmit signals from cytokine or growth factor-receptor interactions on the cellular membrane to influence hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs) which modulate intracellular activity including gene expression. Upadacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. In a cell-free isolated enzyme assay, upadacitinib demonstrated greater inhibitory potency at JAK1 and JAK2 relative to JAK3 and TYK2. In human leukocyte cellular assays, upadacitinib inhibited cytokine-induced STAT phosphorylation mediated by JAK1 and JAK1/JAK3 more potently than JAK2/JAK2 mediated STAT phosphorylation. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

Approved indications

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Atopic Dermatitis
• Ulcerative Colitis
• Crohn’s Disease
• Ankylosing Spondylitis
• Non-radiographic Axial Spondyloarthritis
• Polyarticular Juvenile Idiopathic Arthritis
• Giant Cell Arteritis

Boxed warnings

• WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS SERIOUS INFECTIONS Patients treated with RINVOQ /RINVOQ LQ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt RINVOQ /RINVOQ LQ until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ /RINVOQ LQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ /RINVOQ LQ use. Invasive fungal infections, including cryptococcosis and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. The risks and benefits of treatment with RINVOQ /RINVOQ LQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ /RINVOQ LQ , including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions ( 5.1 )]. MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions ( 5.2 )] . MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with RINVOQ . In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk [see Warnings and Precautions ( 5.3 )] . MAJOR ADVERSE CARDIOVASCULAR EVENTS In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue RINVOQ /RINVOQ LQ in patients that have experienced a myocardial infarction or stroke [see Warnings and Precautions ( 5.4 )] . THROMBOSIS Thrombos e s, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis , have occurred in patients treated for inflammatory conditions with J AK inhibitors , including RINVOQ . Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid RINVOQ /RINVOQ LQ in patients at risk. Patients with symptoms of thrombosis should discontinue RINVOQ /RINVOQ LQ and be promptly evaluated [see Warnings and Precautions ( 5.5 )]. WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral, and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with RINVOQ / RINVOQ LQ if serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative , latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients. ( 5.2 ) Malignancies have occurred in patients treated with RINVOQ. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.4 ) Thrombosis has occurred in patients treated with RINVOQ. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. ( 5.5 )

Common side effects

• UPPER RESPIRATORY TRACT INFECTION
• NASOPHARYNGITIS
• BLOOD CREATINE PHOSPHOKINASE INCREASED
• HEADACHE
• URINARY TRACT INFECTION
• HYPERTENSION
• DERMATITIS ATOPIC
• DIARRHOEA
• BRONCHITIS
• ALANINE AMINOTRANSFERASE INCREASED
• GIANT CELL ARTERITIS
• ARTHRALGIA

Drug interactions

• Strong CYP3A4 inhibitors (ketoconazole, clarithromycin, grapefruit)
• Strong CYP3A4 inducers (rifampin)

Key clinical trials

• A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab (PHASE3)
• A Study of the Change in Early and Sustained Pain Control in Axial Spondylarthritis in Adult Participants Receiving Upadacitinib
• Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Randomized Placebo-controlled Study. (PHASE2)
• A Study to Assess Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Children From 2 to Less Than 12 Years of Age With Moderate to Severe Atopic Dermatitis (PHASE3)
• Study of Oral Upadacitinib to Assess Change in Disease Activity in Adult Participants With Ulcerative Colitis
• A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)
• Effectiveness and Safety of Upadacitinib for Acute Severe Ulcerative Colitis
• An Observational Study to Assess Real-World Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in China

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Rinvoq CI brief — competitive landscape report
• Rinvoq updates RSS · CI watch RSS
• AbbVie Inc. portfolio CI