What is the recommended dosing for Rinvoq (upadacitinib) in patients with ankylosing spondylitis (Ank Spon) or psoriatic arthritis (PsA)?

Rinvoq Dosing for Ankylosing Spondylitis and Psoriatic Arthritis

For ankylosing spondylitis, the FDA-approved dose of Rinvoq (upadacitinib) is 15 mg once daily, and for psoriatic arthritis, the approved dose is also 15 mg once daily. 1

Ankylosing Spondylitis Dosing

• The standard and only recommended dose is 15 mg once daily for all patients with ankylosing spondylitis 1
• This dosing has demonstrated sustained efficacy through 2 years, with 65.6% of patients achieving ASAS40 response at week 104 2
• No dose adjustment is needed for patients with mild, moderate, or severe renal impairment 1
• No dose adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B) 1
• Rinvoq is not recommended for patients with severe hepatic impairment (Child-Pugh C) 1

Psoriatic Arthritis Dosing

• The standard recommended dose is 15 mg once daily for psoriatic arthritis 1
• Phase 3 trials demonstrated that the 15 mg dose showed non-inferiority for ACR20 response compared to adalimumab, while the 30 mg dose showed superiority 3
• Despite the 30 mg dose showing superior efficacy in trials, the FDA-approved dosing for psoriatic arthritis is 15 mg once daily 1
• No dose adjustment is needed for patients with mild, moderate, or severe renal impairment 1
• No dose adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B) 1

Drug Interaction Modifications

• No dosage adjustment is needed when co-administered with strong CYP3A4 inhibitors for either ankylosing spondylitis or psoriatic arthritis 1
• This differs from other indications like atopic dermatitis where dose reduction to 15 mg is required with strong CYP3A4 inhibitors 1

Safety Considerations Across Both Indications

• The safety profile of upadacitinib 15 mg has been consistent across psoriatic arthritis and ankylosing spondylitis through up to 5 years of exposure 4
• Rates of major adverse cardiovascular events (MACE) and venous thromboembolic events (VTE) were similar across both conditions (0.3-0.6 E/100 PY for MACE and 0.2-0.4 E/100 PY for VTE) 5
• In ankylosing spondylitis specifically, no MACEs and only one VTE event occurred in clinical trials 5
• The overall treatment-emergent adverse event rate in ankylosing spondylitis was 242.7/100 patient-years through 2 years 2

Laboratory Monitoring Requirements

• Interrupt treatment if absolute neutrophil count falls below 1000 cells/mm³ and restart once it returns above this value 1
• Interrupt treatment if absolute lymphocyte count falls below 500 cells/mm³ and restart once it returns above this value 1
• Interrupt treatment if hemoglobin falls below 8 g/dL and restart once it returns above this value 1
• Interrupt treatment if drug-induced liver injury is suspected until this diagnosis is excluded 1

Important Clinical Caveats

• Avoid use in patients with active serious infections, including localized infections 1
• The 30 mg dose is not FDA-approved for either ankylosing spondylitis or psoriatic arthritis, despite showing superior efficacy in psoriatic arthritis trials 3, 1
• Treatment should be interrupted if a serious infection develops, including opportunistic infections, until the infection is controlled 1
• Rinvoq is contraindicated in patients with known hypersensitivity to upadacitinib or any excipients 1