What is the recommended use and dosage of Rinvoq (upadacitinib) for patients with rheumatoid arthritis, psoriatic arthritis, or atopic dermatitis?

Rinvoq (Upadacitinib) for Rheumatoid Arthritis, Psoriatic Arthritis, and Atopic Dermatitis

For rheumatoid arthritis, the recommended dose of Rinvoq is 15 mg once daily; for psoriatic arthritis in adults, 15 mg once daily is recommended, while pediatric patients (2-17 years) require weight-based dosing with either oral solution twice daily or tablets once daily; for atopic dermatitis, initiate with 15 mg once daily and consider escalating to 30 mg once daily if inadequate response is achieved, though adults ≥65 years should remain at 15 mg once daily. 1

Rheumatoid Arthritis Dosing

• The FDA-approved dosage for rheumatoid arthritis is 15 mg once daily, taken orally with or without food 1
• Tablets must be swallowed whole and should not be split, crushed, or chewed 1
• Prior to initiating treatment, evaluate for active and latent tuberculosis, viral hepatitis screening, complete blood count (absolute lymphocyte count ≥500 cells/mm³, absolute neutrophil count ≥1000 cells/mm³, hemoglobin ≥8 g/dL), and verify pregnancy status in females of reproductive potential 1

Psoriatic Arthritis Dosing

Adults (≥18 years)

• The recommended dosage is 15 mg once daily 1
• This dose demonstrated superior ACR20 response rates compared to placebo (71% vs 36% in non-biologic DMARD-inadequate responders, and 57% vs 24% in biologic DMARD-inadequate responders at Week 12) 1

Pediatric Patients (2 to <18 years)

Weight-based dosing is required using the following algorithm: 1

• 10 kg to <20 kg: 3 mg (3 mL oral solution) twice daily
• 20 kg to <30 kg: 4 mg (4 mL oral solution) twice daily
• ≥30 kg: Either 6 mg (6 mL oral solution) twice daily OR 15 mg tablet once daily

Critical caveat: Rinvoq LQ oral solution is NOT substitutable with Rinvoq extended-release tablets—changes between formulations must be made by the healthcare provider 1

Atopic Dermatitis Dosing

Pediatric Patients (≥12 years weighing ≥40 kg) and Adults (<65 years)

• Initiate treatment with 15 mg once daily 1
• If inadequate response is achieved, escalate to 30 mg once daily 1
• Discontinue if adequate response is not achieved with the 30 mg dose 1
• Use the lowest effective dose needed to maintain response 1

Adults ≥65 Years

• The recommended dosage is 15 mg once daily only—do not escalate to 30 mg 1

Positioning in Treatment Algorithm

Psoriatic Arthritis Treatment Sequence

According to EULAR 2020 guidelines, JAK inhibitors like upadacitinib should be positioned after inadequate response to at least one csDMARD AND at least one bDMARD, or when a bDMARD is not appropriate 2

• The standard step-up approach is: csDMARD → bDMARD → another bDMARD or JAK inhibitor 2
• "Not appropriate" for bDMARD means non-adherence to injections or strong patient preference for oral medication 2
• At the time of guideline development (2020), upadacitinib was approved for rheumatoid arthritis and showed encouraging results in psoriatic arthritis 2

The American College of Rheumatology (2019) conditionally recommends starting a TNF inhibitor biologic over tofacitinib (another JAK inhibitor) for active psoriatic arthritis, though tofacitinib may be considered if contraindications to TNF inhibitors exist 2

Rheumatoid Arthritis Context

• Upadacitinib 15 mg demonstrated similar efficacy to adalimumab for joint involvement in psoriatic arthritis trials 2
• Safety signals for JAK inhibitors include increased risk of herpes zoster, deep vein thrombosis (particularly with higher doses and in patients with cardiovascular risk factors and older age), and serious infections 2

Safety Monitoring Requirements

Pre-Treatment Evaluations

The following baseline assessments are mandatory before initiating Rinvoq: 1

• Active and latent tuberculosis evaluation (treat if positive before starting)
• Viral hepatitis screening (do not initiate with active hepatitis B or C)
• Complete blood count (do not initiate if ALC <500 cells/mm³, ANC <1000 cells/mm³, or hemoglobin <8 g/dL)
• Baseline hepatic function (do not initiate in severe hepatic impairment, Child-Pugh C)
• Pregnancy status verification in females of reproductive potential
• Update immunizations according to current guidelines

Common Adverse Events

• Upper respiratory tract infection, nasopharyngitis, and increased creatine phosphokinase are the most common treatment-emergent adverse events 3, 4, 5
• Herpes zoster rates are higher with upadacitinib versus adalimumab (1.6-3.6 events per 100 patient-years) 4, 5
• Acne is observed specifically in atopic dermatitis patients 4

Serious Safety Considerations

• Rates of malignancies, major adverse cardiovascular events, venous thromboembolic events, and deaths were similar across upadacitinib and adalimumab treatment groups in integrated analyses 3, 4, 5
• Serious infection rates were similar between upadacitinib 15 mg and adalimumab 5
• Opportunistic infections (excluding tuberculosis, herpes zoster, and oral candidiasis) occurred at higher rates with upadacitinib versus adalimumab 3

Special Populations and Dosing Adjustments

Hepatic Impairment

• Rinvoq initiation is not recommended for patients with severe hepatic impairment (Child-Pugh C) 1

Renal Impairment

• No specific dosing adjustments are provided in the FDA label for renal impairment, but baseline evaluation is required 1

Drug Interactions

• Avoid live vaccines in patients on upadacitinib 1
• The recommended dose for patients taking potent CYP3A4 inhibitors (e.g., ketoconazole) or concomitant moderate CYP3A4 and potent CYP2C19 inhibitors (e.g., fluconazole) is 5 mg once daily 2

Clinical Efficacy Data

Psoriatic Arthritis

• In non-biologic DMARD-inadequate responders, upadacitinib 15 mg achieved 71% ACR20 response versus 36% with placebo at Week 12 1
• In biologic DMARD-inadequate responders, upadacitinib 15 mg achieved 57% ACR20 response versus 24% with placebo at Week 12 1
• ACR50 responses: 38% (upadacitinib 15 mg) vs 13% (placebo) in non-biologic DMARD-IR; 32% vs 5% in biologic DMARD-IR 1
• ACR70 responses: 21% (upadacitinib 15 mg) vs 6% (placebo) in non-biologic DMARD-IR; 18% vs 1% in biologic DMARD-IR 1

Rheumatoid Arthritis

• Upadacitinib 15 mg inhibited radiographic progression of structural joint damage compared to placebo plus methotrexate at Week 26 1
• 83% of patients treated with upadacitinib 15 mg experienced no radiographic progression versus 76% with placebo plus methotrexate 1

Atopic Dermatitis and Psoriasis Overlap

• Case series data demonstrate complete remission in patients with overlapping psoriasis and atopic dermatitis treated with upadacitinib 15-30 mg after failing multiple systemic therapies 6
• In psoriatic arthritis trials, 52.3% of patients achieved PASI75 after one year with upadacitinib 15 mg 6