What is the justification for upadacitinib (Rinvoq) therapy in a 55-year-old woman with severe, lifelong atopic dermatitis, characterized by high Eczema Area and Severity Index (EASI) scores and significant impairment in Dermatology Life Quality Index (DLQI) scores, who has failed treatment with methotrexate, azathioprine, mycophenolate, and ciclosporin, and lacks access to biologics like dupilumab (Dupixent)?

From the Guidelines

I strongly recommend continued coverage of upadacitinib 15mg daily for this 55-year-old woman with severe lifelong atopic dermatitis, as it has been shown to be effective in managing her disease, with significant improvement in her EASI and DLQI scores, and she has already demonstrated a positive response to this therapy 1. The patient's severe disease burden, with EASI scores exceeding 30 and DLQI scores averaging around 20, indicates a substantial impact on her quality of life. Given her history of adverse reactions to conventional systemic immunosuppressants, including methotrexate, azathioprine, mycophenolate, and ciclosporin, and the unavailability of biologics like dupilumab in her country, upadacitinib is a crucial treatment option for her.

The guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies, as outlined in the Journal of the American Academy of Dermatology, support the use of upadacitinib for adults with moderate to severe atopic dermatitis, with a strong recommendation and moderate certainty of evidence 1. Additionally, the executive summary of these guidelines reiterates the strong recommendation for the use of upadacitinib, among other therapies, for the management of atopic dermatitis in adults 1.

Key points to consider in this patient's case include:

• The patient's significant disease burden and impact on quality of life
• The lack of viable alternative treatment options due to adverse reactions and unavailability of certain medications
• The demonstrated efficacy of upadacitinib in this patient
• The potential for disease relapse and associated complications without continued upadacitinib therapy

Overall, continued coverage of upadacitinib 15mg daily is medically necessary and cost-effective for this patient, given the potential to prevent complications, hospitalizations, and additional healthcare utilization associated with uncontrolled severe atopic dermatitis 1.

From the FDA Drug Label

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. The recommended dosage of RINVOQ is 15 mg once daily.

The patient has severe lifelong atopic dermatitis with EASI scores in excess of 30 and DLQI scores averaging around 20, indicating a significant impact on her quality of life. She has tried other treatments, including methotrexate, azathioprine, mycophenolate, and ciclosporin, but has reacted adversely to them. Biologics such as dupilumab are not available in her home country. Upadacitinib 15mg daily has been very helpful in managing her condition.

Given the patient's history and the lack of alternative treatment options, continuation of upadacitinib therapy is recommended. The patient's response to upadacitinib and the lack of alternative treatment options support the use of this medication. However, it is essential to closely monitor the patient for potential side effects, including serious infections, malignancies, and cardiovascular events, as outlined in the drug label 2 and 2.

Key considerations:

• The patient's severe atopic dermatitis and lack of response to other treatments
• The patient's adverse reactions to other medications
• The availability of upadacitinib and its efficacy in managing the patient's condition
• The need for close monitoring for potential side effects

From the Research

Patient Profile

• The patient is a 55-year-old woman with severe lifelong atopic dermatitis.
• She has had EASI scores in excess of 30 and her DLQI scores average around 20.
• She has reacted adversely to methotrexate, azathioprine, mycophenolate, and ciclosporin.
• Biologics such as dupilumab are not available in her home country.

Upadacitinib Therapy

• Upadacitinib in a dose of 15mg daily has been very helpful for the patient.
• However, she is unable to afford to continue the treatment.
• Studies have shown that upadacitinib is effective in treating moderate to severe atopic dermatitis, with significant improvements in EASI scores and quality of life 3, 4, 5.
• A study comparing upadacitinib to dupilumab found that upadacitinib demonstrated superior efficacy, with more patients achieving EASI75 and EASI100 at week 16 3.
• Another study found that upadacitinib was effective in maintaining efficacy through 52 weeks, with a favorable benefit-risk profile 4.
• A real-world study found that upadacitinib was effective in patients who had failed other systemic therapies, including dupilumab, with significant reductions in EASI scores and improvements in quality of life 5.

Safety and Efficacy

• Upadacitinib has been shown to be generally well-tolerated, with a favorable safety profile 3, 4, 5.
• However, studies have also reported adverse events such as nasopharyngitis, creatine phosphokinase elevation, and acne 6.
• A network meta-analysis found that high-dose upadacitinib was among the most effective treatments for atopic dermatitis, but also among the most harmful in increasing adverse events 7.
• The same analysis found that low-dose upadacitinib was among the most effective treatments, but also among the most harmful 7.

Treatment Options

• Given the patient's adverse reactions to other treatments and the unavailability of biologics such as dupilumab, upadacitinib may be a viable treatment option.
• The patient's positive response to upadacitinib 15mg daily suggests that this treatment could be effective in managing her atopic dermatitis.
• However, the cost of the treatment and the potential for adverse events should be carefully considered.