Is there an emerging therapy from Lilly, specifically an oral Janus kinase (JAK) inhibitor like baricitinib (Olumiant), that has received FDA approval for the treatment of atopic dermatitis?

FDA-Approved JAK Inhibitors for Atopic Dermatitis from Lilly

Baricitinib (Olumiant) is not FDA-approved for atopic dermatitis in the United States, despite being approved in Europe for this indication. 1

Current FDA-Approved JAK Inhibitors for Atopic Dermatitis

The FDA has currently approved two oral JAK inhibitors for atopic dermatitis:

1. Upadacitinib (Rinvoq) - Approved by the FDA for patients with atopic dermatitis who have failed other systemic therapies or when use of those therapies is inadvisable 1

2. Abrocitinib (Cibinqo) - Approved by the FDA for patients with atopic dermatitis who have failed other systemic therapies or when use of those therapies is inadvisable 1

Baricitinib Status

• Baricitinib (Olumiant) is manufactured by Eli Lilly but is not FDA-approved for atopic dermatitis in the United States 1
• It is approved in Europe for the treatment of moderate-to-severe atopic dermatitis 2
• In the US, baricitinib has FDA approval for other indications but remains off-label for atopic dermatitis 1, 3

Efficacy and Safety of Available JAK Inhibitors

Efficacy

• Upadacitinib (30mg daily) and abrocitinib (200mg daily) demonstrate the highest efficacy among all currently available treatments for reducing EASI scores in atopic dermatitis 1
• Both were superior to dupilumab in head-to-head clinical trials 1
• Network meta-analysis suggests baricitinib is less efficacious than upadacitinib and abrocitinib 1

Safety Considerations

• JAK inhibitors carry FDA boxed warnings for:

  • Increased risk of serious heart-related events
  • Cancer
  • Blood clots
  • Death 1

• Additional safety concerns include:

  • Increased risk of serious and opportunistic infections, including herpes zoster 1
  • Laboratory abnormalities requiring monitoring (complete blood count, liver enzymes, lipids) 1
  • Venous thromboembolism risk factors should be carefully evaluated 1

Recommended Dosing

For FDA-approved JAK inhibitors in atopic dermatitis:

• Upadacitinib: 15mg or 30mg PO daily 1
• Abrocitinib: 100mg or 200mg PO daily 1

Clinical Implications

• JAK inhibitors are typically recommended after failure of other systemic therapies or when those therapies are inadvisable 1
• They offer rapid onset of action and significant improvement in both skin lesions and itch 1
• Vaccination for shingles is recommended before initiating JAK inhibitors, particularly for older patients 1
• Laboratory monitoring is required before and during treatment 1

Important Considerations for Patient Selection

• Carefully evaluate patients for:

  • Age >65 years
  • Cardiovascular risk factors
  • History of VTE or risk factors for thrombosis
  • Malignancy risk
  • Infection risk 1

• Shared decision-making with patients is essential, considering the risk-benefit profile and boxed warnings 1

While baricitinib has shown efficacy in clinical trials for atopic dermatitis 2, 4, 5, it remains unavailable as an FDA-approved option for this indication in the US market, despite being manufactured by Lilly.