Baricitinib Versus Azathioprine in Patients With Moderate-to-Severe Atopic Dermatitis
Status:
Recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
Atopic dermatitis, which is also known as atopic eczema, is a common inflammatory and chronic
skin disease that is characterized by severe recurrent erythematous and pruritic lesions.
Patients suffer from decreased quality of life and poor work productivity due to the disease
complications like persistent scratching, skin pain, skin damage, sleep disturbances, and
social/emotional distress. In the United States (US), the prevalence of adults with atopic
dermatitis ranges from 5% to 10%.
The mainstay treatment for atopic dermatitis is emollient and tropical corticosteroids which
could be efficient for less severe atopic dermatitis patients but moderate to severe patients
usually need additional therapies like phototherapy or systemic medications.
It is revealed that Janus kinase signal transducers and activators of transcription
(JAK-STAT) pathway has a prominent role in the development and progression of atopic
dermatitis. JAK1/JAK2 inhibitor, baricitinib is a new-class orally available drug that is
approved for systemic treatment of adult patients with moderate to severe atopic dermatitis.
In the phase III clinical trial baricitinib 2-mg and 4-mg were shown efficient results as
monotherapy of adult patients with moderate to severe atopic dermatitis who have an
inadequate response to topical corticosteroids (TCS).
Azathioprine is an immunosuppressant and antimetabolite agent interferes with the formation
of lymphocytes, and suppresses prostaglandin synthesis, both of which are implicated in the
inflammation associated with eczema. Azathioprine can be used (off-label) for moderate to
severe atopic dermatitis patients. Multiple studies have demonstrated that azathioprine might
be effective for patients with moderate-to-severe atopic dermatitis. Azathioprine is usually
prescribed when cyclosporine is either contraindicated or not effective.
This trial will be conducted to test the hypothesis that baricitinib 4-mg daily in
combination with TCS is superior to azathioprine 1.5-2.5 mg/kg a day in combination with TCS
for moderate-to-severe AD at week 12 in terms of efficacy and safety.