Efficacy and Safety of Baricitinib Versus Azathioprine in Combination With Topical Corticosteroids For Patients With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Eczema Area and Severity Index (EASI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Baricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream
干预措施: Baricitinib 4 MG (Drug)
B
Azathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream
干预措施: Azathioprine 1.5-2.5 mg/kg (Drug)
结局指标
主要结局
Eczema Area and Severity Index (EASI)
时间窗: 12 weeks
The EASI is used to measure extent of eczema in 4 body regions (head/neck, trunk, upper limbs, and lower limbs) and assesses the following 4 clinical signs: (1) Erythema/Redness, (2) Thickness/Edema/Papulation, (3) Excoriation/Scratching (4) Lichenification. The intensity of each sign in each body region is assessed as: none (0), mild (1), moderate (2) and severe (3). The EASI score is ranged from 0 to 72. The higher score indicates a worse condition.
次要结局
- Itch Numeric Rating Scale (Itch NRS)(12 weeks)
- Skin Pain Numeric Rating Scale (Skin Pain NRS)(12 weeks)
- Body surface area affected (BSA-Affected)(12 weeks)
- Dermatology Life Quality Index (DLQI)(12 weeks)
- Hospital Anxiety Depression Scale (HADS)(12 weeks)
- Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD)(12 weeks)
- SCORing Atopic Dermatitis (SCORAD)(12 weeks)
- Patient-Oriented Eczema Measure (POEM)(12 weeks)
- Atopic Dermatitis Sleep Scale (ADSS)(12 weeks)
- Adverse Events (Safety assessment)(Throughout the study)
研究者
Mohammad Malekan
Medical Intern
Mazandaran University of Medical Sciences