Baricitinib Versus Azathioprine in Patients With Moderate-to-Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT05969730
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Azathioprine 1.5-2.5 mg/kg Azathioprine 1.5-2.5 mg/kg plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream A Baricitinib 4 MG Baricitinib 4-mg daily plus fluocinolone 0.025% topical ointment and daily emollient of urea 10% topical cream
- Primary Outcome Measures
Name Time Method Eczema Area and Severity Index (EASI) 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.
- Secondary Outcome Measures
Name Time Method Itch Numeric Rating Scale (Itch NRS) 12 weeks The Itch Numeric Rating Scale (Itch NRS) is an 11-point horizontal scale reported by the patient, ranging from 0 to 10, with 0 indicating "no itch" and 10 signifying "worst itch imaginable." Patients select the number that best describes the worst level of itching in the past 24 hours. The higher score indicates a worse condition.
Skin Pain Numeric Rating Scale (Skin Pain NRS) 12 weeks The skin pain Numeric Rating Scale (skin pain NRS) is an 11-point horizontal scale reported by the patient, ranging from 0 to 10, with 0 indicating "no skin pain" and 10 signifying "worst skin pain imaginable." Patients select the number that best describes the worst level of skin pain in the past 24 hours. The higher score indicates a worse condition.
Body surface area affected (BSA-Affected) 12 weeks The SCORAD data will be used to calculate the body surface area affected by atopic dermatitis.
Dermatology Life Quality Index (DLQI) 12 weeks The Dermatology Life Quality Index (DLQI) is a 10-item, validated, patient-administered quality-of-life questionnaire that includes six domains: symptoms and feelings, daily activities, leisure, job and school, personal relationships, and therapy. This scale's recall period is over the last week. Response categories include "not at all," "a little," "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as 0. Total score vary from 0 to 30, with higher socre indicating a lower quality of life.
Hospital Anxiety Depression Scale (HADS) 12 weeks The Hospital Anxiety Depression Scale (HADS) is a patients-reported questionnaire with 14 items that evaluate a patient's degree of anxiety and depression during the previous week. Each item is scored on a 4-point scale, giving maximum scores of 21 for anxiety and depression.
Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) 12 weeks The vIGA-AD showed the dermatologist's global assessment of the patient's overall severity of their atopic dermatitis based on a numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is taken to the degree of erythema, papulation/induration, oozing/crusting, and lichenification in patients. The higher score indicates a worse condition.
SCORing Atopic Dermatitis (SCORAD) 12 weeks The SCORAD index measures 3 aspects of atopic dermatitis in patients and presents a general score (A/5 + 7\*B/2 + C, maximum possible score of 103). These aspects include (A, 0-100%) the extent of disease with the rule of nines, (B, 0-18) disease severity through 6 clinical characteristics \[(1) erythema, (2) edema/papulation, (3) oozing/crusts, (4) excoriation, (5) lichenification, and (6) dryness on a scale of 0 to 3 (0=absence, 1=mild, 2=moderate, 3=severe)\], and (C, 0-20) subjective symptoms of pruritus and sleep loss. The higher score indicates a worse condition.
Patient-Oriented Eczema Measure (POEM) 12 weeks The patient-oriented eczema measure (POEM) is a 7-item patient-reported questionnaire used to assess the severity of atopic dermatitis. Seven symptoms will be asked through questions including (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) on a scale ranging from 0-4 (0=no days, 1=1-2 days, 2=3-4 days, 3=5-6 days, 4=everyday). Scores range from 0 to 28. The higher score indicates a worse condition.
Atopic Dermatitis Sleep Scale (ADSS) 12 weeks The Atopic Dermatitis Sleep Scale (ADSS) is a 3-item questionnaire, reported by patients and designed to measure the impact of itch on sleep including difficulty falling asleep, frequency of waking, and difficulty getting back to sleep over last night. Patients assess their difficulties falling asleep and going to sleep, items 1 and 3, respectively, using a 5-point Likert-type scale with responses ranging from 0 "not at all" to 4 "very difficult." In item 2. Patients indicate their frequency of waking up last night by choosing the number of times between 0 to 29. Each item is scored separately.
Adverse Events (Safety assessment) Throughout the study Investigators are responsible for appropriate medical care throughout the study and monitoring the all adverse effects of patients who have enrolled in this study. Also, investigators must document all related safety data as well as laboratory results based on the prepared guide/list below. The phone number of the responsible investigator will be available for each patient. The patients will be advised to inform the investigator about all unusual events they may experience. An in-person visit may be set for patients as needed.
Trial Locations
- Locations (1)
Iran
🇮🇷Sari, Mazandaran, Iran, Islamic Republic of