Atopic dermatitis (AD) is a skin condition characterized by a rash and itching, resulting from skin inflammation. Ivarmacitinib is an approved medication for treating AD. This study assessed the efficacy and safety of switching to the JAK1 inhibitor ivarmacitinib over 16 weeks in patients with moderate-to-severe atopic dermatitis and inadequate response to IL-4Rα inhibitors under real-world conditions. It is expected that there will be no additional burden for participants in this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Patients with moderate to severe atopic dermatitis are initially treated with 4 mg of ivarmacitinib once daily for 16 weeks.If a suboptimal response is observed with the 4 mg once-daily dose, an increase to 8 mg once daily may be considered. Treatment should be discontinued if an adequate response is not achieved following dose escalation to 8 mg once daily.
Eczema Area and Severity Index (EASI 75) at Week 16
Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16
Time frame: 16 Weeks
Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16
Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16
Time frame: 16 Weeks
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16
Time frame: 16 Weeks
EASI 75 at Week 2, 4, 8 and 12
Proportion of subjects achieving EASI 75 at all scheduled visits during placebo-controlled treatment phase except Week 16
Time frame: Week 2, 4, 8 and 12
Worst-Itch Numeric Rating Scale (WI-NRS) at Week 2, 4, 8 and 12
Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during placebo-controlled treatment phase other than Week 16
Time frame: Week 2, 4, 8 and 12
Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 2, 4, 8, 12 and 16
Change from baseline in Patient-Oriented Eczema Measure (POEM) at all scheduled visits. 7-item, patient-administered scale that assesses disease severity in children and adults. Subjects respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week. Response categories include "No days," "1-2 days," "3-4 days," "5-6 days," and "Every day" with corresponding scores of 0, 1, 2, 3, and 4, respectively. Scores range from 0-28 with higher total scores indicating greater disease severity.
Time frame: Day 1 to Week 16
Change of dermatology life quality index (DLQI) from baseline at Week 2, 4, 8, 12, and 16
The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL.
Time frame: Day 1 to Week 16
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