The Purpose of the Study is to Evaluate the Effect of Ruxolitinib Cream on Itch in Participants With Atopic Dermatitis

The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.

On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments).

The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.

On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments). Confidence intervals were calculated using the Clopper-Pearson method.

The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.

On Day 1, participants were asked to evaluate the current intensity of their itch at the time of assessment (i.e., prior to the morning study drug application, and 15 and 30 minutes and 1, 2, 4, 6, and 12 hours after the morning study drug application; the 12-hour evaluation occurred prior to the second daily study drug application) on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments).

The intensity of pruritus (itch) was recorded daily using the PP-NRS (24-hour recall period). Participants were asked to assign a numerical score representing their itch at the worst moment during the previous 24 hours on a scale of 0 to 10, with 0 being no itch and 10 being the worst itch imaginable. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.

The MCID corresponds to an achievement of a ≥2-grade reduction in PP-NRS from Baseline. The time to MCID was defined as the time from the date (time) of the first dose to the date (time) of the first occurrence of MCID. Baseline was defined as the average of all non-missing PP-NRS scores reported during the 7-day run-in period.

The MCID corresponds to an achievement of a ≥2-grade reduction in mPP-NRS from Baseline. The time to MCID was defined as the time from the date (time) of the first dose to the date (time) of the first occurrence of MCID. Baseline was defined as the last non-missing assessment before or on Day 1 and prior to the first application of study drug (including unscheduled assessments).

The IGA of the current state of the disease is a 5-point morphological assessment of overall disease severity. 0, clear: no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1, almost clear: there may be trace faint pink erythema with almost no induration/papulation and no oozing/crusting. 2, mild: there may be faint pink erythema with mild induration/papulation and no oozing/crusting. 3, moderate: there may be pink-red erythema with moderate induration/papulation, and there may be some oozing/crusting. 4, severe: there may be deep or bright red erythema with severe induration/papulation and with oozing/crusting.

The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade reduction from Baseline. The IGA of the current state of the disease is a 5-point morphological assessment of overall disease severity. 0, clear: no erythema or induration/papulation, no oozing/crusting; there may be minor residual discoloration. 1, almost clear: there may be trace faint pink erythema with almost no induration/papulation and no oozing/crusting. 2, mild: there may be faint pink erythema with mild induration/papulation and no oozing/crusting. 3, moderate: there may be pink-red erythema with moderate induration/papulation, and there may be some oozing/crusting. 4, severe: there may be deep or bright red erythema with severe induration/papulation and with oozing/crusting.

An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose.

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. TEAEs were defined as any AEs with an onset date during or after the first study treatment dose. The severity of AEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.