Upadacitinib Demonstrates Continued Improvements in Patients With Moderate to Severe AD Through 140 Weeks

Atopic dermatitis of the hand | Image credit: DermNet

A poster presentation from the 2024 Revolutionizing Alopecia Areata, Vitiligo, and Eczema conference held in Chicago, Illinois, detailed the integrated results of patients with moderate to severe atopic dermatitis who were randomized to receive upadacitinib 15mg or 30mg at baseline in the Measure Up 1 (NCT03569293) and Measure Up 2 (NCT03607422) studies from week 16 through week 140. From their integrated analysis, Prajapati et al found that patient-reported outcomes (PROs) improved in patients with moderate to severe atopic dermatitis who received upadacitinib vs placebo, and specifically long-term PROs improved with upadacitinib 30mg versus upadacitinib 15mg.

In the identical, phase 3, multicenter Measure Up studies evaluating upadacitinib as monotherapy for adolescents aged 12 to 17 years and adults aged 18 years and older with moderate to severe atopic dermatitis, patients were randomized at baseline 1:1:1 to receive upadacitinib 15mg, upadacitinib 30mg, or placebo. In Prajapati et al’s analysis, data from the patients who were randomized to receive upadacitinib 15mg or 30mg at baseline were integrated and reported based on observed cases from week 16 through week 140. Week 16 data of patients who were randomized to receive placebo were also included.

The assessments in the integrated analysis included itch (Worst Pruritus Numerical Rating Scale [WP-NRS]); Eczema Area and Severity Index (EASI); skin pain (AD Symptom Scale [ADerm-SS] Skin Pain); skin symptoms (ADerm-SS 7-item Total Symptom Score [TSS-7]); skin symptom severity (Patient Oriented Eczema Measure [POEM]); QoL (Dermatology Life Quality Index [DLQI; patients aged ≥ 16 years], and Children’s DLQI [CDLQI; patients aged < 16 years]); and sleep, daily activities, and emotional state (AD Impact Scale [ADermIS]).

“Assessed outcomes included achievement of (1) minimal clinically important differences vs baseline (WPNRS, ADerm-SS Skin Pain, and POEM improvement ≥ 4; ADermSS TSS-7 improvement ≥ 28; ADerm-IS Sleep, Daily Activities, and Emotional State improvements ≥ 12, ≥ 14, and ≥ 11, respectively), (2) no/minimal disease burden or impact (WP-NRS 0/1, ≥ 90% improvement from baseline in EASI [EASI 90], DLQI 0/1, and CDLQI 0/1), and (3) simultaneous achievement of EASI 90 and WPNRS 0/1, an endpoint that aligns with the recently proposed minimal disease activity concept,” wrote Prajapati et al.

Results

The integrated analysis included data from 1213 patients (upadacitinib 15mg, n=603; upadacitinib 30mg, n=610), including 241 adolescents (19.9%) and 972 adults (80.1%), from Measure Up 1 and Measure Up 2. Based on the analysis, over 50% of patients receiving either dose of upadacitinib reported clinically meaningful improvements in PROs at week 16. Out of the patients who received upadacitinib 15mg or upadacitinib 30mg, 36.7% and 53.1% achieved WP-NRS 0/1, while 29.0% and 44.1% achieved DLQI 0/1, and 23.5% and 50.0% achieved CDLQI 0/1, respectively.

Overall response rates at week 16 were sustained or continued to improve through week 140. At week 140, the proportion of patients who were treated with upadacitinib15mg and upadacitinib30mg from baseline who achieved clinically meaningful improvements were

• 64.8% and 70.9% for itch
• 74.6% and 81.5% for skin pain
• 67.6% and 75.4% for skin symptoms
• 89.0% and 94.2% for skin symptom severity
• 76.5% and 84.0% for sleep
• 79.2% and 84.0% for daily activities
• 78.6% and 82.7% for emotional state

Additionally at week 140, achievement rates with upadacitinib 15mg and upadacitinib 30mg were 45.1% and 51.4% for WP-NRS 0/1, 67.3% and 75.6% for EASI 90, 40.5% and 47.1% for simultaneous EASI 90 and WP-NRS 0/1 achievement, 40.2% and 48.5% for DLQI 0/1, and 35.7% and 65.0% for CDLQI 0/1, respectively.

Due to the burdensome symptoms of atopic dermatitis, the study authors felt that their analysis needed to consider signs, symptoms, and QoL impairments when also evaluating the long-term benefits of certain atopic dermatitis therapeutics.

“Patients with moderate-to-severe AD experienced sustained improvements in skin signs/symptoms through 140 weeks while receiving upadacitinib. Rates of long-term PRO improvements were numerically higher with upadacitinib 30mg compared with upadacitinib 15 mg,” concluded Prajapati et al.

Reference

Prajapati VH, Bunick CG, Eyerich K, et al. Sustained improvements over 140 weeks in signs, symptoms, and quality of life with upadacitinib in adolescents and adults with moderate-to-severe atopic dermatitis: integrated results from the phase 3 Measure Up 1 and Measure Up 2 studies. Poster presented at: 2024 Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference; June 8-10, 2024; Chicago IL.