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NORTH CHICAGO, Ill., Oct. 11, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data analyses from the Measure Up 1, Measure Up 2 and AD Up Phase 3 studies that further demonstrated the long-term efficacy and safety profile of RINVOQ® (upadacitinib) among adults and adolescents 12 years and older with moderate to severe atopic dermatitis through 140 weeks. Study results will be orally presented on Wednesday, October 11, at the 32nd European Academy of Dermatology and Venereology (EADV) Congress in Berlin.
"Patients with moderate to severe atopic dermatitis often face relentless itch and inflammatory skin symptoms that can impact their everyday lives," said Mudra Kapoor, M.D., vice president, global medical affairs, immunology, AbbVie. "These results reinforce our commitment to providing an effective, long-term treatment option for those living with this debilitating disease and other chronic, immune-mediated conditions."
In the Measure Up 1, Measure Up 2 and AD Up Phase 3 studies, a significantly higher proportion of patients treated with upadacitinib (15 mg or 30 mg) achieved the co-primary endpoints of improvement in skin clearance, measured by an EASI score of 75 (EASI 75) and vIGA-AD 0/1 at week 16, compared to those who received placebo.1 Additionally, more upadacitinib-treated patients achieved the secondary endpoint of improvement in skin clearance, measured by an EASI score of 90 (EASI 90), and an additional endpoint of itch reduction (WP-NRS 0/1) at week 16, compared to placebo-treated patients.1 The efficacy of both upadacitinib doses was consistently maintained for these important measures across all three studies through week 140.1
Week 140 Efficacy Results (ITT-OC)1,* | ||||||
Measure Up 1 | Measure Up 2 | AD Up | ||||
Percent responders | UPA 15 mg (N=205) | UPA 30 mg (N=206) | UPA 15 mg (N=189) | UPA 30 mg (N=204) | UPA 15 mg (N=200) | UPA 30 mg (N=229) |
EASI 75 | 88.8 | 90.3 | 82.0 | 90.7 | 81.5 | 90.0 |
vIGA-AD 0/1 | 63.4 | 65.5 | 49.2 | 63.2 | 52.0 | 56.8 |
EASI 90 | 70.7 | 73.8 | 63.5 | 77.5 | 60.0 | 67.2 |
WP-NRS ≥4 | 68.0 (N=200) | 70.5 (N=207) | 61.4 (N=184) | 71.4 (N=199) | 63.9 (N=191) | 75.2 (N=222) |
WP-NRS 0/1 | 46.8 (N=203) | 50.2 (N=207) | 43.2 (N=185) | 52.5 (N=200) | 43.9 (N=196) | 50.0 (N=224) |
* Intent to treat – observed cases | ||||||
Upadacitinib (15 mg and 30 mg) was generally well tolerated, and the safety data in the long-term extension of the three studies were consistent with the known safety profile of upadacitinib, with no new safety signals observed.1 These results demonstrated that when taken continuously for a long-term period, upadacitinib has an acceptable benefit and risk profile for the treatment of moderate to severe atopic dermatitis.
Long-term Safety Results1,** | ||||||
Measure Up 1 | Measure Up 2 | AD Up | ||||
Events per 100 Patient-Years (E/100 PY) | UPA 15 mg (N=432) PY=1238.2 | UPA 30 mg (N=432) PY=1270.6 | UPA 15 mg (N=431) PY=1178.6 | UPA 30 mg (N=442) PY=1258.5 | UPA 15 mg (N=474) PY=1295.8 | UPA 30 mg (N=472) PY=1429.9 |
Treatment-Emergent Adverse Events | ||||||
Any Serious Adverse Event | 5.4 | 7.9 | 6.2 | 6.8 | 8.6 | 8.0 |
Treatment-Emergent Adverse Events of Special Interest | ||||||
Serious Infections | 1.9 | 3.4 | 2.3 | 2.5 | 2.5 | 2.2 |
Malignancy Excluding Non-Melanoma Skin Cancer | 0.3 | 0.5 | 0.2 | 0.4 | 0.5 | 0.4 |
Major Adverse Cardiovascular Events (MACE)a,* | 0.2 | 0 |
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