TY - JOUR
T1 - Safety of upadacitinib in moderate-to-severe atopic dermatitis
T2 - An integrated analysis of phase 3 studies
AU - Guttman-Yassky, Emma
AU - Thyssen, Jacob P.
AU - Silverberg, Jonathan I.
AU - Papp, Kim A.
AU - Paller, Amy S.
AU - Weidinger, Stephan
AU - Chih-ho Hong, H.
AU - Hendrickson, Barbara
AU - Dilley, Deanne
AU - Tenorio, Allan R.
AU - Ladizinski, Barry
AU - Chu, Alvina D.
AU - Liu, John
AU - Irvine, Alan D.
N1 - Funding Information:
We, along with AbbVie, thank all study investigators for their contributions and the patients who participated in these studies. Medical writing assistance, funded by AbbVie , was provided by Benjamin Holmes, DVM, and Lamara D. Shrode, PhD, ISMPP CMPP, of JB Ashtin.
Publisher Copyright:
© 2022 The Authors
PY - 2023/1
Y1 - 2023/1
N2 - Background: Upadacitinib is a selective reversible Janus kinase (JAK) inhibitor with established efficacy in moderate-to-severe atopic dermatitis (AD). Objective: We evaluated the safety of upadacitinib in patients with moderate-to-severe AD. Methods: Integrated safety data from the 16-week placebo-controlled periods of 1 phase 2b and 3 ongoing phase 3 studies (16 weeks) and longer-term safety data from patients receiving upadacitinib during the blinded extension periods of the three phase 3 studies were analyzed (all upadacitinib exposure). Treatment-emergent adverse events (TEAEs) were presented as exposure-adjusted rates per 100 patient-years (PY). Results: Safety results were similar between the 16-week and all upadacitinib exposure groups. The latter group included 2485 patients (333 adolescents), receiving upadacitinib 15 mg (n = 1239) or 30 mg (n = 1246) for a mean duration of approximately 1 year. Upadacitinib was well tolerated by both adults and adolescents. TEAEs and discontinuation due to AEs were reported more frequently in patients receiving 30 mg upadacitinib (respectively, 311.9 and 5.7 events per 100 PY) versus 15 mg (respectively, 274.6 and 4.4 events per 100 PY). Serious adverse event rates (15/30 mg, 7.1/7.7 events per 100 PY) were similar in both groups. Acne was the most frequently reported adverse event (15/30 mg, 13.3/20.2 events per 100 PY). Serious infection rates were similar across treatment groups. Adjudicated major adverse cardiovascular event and venous thromboembolic event rates were ≤0.1 events per 100 PY. Rates of malignant neoplasms were within the expected range for the general population. Conclusions: Upadacitinib was well tolerated, and no new important safety risks were observed among adults and adolescents with moderate-to-severe AD treated for approximately 1 year compared to the known safety profile of upadacitinib.
AB - Background: Upadacitinib is a selective reversible Janus kinase (JAK) inhibitor with established efficacy in moderate-to-severe atopic dermatitis (AD). Objective: We evaluated the safety of upadacitinib in patients with moderate-to-severe AD. Methods: Integrated safety data from the 16-week placebo-controlled periods of 1 phase 2b and 3 ongoing phase 3 studies (16 weeks) and longer-term safety data from patients receiving upadacitinib during the blinded extension periods of the three phase 3 studies were analyzed (all upadacitinib exposure). Treatment-emergent adverse events (TEAEs) were presented as exposure-adjusted rates per 100 patient-years (PY). Results: Safety results were similar between the 16-week and all upadacitinib exposure groups. The latter group included 2485 patients (333 adolescents), receiving upadacitinib 15 mg (n = 1239) or 30 mg (n = 1246) for a mean duration of approximately 1 year. Upadacitinib was well tolerated by both adults and adolescents. TEAEs and discontinuation due to AEs were reported more frequently in patients receiving 30 mg upadacitinib (respectively, 311.9 and 5.7 events per 100 PY) versus 15 mg (respectively, 274.6 and 4.4 events per 100 PY). Serious adverse event rates (15/30 mg, 7.1/7.7 events per 100 PY) were similar in both groups. Acne was the most frequently reported adverse event (15/30 mg, 13.3/20.2 events per 100 PY). Serious infection rates were similar across treatment groups. Adjudicated major adverse cardiovascular event and venous thromboembolic event rates were ≤0.1 events per 100 PY. Rates of malignant neoplasms were within the expected range for the general population. Conclusions: Upadacitinib was well tolerated, and no new important safety risks were observed among adults and adolescents with moderate-to-severe AD treated for approximately 1 year compared to the known safety profile of upadacitinib.
KW - Atopic dermatitis
KW - Janus kinase inhibitor
KW - safety
KW - upadacitinib
UR - http://www.scopus.com/inward/record.url?scp=85141531529&partnerID=8YFLogxK
U2 - 10.1016/j.jaci.2022.09.023
DO - 10.1016/j.jaci.2022.09.023
M3 - Article
C2 - 36195170
AN - SCOPUS:85141531529
SN - 0091-6749
VL - 151
SP - 172
EP - 181
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 1
ER -