TY - JOUR
T1 - Real-World Evidence of Tralokinumab Effectiveness and Safety
T2 - A Systematic Review and Meta-analysis
AU - Rønnstad, Amalie Thorsti Møller
AU - Bunick, Christopher G
AU - Chovatiya, Raj
AU - Kamata, Masahiro
AU - Nielsen, Mia-Louise
AU - Isufi, Daniel
AU - Thomsen, Simon F
AU - Vestergaard, Christian
AU - Wollenberg, Andreas
AU - Egeberg, Alexander
AU - Thyssen, Jacob P
AU - Loft, Nikolai
N1 - © 2025. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
PY - 2025/5
Y1 - 2025/5
N2 - BACKGROUND: Tralokinumab, a first-in-class and second biologic approved for treating moderate-to-severe atopic dermatitis in adolescents and adults, has demonstrated consistent efficacy and safety across multiple clinical trials.OBJECTIVE: We aimed to assess the real-world effectiveness and safety of tralokinumab by performing a systematic review and meta-analysis on the real-world evidence of tralokinumab.METHODS: We systematically searched PubMed and EMBASE from inception until 28 July, 2024 for observational studies describing the effectiveness and safety of tralokinumab for the treatment of atopic dermatitis. The primary outcome was the proportion of patients achieving a ≥75% improvement in the Eczema Area and Severity Index (EASI-75) after 16 weeks and secondary outcomes included the proportion of patients achieving EASI-50 and EASI-90 and the proportion of patients experiencing adverse events.RESULTS: Nineteen unique studies encompassing 911 bio-naïve and bio-experienced patients with atopic dermatitis treated with tralokinumab were included. After 16 weeks of treatment, 82%, 59% and 26% of patients achieved EASI-50, EASI-75 and EASI-90, respectively, and the proportion of patients developing conjunctivitis was 3.2%.CONCLUSIONS: Tralokinumab demonstrates strong effectiveness and good tolerability in real-world settings, with a high proportion of patients achieving a clinical response and adverse events being observed only infrequently.
AB - BACKGROUND: Tralokinumab, a first-in-class and second biologic approved for treating moderate-to-severe atopic dermatitis in adolescents and adults, has demonstrated consistent efficacy and safety across multiple clinical trials.OBJECTIVE: We aimed to assess the real-world effectiveness and safety of tralokinumab by performing a systematic review and meta-analysis on the real-world evidence of tralokinumab.METHODS: We systematically searched PubMed and EMBASE from inception until 28 July, 2024 for observational studies describing the effectiveness and safety of tralokinumab for the treatment of atopic dermatitis. The primary outcome was the proportion of patients achieving a ≥75% improvement in the Eczema Area and Severity Index (EASI-75) after 16 weeks and secondary outcomes included the proportion of patients achieving EASI-50 and EASI-90 and the proportion of patients experiencing adverse events.RESULTS: Nineteen unique studies encompassing 911 bio-naïve and bio-experienced patients with atopic dermatitis treated with tralokinumab were included. After 16 weeks of treatment, 82%, 59% and 26% of patients achieved EASI-50, EASI-75 and EASI-90, respectively, and the proportion of patients developing conjunctivitis was 3.2%.CONCLUSIONS: Tralokinumab demonstrates strong effectiveness and good tolerability in real-world settings, with a high proportion of patients achieving a clinical response and adverse events being observed only infrequently.
KW - Humans
KW - Dermatitis, Atopic/drug therapy
KW - Treatment Outcome
KW - Antibodies, Monoclonal/adverse effects
KW - Severity of Illness Index
KW - Dermatologic Agents/adverse effects
KW - Observational Studies as Topic
KW - Conjunctivitis/chemically induced
UR - http://www.scopus.com/inward/record.url?scp=86000324639&partnerID=8YFLogxK
U2 - 10.1007/s40257-025-00927-x
DO - 10.1007/s40257-025-00927-x
M3 - Review
C2 - 40045152
SN - 1175-0561
VL - 26
SP - 411
EP - 424
JO - American Journal of Clinical Dermatology
JF - American Journal of Clinical Dermatology
IS - 3
M1 - s318
ER -