PMID- 37610789
OWN - NLM
STAT- MEDLINE
DCOM- 20231023
LR  - 20231025
IS  - 2168-6084 (Electronic)
IS  - 2168-6068 (Print)
IS  - 2168-6068 (Linking)
VI  - 159
IP  - 10
DP  - 2023 Oct 1
TI  - Safety and Efficacy of Tralokinumab in Older Adults With Moderate-to-Severe 
      Atopic Dermatitis: A Secondary Analysis.
PG  - 1119-1123
LID - 10.1001/jamadermatol.2023.2626 [doi]
AB  - IMPORTANCE: Older adults with atopic dermatitis (AD) face unique treatment 
      challenges, including comorbidities, polypharmacy, and a higher risk for 
      infections (eg, herpes zoster). Furthermore, limited data are available from 
      clinical trials for treatments in this population. In phase 3 studies, 
      tralokinumab showed superior efficacy in moderate-to-severe AD vs placebo, but 
      results were not stratified by age group. OBJECTIVE: To evaluate the safety and 
      efficacy of tralokinumab in older (>/=65 years) patients with moderate-to-severe 
      AD. DESIGN, SETTING, AND PARTICIPANTS: A post hoc analysis for adults 65 years or 
      older was conducted from a subset of patients in the US, Canada, Europe, and Asia 
      in 3 randomized, placebo-controlled, phase 3 trials (ECZTRA 1 and 2 [monotherapy] 
      and ECZTRA 3 [tralokinumab + topical corticosteroids as needed]). The post hoc 
      data were analyzed in 2022. MAIN OUTCOMES AND MEASURES: Pooled data from up to 16 
      weeks of treatment from ECZTRA 1, 2, and 3 were used to assess safety. 
      Statistical analyses followed prespecifications of primary end points. Separate 
      efficacy analyses were conducted in these trials respectively at 16 weeks. 
      RESULTS: A total of 75 older adults (42 women [56%]) treated with tralokinumab 
      from the ECZTRA 1, 2, and 3 trials were included in this post hoc analysis. 
      Similar proportions of patients reported adverse events (AEs) with tralokinumab 
      and placebo (44 [58%]). Three patients (4%) in the tralokinumab arm and 3 (10.3%) 
      in the placebo arm experienced severe AEs, and 4 (5.3%) and 2 (6.9%), 
      respectively, had AEs leading to discontinuation. More patients achieved 75% or 
      greater improvement in Eczema Area and Severity Index scores with tralokinumab 
      than placebo (33.9% vs 4.8%; P < .001) in ECZTRA 1 and 2. Similar trends, 
      although not statistically significant, were seen in ECZTRA 3. Safety and 
      efficacy outcomes in this population were similar compared with the younger 
      patient cohorts. The small sample size limited generalizations from this 
      analysis. CONCLUSION AND RELEVANCE: The results of this post hoc analysis suggest 
      that tralokinumab is well tolerated and efficacious in patients 65 years or older 
      with moderate-to-severe AD.
FAU - Merola, Joseph F
AU  - Merola JF
AD  - Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
FAU - Butler, Daniel C
AU  - Butler DC
AD  - Department of Dermatology, University of California, San Francisco.
FAU - Mark, Thomas
AU  - Mark T
AD  - LEO Pharma A/S, Ballerup, Denmark.
FAU - Schneider, Shannon
AU  - Schneider S
AD  - LEO Pharma Inc, Madison, New Jersey.
FAU - Kim, Yestle
AU  - Kim Y
AD  - LEO Pharma Inc, Madison, New Jersey.
FAU - Abuabara, Katrina
AU  - Abuabara K
AD  - Department of Dermatology, University of California, San Francisco.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JAMA Dermatol
JT  - JAMA dermatology
JID - 101589530
RN  - GK1LYB375A (tralokinumab)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Glucocorticoids)
SB  - IM
MH  - Humans
MH  - Female
MH  - Aged
MH  - *Dermatitis, Atopic/drug therapy
MH  - Antibodies, Monoclonal/adverse effects
MH  - *Dermatologic Agents/adverse effects
MH  - Glucocorticoids/therapeutic use
MH  - Treatment Outcome
MH  - Severity of Illness Index
MH  - Double-Blind Method
PMC - PMC10448370
COIS- Conflict of Interest Disclosures: Dr Merola reported grants from LEO Pharma 
      during the conduct of the study as well as personal fees from LEO Pharma and 
      consulting fees from Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, AbbVie, 
      Dermavant, Eli Lilly, Incyte, Novartis, Janssen, UCB, Sanofi-Regeneron, Sun 
      Pharma, Biogen, and Pfizer outside the submitted work. Drs Mark and Schneider 
      reported being employed by LEO Pharma during the conduct of the study. Dr Kim 
      reported personal fees from LEO Pharma during the conduct of the study. Dr 
      Abuabara reported personal fees from Target RWE and grants from Pfizer and 
      Cosmotique Internacional SNC outside the submitted work. No other disclosures 
      were reported.
EDAT- 2023/08/23 12:43
MHDA- 2023/10/23 00:42
PMCR- 2023/08/23
CRDT- 2023/08/23 11:43
PHST- 2023/10/23 00:42 [medline]
PHST- 2023/08/23 12:43 [pubmed]
PHST- 2023/08/23 11:43 [entrez]
PHST- 2023/08/23 00:00 [pmc-release]
AID - 2808887 [pii]
AID - dbr230013 [pii]
AID - 10.1001/jamadermatol.2023.2626 [doi]
PST - ppublish
SO  - JAMA Dermatol. 2023 Oct 1;159(10):1119-1123. doi: 10.1001/jamadermatol.2023.2626.