Tralokinumab does not impact vaccine-induced immune responses: Results from a 30-week, randomized, placebo-controlled trial in adults with moderate-to-severe atopic dermatitis.
J Am Acad Dermatol
; 85(1): 71-78, 2021 Jul.
Article
in En
| MEDLINE
| ID: mdl-33744356
ABSTRACT
BACKGROUND:
Atopic dermatitis (AD) is a chronic inflammatory skin disease. Interleukin (IL) 13 is a type 2 cytokine that is key to the inflammation underlying AD. Tralokinumab is a first-in-class, fully human, monoclonal antibody that specifically binds with high affinity to IL-13, neutralizing it in AD. Immunomodulatory treatments may impair vaccine-induced immune responses.OBJECTIVE:
Assess the immune responses to standard vaccines in adults with moderate-to-severe AD who are undergoing treatment with tralokinumab.METHODS:
ECZema TRAlokinumab Trial No. 5 (ECZTRA 5; NCT03562377) was a phase 2, double-blind, randomized, placebo-controlled trial taking place over 30 weeks. Eligible adults were randomized 11, with 107 patients receiving tralokinumab 300 mg and 108 patients receiving a placebo every 2 weeks for 16 weeks. All patients received Tdap (tetanus/diphtheria/pertussis) and meningococcal vaccines at week 12. The primary end points were positive antitetanus and antimeningococcal responses between weeks 12 and 16 (noninferiority margin, -25%; responder, >3-fold increase in IgG).RESULTS:
The noninferiority of tralokinumab versus placebo for immune response to Tdap (91.9% vs 96.1%) and meningococcal (86.0% vs 84.2%) vaccines was demonstrated at week 16. During treatment, the rates of adverse events were lower for tralokinumab than for the placebo, with most events being mild or moderate.LIMITATIONS:
Responses to other vaccines (including influenza) were not examined.CONCLUSIONS:
Treatment with tralokinumab 300 mg every 2 weeks did not affect immune responses to Tdap and meningococcal vaccines. Treatment was well tolerated when administered concomitantly with the vaccines and demonstrated a safety profile comparable to phase 3 trials.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Diphtheria-Tetanus-Pertussis Vaccine
/
Meningococcal Vaccines
/
Dermatologic Agents
/
Antibodies, Monoclonal
Type of study:
Clinical_trials
Limits:
Adult
/
Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
J Am Acad Dermatol
Year:
2021
Type:
Article