TRALO-OEIL

Introducing the TRALO-ŒIL project

logo TRALO OEIL

Conjunctivitis is an adverse event reported in patients treated with biotherapy in clinical trials. As baseline ophthalmological comorbidities affect approximately 20% of patients with atopic dermatitis, it is crucial to include an assessment in future prospective real-life longitudinal studies to evaluate the true incidence of biologic-induced ophthalmological adverse events. No such study is currently available for Tralokinumab®.

The French group GREAT (Groupe de Recherche sur l'Eczema ATopique) recently conducted a study on ocular adverse events of dupilumab (DUPI-OEIL study, I. Costedoat, M. Wallaert et al, submitted) which included 180 patients followed for at least 4 months. The results show that the majority of dupilumab-induced conjunctivitis is de novo (frequency 18%). Conjunctivitis-like adverse events were also reported at a frequency of 3.0% to 11.0% in the ECZTRA pivotal studies with Tralokinumab.

Further characterisation of ophthalmological adverse events in patients treated with Tralokinumab in real life is needed to support future recommendations (including prioritisation of indications for systemic therapy) and to improve treatment compliance.

The main objective of the TRALO-OEIL project is to determine the frequency of occurrence of ophthalmological adverse events with TRALOKINUMAB and also to:

  • - Characterise the type of ophthalmological adverse event during 4 months (conjunctivitis, kerato-conjunctivitis, blepharitis, etc.).
  • - To determine the frequency of occurrence and type of ophthalmologic adverse events with TRALOKINUMAB during 12 months.
  • - To assess the severity of opthalmic adverse events at onset, at 4 months and at 12 months
  • - To assess risk factors for the occurrence of adverse events at 4 and 12 months.

11 university hospitals are participating in the TRALO-OEIL project, all the investigators are members of GREAT and of FRADEN.

consultation

Inclusion criteria

  • Adult patients over 18 years of age,
  • Patients with atopic dermatitis,
  • Patients indicated for treatment with Tralokinumab,
  • Patients capable of expressing non-opposition.

Non inclusion criteria

  • Patients who stopped Dupilumab less than one month ago,
  • Patients under guardianship or curatorship,
  • Pregnant or breastfeeding women.

The inclusion visit takes place on the day of initiation of TRALOKINUMAB.

Initiation of treatment is done at the Dermatology Day Hospital or in consultation.

Current recommendations for ophthalmological follow-up include an initial examination before the start of treatment and then regularly during the course of treatment and in case of ocular events. Patients are advised to consult promptly with the ophthalmology department of the hospital where they are being treated for ophthalmological adverse events.

We will collect data from the initial routine visit (M0) and from visits at 4 months (M4) and 12 months (M12).

Any other visits for ocular events during follow-up will be collected (Unscheduled visits).

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Updated on 20 February 2023