Ophthalmological Adverse Events of Tralokinumab in AD
- Conditions
- Atopic Dermatitis
- Registration Number
- NCT05682976
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
Atopic dermatitis (AD) is a skin disease characterised by xerosis, pruritus and erythematous plaques. It is common in children (10 to 20%) with an increasing prevalence (multiplied by 2 in 20 years) and begins to develop at 3 months of age. Half of all atopic dermatitis cases disappear by the age of 5, but 10 to 15% of cases persist into adulthood (i.e. about 3.5% of the French adult population). Conventional treatments consist of emollient creams, topical corticosteroid, topical immunomodulators (topical calcineurin inhibitor: tacrolimus) or systemic cyclosporine. However, a proportion of patients (10%) do not respond sufficiently to this therapeutic arsenal. Recent therapies using monoclonal antibodies (biotherapies) are available (DUPILUMAB -anti Interleukin-4 (IL4) antibody and soon TRALOKINUMAB-anti Interleukin-L13 (IL13) antibody). Conjunctivitis is an adverse event reported in patients treated with dupilumab and tralokinumab in clinical trials. Given that baseline ophthalmic comorbidities affect approximately 20% of AD patients, it is crucial to include an evaluation in future prospective real-life longitudinal studies to assess the true incidence of biologic-induced ophthalmic adverse events. No such study is currently available for Tralokinumab. The French group GREAT (GROUPE DE RECHERCHE SUR L'ECZEMA ATOPIQUE) has recently conducted a study on ocular adverse events of dupilumab (DUPI-ΕIL 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-type adverse events were also reported at a frequency of 3.0% to 11.0% in the ECZTRA pivotal studies with Tralokinumab. However, the ophthalmological impact of IL13 inhibition remains partially unknown. Further characterisation of ophthalmological adverse events in patients treated with Tralokinumab in real life is needed to provide information for future recommendations (including prioritisation of indications for systemic therapy) and to improve compliance. The primary objective of the TRALO-OEIL study is to determine the frequency of occurrence of ophthalmologic adverse events with TRALOKINUMAB.
- Detailed Description
The study consists of following over 12 months patients who have been prescribed Tralokinumab to treat their AD.
The inclusion visit takes place on the day of initiation of TRALOKINUMAB. Current ophthalmic follow-up recommendations include an initial examination before the start of treatment and then regularly during treatment and in case of ocular events. Patients are advised to consult the ophthalmology department of the university hospital where they are treated promptly in case of ophthalmological adverse events.
The investigators 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Adult patient (> 18 years),
- Patients with atopic dermatitis,
- Patients indicated for treatment with Tralokinumab
- Patients able to express non opposition.
- Patients who have stopped Dupilumab for less than one month,
- Patients under guardianship or trusteeship
- Pregnant or breastfeeding women.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method occurrence of an ophthalmologic adverse event (conjunctivitis, keratoconjunctivitis, etc.) 4 months the occurrence of an ophthalmologic adverse event (conjunctivitis, keratoconjunctivitis, etc.) 4 months after initiation of treatment with TRALOKINUMAB or an increase in a pre-existing ophthalmologic condition on treatment
- Secondary Outcome Measures
Name Time Method Severity score of ophthalmological damage 12 months Severity score of ophthalmological damage used in a previous study (DUPI-ΕIL study, I. Costedoat, M. Wallaert et al, submitted). minimum value: 0, maximum value: 68. A lower score mean a better outcome.
Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis 12 months Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis,... within 12 months of initiation of TRALOKINUMAB
Trial Locations
- Locations (11)
CHRU de Lille
π«π·Lille, France
CHU de Bordeaux
π«π·Bordeaux, France
CHU de Brest
π«π·Brest, France
CHU de Clermont Ferrand
π«π·Clermont-Ferrand, France
CHU de Nantes
π«π·Nantes, France
CHu de Dijon
π«π·Dijon, France
Hospice Civil de Lyon
π«π·Lyon, France
HΓ΄pital Saint Louis
π«π·Paris, France
CHu de Poitiers
π«π·Poitiers, France
CHu de Rennes
π«π·Rennes, France
CHU de Rouen
π«π·Rouen, France