Ophthalmological Adverse Events of Tralokinumab in AD

Study Overview
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Brief Summary
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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-ŒIL 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
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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).

Official Title
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Prospective Multicentre Study on Ophthalmological Adverse Events of Tralokinumab in the Treatment of Atopic Dermatitis

Conditions
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Atopic Dermatitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient (> 18 years), Patients with atopic dermatitis, Patients indicated for treatment with Tralokinumab Patients able to express non opposition. Exclusion Criteria: Patients who have stopped Dupilumab for less than one month, Patients under guardianship or trusteeship Pregnant or breastfeeding women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AD patient treated by Tralokinumab<br>AD patient treated by Tralokinumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of an ophthalmologic adverse event (conjunctivitis, keratoconjunctivitis, etc.) | 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 | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis | Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis,... within 4 months of initiation of TRALOKINUMAB | 4 months | 
| Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis | Occurrence or worsening of conjunctivitis, keratoconjunctivitis, blepharitis,... within 12 months of initiation of TRALOKINUMAB | 12 months | 
| Severity score of ophthalmological damage | Severity score of ophthalmological damage used in a previous study (DUPI-ŒIL study, I. Costedoat, M. Wallaert et al, submitted). minimum value: 0, maximum value: 68. A lower score mean a better outcome. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, Tralokinumab, adverse event, conjunctivitis