Conjunctivitis in Adult Patients With Moderate-to-severe Atopic Dermatitis

Adverse events collected during the exposure time in the initial treatment period (12 weeks in the dose-finding trial and 16 weeks in the ECZTRA trials) are shown. Conjunctivitis AESI are shown as preferred terms. At each level of patient summarization, a patient is counted once if they reported one or more events. Data are based on adjusted pooling. N, number of patients with one or more events; n, number of patients; PYE, patient-years of exposure. ^aCalculated using Cochran–Mantel–Haenszel weights. Rate calculated as number of patients divided by PYE multiplied by 100. HRs and 95% CIs were obtained from a Cox regression model with treatment groups as fixed effects and stratified by trial and baseline disease severity (Investigator's Global Assessment).

Data are n (%). Adverse events collected during the exposure time in the initial treatment period (12 weeks in the dose-finding trial and 16 weeks in the ECZTRA trials) are shown. Data from the atopic dermatitis pool using simple pooling. Percentages are calculated based on the number of events divided by the number of events (E) within the category (E/E [for all events] × 100).

^aNumber of patients with events who did and did not receive treatment for their conjunctivitis. ^bOf the total conjunctivitis events within the given treatment; data are number of events (%). ^cPercentages are calculated based on the number of events divided by the number of events (E) within the category (E/E [for all events] × 100). ECZTRA trials are coded in World Health Organization Drug version Jun17B3. Data are from the atopic dermatitis pool.

Data are n (%) unless otherwise stated. AD, atopic dermatitis; BMI, body mass index; BSA, body surface area; EASI, Eczema Area and Severity Index; IGA, Investigator's Global Assessment; IQR, interquartile range; NRS, numerical rating scale. ^aData are from ECZTRA 1, ECZTRA 2 and ECZTRA 3 only.

Data are n (%). Data are from the ECZTRA trials only.

Adverse events collected during the exposure time in the initial treatment period (16 weeks in the ECZTRA trials) are shown. Data are from the ECZTRA trials only. AD, atopic dermatitis; N, number of patients with one or more events. ^aComorbidities included AD, asthma, food allergy and hay fever. ^bCalculated using Cochran–Mantel–Haenszel weights.

Authors and Disclosures

A. Wollenberg¹, L.A. Beck², M. de Bruin Weller³, E.L. Simpson⁴, S. Imafuku⁵, M. Boguniewicz⁶, R. Zachariae⁷, C.K. Olsen⁷ and J.P. Thyssen<sup>8

1</sup>Klinikum der Universität München, Klinik und Poliklinik für Dermatologie und Allergologie, Munich, Germany
²Department of Dermatology, Medicine and Pathology, University of Rochester Medical Center, Rochester, NY, USA
³Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, the Netherlands
⁴Department of Dermatology, Oregon Health & Science University, Portland, OR, USA
⁵Department of Dermatology, Fukuoka University Faculty of Medicine, Fukuoka, Japan
⁶Division of Allergy-Immunology, Department of Pediatrics, National Jewish Health, Denver, CO, USA
⁷LEO Pharma A/S, Ballerup, Denmark
⁸Department of Dermatology and Venereology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark

Correspondence
Andreas Wollenberg. Email: wollenberg@lrz.uni-muenchen.de

Sidebar 1

What is Already Known About This Topic?

• Ocular disorders, including conjunctivitis, occur more frequently in patients with atopic dermatitis (AD).

• When using the interleukin (IL)-4 and IL-13 receptor blocking biologic dupilumab, patients with AD in clinical trials and real-world practice experience higher rates of conjunctivitis, which increases with baseline AD severity.

• Tralokinumab, a fully human monoclonal antibody, binds specifically to IL-13 with high affinity.

• Various rates of conjunctivitis have been observed in different clinical trials of tralokinumab.

Sidebar 2

What Does This Study Add?

• This is the first investigation of conjunctivitis in phase III studies of a biological drug specifically targeting IL-13, in contrast to dupilumab, which targets the IL-4 and IL-13 receptors

• The incidence of conjunctivitis was higher with tralokinumab (7_5%) vs. placebo (3_2%); most cases were mild and resolved, or were resolving during study treatment.

• Risk factors included high AD severity, history of conjunctivitis, disease biomarker levels, and number and type of atopic comorbidities.

• This is the first study to show that some atopic comorbidities have a greater influence on the risk of conjunctivitis than others.