Conjunctivitis in adult patients with moderate-to-severe atopic dermatitis: results from five tralokinumab clinical trials.

Background Tralokinumab, a fully human immunoglobulin G4 monoclonal antibody that specifically binds to the interleukin-13 cytokine with high affinity, effectively reduces moderate-to-severe atopic dermatitis when given every 2 weeks. The incidence of conjunctivitis is elevated compared to placebo, but severity and etiology have not been examined. Objective To analyze conjunctivitis data recorded in five randomized, placebo-controlled trials of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Methods Overall, 2285 adults with atopic dermatitis were studied up to 16 weeks. Cochran-Mantel-Haenszel weights were applied to calculate adjusted adverse-event incidences. Results Incidence of conjunctivitis was higher (7.5%) with tralokinumab compared to placebo (3.2%). Most events were mild or moderate in severity and 78.6% and 73.9% of events resolved during the trial in the tralokinumab and placebo groups, respectively. Two (1.4%) events led to permanent discontinuation of tralokinumab. An increased incidence of conjunctivitis, regardless of treatment group, was associated with more severe baseline atopic dermatitis, and history of allergic conjunctivitis/atopic keratoconjunctivitis, as well as the number of atopic comorbidities. Limitation This analysis reports events up to Week 16 only, with limited confirmation of conjunctivitis and its etiology by an ophthalmologist and insufficient reporting of ophthalmic treatments. Conclusions Treatment with tralokinumab was associated with increased incidence of conjunctivitis compared to placebo, but these cases were mostly mild and transient.