Two identically designed studies to test the effectiveness of tralokinumab for treatment of atopic dermatitis in adults

Abstract

British Journal of DermatologyVolume 184, Issue 3 p. e101-e102 Plain Language SummaryFree Access Two identically designed studies to test the effectiveness of tralokinumab for treatment of atopic dermatitis in adults First published: 05 March 2021 https://doi.org/10.1111/bjd.19778AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat Abstract Atopic dermatitis, or eczema, is a chronic, itchy skin disease that is common in children and adults. Atopic dermatitis occurs when the barrier function of the skin is disrupted, allowing chemicals and allergens (that cause an allergic reaction) to enter the skin and cause inflammation. Tralokinumab is a drug injected under the skin that targets interleukin (IL)-13, a molecule that is important in causing the skin inflammation associated with atopic dermatitis. Tralokinumab, which belongs to a class of drugs called biologics, is not yet licensed for medical use, but is being investigated in clinical trials as a potential treatment for atopic dermatitis. Two identically designed clinical trials, ECZTRA 1 and ECZTRA 2, investigated if tralokinumab alone (used without any other atopic dermatitis treatment) was more effective than a nonactive drug (placebo) for improving the severity and symptoms of atopic dermatitis. The trials, funded by LEO Pharma, involved over 1500 patients from Europe, North America, Asia and Australia. Adult patients who had moderate-to-severe atopic dermatitis for more than 1 year that had not improved sufficiently with topical treatments (treatments applied directly to the skin) were included. Patients received tralokinumab 300 mg or placebo every 2 weeks for an initial 16 weeks. Patients who showed a good response to tralokinumab either continued with the same treatment, received less-frequent dosing of tralokinumab (once every 4 weeks), or received placebo for a further 36 weeks to assess long-term safety. Neither the patients nor the medical team knew which treatment the patients were receiving. The medical team monitored patients throughout the trials to assess changes in the amount and severity of atopic dermatitis. Patients also self-recorded changes in itch, sleep disruption and quality of life. The medical team also documented the occurrence of any side-effects of the drug. In both trials at week 16, more patients receiving tralokinumab had an improvement in their atopic dermatitis compared with patients receiving placebo. Patients felt meaningful improvements in itch (Figure 1), sleep and quality of life as early as 1–2 weeks after starting tralokinumab. Figure 1Open in figure viewerPowerPoint Top panel: Graphs show the percentage of patients who had a meaningful improvement in their perceived itch at 16 weeks. In the ECZTRA 1 trial (left), more tralokinumab-treated patients (20.0%, green bar) had a meaningful improvement in their perceived itch compared with those who received placebo (10.3%, blue bar). In the ECZTRA 2 trial (right), more tralokinumab-treated patients (25.0%) had a meaningful improvement in their perceived itch compared with placebo (9.5%). Bottom panel: Patients recorded how bad their itch was each day on a scale of 0 (no itch) to 10 (worst itch imaginable); a meaningful improvement was defined as a reduction of 4 points or more from the start of the trial on the itch scale. The majority of patients who had high levels of improvement at week 16 with tralokinumab maintained that level of improvement after another 36 weeks of treatment with dosing every 2 weeks. In addition, some patients maintained their improved skin with less-frequent dosing every 4 weeks. The most common side-effects with tralokinumab were upper respiratory tract infections (mainly common cold) and conjunctivitis (inflammation of the eye or eyelid). Based on the results from these trials, tralokinumab may be a long-term treatment option for adult patients with moderate-to-severe atopic dermatitis. Acknowledgements: the authors thank Korey Capozza, MPH, Director, Global Parents for Eczema Research, for critical review of this summary. Linked Article: Wollenberg et al. Br J Dermatol 2021; 184:437–449. Volume184, Issue3March 2021Pages e101-e102 FiguresRelatedInformation