Treatment with tralokinumab every 2 weeks improved health-related quality of life (HRQoL) in patients with moderate to severe atopic dermatitis (AD) better than placebo, according to study data published in the Annals of Allergy, Asthma and Immunology.
In this phase 2b, randomized study, patients with moderate to severe AD were randomly assigned to either subcutaneous tralokinumab (n=153) or placebo (n=51). Treatment was given once every 2 weeks for a total of 12 weeks. In addition, patients received class 3 topical corticosteroid cream or ointment 1 or more times a day starting from the run-in phase to the end of follow up. The endpoints of the study were changes in the Dermatology Life Quality Index (DLQI), 36-item Short-Form Health Survey version 2 (SF-36v2), and sleep interference Numeric Rating Score from baseline to week 12.
Participants assigned to tralokinumab received 3 different doses of the drug: 45 mg (n=50), 150 mg (n=51), and 300 mg (n=52). Treatment with the highest dose of tralokinumab was associated with a significant improvement in total DLQI compared with placebo at week 12 (placebo-adjusted mean change, ‐3.51; 95% CI, ‐6.00 to ‐1.02; P =.006). By 12 weeks, patients treated with the 300 mg dose of tralokinumab had significantly greater improvements in the Physical Component Summary (mean change, 4.26; 95% CI, 1.83-6.69; P <.001) scores relative to placebo.
Limitations of the study were the small number of patients included in each dosing group as well as the relatively short duration of treatment.
The researchers noted that “HRQoL is a major goal of dermatological treatment, and compared to placebo, a higher proportion of tralokinumab-treated patients achieved a clinically meaningful improvement in HRQoL, as measured by DLQI.”
Disclosure: This clinical trial was supported by MedImmune. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Silverberg JI, Guttman-Yassky E, Gooderham M, et al. Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study. Published online December 14, 2020. Ann Allergy Asthma Immunol. doi:10.1016/j.anai.2020.12.004