Results from a post-hoc subanalysis of the Phase 3 ECZTRA 3 trial demonstrate the potential for LEO Pharma’s tralokinumab as a treatment for adults with moderate-to-severe atopic dermatitis.  

Investigational tralokinumab has not yet been approved by any regulatory authority. The data, shared virtually at the 2021 Winter Clinical Dermatology Conference, demonstrates safety and efficacy of tralokinumab in 100 US adult patients with moderate-to-severe atopic dermatitis. 

Key results of the US subanalysis include: 

Primary Endpoints

• More patients achieved the primary endpoints of IGA 0/1 and EASI-75 with tralokinumab 300 mg q2w (every 2 weeks) plus topical corticosteroid (TCS) (n= 72) compared with placebo q2w plus TCS (n= 28) at Week 16 (40.8 vs 10.7%; P<0.05 for IGA 0/1 and 56.3 vs 21.4%; P<0.01 for EASI-75)
  • Separation between treatment groups in achievement of IGA 0/1 and EASI-75 occurred early in the studies from Weeks 6–8 
  • Rescue medication (mostly topical treatments) was used by 3/72 (4.2%) patients in the tralokinumab plus TCS group and by 3/28 (10.7%) patients in the placebo plus TCS group 

Secondary Endpoints 

• A numerically greater proportion of patients achieved a reduction in weekly average worst daily pruritus ≥4 points at Week 16, 40% with tralokinumab plus TCS and 28.6% with placebo plus TCS (difference 11.1%; 95% confidence interval [CI] –9.9, 32.0; P=0.32)
• Mean (standard error [SE]) total SCORAD score was reduced by 36.9 with tralokinumab plus TCS versus 16.7 with placebo plus TCS at Week 16(difference –20.2; 95% CI –28.9, –11.4; P<0.001)
• Mean (SE) DLQI total score was reduced by 11.9 with tralokinumab plus TCS versus 7.0 with placebo plus TCS at Week 16 (difference –5.0; 95% CI –7.7, –2.2; P<0.001)

Maintenance Endpoints 

• At Week 32, IGA 0/1 and EASI-75 were maintained by 87.5 and 90.0% of patients, respectively, who continued on tralokinumab q2w plus TCS and by 84.6 and 93.3% of patients, respectively, who were rerandomized at Week 16 to tralokinumab q4w plus TCS 

Safety

• Tralokinumab plus TCS was well tolerated in the U.S. trial population, with an overall safety profile comparable to that of placebo plus TCS in the initial 16-week treatment period
• At least one AE was experienced in 56.3% of tralokinumab q2W plus TCS patients, compared to 57.1% of placebo plus TCS patients
• At Week 16, AEs leading to withdrawal from the trial occurred in 2 (2.8%) patients treated with tralokinumab q2W plus TCS compared to 0 patients in the placebo + TCS group
• All AEs in the tralokinumab plus TCS group were of mild or moderate severity and most recovered/resolved during the study
• The safety profile at Week 32 was comparable to that of the initial 16-week treatment period