Dupilumab reduces pruritus, anxiety, depression in atopic dermatitis
Post hoc analyses of the LIBERTY AD SOLO 1 & 2* and ADOL** trials demonstrated significant reductions in pruritus, anxiety, and depression with dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis (AD).
Adults in the SOLO 1 & 2 trials received dupilumab 300 mg QW or Q2W or placebo, while adolescents in the ADOL trial received dupilumab 200 or 300 mg Q2W, 300 mg Q4W, or placebo for treatment of moderate-to-severe AD.
The first analysis of the trials examined the effect of dupilumab vs placebo on pruritus in adults and adolescents with AD, as measured with the Peak Pruritus Numerical Rating Scale (NRS). [AAAAI 2020, abstract 609]
In general, adolescents demonstrated more severe disease than adults, with NRS scores of 7.5, 7.5, and 7.7 in the Q2W, Q4W, and placebo groups at baseline compared with scores of 7.3, 7.4, and 7.4 in adults in the QW, Q2W, and placebo groups, respectively.
At day 15, dupilumab significantly improved pruritus in adolescents compared with placebo (least squares [LS] mean percent change in NRS score, -25.3 and -21.8 percent [Q2W and Q4W, respectively] vs -5.7 percent with placebo [p<0.0001 for both doses vs placebo]). Similar improvements were noted among adults (LS mean percent change, -22.5 and -24.7 percent [QW and Q2W, respectively] vs -3.4 percent with placebo [p<0.0001 for both doses]).
The benefit of dupilumab vs placebo was evident as early as day 2 in adults (p<0.003) and day 6 in adolescents (p<0.01).
“AD is characterized by intense pruritus/itch that negatively impacts patient’s quality of life; therefore, improvement in pruritus is an important marker of treatment benefit,” said the researchers.
“Dupilumab treatment demonstrated rapid improvement in pruritus/itch in adult and adolescent patients with moderate-to-severe AD,” they said.
A second post hoc analysis of the same trials used the Hospital Anxiety and Depression Scale (HADS) to assess the impact of dupilumab in reducing anxiety (HADS-A) and depression (HADS-D) in patients with moderate-to-severe AD. Scores of ≥8 or ≥11 were suggestive of anxiety or depression symptoms. [AAAAI 2020, abstract 612]
At baseline, total HADS scores in adults were 13.7, 13.0, and 13.2 in the QW, Q2W, and placebo groups, respectively, while scores in adolescents were 12.6, 13.3, and 11.6 in the Q2W, Q4W, and placebo groups, respectively.
At week 16, there was a significant reduction in total HADS scores in adults with both dupilumab doses (LS mean change, -5.5 and -5.1 [QW and Q2W, respectively] vs -1.6 [placebo]; p<0.0001 for both doses).
However, the impact of dupilumab in reducing total HADS score among adolescents was only significant with dupilumab Q4W compared with placebo (LS mean change, -5.2 vs -2.5; p=0.0133), with no significant benefit noted with dupilumab Q2W (LS mean change, -3.8; p=0.2203 vs placebo).
“AD patients have an increased risk of anxiety, depression, and suicide. Dupilumab monotherapy improved symptoms of anxiety and depression in adult and adolescent patients with AD, and was well tolerated with an acceptable safety profile,” said the researchers.