Infection rates low among children treated with long-term dupilumab for atopic dermatitis
Click Here to Manage Email Alerts
Key takeaways:
- The total infection rate among dupilumab-treated patients was 101 per 100 patient-years (PY) in the 52-week study.
- In the 16-week study, the rate was 185.2 per 100 PY among dupilumab-treated patients.
Infection rates were lower following longer dupilumab treatment exposure in children with moderate to severe atopic dermatitis, according to a study.
“Patients with AD, particularly infants and young children, are at higher risk of developing both cutaneous and noncutaneous infections, including herpetic infections, molluscum contagiosum and bacterial infections primarily caused by Staphylococcus aureus,” Amy S. Paller, MD, MS, Walter J. Hamlin Professor and Chair of Dermatology, professor of pediatrics and director of the Skin Biology and Diseases Resource-based Center at Northwestern University’s Feinberg School of Medicine, and colleagues wrote. “As bacterial, viral and fungal infections are not primarily targeted by type 2 immune responses, dupilumab is unlikely to interfere with the primary host defenses against these organisms.”
To confirm this theory, the authors conducted a post hoc analysis of an ongoing open-label extension (OLE) study of dupilumab (Dupixent, Sanofi/Regeneron).
The study included 180 children (mean age, 3.86 years; 64.4% boys) aged 6 months to 5 years with moderate to severe AD from the LIBERTY AD PRESCHOOL phase 2 and 3 trials. Each patient received a subcutaneous, weight-based dupilumab dose for 52 weeks, including 200 mg every 4 weeks for those who weighed 5 kg to less than 15 kg; 300 mg every 4 weeks for 15 kg to less than 30 kg; or 200 mg every 2 weeks for 30 kg to less than 60 kg.
Results showed that the rate of infections was much lower in the 52-week OLE study, with 101 patients experiencing one or more infections per 100 patient-years (PY) compared with the 16-week study, with 185.2 dupilumab-treated patients and 245.7 placebo-treated patients having one or more infections per 100 PY.
Rates of nonherpetic skin infections and herpetic infections among dupilumab-treated patients were 22.7 and 7.3 patients per 100 PY, respectively, in the OLE study. In contrast, the rates among patients in the 16-week study for nonherpetic infections and herpetic infections were 42.7 and 20 patients per 100 PY, respectively, in the dupilumab group, and 92.7 and 17.1 patients per 100 PY, respectively, in the placebo group.
Serious infections among dupilumab-treated patients occurred at a rate of 3.1 patients per 100 PY in the OLE trial vs. zero patients per 100 PY in the 16-week trial. On the other hand, placebo-treated patients in the 16-week trials saw a serious infection rate of 17.1 patients per 100 PY.
No infections in either trial led to treatment discontinuation.
“Overall, infection rates were lower following longer dupilumab treatment exposure, supplementing comparable results observed in short-term clinical trials in children, adolescents and adults,” the authors concluded.