Dupilumab efficacy at week 52 for treatment of moderate to severe atopic dermatitis exceeded investigator’s global assessment (IGA) response rates reported in randomized clinical trials (RCTs). The results may be tied to the use of adjunctive therapies, according to study data published in the Journal of the American Academy of Dermatology.
Current knowledge of the long-term effectiveness and safety of dupilumab for atopic dermatitis therapy is limited to the results of 2 RCTs and 1 real-world study. For a better understanding of the long-term efficacy of dupilumab, a retrospective chart review was conducted at 2 academic hospitals.
A total of 52 patients meeting demographic and atopic dermatitis disease characteristics were included in the study that included ≥3 IGA score, ≥18 years of age, and ≥52 weeks of dupilumab treatment or discontinued treatment between weeks 16 and 52 due to lack of efficacy or safety. The primary efficacy outcome was an IGA score of 0/1, representing “clear or almost” week 52 based on a 0 to-4 IGA scale.
When evaluating efficacy, the researchers found that 54% of patients met the primary outcome, similar to the percentage of patients (63%) who met IGA 0/1 at week 16. Overall, 54% of patients who initially responded at week 16 maintained efficacy, whereas 5 of the 18 initial nonresponding patients reached IGA response by week 52. During the first 16 weeks of the trial, 14% of patients, and 6% of patients between weeks 16 and 52, used concomitant nontopical treatments. When evaluating safety, 29% of patients reported at least 1 adverse event (AE) during weeks 16 to 52. Only 12% of patients discontinued treatment during weeks 16 to 52 due to lack of efficacy and from intolerance to an AE; these patients were counted as IGA non-responders. Although there were no discontinuations or serious AEs in the first 16 weeks, a similar percentage of patients reported 1 AE in the short and long term (27% vs 29%).
Limitations of the study include small sample size, retrospective nature, lack of systematic AE reporting, and lack of a control group.
The authors concluded that use of adjunctive therapies most likely supported dupilumab’s efficacy at week 52 for the treatment of moderate to severe atopic dermatitis and explains why the therapy exceeded IGA response rates reported in RCTs.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Jo CE, Georgakopoulos JR, Ladda M, et al. Evaluation of long-term efficacy, safety, and reasons for discontinuation of Dupilumab for moderate-to-severe atopic dermatitis in clinical practice: A retrospective cohort study [published online February 16, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.02.029