Year-long treatment with the biologic resulted in significant improvements in patient perception of well-being and treatment effect.
Eric L. Simpson, MD
A new investigation into the monoclonal antibody dupilumab suggested that patients with moderate-to-severe atopic dermatitis reported significant improvements in their perception of well-being and treatment effect over 1 year of treatment.
The findings were presented at the 2021 American College of Allergy, Asthma, and Immunology (ACAAI) Scientific Meeting in New Orleans during the session “Patient Perception of Treatment with Long-Term Dupilumab Monotherapy in Adults with Moderate-to-Severe Atopic Dermatitis”
Investigators led by Eric L. Simpson, MD, Oregon Health and Science University, Portland, Oregon, noted that patients with moderate-to-severe atopic dermatitis typically suffer from a high burden of disease.
As such, a patient’s self-assessment of response to dupilumab treatment was considered an important factor into the long-term management of the chronic condition.
Simpson and colleagues investigated patient perception of well-being and of treatment effect of maintenance treatment with dupilumab monotherapy every 2 weeks for a total of 36 weeks during the SOLO-CONTINUE study after an optimal response at week 16 in the SOLO 1 and 2 parent studies.
The SOLO-CONTINUE study was a double-blind, randomized, placebo-controlled study that focused on the efficacy and safety of dupilumab monotherapy.
A total of 83 adult patients with moderate-to-severe atopic dermatitis who had previously participated in either parent study and achieved optimal responses (EASI-75 orIGA 0/1) were enrolled in phase 3 of the SOLO-CONTINUE study.
In this study, patients who optimally responded to the parent trial at Week 16 were re-randomized to 300mg dupilumab monotherapy every 1,2,4, and 8 weeks (qw/q2w/q4w/q8w) or placebo for an additional 36 weeks.
Patients were asked to assess both their perception of well-being and perception of treatment effect.
Specific questions asked included “How would you rate the way your eczema responded to the study medication”, and “Considering all the ways in which your eczema affects you, indicate how well you are doing”, the former of which was asked via the Patient Global Assessment of Treatment Effect (PGATE), and latter of which was posed via the Patient Global Assessment of Disease Status (PGADS).
Possible responses to both PGATE and PGADS assessments included poor, fair, good, very good, and excellent.
The percentage of patients with responses of good/very good/excellent in both assessments were later analyzed using a chi-squared test.
Simpson and colleagues reported that at Week 16, 80/83 patients were treated with 300mgdupilumab q2w/placebo.
After 52 weeks on dupilumab q2w monotherapy, significantly more patients responded with “good”, “very good” or “excellent” in their assessment of well-being (86%) and treatment effect (93%) compared with patients re-randomized to placebo at Week 16 for 36 weeks (48% and 49%; P<0.0001).
Dupilumab was generally well-tolerated among patients, with an acceptable safety profile.
Overall, maintenance of dupilumab treatment resulted in significantly improved patient perception of well-being and of treatment effect over 1 year of treatment compared to patients randomized from dupilumab to placebo.
“In patients who switched to placebo after 16 weeks of dupilumab treatment, these effects progressively declined, suggesting that continued treatment with dupilumab has an impact on maintenance of benefit treatment,” the team wrote.