Dupilumab showed consistent and sustained efficacy in an open-label extension study in adults previously enrolled in 12 parent studies assessing dupilumab in moderate to severe atopic dermatitis.
“More than half of patients did not require additional treatment for [atopic dermatitis] during the treatment period,” Mette Deleuran, MD, DMSc, of Aarhus University Hospital in Denmark, and colleagues wrote. “This, combined with the relatively small numbers of patients requiring systemic rescue therapy, supports that dupilumab monotherapy or concomitant with topical [atopic dermatitis] medications provides long-term disease control in moderate to severe [atopic dermatitis] patients.”
A total of 1,491 patients were given an initial subcutaneous dose of Dupixent (dupilumab, Sanofi/Regeneron) 600 mg on day 1 and then most received dupilumab 300 mg weekly for up to 76 weeks, with 92.9% remaining on treatment at the cutoff; 312 patients received dupilumab 200 mg every week, for a mean of 18.5 doses, before switching to 300 mg every week.
Patients received a mean of 37.5 doses of dupilumab, with 17.8% of patients receiving 76 or more cumulative doses.
A total of 4,384 adverse events were reported, with 70.7% of patients experiencing at least one adverse event. Most were mild to moderate in nature, and less than 5% of patients had a severe adverse event.
Conjunctivitis was reported by 10.7% of patients; most cases were mild to moderate, with five patients reporting severe conjunctivitis. Most cases were seen at the beginning of treatment and diminished over time.
Researchers found that atopic dermatitis skin lesion severity and related symptoms generally improved throughout the open-label extension period. There was a continuous progressive improvement in Eczema Area and Severity Index (EASI-75) score from week 2 to week 24, followed by subtle improvement thereafter. More than 60% of patients achieved EASI-90 at week 56 and week 76.
Limitations included the lack of a control arm, a limited number of patients with 76 weeks or more of treatment, and patients not receiving the approved regimen dose of 300 mg every 2 weeks.
“The favorable benefit-risk profile in this study supports the long-term role of dupilumab treatment for patients with moderate to severe [atopic dermatitis] and demonstrates that blocking IL-4 and IL-13 signaling can achieve sustained control of [atopic dermatitis] and symptoms with an acceptable safety profile in patients with significant disease burden and for whom conventional topical treatments are inadequate,” Deleuran and colleagues wrote. – by Abigail Sutton
Disclosures: Deleuran reports she receives research support, has consulting/advisory board agreements and/or receives honoraria from AbbVie, Eli Lilly, Galapagos, LEO Pharma, Meda, Pfizer, Pierre Fabre, Regeneron Pharmaceuticals and Sanofi Genzyme. Please see the study for all other authors’ relevant financial disclosures.