Long-term dupilumab safe, efficacious in atopic dermatitis

Key takeaways:

• Patients treated with dupilumab for 5 years showed sustained improvement.
• At week 260, 88.9% of patients reached EASI 75 and an IGA score of 0 or 1 was achieved by 67.5% of patients.

Dupilumab showed continuous efficacy and safety in the long-term treatment of atopic dermatitis, according to a study.

“AD is a chronic inflammatory skin disease characterized by recurrent eczematous lesions and sustained pruritus,” Lisa A. Beck, MD, of the department of dermatology at University of Rochester Medical Center, and colleagues wrote. “Due to its chronic and recurrent nature, patients with moderate to severe AD usually require long-term treatment.”

Dupilumab (Dupixent, Sanofi/Regeneron) is a monoclonal interleukin-4 and IL-13 inhibitor approved by the FDA for the treatment of atopic dermatitis, as well as for asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis and eosinophilic esophagitis.

The phase 3, multinational, 5-year open-label LIBERTY extension trial included 334 patients who had completed one of the dupilumab’s parent studies and up to 260 weeks of treatment.

Patients initially received weekly subcutaneous injections of 200 mg subcutaneous following a 400 mg loading dose. Later-enrolled patients received a 600 mg loading dose followed by 300 mg weekly, switching to every 2-week dosing after 108 weeks.

IGA scores of clear (0) or almost clear (1), with a reduction of at least two points, was achieved by 220 of 326 (67.5%) patients at week 260. A 50%, 75% or 90% greater improvement in EASI occurred in 314 (96.9%), 288 (88.9%) and 247 (76.2%) of 324 patients, respectively, at this same time point.

For patients who switched from weekly 300 mg doses to every 2-week doses, the proportion of patients achieving IGA scores of 0 or 1 were stable after 48 weeks.

Nasopharyngitis and worsening AD were the most common treatment-emergent adverse events, occurring in 28.9% and 16.7% of patients, respectively. Upper respiratory tract infection (13.6%), conjunctivitis (10.3%), allergic conjunctivitis (9%), headache (8.1%), oral herpes (7.5%) and injection-site reaction (5.2%) were also among the most-reported treatment-emergent adverse events.

The treatment-emergent adverse events incidence rates decreased over time when exposure adjusted in the long-term extension trial.

“In this final analysis of up to 5 years of treatment in the LIBERTY AD open-label extension study, dupilumab showed acceptable safety and sustained efficacy with improvements in AD signs, symptoms and quality of life in adults with moderate to severe AD,” the authors wrote.