Across 3 Disease States, Dupixent Rapidly Improves Symptoms

Across 3 disease states—asthma, atopic dermatitis (AD) and chronic rhinosinusitis with nasal polyps (CRSwNP)—the first dose of Dupixent (dupilumab) created clinically meaningful responses that were sustained throughout treatment, according to a study published in Journal of Allergy and Clinical Immunology: In Practice.

A fast-acting treatment with meaningful responses early in treatment may help to address challenges with medication adherence, the authors speculated. Dupixent is currently approved in the U.S. for patients with moderate-to-severe AD, moderate-to-severe, asthma and CRSwNP.

“For chronic diseases, the ultimate treatment goal is to achieve long-term control,” the authors explained. “Therapies with a rapid onset of action may impact the patient or healthcare providers’ choice of therapy earlier in the management process by reducing patient distress and impairment, increasing adherence, and contributing to optimal disease management.”

In this study, the researchers evaluated more than 3000 patients enrolled in five phase three studies of Dupixent. All of the studies were randomized, double-blind and placebo controlled.

LIBERTY AD SOLO-1 and LIBERTY SOLO-2 were identical trials assessing the efficacy and safety of Dupixent in adults with moderate-to-severe AD. There were 671 patients in SOLO-1 and 708 in SOLO-2, and they were treated for 16 weeks. They were randomized 1:1:1 to receive Dupixent 300 mg every week, placebo every week, or Dupixent 300 mg subcutaneously every two weeks alternating with placebo.

Nearly half (48.1%) of the patients achieved a statistically significant clinically meaningful response on day 7 after starting Dupixent compared with 30.2% of patients receiving placebo. The meaningful response was defined as 50% or greater improvement in Eczema Area and Severity Index, a 3-point or greater improvement in daily peak pruritus assessed by a Numerical Rating Scale, or a 4-point or greater improvement on Dermatology Life Quality Index.

At week 2 the proportion of responders in patients treated with Dupixent had increased further to 67.8% vs 36.5% for placebo, and by the end of the 16 weeks, responses had increased to 76.6% for Dupixent and dropped for placebo to 35.0%.

LIBERTY ASTHMA QUEST assessed the effect of Dupixent in 1902 patients 12 years and older who had uncontrolled moderate-to-severe asthma. The patients were randomized 2:2:1:1 to receive add-on Dupixent 200 mg or 300 mg every two weeks or matched placebos. The study was 52 weeks long.

By the end of week 2, 61.6% of patients on Dupixent achieved forced expiratory volume (FEV1) improvements of ≥ 100 mL and 48.8% of patients on Dupixent achieved improvements of ≥ 200 mL compared with 39.9% and 26.3% in the placebo group, respectively. By the end of the 52 weeks, this improved further to 65.7% and 55.3% of patients treated with Dupixent achieving improvements of ≥ 100 mL and ≥ 200 mL, respectively, and to 53.2% and 42.0% of patients on placebo, respectively.

LINERTY NP SINUS-24 and LIBERTY NP SINUS-52 assessed the effects of Dupixent added to standard of care in adults with severe CRSwNP. There were 276 patients in SINUS-24 randomized 1:1 to Dupixent 300 mg or placebo every 2 weeks for 24 weeks, and 448 patients in SINUS-52 randomized 1:1:1 to Dupixent 300 mg every 2 weeks for 52 weeks, Dupixent 300 mg every 2 weeks for 24 weeks followed by every 4 weeks for 28 weeks, or placebo every 2 weeks for all 52 weeks.

These studies showed 55.4% of patients on Dupixent vs 28.0% on placebo had clinically meaningful improvements in sense of smell as measured by University of Pennsylvania Smell Identification Test by week 2. This increased to 72.0% and 22.9% by week 24. In the Dupixent group, daily congestion/obstruction score significantly improved from day 1 after treatment and daily loss of smell improved from day 2 over baseline.

“Type 2 inflammatory comorbidities often overlap, resulting in an increase in overall symptom and disease burden,” the authors explained. “A drug that can rapidly provide clinical benefits simultaneously for these comorbidities by targeting the underlying and shared type 2 inflammatory process may be a more desired option for patients.”