Dupixent Reduced Symptom Burden in Patients With CRSwNP Over 52 Weeks

More patients with chronic rhinosinusitis with nasal polyps (CRSwNP) reported mild symptoms or symptom-free days (SFD) compared with placebo after treatment with Dupixent (dupilumab), according to an analysis of SINUS-24 and SINUS-52 conducted after the trials. The results were presented at AMCP Nexus, held October 11-14, 2022, in National Harbor, Maryland.

CRSwNP is a type 2 inflammatory disease that causes nasal congestion, loss of smell, and anterior and posterior rhinorrhea. Dupixent is a fully human monoclonal antibody that blocks the central drivers of type 2 inflammation: interleukin-4 and interleukin-13.

SINUS-24 and SINUS-52 were randomized, double-blind, placebo-controlled pivotal phase 3 trials evaluating Dupixent for up to 24 weeks and 52 weeks, respectively, in patients with severe CRSwNP. In SINUS-24, patients received Dupixent or placebo every two weeks for 24 weeks. In SINUS-52, patients received Dupixent every four weeks, Dupixent every two weeks for 24 weeks and then every 4 weeks until 52 weeks, or placebo every two weeks for 52 weeks

The purpose of the poster presented at AMCP Nexus was to assess the effect of treatment on proportions of patients reporting SFD based on a post-hoc analysis of the two trials. Patients without data for at least 21 days in the 28 days prior to being randomized in SINUS-24 and SINUS-52 were excluded.

Overall, 723 patients were included (437 on Dupixent and 286 on placebo). The researchers also evaluated a subgroup of 537 patients (328 on Dupixent and 209 on placebo) who had used systemic corticosteroids (SCS) in the 2 years prior to the trials.

While symptom severity showed little change over 52 weeks for patients on placebo, patients on Dupixent had a reduction in the mean number of days with moderate or severe nasal congestion or loss of smell, while symptom severity showed little change in the placebo group. According to the results:

• At baseline, patients had a mean number of 14.8 days with severe nasal congestion and 22.7 days with severe loss of smell
• At Week 52, the patients on Dupixent had a mean number of 2.1 days with severe nasal congestion and 6.7 days with severe loss of smell compared with 9.0 and 19.1 on placebo, respectively
• At baseline, patients had a mean number of 0.2 days of no nasal congestion or loss of smell
• At Week 52, patients on Dupixent had a mean number of 19.2 days with no or mild nasal congestion and 15.2 days with no or mild loss of smell compared with only 6.9 days and 2.7 days, respectively, on placebo

The results were similar in the overall population and in the subgroup of patient who had previously used SCS. In the overall population, 50.0% of patients taking Dupixent had SFD for loss of smell, nasal congestion, anterior or posterior rhinorrhea). Similarly, in the SCS group, 50.5% reported SFD. At week 24, 35.4% of the overall population taking Dupixent and 36.3% of the SCS group taking Dupixent reported SFD. In comparison, the proportion of patients on placebo decreased from 10.8% of the overall population and 10.9% of the SCS group at Week 24 to 9.2% and 8.3%, respectively, at Week 52.

The researchers concluded that SFD is an effective way to assess treatment efficacy in reducing symptom burden, which is an important treatment goal, and that Dupixent not only reduced the number of days with severe symptoms but “increased the proportions of patients reporting mild or SFD versus placebo at Weeks 24 and 52 for all symptoms assessed.”