Нов третман го намалува чешањето и копривата од хронична спонтана уртикарија

A HOLD FreeRelease 3 | eTurboNews | eTN
Аватар на Линда Хонхолц
Напишано од Линда Хонхолц

In this Phase 3 trial, Dupixent added to standard-of-care antihistamines nearly doubled reduction in itch and urticaria activity scores compared to standard-of-care alone at 24 weeks in biologic-naïve patients uncontrolled on antihistamines

Data reinforce the potential of targeting IL-4 and IL-13, key drivers of type 2 inflammation, in this complex chronic disease

Regeneron Pharmaceuticals, Inc. and Sanofi today announced detailed positive results for Dupixent® (dupilumab) in patients with chronic spontaneous urticaria (CSU) who are biologic-naïve (i.e., not previously treated with omalizumab). The pivotal trial showed adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives at 24 weeks compared to antihistamines alone in this investigational setting. These results will be presented today in a late-breaking session at the 2022 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting.

“Despite standard-of-care antihistamines, many patients with chronic spontaneous urticaria continue to struggle with extreme itch, burning and pain associated with hives and swelling under the skin, which can significantly disrupt their daily lives,” said Marcus Maurer, M.D., Professor of Dermatological Allergology, Clinic for Dermatology, Venerology and Allergology at the Charité University of Medicine in Berlin, Germany. “These encouraging results showed that, in those unable to achieve disease control on antihistamines alone, patients who added dupilumab experienced improved signs and symptoms and better control of their disease.”

Topline results from the randomized, double-blind, placebo-controlled pivotal trial, which met primary and all key secondary endpoints at week 24, were announced in July 2021. Data presented at the 2022 AAAAI Annual Meeting showed that patients who added Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (placebo) with continuous improvement out to 24 weeks. These patients experienced a:

•             63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale (10.24 point reduction with Dupixent versus 6.01 point reduction with placebo, p<0.001), the primary endpoint in the U.S. (secondary endpoint in the EU).

•             65% reduction in urticaria activity (itch and hive) severity with Dupixent versus 37% with placebo, as measured by a 0-42 point urticaria activity scale (20.53 point reduction with Dupixent versus 12.00 point reduction with placebo, p<0.001), the primary endpoint in EU (secondary endpoint in the U.S.).

The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved dermatology indications. For the 24-week treatment period, overall rates of adverse events were generally similar between the Dupixent and placebo groups (50% Dupixent, 59% placebo). The most common adverse event was injection site reactions (11% Dupixent, 13% placebo).

The potential use of Dupixent in CSU is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

За авторот

Аватар на Линда Хонхолц

Линда Хонхолц

Главен уредник за eTurboNews со седиште во седиштето на eTN.

Зачленете се
Известување за
гостин
0 коментари
Влезни повратни информации
Погледнете ги сите коментари
0
Ве сакам вашите мисли, ве молиме коментирајте.x
Споделете на...