Benzinga | Sep 29, 2021 05:13AM EDT

Novartis Announced Data Show Achieving Complete Control of Chronic Spontaneous Urticaria Improves Overall Quality of Life, as Reported by Patients

Novartis today announced new analysis from a Phase IIb study demonstrating the importance of achieving complete control of chronic spontaneous urticaria (CSU) symptoms in improving overall health-related quality of life (HRQoL) for patients1. Complete control of symptoms brings enormous benefit to people with CSU and is associated with improvements in key HRQoL measures such as overall quality of life, sleep interference, activity interference and work impairment1,3. There is a marked decline in these improvements to quality of life even when patients are living with only a low level of CSU symptoms1.

Complete control of CSU symptoms was assessed by a composite of patient reported outcomes (PROs) and was shown to be more likely achieved and sustained with ligelizumab than Xolair(r) (omalizumab) or placebo2. These data were presented at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress.

CSU is a severe and unpredictable disease of the skin, affecting up to 1% of the global population at any time4. When compared with the general population, patients with CSU are twice as likely to experience difficulty sleeping, anxiety, distress and depression5-7. Many people with CSU do not achieve complete control of signs and symptoms despite using standard-of-care treatments (antihistamines and omalizumab)1,4,8.

The data show that ligelizumab was more likely to provide complete control of CSU symptoms than omalizumab when assessed using a composite of PROs2. A patient free from signs and symptoms of urticaria with concurrent hive severity score (HSS7)=0, itch severity score (ISS7)=0 and angioedema activity score (AAS7)=0 was considered to have CSU completely controlled. Concurrent Dermatology Life Quality Index (DLQI)=0-1 indicated a patient being CSU free2:

At Week 12, the proportion of patients showing CSU completely controlled was 44.1% with ligelizumab 72 mg (P=0.007 vs omalizumab, and P=0.003 vs placebo), 40.0% with ligelizumab 240 mg (P=0.025 vs omalizumab, and P=0.004 vs placebo), 23.5% with omalizumab (P=0.021 vs placebo) and 0.0% with placebo. The proportion of CSU-free patients was 38.1% with ligelizumab 72 mg (P=0.008 vs omalizumab, and P=0.006 vs placebo), 35.3% with ligelizumab 240 mg (P=0.020 vs omalizumab, and P=0.007 vs placebo), 18.8% with omalizumab (P=0.035 vs placebo) and 0.0% with placebo.At Week 20, the proportion of patients with CSU completely controlled was 33.3%, 34.1%, 25.9% and 4.7%, and for CSU-free patients was 32.1%, 31.8%, 23.5% and 4.7% for ligelizumab 72 mg, 240 mg, omalizumab and placebo, respectively.During the treatment-free follow-up period, at Week 28, the proportion of patients remaining CSU free for ligelizumab 72 mg, 240 mg, omalizumab and placebo was 22.8%, 25.0%, 5.3% and 4.9%, respectively."Novartis is committed to the discovery and development of medicines that can ease the burden of immuno-dermatological diseases, which impact more than 100 million people worldwide," said Angelika Jahreis M.D., Ph.D., Novartis Global Head Development Unit Immunology, Hepatology & Dermatology. "These Phase II results are encouraging as they speak to the benefits of symptom control as reported directly by patients. This is particularly revealing as we know that established methods of assessing disease impact such as the Urticaria Activity Score of 7 days (UAS7) can sometimes fail to capture a patient's entire experience of living with CSU."

Novartis will also present late-breaking Phase II data for remibrutinib in CSU, showing that multiple doses provide significant improvements from baseline versus placebo with a favorable safety profile across the entire dose range. Remibrutinib is being investigated as a potential oral treatment across a number of immune-mediated conditions.

Lay summaries for the Phase IIb ligelizumab data and other key abstracts presented at EADV 2021 are available from the Novartis website: https://www.novartis.com/our-focus/immunology-dermatology/abstract-summaries-eadv .