- Data analysis shows that preventing the symptoms of CSU (achieving complete control) improves overall health-related quality of life (HRQoL); including sleep and work productivity, among other measures1
- Complete control of CSU symptoms, assessed by a composite of patient reported outcomes (PROs), is more likely to be achieved and sustained with ligelizumab than Xolair® (omalizumab) or placebo2
- Phase III results are expected in H2 2021 with first regulatory filing in 2022
Basel, September 29, 2021 — Novartis, a leader in immuno-dermatology and rheumatology, 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® (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.
Novartis in chronic spontaneous urticaria (CSU)
Novartis is curious about the science beneath the skin and dedicated to reimagining the care of patients with diseases that can severely limit quality of life such as CSU, psoriasis, acne, and atopic dermatitis. Novartis is committed to developing medicines that will advance the treatment of CSU, so patients are able to live their lives without the distressing and unpredictable symptoms of this debilitating disease. These include ligelizumab (QGE031) a next generation high-affinity monoclonal anti-immunoglobulin (Ig) E antibody and remibrutinib (LOU064) a potentially best-in-class oral BTK inhibitor. It is intended that these investigational therapies will complement Xolair, our existing approved add-on therapy for CSU.
In the US, Novartis and Genentech, a member of the Roche Group, work together to develop and co-promote Xolair. Outside the US, Novartis markets Xolair and records all sales and related costs.
Ligelizumab (QGE031) is a next generation high-affinity monoclonal anti-immunoglobulin (Ig) E antibody. Ligelizumab is thought to work by blocking the IgE/FcεRI pathway, a key driver of the inflammatory process in CSU9,10. In a Phase IIb dose-finding trial, more patients experienced complete resolution of wheals (hives) with ligelizumab compared with Xolair® (omalizumab)11. No safety concerns were found with ligelizumab compared with omalizumab or placebo in a Phase IIb dose-finding trial in CSU patients with inadequate control on antihistamines11. Ligelizumab compared with omalizumab is currently being investigated in ongoing Phase III clinical trials including PEARL 1 and PEARL 2 (NCT03580369 and NCT03580356). The clinical trials have recruited more than 2,000 patients globally across 48 countries and results are expected in the second half of 202112,13.
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
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- Bernstein JA, Giménez-Arnau A, Maurer M et al. Complete Symptom Control in Patients with Chronic Spontaneous Urticaria is associated with an Improvement in Health-Related Quality of Life: Data from the Phase 2b Ligelizumab Study. EADV 2021, abstract 1071.
- Giménez-Arnau A.M, Bernstein J, Hide M, et al. A composite score combining symptoms with QoL to evaluate complete control of urticaria with ligelizumab. EADV 2021, abstract 705.
- Kanani A, Betschel SD and Warrington R. Urticaria and angioedema. Allergy Asthma Clin Immunol. 2018;14:59.
- Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA(2)LEN task force report. Allergy. 2011;66:317-30.
- Balp MM, Vietri J, Tian H, et al. The Impact of Chronic Urticaria from the Patient's Perspective: A Survey in Five European Countries. Patient. 2015;8:551-8.
- Balp MM, Khalil S, Tian H, et al. Burden of chronic urticaria relative to psoriasis in five European countries. J Eur Acad Dermatol Venereol. 2018;32:282-290.
- Vietri J, Turner SJ, Tian H, et al. Effect of chronic urticaria on US patients: analysis of the National Health and Wellness Survey. Ann Allergy Asthma Immunol. 2015;115:306-11.
- Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA2LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69:868-87.
- Gasser P, Tarchevskaya SS, Guntern P, et al. The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab. Nat Commun. 2020;11:165.
- Arm JP, Bottoli I, Skerjanec A, et al. Pharmacokinetics, pharmacodynamics and safety of QGE031 (ligelizumab), a novel high-affinity anti-IgE antibody, in atopic subjects. Clin Exp Allergy. 2014;44:1371-85.
- Maurer M, Gimenez-Arnau AM, Sussman G, et al. Ligelizumab for Chronic Spontaneous Urticaria. N Engl J Med. 2019;381:1321-1332.
- ClinicalTrials.gov. NCT03580369. A Phase III Study of the Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled with H1-histamines [online] April 2020. Available from: https://clinicaltrials.gov/ct2/show/NCT03580369 [Last accessed: September 2021].
- ClinicalTrials.gov. NCT03580356. A Phase III Study of the Efficacy and Safety of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled with H1-histamines [online] March 2020. Available from: https://clinicaltrials.gov/ct2/show/NCT03580356 [Last accessed: September 2021].
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