Comparative analysis of clinical efficacy and safety of omalizumab biosimilar in the treatment of patients with chronic spontaneous urticaria

Shulzhenko A.E. Sorokina L.E. Kovalkova E.V. Kuznetsova E.V. Fomina D.S.
2023 Pharmarus Print Media

Russian Journal of Allergy
2023 #20 Issue 3 309 - 320 pp.

BACKGROUND: Importance of optimizing strategy for treatment of chronic spontaneous urticaria is highly becoming relevance for the clinicians. Nowadays monoclonal antibodies are preferred option of treatment the refractory chronic spontaneous urticaria, main of that is omalizumab. AIM: to establish comparative analysis of the efficacy and safety of Genolair (JSC Generium, Russia) and Xolair (Novartis Pharma AG, Switzerland) in the treatment of patients with chronic spontaneous urticaria. MATERIALS AND METHODS: A 36-week, open parallel-group study was conducted. Were included 43 adult patients with chronic spontaneous urticaria who were resistant to ongoing therapy with standard and escalated doses of second-generation H₁-antihistamines. All patients were divided into 2 groups: the main group (MG; n=18) ― patients who administrated Genolair; the comparison group (CG; n=25) ― patients who firstly administrated Xolair and then switching therapy to Genolair. Throughout the study period, patients completed questionnaires on the assessment of disease activity (UAS 7), urticaria control (UCT), quality of life index (DLQI). Additionally, the level of total IgE in blood serum was assessed. For statistical data processing, EXCEL 2010 and STATISTICA 7.0 software packages were used. RESULTS: After 4 weeks from the start of monoclonal antibody therapy, patients in both groups were responders to omalizumab. At the same time, there were no significant differences when comparing scores on the UAS 7, UCT scale between patients of the MG and the CG during the entire observation period (p >0.05). The change in treatment paradigm in CG also did not have a statistically significant effect on the indicators of urticaria activity and disease control (p >0.05). At the same time, the quality of everyday life changed more positively in the MG, which was reflected in a more pronounced change in the DLQI index at the time of the control assessment since 20 weeks of therapy (p=0.032). An increase in the level of total IgE in the blood serum of all patients with chronic spontaneous urticaria after the initiation of a course of immunobiological therapy was demonstrated, while there were no statistically significant intergroup differences in relation to changes in this laboratory parameter (p >0.05). CONCLUSION: During the treatment of patients with severe chronic spontaneous urticaria, resistant to ongoing therapy with standard and escalated doses of second-generation H₁-antihistamines, comparable clinical efficacy and safety of the study drug Genolair and the reference drug Xolair were shown.

antihistamine therapy , biosimilar , chronic spontaneous urticaria , omalizumab

Text of the article Перейти на текст статьи

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia, Moscow, Russian Federation
Center of Allergy and Immunology Clinical Moscow City Hospital 52, Moscow, Russian Federation
The First Sechenov Moscow State Medical University (Sechenov University), Moscow, Russian Federation
Astana Medical University, Astana, Kazakhstan

National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia
Center of Allergy and Immunology Clinical Moscow City Hospital 52
The First Sechenov Moscow State Medical University (Sechenov University)
Astana Medical University

10 лет помогаем публиковать статьи Международный издатель

Книга Публикация научной статьи Волощук 2026 Book Publication of a scientific article 2026