Comparative analysis of clinical efficacy and safety of omalizumab biosimilar in the treatment of patients with chronic spontaneous urticaria
- Authors: Shulzhenko A.E.1, Sorokina L.E.1, Kovalkova E.V.2, Kuznetsova E.V.3, Fomina D.S.2,3,4
-
Affiliations:
- 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
- Issue: Vol 20, No 3 (2023)
- Pages: 309-320
- Section: Original studies
- URL: https://journals.rcsi.science/raj/article/view/251324
- DOI: https://doi.org/10.36691/RJA15046
- ID: 251324
Cite item
Abstract
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.
Full Text
##article.viewOnOriginalSite##About the authors
Andrey E. Shulzhenko
National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia
Email: shulzhenko_ae@mail.ru
ORCID iD: 0000-0003-0268-9350
SPIN-code: 4584-4915
MD, Dr. Sci. (Med.), Professor
Russian Federation, MoscowLeya E. Sorokina
National Research Center ― Institute of Immunology Federal Medical-Biological Agency of Russia
Author for correspondence.
Email: leya.sorokina@mail.ru
ORCID iD: 0000-0002-1862-6816
SPIN-code: 5934-0679
Russian Federation, Moscow
Elena V. Kovalkova
Center of Allergy and Immunology Clinical Moscow City Hospital 52
Email: ev-kovalkova@ya.ru
ORCID iD: 0000-0002-1212-3767
SPIN-code: 3078-0976
Russian Federation, Moscow
Elizaveta V. Kuznetsova
The First Sechenov Moscow State Medical University (Sechenov University)
Email: wuiw105@mail.ru
ORCID iD: 0000-0001-7098-0049
Russian Federation, Moscow
Daria S. Fomina
Center of Allergy and Immunology Clinical Moscow City Hospital 52; The First Sechenov Moscow State Medical University (Sechenov University); Astana Medical University
Email: daria_fomina@mail.ru
ORCID iD: 0000-0002-5083-6637
SPIN-code: 3023-4538
MD, Cand. Sci. (Med.), Associate Professor
Russian Federation, Moscow; Moscow; AstanaReferences
- Urticaria. Clinical recommendations. Russian Society of Allergologists and Clinical Immunologists, Russian Society of Dermatovenerologists and Cosmetologists, Union of Pediatricians of Russia; 2020. (In Russ).
- Pereverzina NO, Kruglova LS, Musaev IE. Present and future in the therapy of chronic spontaneous urticaria. Clin Dermatol Venereol. 2020;19(5):604–612. (In Russ). doi: 10.17116/klinderma202019051604
- Kocatürk E, Maurer M, Metz M, Grattan C. Looking forward to new targeted treatments for chronic spontaneous urticaria. Clin Transl Allergy. 2017;(7):1. doi: 10.1186/s13601-016-0139-2
- Guillen-Aguinaga S, Presa I, Aguinaga-Ontoso E, et al. Updosing nonsedating antihistamines in patients with chronic spontaneous urticaria: A systematic review and meta-analysis. Br J Dermatol. 2016;175(6):1153–1165. doi: 10.1111/bjd.14768
- Soresi S, Togias A. Mechanisms of anti-immunoglobulin E thеrapy. Allergy Asthma Proc. 2006;27(2 Suppl 1):15–23.
- Hu J, Chen J, Ye L, et al. Anti-IgE therapy for IgE-mediated allergic diseases: From neutralizing IgE antibodies to eliminating IgE+ B cells. Clin Transl Allergy. 2018;(8):27. doi: 10.1186/s13601-018-0213-z
- Hill DA, Siracusa MC, Ruymann KR, et al. Omalizumab therapy is associated with reduced circulating basophil populations in asthmatic children. Allergy. 2014;69(5):674–677. doi: 10.1111/all.12375
- Ivanov R, Sekareva G, Kravtsova O, et al. Rules for conducting research on biosimilar medications (biosimilars). Pharmacokinetics Pharmacodynamics. 2014;(1):21–36. (In Russ).
- Nosbaum A, Augey F, Nicolas JF, Bérard F. Pathophysiology of urticaria. Ann Dermatol Venereol. 2014;141(Suppl 3):559–564. doi: 10.1016/S0151-9638(14)70158-9
- Kolkhir PV, Olisova OY, Kochergin NG. Endotypic classification of chronic spontaneous urticaria: The way to personalized therapy. Attending Physician. 2015;(5):45. (In Russ).
- Saini SS, Bindslev-Jensen C, Maurer M, et al. Efficacy and safety of omalizumab in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamines: A randomized, placebo-controlled study. J Invest Dermatol. 2015;135(1):67–75. doi: 10.1038/jid.2014.306
- Labrador-Horrillo M, Valero A, Velasco M, et al. Efficacy of omalizumab in chronic spontaneous urticaria refractory to conventional therapy: Analysis of 110 patients in reallife practice. Expert Opin Biol Ther. 2013;13(9):1225–1228. doi: 10.1517/14712598.2013.822484
- Metz M, Ohanyan T, Church MK, Maurer M. Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: A retrospective clinical analysis. J Dermatol Sci. 2014;73(1):57–62. doi: 10.1016/j.jdermsci.2013.08.011
- Rottem M, Segal R, Kivity S, et al. Omalizumab therapy for chronic spontaneous urticaria: The Israeli experience. Isr Med Assoc J. 2014;16(8):487–490.
- Sussman G, Hebert J, Barron C, et al. Real-life experiences with omalizumab for the treatment of chronic urticaria. Ann Allergy Asthma Immunol. 2014;112(2):170–174. doi: 10.1016/j.anai.2013.12.005
- Demko IV, Sobko EA, Kraposhina AY, Shestakova NA. Aspects of the application of the Russian biosimilar omalizumab in clinical practice. Practical Pulmonol. 2022;(1):17–22. (In Russ). doi: 10.24412/2409-6636-2022-12829
- Kolbin AS, Klimko NN, Andreev BV. Clinical and pharmacological justification of the use of Xolar (omalizumab) in the bronzial system. Qualitative Clin Pract. 2008;(2):53–61. (In Russ).
- Dorzhieva VV. State policy of import substitution as a factor in the development of the pharmaceutical industry in Russia: The impact of sanctions and steps to success. Bulletin Institute Economics Russ Academy Sci. 2022;(6):68–78. (In Russ). doi: 10.52180/2073-6487-2022-6-68-78
- Krysanova VS, Ermolaeva D, Ermolaeva TN, et al. Economic aspects of the use of the Russian biosimilar omalizumab in patients with atopic bronchial asthma of moderate and severe course. Pharmacy Pharmacol. 2021;9(3):235–248. (In Russ). doi: 10.19163/2307-9266-2021-9-3-235-248
- Nenasheva NM, Averyanov AV, Ilyina NI, et al. Comparative study of the clinical efficacy of a bio-analogous drug Genolar based on the results of a randomized phase III clinical trial. Pulmonology. 2020;30(6):782–796. (In Russ).
- Gericke J, Metz M, Ohanyan T, et al. Serum autoreactivity predicts time to response to omalizumab therapy in chronic spontaneous urticaria. J Allergy Clin Immunol. 2017;139(3):1059–1061, e1051. doi: 10.1016/j.jaci.2016.07.047
- Ertas R, Ozyurt K, Atasoy M, et al. The clinical response to omalizumab in chronic spontaneous urticaria patients is linked to and predicted by IgE levels and their change. Allergy. 2018;73(3):705–712. doi: 10.1111/all.13345
- Weller K, Ohanyan T, Hawro T, et al. Total IgE levels are linked to the response of chronic spontaneous urticaria patients to omalizumab. Allergy. 2018;73(12):2406–2408. doi: 10.1111/all.13586
- Cugno M, Genovese G, Ferrucci S, et al. IgE and D-dimer baseline levels are higher in responders than nonresponders to omalizumab in chronic spontaneous urticaria. Br J Dermatol. 2018;179(3): 776–777. doi: 10.1111/bjd.16593
- Türk M, Carneiro-Leão L, Kolkhir P, et al. how to treat patients with chronic spontaneous urticaria with omalizumab: questions and answers. J Allergy Clin Immunol Pract. 2020;8(1):113–124. doi: 10.1016/j.jaip.2019.07.021
- Kulthanan K, Tuchinda P, Likitwattananurak C, et al. Does omalizumab modify a course of recalcitrant chronic spontaneous urticaria? A retrospective study in Asian patients. J Dermatol. 2018;45(1):17–23. doi: 10.1111/1346-8138.14081
Supplementary files
![](/img/style/loading.gif)