The use of Alflutop® in real clinical practice: Results of a multicenter prospective observational study


DOI: https://dx.doi.org/10.18565/therapy.2023.7.90-101

Lila A.M., Strebkova E.A., Alekseeva L.I., Taskina E.A., Kashevarova N.G.

1) V.A. Nasonova Research Institute of Rheumatology, Moscow; 2) Russian Medical Academy of Continuing Professional Education of the Ministry of Healthcare of Russia, Moscow
Abstract. The osteoarthritis localization – an important aspect in the personalized therapy.
Purpose: to study the effectiveness of the Alflutop® in patients with OA of different localization and/ or lower back pain (LBP).
Material and methods. The observational prospective study involved 163 clinical centers from 58 regions of Russia. The study participants were 22,525 patients with OA of different localization and/or LBP. The duration of the study ranged from 20 to 31 days. Alflutop® was prescribed 1 ml intramuscularly (IM) daily No. 20 or 2 ml IM every other day No. 10. The effectiveness of treatment was determined by the following parameters: the time of the onset of the effect, the dynamics of the intensity of pain according to VAS, the assessment of the quality of life according to EQ-5D and the patient’s general health status (PGH) according to VAS.
Results. Against the background of therapy with Alflutop® in patients with OA of different localization and/or LBP, a significant symptomatic effect was noted. In patients with OA of small joints of the hands, the analgesic effect developed on the 9th [5; 10] day of therapy, while the intensity of pain in VAS decreased by 62,3%, the PGH improved by 28,6%. Similar results were obtained with other OA localizations. In patients with OA of the hip joints, knee joints, as well as with a generalized form, the rapidity of the effect was noted – on average on the 9th day of therapy, a significant decrease in the level of pain when moving in the joint, an improvement in the PGH (p <0,05) and quality of life parameters according to EQ-5D (p <0,05) compared with the initial indicators.
Conclusion. The results of a multicenter study demonstrated the effectiveness of Alflutop® in patients with OA of different localization. Significant clinical improvement was observed in more than 90% of the participants after 1 course of therapy. The use of Alflutop® in clinical practice is appropriate for the treatment of patients with local and generalized forms of OA.
Keywords: Alflutop®, different localization of osteoarthritis, osteoarthritis, pain
Read entire article

Literature

1. Алексеева Л.И., Таскина Е.А., Кашеварова Н.Г. Остеоартрит: эпидемиология, классификация, факторы риска и прогрессирования, клиника, диагностика, лечение. Современная ревматология. 2019; 13(2): 9–21. [Alekseeva L.I., Taskina E.A., Kashevarova N.G. Osteoarthritis: Epidemiology, classification, risk factors, and progression, clinical presentation, diagnosis, and treatment. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2019; 13(2): 9–21 (In Russ.)]. https://dx.doi.org/10.14412/1996-7012-2019-2-9-21. EDN: GIKYDR.


2. Safiri S., Kolahi A.A., Smith E. et al. Global, regional and national burden of osteoarthritis 1990–2017: A systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020; 79(6): 819–28. https://dx.doi.org/10.1136/annrheumdis-2019-216515.


3. Long H., Liu Q., Yin H. et al. Prevalence trends of site-specific osteoarthritis from 1990 to 2019: Findings from the Global Burden of Disease Study 2019. Arthritis Rheumatol. 2022; 74(7): 1172–83. https://dx.doi.org/10.1002/art.42089.


4. Галушко Е.А., Насонов Е.Л. Распространенность ревматических заболеваний в России. Альманах клинической медицины. 2018; 46(1): 32–39. [Galushko E.A., Nasonov E.L. Prevalence of rheumatic diseases in Russia. Al’manakh klinicheskoy meditsiny = Almanac of Clinical Medicine. 2018; 46(1): 32–39 (In Russ.)]. https://dx.doi.org/10.18786/2072-0505-2018-46-1-32-39. EDN: YVSHGT.


5. Liu Q., Niu J., Li H. et al. Knee symptomatic osteoarthritis, walking disability, NSAIDs use and all-cause mortality: Population-based Wuchuan Osteoarthritis Study. Sci Rep. 2017; 7(1): 3309. https://dx.doi.org/10.1038/s41598-017-03110-3.


6. Wang S.X., Ganguli A.X., Bodhani A. et al. Healthcare resource utilization and costs by age and joint location among osteoarthritis patients in a privately insured population. J Med Econ. 2017; 20(12): 1299–306. https://dx.doi.org/10.1080/13696998.2017.1377717.


7. Little C.B., Hunter D.J. Post-traumatic osteoarthritis: From mouse models to clinical trials. Nat Rev Rheumatol. 2013; 9(8): 485–97. https://dx.doi.org/10.1038/nrrheum.2013.72.


8. Wylde V., Beswick A., Bruce J. et al. Chronic pain after total knee arthroplasty. EFORT Open Rev. 2018; 3(8): 461–70. https://dx.doi.org/10.1302/2058-5241.3.180004.


9. Woodell-May J.E., Sommerfeld S.D. Role of inflammation and the immune system in the progression of osteoarthritis. J Orthop Res. 2020; 38(2): 253–57. https://dx.doi.org/10.1002/jor. 24457.


10. Wu C.L., Harasymowicz N.S., Klimak M.A. et al. The role of macrophages in osteoarthritis and cartilage repair. Osteoarthritis Cartilage. 2020; 28(5): 544–54. https://dx.doi.org/10.1016/j.joca. 2019.12.007.


11. Yao Q., Wu X., Tao C. et al. Osteoarthritis: Pathogenic signaling pathways and therapeutic targets. Signal Transduct Target Ther. 2023; 8(1): 56. https://dx.doi.org/10.1038/s41392-023-01330-w.


12. Таскина Е.А., Алексеева Л.И., Кашеварова Н.Г. с соавт. Мультиморбидность при остеоартрите. Научно-практическая ревматология. 2022; 60(3): 306–313. [Taskina E.A., Alekseeva L.I., Kashevarova N.G. et al. Multimorbidity in osteoarthritis. Nauchno- prakticheskaya revmatologiya = Rheumatology Science and Practice. 2022; 60(3): 306–313 (In Russ.)]. https://dx.doi.org/10.47360/1995-4484-2022-306-313. EDN: VTPZIF.


13. Swain S., Sarmanova A., Coupland C. et al. Comorbidities in osteoarthritis: A systematic review and meta-analysis of observational studies. Arthritis Care Res (Hoboken). 2020; 72(7): 991–1000. https://dx.doi.org/10.1002/acr.24008.


14. Bruyere O., Honvo G., Veronese N. et al. An updated algorithm recommendation for the management of knee osteoarthritis from the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Semin Arthritis Rheum. 2019; 49(3): 337–50. https://dx.doi.org/10.1016/j.semarthrit.2019.04.008.


15. Насонов Е.Л. Российские клинические рекомендации. Ревматология. М.: ГЭОТАР-Медиа. 2020; с. 240. [Nasonov E.L. Russian clinical guidelines. Rheumatology. Moscow: GEOTAR-Media. 2020; p. 240 (In Russ.)]. ISBN: 978-5-9704-5398-8.


16. Olariu L., Dumitriu B., Craciun L. et al. The in vitro influence of a pharmaceutically active small sea fish extract on apoptosis and proliferation mechanisms amplified by inflammatory conditions. Farmacia. 2018; 66(3): 524–29.


17. Olariu L., Dumitriu B., Manuela Ene D. et al. Alflutop modulates «in vitro» relevant mechanisms of osteoarthritic pathology. Annals Series on Biological Sciences. 2017 Academy of Romanian Scientists. 2017; 6(1): 82–99. ISSN 2285 – 4177.


18. Olariu L., Dumitriu B., Buse E., Rosoiu N. The «in vitro» effect of Alflutop product on some extracellular signaling factors involved in the osteoarthicular pathology inflammation. Academy of Romanian Scientists. Annals Series on Biological Sciences. 2015; 4(2): 7–18. ISSN 2285 – 4177. Online edition. Original paper. Received for publication, September, 15, 2015. Accepted, December, 01, 2015.


19. Каратеев А.Е. Биоактивный концентрат мелкой морской рыбы: оценка эффективности и безопасности препарата на основании анализа 37 клинических исследований. Современная ревматология. 2020; 14(4): 111–124. [Karateev A.E. Bioactive concentrate from small sea fish: evaluation of the efficacy and safety of the drug on the basis of the analysis of 37 clinical trials. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2020; 14(4): 111–124 (In Russ.)]. https://dx.doi.org/10.14412/1996-7012-2020-4-111-124. EDN: JEPCAS.


20. Алексеева Л.И., Шарапова Е.П., Таскина Е.А. с соавт. Многоцентровое слепое рандомизированное плацебо-контролируемое исследование симптом- и структурно-модифицирующего действия препарата Алфлутоп у больных остеоартрозом коленных суставов. Сообщение 1. Симптоммодифицирующее действие препарата. Научно-практическая ревматология. 2013; 51(5): 532–538. [Alekseeva L.I., Sharapova E.P., Taskina E.A. et al. Multicenter double-blind randomized placebo-controlled trial of the symptom-and structure-modifying effect of alflutop in patients with knee osteoarthrosis. Communication 1. Evaluation of the symptom-modifying effect of the drug. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2013; 51(5): 532–538 (In Russ.)]. EDN: RWUMTT.


21. Алексеева Л.И., Шарапова Е.П., Таскина Е.А. с соавт. Многоцентровое слепое рандомизированное плацебо-контролируемое исследование симптом- и структурно-модифицирующего действия препарата Алфлутоп у больных остеоартрозом коленных суставов. Сообщение 2. Оценка структурно-модифицирующего действия препарата. Научно-практическая ревматология. 2014; 52(2): 174–77. [Alekseeva L.I., Sharapova E.P., Taskina E.A. et al. A multicenter, blind, randomized, placebo-controlled study of the symptom and structure-modifying effect of Alflutop in patients with knee osteoarthrosis. Report 2: The assessment of the structure- modifying effect of the drug. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2014; 52(2): 174–77 (In Russ.)]. https://dx.doi.org/10.14412/1995-4484-2014-174-177. EDN: SMYQVD.


22. Алексеева Л.И., Таскина Е.А., Лила А.М. с соавт. Многоцентровое проспективное рандомизированное исследование эффективности и безопасности препарата Алфлутоп® в альтернирующем режиме по сравнению со стандартным режимом. Сообщение 1: оценка эффективности препарата при различных схемах применения. Современная ревматология. 2019; 13(3): 51–59. [Alekseeva L.I., Taskina E.A., Lila A.M. et al. A multicenter, prospective, randomized trial of the efficacy and safety of Alflutop® in an alternating dosing regimen versus the standard one. Communication 1: Evaluation of the efficacy of the drug in different treatment regimens. Sovremennaya revmatologiya = Modern Rheumatology Journal. 2019; 13(3): 51–59 (In Russ.)]. https://dx.doi.org/10.14412/1996-7012-2019-3-51-59. EDN: YXZKNO.


23. Лукина Г.В., Сигидин Я.А., Чичасова Н.В. с соавт. Алфлутоп в терапии остеоартроза. Научно-практическая ревматология. 2004; 42(3): 52–54. [Lukina G.V., Sigidin J.A., Chichasova N.V. et al. Alflutop in osteoarthritis therapy. Nauchno-prakticheskaya revmatologiya = Rheumatology Science and Practice. 2004; 42(3): 52–54 (In Russ.)]. EDN: QCWXIN.


About the Autors

Alexander M. Lila, MD, professor, corresponding member of RAS, director of V.A. Nasonova Research Institute of Rheumatology, head of the Department of rheumatology, Russian Medical Academy of Continuing Professional Education of the Ministry of Healthcare of Russia. Address: 115522, Moscow, 34А Kashirskoe Highway.
E-mail: amlila@mail.ru. ORCID: https://orcid.org/0000-0002-6068-3080
Ekaterina A. Strebkova, PhD in Medical Sciences, researcher at the Laboratory of osteoarthritis of the Department of metabolic diseases of bone and joints, V.A. Nasonova Research Institute of Rheumatology. Address: 115522, Moscow, 34А Kashirskoe Highway. E-mail: dr.ekaterinastrebkova@yandex.ru. ORCID: https://orcid.org/0000-0001-8130-5081 Lyudmila I. Alekseeva, MD, head of the Department of metabolic diseases of bone and joints, V.A. Nasonova Research Institute of Rheumatology, professor of the Department of rheumatology, Russian Medical Academy of Continuing Professional Education of the Ministry of Healthcare of Russia. Адрес: 115522, Moscow, 34А Kashirskoe Highway.
ORCID: https://orcid.org/0000-0001-7017-0898
Elena A. Taskina, PhD in Medical Sciences, senior researcher at the Department of metabolic diseases of bone and joints, V.A. Nasonova Research Institute of Rheumatology. Address: 115522, Moscow, 34А Kashirskoe Highway.
ORCID: https://orcid.org/0000-0001-8218-3223
Natalya G. Kashevarova, PhD in Medical Sciences, researcher at the Department of metabolic diseases of bone and joints, V.A. Nasonova Research Institute of Rheumatology. Address: 115522, Moscow, 34А Kashirskoe Highway.
ORCID: https://orcid.org/0000-0001-8732-2720


Similar Articles

Back to Content

Бионика Медиа