Safety of biological and targeted therapy for the risk of malignant neoplasms arising


DOI: https://dx.doi.org/10.18565/therapy.2025.1.47-54

Trofimov E.A., Mazurov V.I., Makhortova S.A., Samigullina R.R., Shostak M.S., Trofimova A.S.

1) I.I. Mechnikov North-West State Medical University of the Ministry of Healthcare of Russia, Saint Petersburg; 2) V.A. Nasonova Clinical Rheumatology Hospital No. 25, Saint Petersburg
Abstract. Widespread use of genetically engineered biological therapy (GEBT) dictates the need for a thorough assessment of the risk of adverse events. Currently, there are different points of view regarding the risk of developing malignant neoplasms (MN) during GEBT performing.
The aim: to determine the risk of MN developing MN during biological and targeted therapy performing in patients with immune-inflammatory rheumatic diseases.
Material and methods. An analysis of the registry of GEBT center of I.I. Mechnikov North-West State Medical University of the Ministry of Healthcare of Russia was made, including data on 3827 individuals. The study included 28 patients with malignant neoplasms: 13 with rheumatoid arthritis (46.43%), 9 with ankylosing spondylitis (32.14%), 4 with psoriatic arthritis (14.29%), 1 with systemic scleroderma (3.57%), and 1 with eosinophilic granulomatosis with polyangiitis (3.57%). Among examined persons, there were 19 (67.86%) females, the average age of patients was 56.93 ± 9.78 years. Median duration of therapy at the time of detection of malignant neoplasms was 10 [0.083–16] years, average duration of the main disease was 15.57 ± 9.4 years.
Results. The total observation period was 72,713 patient-years. For treatment, drugs from the groups of tumor necrosis factor-alpha inhibitors (TNF-α), interleukin (IL) 6 inhibitors, IL-17 inhibitors, IL-23 inhibitors, Janus kinase inhibitors, anti-B-cell therapy and T-lymphocyte costimulation blockers were used. 28 solid tumors were detected (0.03 per 100 patient-years), including 6 cases of breast cancer, 3 cases each of thyroid, kidney and skin cancer, 2 cases of lung and ovarian cancer and 1 case of cancer of other localizations (stomach, testicle, prostate, cervix, pleura, larynx, liver, bladder, sarcoma). 12 cases of malignant neoplasms (42.86%) developed during TNF-α therapy.
Conclusion. Obtained data indicate that the incidence of malignant neoplasms arising during GEBT performing (0.73%) does not exceed the same in the general population of Russia (2.84%). Thus, this type of therapy has a favorable safety profile, without increasing the risks of malignant neoplasms in patients with rheumatic diseases.

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About the Autors


Evgeny A. Trofimov, MD, Dr. Sci. (Medicine), professor of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care with a course in hematology and transfusiology named after E.E. Eichwald, I.I. Mechnikov North-West State Medical University of the Ministry of Healthcare of Russia. Address: 191015, Saint Petersburg, 41 Kirochnaya St.
E-mail: Evgeniy.trofimov@szgmu.ru
ORCID: https://orcid.org/0000-0003-3236-4485. eLibrary SPIN: 4358-1663
Vadim I. Mazurov, MD, Dr. Sci. (Medicine), professor, academician of RAS, vice president of RSMSIM, principal scientific advisor and director of the Research Institute of Rheumatology, head of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care with a course in hematology and transfusiology named after E.E. Eichwald of I.I. Mechnikov North-West State Medical University of the Ministry of Healthcare of Russia, head of Autoimmune center of V.A. Nasonova Clinical Rheumatology Hospital No. 25, chief freelance specialist – rheumatologist of the Healthcare Committee of the Government of Saint Petersburg, Honored Worker of Science of the Russian Federation. Address: 191015, Saint Petersburg, 41 Kirochnaya St.
E-mail: maz.nwgmu@yandex.ru
ORCID: https://orcid.org/0000-0002-0797-2051. Scopus Author ID: 16936315400. eLibrary SPIN: 6823-5482
Svetlana A. Makhortova, MD, 1st year resident in the specialty “Rheumatology” of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care with a course in hematology and transfusiology named after E.E. Eichwald, I.I. Mechnikov North-West State Medical University of the Ministry of Healthcare of Russia. Address: 191015, Saint Petersburg, 41 Kirochnaya St.
Email: mahortova.sweta@yandex.ru
ORCID: https://orcid.org/0000-0001-7812-2655
Ruzana R. Samigullina, MD, PhD (Medicine), assistant at the Department of therapy, rheumatology, examination of temporary disability and quality of medical care with a course in hematology and transfusiology named after E.E. Eichwald, I.I. Mechnikov North-West State Medical University of the Ministry of Healthcare of Russia. Address: 191015, Saint Petersburg, 41 Kirochnaya St.
E-mail: dr.samigullina@yandex.ru
ORCID: https://orcid.org/0000-0002-6341-3334
Mikhail S. Shostak, MD, PhD (Medicine), associate professor of the Department of therapy, rheumatology, examination of temporary disability and quality of medical care with a course in hematology and transfusiology named after E.E. Eichwald, head of the Department of rheumatology of the Clinic named after. E.E. Eichwald, I.I. Mechnikov North-West State Medical University of the Ministry of Healthcare of Russia. Address: 191015, Saint Petersburg, 41 Kirochnaya St.
eLibrary SPIN: 3438-1747
Anna S. Trofimova, MD, PhD (Medicine), assistant at the Department of therapy, rheumatology, examination of temporary disability and quality of medical care with a course in hematology and transfusiology named after E.E. Eichwald, I.I. Mechnikov North-West State Medical University of the Ministry of Healthcare of Russia. Address: 191015, Saint Petersburg, 41 Kirochnaya St.
E-mail: Anna.Trofimova@szgmu.ru
ORCID: https://orcid.org/0000-0001-5926-7912. eLibrary SPIN: 6827-3934


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