Systemic characteristic of safety profile of monoclonal antibodies used in rheumatology practice
https://doi.org/10.24411/2588-0519-2019-10075
Abstract
Monoclonal antibodies are highly effective medications, which made a breakthrough in medicine. Taking into consideration the properties of monoclonal antibodies safety plays a key role in “risk-benefit” assessment. For monoclonal antibodies this remains studied insufficiently. The article presents a systemic characteristic of safety profile of monoclonal antibodies used in rheumatology, based on the database of spontaneous reports of the Federal Service for the Supervision of Healthcare. Specified greater alertness of Russian practitioners regarding the risk of developing tuberculosis infections in comparison to their foreign counterparts. Spontaneous reports of the development of neoplasms and deviations of laboratory tests, according to our data, on the contrary, are reported less. It is advisable to draw the attention of practitioners to the peculiarities of work with isolated deviations in laboratory tests and keep alert about the safety issues of monoclonal antibodies in general. It is important to continue monitoring to characterize delayed type D adverse drug reactions.
About the Authors
A. V. Philippova
Pavlov First Saint Petersburg State Medical University
Russian Federation
Russian Federation
Philippova Anastasia - MD, Post-graduate student, Department of Clinical Pharmacology and Evidence-Based Medicine, First St. Petersburg SMU named after I.P. Pavlova
SPIN-code: 3989-9803A. S. Kolbin
Pavlov First Saint Petersburg State Medical University; St. Petersburg State University
Russian Federation
Russian Federation
Kolbin Alexey - MD, DrSci, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE I.P. Pavlov SPbSMu MOH Russia; professor of the Department of Pharmacology Medical Faculty St. Petersburg SU
SPIN-code: 7966-0845
E. V. Verbitskaya
Pavlov First Saint Petersburg State Medical University
Russian Federation
Russian Federation
Verbitskaya Elena - PhD (Pharm. med), Associate Professor Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE I.P. Pavlov SPbSMU MOH Russia; Chief of Department of Pharmacoepidemiology and Biostatistics, A.V. Valdman Institute of Pharmacology FSBEI HE I.P. Pavlov SPbSMU MOH Russia
SPIN-code: 4701-8118
S. V. Glagolev
Federal Service for the Supervision of Healthcare
Russian Federation
Russian Federation
Glagolev Sergey - MD, MSc (Pharm. med), Deputy chief, Department for quality control of medical products, Chief, Division for pharmacovigilance, Roszdravnadzor
V. A. Polivanov
Information and Methodological Center for Expert Evaluation, Recording and Analysis of Circulation of Medical Products of Roszdravnadzor
Russian Federation
Russian Federation
Vitaly Polivanov - MD, Director of the Center for pharmacovigilance FSBU “IMCEAACMP”
SPIN-code: 1699-3254
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For citations:
Philippova A.V., Kolbin A.S., Verbitskaya E.V., Glagolev S.V., Polivanov V.A. Systemic characteristic of safety profile of monoclonal antibodies used in rheumatology practice. Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice. 2019;(2):75-84. (In Russ.) https://doi.org/10.24411/2588-0519-2019-10075
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