THE PROBLEMS OF THE SAFETY OF THERAPY WITH TUMOR NECROSIS FACTOR-а INHIBITORS

Dmitry Evgenyevich Karateyev

doi:10.14412/1996-7012-2009-555

Abstract

Due to the fact that tumor necrosis factor-а (TNF-а) inhibitors are in wide use, the problem of the safety of therapy with drugs of this group is pressing. The review discusses the data of randomized and observational clinical trials of three drugs of this group (adalimumab, infliximab, and etanercept) whether they can cause serious adverse reactions (SAR). The analysis leads to the conclusion that 10 years' experience in using TNF-а inhibitors generally suggests their satisfactory safety profile. Anti-TNF-а therapy is unassociated with the increased risk of fatal outcomes, at the same time one should be alert to tuberculosis, serious bacterial infections, and lymphoma although the frequency of SAR is generally low; the risk for the development of SAR becomes higher as the dose of TNF-а inhibitors is increased and it does not with longer survival. The currently available preventive methods and physicians' alertness to SAR help prevent their development.

Highlights

Due to the fact that tumor necrosis factor-α (TNF-α) inhibitors are in wide use, the problem of the safety of therapy with drugs of this group is pressing
The analysis leads to the conclusion that 10 years' experience in using TNF-α inhibitors generally suggests their satisfactory safety profile
Anti-TNF-α therapy is unassociated with the increased risk of fatal outcomes, at the same time one should be alert to tuberculosis, serious bacterial infections, and lymphoma the frequency of serious adverse reactions (SAR) is generally low; the risk for the development of SAR becomes higher as the dose of TNF-α inhibitors is increased and it does not with longer survival

Summary

Вопросы безопасности терапии ингибиторами ФНО α

Ввиду широкого распространения ингибиторов фактора некроза опухоли α (ФНО α) актуальна проблема безопасности терапии препаратами этой группы. В настоящее время, несмотря на появление значительного числа новых ГИБП с различными механизмами действия, таких как ритуксимаб [10,11,12,13], тоцилизумаб [14] и абатацепт [7], основными средствами биологической терапии остаются ингибиторы фактора некроза опухоли α (ФНО α), что отражено в клинических рекомендациях, основанных на клинических исследованиях и мнении экспертов [6, 15, 16], а также практическом опыте ревматологов [17]. Ввиду широкого распространения ингибиторов ФНО α как препаратов первой линии, помимо вопросов их эффективности, обсуждается проблема безопасности терапии. Относительный риск развития серьезных инфекций у больных РА при лечении ингибиторами ФНО α, по данным различных исследований

Метаанализ РКИ

Число больных

ПРАВИЛА ДЛЯ АВТОРОВ