Terapevticheskii arkhiv · 2013
[Severe adverse events from treatment with genetically engineered biological agents in patients with rheumatic diseases].
Контролируемое клиническое исследованиеАннотация на английскомСтатьяНазвание и аннотация: Перевод в очереди
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Moiseev S V, Novikov P I, Semenkova E N, Strizhakov L A, Gulyaev S V, Yanushkevich T N, Nikiforova N V, Meshkov A D, Panasyuk V V, Sokorin Yu D, Taranova M V, Parfenova S A, Dubrovskaya L V, Zhabina E S, Kuznetsova E I, Lopatina I A, Bulanov N M, Mukhin N A
Аннотация
AIM: To assess the risk of severe adverse events (AEs) within 6 months after treatment with biological agents in patients with rheumatic diseases (RD).
SUBJECTS AND METHODS: The 6-month open-label trial included 107 patients with rheumatoid arthritis, antineutrophil cytoplasmic antibody-associated vasculitides, systemic lupus erythematosus, and other RDs who received genetically engineered biological agents (GEBAs), primarily rituximab (n = 66) and infliximab (n = 31).
RESULTS: The majority of patients were noted to have improvements, including complete and partial remission in 62 (57.9%) and 42 (39.3%), respectively. There were mild or moderate AEs in 22 (20.6%) of the 107 patients, severe AEs in 6 (5.6%): grade IV neutropenia in 2 patients (after the use of rituximab), severe infusion reactions in 2 (after the administration of infliximab and rituximab), and systemic infections in 2 (fatal nocardial sepsis after rituximab treatment and unspecified sepsis after infliximab treatment).
CONCLUSION: The rate of serious AEs, mainly infusion AEs and infections during treatment with infliximab, rituximab, and other GEBAs proved to be relatively low in patients with different RDs. At the same time, the use of biological agents could lower RD activity in the presence of severe visceral injuries refractory to conventional immunosuppressive therapy.
SUBJECTS AND METHODS: The 6-month open-label trial included 107 patients with rheumatoid arthritis, antineutrophil cytoplasmic antibody-associated vasculitides, systemic lupus erythematosus, and other RDs who received genetically engineered biological agents (GEBAs), primarily rituximab (n = 66) and infliximab (n = 31).
RESULTS: The majority of patients were noted to have improvements, including complete and partial remission in 62 (57.9%) and 42 (39.3%), respectively. There were mild or moderate AEs in 22 (20.6%) of the 107 patients, severe AEs in 6 (5.6%): grade IV neutropenia in 2 patients (after the use of rituximab), severe infusion reactions in 2 (after the administration of infliximab and rituximab), and systemic infections in 2 (fatal nocardial sepsis after rituximab treatment and unspecified sepsis after infliximab treatment).
CONCLUSION: The rate of serious AEs, mainly infusion AEs and infections during treatment with infliximab, rituximab, and other GEBAs proved to be relatively low in patients with different RDs. At the same time, the use of biological agents could lower RD activity in the presence of severe visceral injuries refractory to conventional immunosuppressive therapy.
Предметные рубрики MeSH
AdultAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAntibodies, MonoclonalAntibodies, Monoclonal, Murine-DerivedArthritis, RheumatoidFemaleGenetic EngineeringHumansImmunologic FactorsInfliximabLupus Erythematosus, SystemicMaleRemission InductionRheumatic DiseasesRituximabSeverity of Illness IndexTreatment Outcome