PMID- 23819337
OWN - NLM
STAT- MEDLINE
DCOM- 20130722
LR  - 20151119
IS  - 0040-3660 (Print)
IS  - 0040-3660 (Linking)
VI  - 85
IP  - 5
DP  - 2013
TI  - [Severe adverse events from treatment with genetically engineered biological 
      agents in patients with rheumatic diseases].
PG  - 37-43
AB  - 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.
FAU - Moiseev, S V
AU  - Moiseev SV
FAU - Novikov, P I
AU  - Novikov PI
FAU - Semenkova, E N
AU  - Semenkova EN
FAU - Strizhakov, L A
AU  - Strizhakov LA
FAU - Gulyaev, S V
AU  - Gulyaev SV
FAU - Yanushkevich, T N
AU  - Yanushkevich TN
FAU - Nikiforova, N V
AU  - Nikiforova NV
FAU - Meshkov, A D
AU  - Meshkov AD
FAU - Panasyuk, V V
AU  - Panasyuk VV
FAU - Sokorin, Yu D
AU  - Sokorin YD
FAU - Taranova, M V
AU  - Taranova MV
FAU - Parfenova, S A
AU  - Parfenova SA
FAU - Dubrovskaya, L V
AU  - Dubrovskaya LV
FAU - Zhabina, E S
AU  - Zhabina ES
FAU - Kuznetsova, E I
AU  - Kuznetsova EI
FAU - Lopatina, I A
AU  - Lopatina IA
FAU - Bulanov, N M
AU  - Bulanov NM
FAU - Mukhin, N A
AU  - Mukhin NA
LA  - rus
PT  - Controlled Clinical Trial
PT  - English Abstract
PT  - Journal Article
PL  - Russia (Federation)
TA  - Ter Arkh
JT  - Terapevticheskii arkhiv
JID - 2984818R
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Murine-Derived)
RN  - 0 (Immunologic Factors)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Adult
MH  - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug 
      therapy/physiopathology
MH  - Antibodies, Monoclonal/*adverse effects/therapeutic use
MH  - Antibodies, Monoclonal, Murine-Derived/*adverse effects/therapeutic use
MH  - Arthritis, Rheumatoid/drug therapy/physiopathology
MH  - Female
MH  - Genetic Engineering
MH  - Humans
MH  - Immunologic Factors/*adverse effects/therapeutic use
MH  - Infliximab
MH  - Lupus Erythematosus, Systemic/drug therapy/physiopathology
MH  - Male
MH  - Remission Induction/methods
MH  - Rheumatic Diseases/*drug therapy/physiopathology
MH  - Rituximab
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2013/07/04 06:00
MHDA- 2013/07/23 06:00
CRDT- 2013/07/04 06:00
PHST- 2013/07/04 06:00 [entrez]
PHST- 2013/07/04 06:00 [pubmed]
PHST- 2013/07/23 06:00 [medline]
PST - ppublish
SO  - Ter Arkh. 2013;85(5):37-43.