Document Detail


Patient survival and safety with biologic therapy. Results of the Mexican National Registry Biobadamex 1.0.
MedLine Citation:
PMID:  22673388     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This work reports patient treatment survival and adverse events related to Biologic Therapy (BT), identified by a multicenter ambispective registry of 2047 rheumatic patients undergoing BT and including a control group of Rheumatoid Arthritis (RA) patients not using BT. The most common diagnoses were: RA 79.09%, Ankylosing Spondilytis 7.96%, Psoriatic Arthritis 4.40%, Systemic Lupus Erythematosus 3.37%, Juvenile Idiopathic Arthritis 1.17%. A secondary analysis included 1514 cases from the total sample and was performed calculating an incidence rate of any adverse events of 178 × 1000/BT patients per year vs 1009 × 1000/control group patients per year with a 1.6 RR (95% CI 1.4-1.9). For serious adverse events the RR was: 15.4 (95% CI 3.7-63.0, P<.0001). Global BT survival was 80% at 12 months, 61% at 24 months, 52% at 36 months and 45% at 48 months and SMR: 0.23 (95% CI 0.0-49.0) for BT vs 0.00 (95% CI 0.0-0.2) for the control group. In conclusion, BT was associated to a higher infection risk and adverse events, compared to other patients. Mortality using BT was not higher than expected for general population with same gender and age.
Authors:
Lucio Ventura-Ríos; David Bañuelos-Ramírez; María del Carmen Hernández-Quiroz; Manuel Robles-San Román; Fedra Irazoque-Palazuelos; María Victoria Goycochea-Robles
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Publication Detail:
Type:  Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2012-06-04
Journal Detail:
Title:  Reumatología clinica     Volume:  8     ISSN:  1885-1398     ISO Abbreviation:  Reumatol Clin     Publication Date:    2012 Jul-Aug
Date Detail:
Created Date:  2012-07-06     Completed Date:  2012-11-29     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  101293923     Medline TA:  Reumatol Clin     Country:  Spain    
Other Details:
Languages:  eng; spa     Pagination:  189-94     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier España, S.L. All rights reserved.
Affiliation:
Consulta de Reumatología, Hospital Central Sur PEMEX, México DF, México.
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Antibodies, Monoclonal / adverse effects
Antibodies, Monoclonal, Humanized / adverse effects
Antibodies, Monoclonal, Murine-Derived / adverse effects
Antirheumatic Agents / adverse effects*,  therapeutic use
Biological Therapy / adverse effects*,  mortality
Cardiovascular Diseases / epidemiology
Comorbidity
Female
Humans
Immunoglobulin G / adverse effects
Incidence
Infection / epidemiology
Kaplan-Meier Estimate
Lung Diseases / epidemiology
Male
Metabolic Diseases / epidemiology
Mexico
Middle Aged
Neoplasms / epidemiology
Patient Dropouts
Prospective Studies
Receptors, Tumor Necrosis Factor
Registries
Retrospective Studies
Rheumatic Diseases / drug therapy,  mortality
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; 0/Antibodies, Monoclonal, Murine-Derived; 0/Antirheumatic Agents; 0/Immunoglobulin G; 0/Receptors, Tumor Necrosis Factor; 0/infliximab; 0/rituximab; 185243-69-0/TNFR-Fc fusion protein; FYS6T7F842/adalimumab

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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