Patient survival and safety with biologic therapy. Results of the Mexican National Registry Biobadamex 1.0.
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.
Consulta de Reumatología, Hospital Central Sur PEMEX, México DF, México.
Lucio
L
Ventura-Ríos
David
D
Bañuelos-Ramírez
María del Carmen
Mdel C
Hernández-Quiroz
Manuel
M
Robles-San Román
Fedra
F
Irazoque-Palazuelos
María Victoria
MV
Goycochea-Robles
D000068879:Adalimumab; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001691:Biological Therapy / Q000009:adverse effects* / Q000401:mortality; D002318:Cardiovascular Diseases / Q000453:epidemiology; D015897:Comorbidity; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects; D015994:Incidence; D007239:Infections / Q000453:epidemiology; D000069285:Infliximab; D053208:Kaplan-Meier Estimate; D008171:Lung Diseases / Q000453:epidemiology; D008297:Male; D008659:Metabolic Diseases / Q000453:epidemiology; D008800:Mexico; D008875:Middle Aged; D009369:Neoplasms / Q000453:epidemiology; D010352:Patient Dropouts; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor; D012042:Registries; D012189:Retrospective Studies; D012216:Rheumatic Diseases / Q000188:drug therapy / Q000401:mortality; D000069283:Rituximab
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000069283:Rituximab; D000069285:Infliximab; D000068879:Adalimumab; D000068800:Etanercept