Terapia biológica: sobrevida y seguridad en padecimientos reumáticos. Resultados del Registro Nacional Biobadamex 1.0 |
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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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Institution: | 1. Consulta de Reumatología, Hospital Central Sur PEMEX, México DF, México;2. Consulta de Reumatología, Hospital Manuel Avila Camacho IMSS, Puebla, México;3. Departamento de Reumatología, Hospital Especialidades Centro Médico La Raza IMSS, México DF, México;4. Consulta de Reumatología, Centro Médico Toluca, Toluca, Estado de México, México;5. Departamento de Reumatología, Centro Médico Nacional 20 de Noviembre ISSSTE, México DF, México;6. Unidad de Investigación en Epidemiología Clínica, Hospital Regional N.° 1 IMSS, México DF; Unidad de Investigación Colegio Mexicano de Reumatología, México DF, México |
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Abstract: | 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 x 1000/control group patients per year with a 1.6 RR (IC95% 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. 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. |
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