Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis.
Ann Rheum Dis
; 76(2): 414-417, 2017 Feb.
Article
en En
| MEDLINE
| ID: mdl-27338778
ABSTRACT
BACKGROUND:
Adalimumab has been used in patients with moderately to severely active rheumatoid arthritis (RA) for over 10â years and has a well-established safety profile across multiple indications.OBJECTIVE:
To update adverse events (AEs) of special interest from global adalimumab clinical trials in patients with RA.METHODS:
This analysis includes 15â 132 patients exposed to adalimumab in global RA clinical trials. AEs of interest included overall infections, laboratory abnormalities and AEs associated with influenza vaccination. Pregnancy outcome data were collected from the Adalimumab Pregnancy Registry.RESULTS:
Serious infections and tuberculosis occurred at a rate of 4.7 and 0.3 events/100 patient-years, respectively. Two patients experienced hepatitis B reactivation. No significant laboratory abnormalities were reported with adalimumab-plus-methotrexate compared with placebo-plus-methotrexate. Influenza-related AEs occurred in 5% of vaccinated patients compared with 14% of patients not vaccinated during the study. Relative risk of major birth defects and spontaneous abortions in adalimumab-exposed women were similar between that of unexposed women with RA and healthy women.CONCLUSIONS:
This analysis confirms and expands the known safety profile of adalimumab and reports no additional safety risk of laboratory abnormalities, hepatitis B reactivation and pregnancy outcomes, including spontaneous abortions and birth defects. The benefits of influenza vaccination are reinforced. TRIAL REGISTRATION NUMBERS NCT00195663, NCT00195702, NCT00448383, NCT00049751, NCT00234845, NCT00650390, NCT00235859, NCT00647920, NCT00649545, NCT00647491, NCT00649922, NCT00538902, NCT00420927, NCT00870467, NCT00650156, NCT00647270, NCT01185288, NCT01185301.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Artritis Reumatoide
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Anomalías Congénitas
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Tuberculosis
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Aborto Espontáneo
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Antirreumáticos
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Gripe Humana
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Adalimumab
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Hepatitis B
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Incidence_studies
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Prognostic_studies
Límite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
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Pregnancy
Idioma:
En
Revista:
Ann Rheum Dis
Año:
2017
Tipo del documento:
Article
País de afiliación:
Alemania