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Longterm, Real-world Safety of Adalimumab in Rheumatoid Arthritis: Analysis of a Prospective US-based Registry.
Harrold, Leslie R; Griffith, Jenny; Zueger, Patrick; Litman, Heather J; Gershenson, Bernice; Islam, Syed S; Barr, Christine J; Guo, Dianlin; Fay, Jonathan; Greenberg, Jeffrey D.
Afiliación
  • Harrold LR; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA. lharrold@corrona.org.
  • Griffith J; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
  • Zueger P; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
  • Litman HJ; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
  • Gershenson B; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
  • Islam SS; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
  • Barr CJ; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
  • Guo D; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
  • Fay J; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
  • Greenberg JD; From the University of Massachusetts Medical School, Worcester; Corrona LLC, Waltham, Massachusetts; AbbVie, North Chicago, Illinois; New York University School of Medicine, New York, New York, USA.
J Rheumatol ; 47(7): 959-967, 2020 07 01.
Article en En | MEDLINE | ID: mdl-31371657
OBJECTIVE: To assess longterm safety in a US cohort of patients with rheumatoid arthritis (RA) treated with adalimumab (ADA) in real-world clinical care settings. METHODS: This observational study analyzed the longterm incidence of safety outcomes among patients with RA initiating ADA, using data from the Corrona RA registry. Patients were adults (≥ 18 yrs) who initiated ADA treatment between January 2008 and June 2017, and who had at least 1 followup visit. RESULTS: In total, 2798 ADA initiators were available for analysis, with a mean age of 54.5 years, 77% female, and mean disease duration of 8.3 years. Nearly half (48%) were biologic-naive, and 9% were using prednisone ≥ 10 mg at ADA initiation. The incidence rates per 100 person-years for serious infections, congestive heart failure requiring hospitalization, malignancy (excluding nonmelanoma skin cancer), and all-cause mortality were 1.86, 0.15, 0.64, and 0.33, respectively. The incidence of serious infections was higher in the first year of therapy (3.44, 95% CI 2.45-4.84) than in subsequent years, while other measured adverse effects did not vary substantially by duration of exposure. The median time to ADA discontinuation was 11 months, while the median time to first serious infection among those experiencing a serious infection event was 12 months. CONCLUSION: Analysis of longterm data from this prospective real-world registry demonstrated a safety profile consistent with previous studies in patients with RA. This analysis did not identify any new safety signals associated with ADA treatment and provides guidance for physicians prescribing ADA for extended periods.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artritis Reumatoide / Antirreumáticos Tipo de estudio: Guideline / Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Rheumatol Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Canadá
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Artritis Reumatoide / Antirreumáticos Tipo de estudio: Guideline / Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Rheumatol Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Canadá