title: Safety profile of biological intravenous therapy in a rheumatoid arthritis patients cohort. Clinical nursing monitoring (Sebiol study).
abstract: BACKGROUND
  The Biologics used in the management of rheumatoid arthritis (RA) in recent years, have comprehensively permitted to understand its security, as shown in registries such as BIOBADASER. The present manuscript represents an observational cohort study to describe the safety perinfusional profile of those intravenous treatments.
  
  
  OBJECTIVE
  To confirm the safety profile of biological therapies in routine clinical practice, after the administration of intravenous drugs and 24 hours post-administration.
  
  
  METHODS
  We evaluated a cross-sectional cohort of 114 patients with RA (according to the American College of Rheumatology ACR criteria), attending within one month in 2009 the nursing clinics of day care hospital of 12 Catalonian hospitals. All patients were treated with intravenous biological agents. We recorded the age, sex, current and previous drug treatments, we also collected data about previous vaccination and premedication received and any adverse event occurring at the time of drug administration or within 24 hours. If an adverse event occurred, was categorized by MedDRAv11.0 International Dictionary, and categorized in terms of intensity (mild, moderate, severe), relationship to drug administration according to Karch and Lasagna algorithm (unrelated, unlikely, possible, probable, definite) and the further measures taken.
  
  
  RESULTS
  111 patients met the inclusion criteria, with a mean age of 56.06 years (SD: 12.12), 90 of them women (81.1%) and mean time since diagnosis of the disease of 11.97 years (SD: 7.95). 24 patients (21.6%) had a history of allergy. 12 adverse events were observed in 7 patients, 9 of which at the time of administration and 3 in 24 hours after. There were no serious adverse events and only one of the adverse events (AEs) was rated as moderate (urticaria). The remaining AA were mild.
authors.affiliation: Servicio de Reumatología, Hospital Moisès Broggi, Sant Joan Despí, Hospital General de L'Hospitalet, Barcelona, España. vancor@yahoo.com
authors.forename: Hèctor
authors.initials: H
authors.lastname: Corominas
authors.forename: Lucinda
authors.initials: L
authors.lastname: Sánchez-Eslava
authors.forename: Guadalupe
authors.initials: G
authors.lastname: García
authors.forename: Isabel
authors.initials: I
authors.lastname: Padró
authors.forename: Cristina
authors.initials: C
authors.lastname: Aimarich
authors.forename: Joana
authors.initials: J
authors.lastname: Gonzàlez
authors.forename: Maria
authors.initials: M
authors.lastname: Franco
authors.forename: Emilia
authors.initials: E
authors.lastname: Mur
authors.forename: Silvia
authors.initials: S
authors.lastname: Sanchez
authors.forename: Glòria
authors.initials: G
authors.lastname: Roldán
authors.forename: Silvia
authors.initials: S
authors.lastname: Iniesta
authors.forename: Montse
authors.initials: M
authors.lastname: Sesma
authors.forename: Josefina
authors.initials: J
authors.lastname: Martín
authors.forename: Mari Carmen
authors.initials: MC
authors.lastname: Rodriguez
authors.forename: Maria Rosa
authors.initials: MR
authors.lastname: Capellan
authors.forename: Coral
authors.initials: C
authors.lastname: Gosálvez
authors.forename: Silvia
authors.initials: S
authors.lastname: Garcia-Diaz
authors.forename: Encarnación
authors.initials: E
authors.lastname: Sáez
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Luna
authors.forename: Pilar
authors.initials: P
authors.lastname: Plana
mesh_terms: D000069594:Abatacept; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects* / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000451:nursing; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D018796:Immunoconjugates / Q000009:adverse effects* / Q000627:therapeutic use; D000069285:Infliximab; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D018796:Immunoconjugates; D000069283:Rituximab; D000069594:Abatacept; D000069285:Infliximab