PMID- 23099285
OWN - NLM
STAT- MEDLINE
DCOM- 20131219
LR  - 20151119
IS  - 1885-1398 (Electronic)
IS  - 1699-258X (Linking)
VI  - 9
IP  - 2
DP  - 2013 Mar-Apr
TI  - Safety profile of biological intravenous therapy in a rheumatoid arthritis 
      patients cohort. Clinical nursing monitoring (Sebiol study).
PG  - 80-4
LID - S1699-258X(12)00163-5 [pii]
LID - 10.1016/j.reuma.2012.06.001 [doi]
AB  - INTRODUCTION: 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. OBJECTIVES: To confirm the safety profile of biological 
      therapies in routine clinical practice, after the administration of intravenous 
      drugs and 24 hours post-administration. MATERIAL AND 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.
CI  - Copyright (c) 2012 Elsevier Espana, S.L. All rights reserved.
FAU - Corominas, Hector
AU  - Corominas H
AD  - Servicio de Reumatologia, Hospital Moises Broggi, Sant Joan Despi, Hospital 
      General de L'Hospitalet, Barcelona, Espana. vancor@yahoo.com
FAU - Sanchez-Eslava, Lucinda
AU  - Sanchez-Eslava L
FAU - Garcia, Guadalupe
AU  - Garcia G
FAU - Padro, Isabel
AU  - Padro I
FAU - Aimarich, Cristina
AU  - Aimarich C
FAU - Gonzalez, Joana
AU  - Gonzalez J
FAU - Franco, Maria
AU  - Franco M
FAU - Mur, Emilia
AU  - Mur E
FAU - Sanchez, Silvia
AU  - Sanchez S
FAU - Roldan, Gloria
AU  - Roldan G
FAU - Iniesta, Silvia
AU  - Iniesta S
FAU - Sesma, Montse
AU  - Sesma M
FAU - Martin, Josefina
AU  - Martin J
FAU - Rodriguez, Mari Carmen
AU  - Rodriguez MC
FAU - Capellan, Maria Rosa
AU  - Capellan MR
FAU - Gosalvez, Coral
AU  - Gosalvez C
FAU - Garcia-Diaz, Silvia
AU  - Garcia-Diaz S
FAU - Saez, Encarnacion
AU  - Saez E
FAU - Luna, Yolanda
AU  - Luna Y
FAU - Plana, Pilar
AU  - Plana P
LA  - eng
LA  - spa
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20121024
PL  - Spain
TA  - Reumatol Clin
JT  - Reumatologia clinica
JID - 101293923
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Murine-Derived)
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Immunoconjugates)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - 7D0YB67S97 (Abatacept)
RN  - B72HH48FLU (Infliximab)
SB  - IM
MH  - Abatacept
MH  - Adult
MH  - Aged
MH  - Antibodies, Monoclonal/*adverse effects/therapeutic use
MH  - Antibodies, Monoclonal, Murine-Derived/*adverse effects/therapeutic use
MH  - Antirheumatic Agents/*adverse effects/therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy/nursing
MH  - Cohort Studies
MH  - Cross-Sectional Studies
MH  - Drug Monitoring
MH  - Female
MH  - Humans
MH  - Immunoconjugates/*adverse effects/therapeutic use
MH  - Infliximab
MH  - Infusions, Intravenous
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - Rituximab
MH  - Treatment Outcome
EDAT- 2012/10/27 06:00
MHDA- 2013/12/20 06:00
CRDT- 2012/10/27 06:00
PHST- 2012/03/17 00:00 [received]
PHST- 2012/06/04 00:00 [revised]
PHST- 2012/06/05 00:00 [accepted]
PHST- 2012/10/27 06:00 [entrez]
PHST- 2012/10/27 06:00 [pubmed]
PHST- 2013/12/20 06:00 [medline]
AID - S1699-258X(12)00163-5 [pii]
AID - 10.1016/j.reuma.2012.06.001 [doi]
PST - ppublish
SO  - Reumatol Clin. 2013 Mar-Apr;9(2):80-4. doi: 10.1016/j.reuma.2012.06.001. Epub 
      2012 Oct 24.