PMID- 20601654
OWN - NLM
STAT- MEDLINE
DCOM- 20110912
LR  - 20101214
IS  - 1462-0332 (Electronic)
IS  - 1462-0324 (Linking)
VI  - 50
IP  - 1
DP  - 2011 Jan
TI  - Safety and retention rate of off-label uses of TNF antagonists in rheumatic 
      conditions: data from the Spanish registry BIOBADASER 2.0.
PG  - 85-92
LID - 10.1093/rheumatology/keq207 [doi]
AB  - OBJECTIVE: To compare the safety and retention rate of TNF antagonists used in 
      approved indications (AIs) and non-AIs. METHODS: Analysis of the Spanish registry 
      BIOBADASER 2.0 (February 2000 to October 2009). Patients were classified into AIs 
      and off-label uses (OUs), according to the European Medicines Agency approval. 
      Retention rates, incidence rates (IRs) and IR ratios (IRRs) of adverse events 
      (AEs) with 95% CI were compared between uses, by log-rank test, cause-specific 
      Cox regression models and generalized linear models with Poisson's distribution. 
      RESULTS: First treatment with TNF antagonist was available in 5150 patients, of 
      whom 4594 (89%) were AIs (2854 RA, 882 AS and 858 PsA) and 556 (11%) were OUs 
      [437 chronic arthropathies in the spectrum of SpAs (CA) and 119 chronic 
      immune-mediated diseases (CIDs)]. The IR of AE was largest in CID (649 events per 
      1000 patient-years) and lowest in PsA (250 events per 1000 patient-years). The 
      occurrence of AEs was significantly associated with OU [IRR of CA vs RA 1.33 (95% 
      CI 1.19, 1.49); IRR of CID vs RA 1.94 (95% CI 1.62, 2.31). The largest hazard 
      ratio for discontinuation was for CID vs RA (1.33; 95% CI 1.02, 1.71) and 
      especially vs AS (2.18; 95% CI 1.63, 2.90). CONCLUSIONS: OUs of TNF antagonists 
      need a very close ascertainment of risk/benefit. The safety and retention pattern 
      for CID is similar to that for RA and the pattern for CA resembles that of AS. 
      This study shows an additional value of a national registry.
FAU - Carmona, Loreto
AU  - Carmona L
AD  - Research Unit, Spanish Society of Rheumatology, Madrid, Spain.
FAU - Descalzo, Miguel A
AU  - Descalzo MA
FAU - Ruiz-Montesinos, Dolores
AU  - Ruiz-Montesinos D
FAU - Manero-Ruiz, Francisco J
AU  - Manero-Ruiz FJ
FAU - Perez-Pampin, Eva
AU  - Perez-Pampin E
FAU - Gomez-Reino, Juan J
AU  - Gomez-Reino JJ
CN  - BIOBADASER 2.0 Study Group
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100703
PL  - England
TA  - Rheumatology (Oxford)
JT  - Rheumatology (Oxford, England)
JID - 100883501
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Off-Label Use
MH  - Registries
MH  - Rheumatic Diseases/*drug therapy/epidemiology
MH  - Risk Assessment
MH  - Spain/epidemiology
MH  - Statistics as Topic
MH  - Time Factors
MH  - Tumor Necrosis Factor-alpha/adverse effects/*antagonists & inhibitors
FIR - Sellas, Agusti
IR  - Sellas A
FIR - Rodriguez, Basilio
IR  - Rodriguez B
FIR - Barcelo, Mireia
IR  - Barcelo M
FIR - Cebrian, Laura
IR  - Cebrian L
FIR - Montoro, Maria
IR  - Montoro M
FIR - Montesinos, Dolores
IR  - Montesinos D
FIR - Perez-Pampin, Eva
IR  - Perez-Pampin E
FIR - Ortiz, Ana Ma
IR  - Ortiz AM
FIR - Anton, Fred
IR  - Anton F
FIR - Zea, Antonio
IR  - Zea A
FIR - Manero Ruiz, Francisco Javier
IR  - Manero Ruiz FJ
FIR - Beltran, Chesus
IR  - Beltran C
FIR - Ubeda, Eugenio Gimenez
IR  - Ubeda EG
FIR - Zorzo, Fernando Jimenez
IR  - Zorzo FJ
FIR - Marzo, Jesus
IR  - Marzo J
FIR - Pecondon, Angela
IR  - Pecondon A
FIR - Hernandez, Ma Victoria
IR  - Hernandez MV
FIR - Sanmarti, Raimon
IR  - Sanmarti R
FIR - Canete, Juan D
IR  - Canete JD
FIR - Lozano, Carlos Rodriguez
IR  - Lozano CR
FIR - Naranjo, Antonio
IR  - Naranjo A
FIR - Ojeda, Soledad
IR  - Ojeda S
FIR - Hernandez, Felix Francisco
IR  - Hernandez FF
FIR - Erausquin, Celia
IR  - Erausquin C
FIR - Rua, Inigo
IR  - Rua I
FIR - Urena, Inmaculada
IR  - Urena I
FIR - Irigoyen, Maria Victoria
IR  - Irigoyen MV
FIR - Cano, Laura
IR  - Cano L
FIR - Pardo, Rosa Rosello
IR  - Pardo RR
FIR - Galeano, Carlos Vazquez
IR  - Galeano CV
FIR - de Juanes, Alexia
IR  - de Juanes A
FIR - Joven, Beatriz
IR  - Joven B
FIR - Garcia, Javier
IR  - Garcia J
FIR - Calvo, Javier
IR  - Calvo J
FIR - Campos, Cristina
IR  - Campos C
FIR - Borras, Juan Jose Garcia
IR  - Borras JJ
FIR - Negueroles, Rosa
IR  - Negueroles R
FIR - Munoz, Luisa
IR  - Munoz L
FIR - Valero, J L
IR  - Valero JL
FIR - Ybanez, D
IR  - Ybanez D
EDAT- 2010/07/06 06:00
MHDA- 2011/09/13 06:00
CRDT- 2010/07/06 06:00
PHST- 2010/07/06 06:00 [entrez]
PHST- 2010/07/06 06:00 [pubmed]
PHST- 2011/09/13 06:00 [medline]
AID - keq207 [pii]
AID - 10.1093/rheumatology/keq207 [doi]
PST - ppublish
SO  - Rheumatology (Oxford). 2011 Jan;50(1):85-92. doi: 10.1093/rheumatology/keq207. 
      Epub 2010 Jul 3.