Download biobadasar 2013 horizontal correccion

FRI-0560
Argentinian Register of Biologics Treatments (BIOBADASAR) RESULTS
2.6
Disease
Evolution
12.7 yrs
(range 0-71)
50%
40%
30%
20%
Biologics
PSA
RA
JIA
s
tin
ue
sc
on
s
79,5
tin
ue
0
SLE
AS
Treatment
Survival
20.5
20
COMORBIDITY
Hypertension
Osteoporosis
Diabetes
40
60
Non-biologics
54.5%
n: 822
BIOBADASAR
(n:1508)
treatments: 1909
80
TOTAL
24.9%
17.8%
5.8%
45.5%
n: 686
CONTROL
24.6%
15.4%
5.9%
CASES
25.5%
19.7%
5.7%
DEMOGRAPHIC DATA
79.4% n: 1197
60%
0%
Co
n
Event
Biologic
Serious Adverse 86
Events
28/1000 P/yr
Infection
80%
70%
10%
Di
ADVERSE EVENTS. INCIDENCE AND RELATIVE RISK
Serious
Infection
20.6% n: 311
Diagnosis
PANLAR-SER Iniciative
Argentina, Chile, Brazil,
Uruguay, Paraguay, Peru
Ecuador, Venezuela,
Colombia, Honduras,
Costa Rica, Mexico, Guatemala,
El Salvador, Dominican Republic
Average
Age
54.8 yrs
(Range 1-90)
Pneumonia
Herpes Zoster
Cellulitis
Tuberculosis
Chickenpox
Neoplasms
Control
19
3/1000 P/yr
P<0,05
P<0,05
Adverse Event 42.6%
Inefficacy 34.8%
Pregnancy 1.4%
Unknown 2.1%
Other 19.1%
RATE OF ADVERSE EVENTS
P<0,05
P<0,05
Infections
P<0,05
Skin
Disorders
P<0,05
Infusion site
reactions
P> 0,05
P>0,05
P<0,05
ab
TREATMENT DISCONTINUATION CAUSE
RR– CI (IL;SL)-p-value
6,84
(4,17;11,21)
55
3
27,10
18/1000 P/yr 1/1000 P/yr
(8,67;88,47)
236
55
5,49
78/1000 P/yr 12/1000 P/yr
(4.18;7,19)
40
2
30,22
13/1000 P/yr 0,44/1000 P/yr (7,3;14,95)
14
4
5,29
5/1000 P/yr
1/1000 P/yr
(1,74;16,05)
11
3
5,54
4/1000 P/yr
1/1000 P/yr
(1.54;19,84)
1
4,53
3
1/1000 P/yr
0,2/1000 P/yr
(0,47;43,56)
1
1
1,51
33/1000 P/yr 0,22/1000 P/yr (0,09;24,15)
22
10
3,32
7/1000 P/yr
2/1000 P/yr
(1.57;7,01)
izu
m
TOCILIZUMAB
cil
MONTHS
To
ep
t
16.50
6.5
ab
RITUXIMAB
8.68
xim
MONTHS
9.6
Ri
tu
22.00
ab
MONTHS
ABATACEPT
fli
xim
23.00
22.6
In
INFLIXIMAB
pt
MONTHS
um
25.00
at
ac
e
MONTHS
ADALIMUMAB
Ab
26.00
Ad
al
im
ETANERCEPT
ab
MONTHS
rc
METHODS
All Patients with rheumatic diseases that requires biologic treatment and a control patient, not treated with
biological agents, were included in the database from 31 sites participating along Argentine. Three data areas
were studied: patient features, treatment assigned and adverse events(AE). The BIOBADASER database was
given from the Spanish Society of Rheumatology for our use. Loading data began in August 2010 and closed for
this analysis, in July 2012. The Infostat software was used to stadistic analysis. Incident rates, relative risk
and person/year incidence for adverse events were calculated.
28.00
an
e
Objective:
The objective of this paper is to communicate data from BIOBADASAR, Argentine Registry
of Adverse Events (AE) caused by the use of biological agents in Rheumatology.
50.1
Et
Background
It´s known that LatinAmerican countries
have different prevalence of infectious
diseases and so it´s important to assess
the incidence of adverse events using
biologics to compare in the future with
results from other registries.
SURVIVAL ON BIOLOGICS
(median)
%BIOLOGICAL AGENT USED
V . Saurit 1, M. C. de La Vega 2,*, G. Citera 2, E. Catay 2, A. Quinteros 3, O. Rillo 2, Gi. Gomez 2, C. Gobbi 1, A. Capuccio 2, I. Exeni 1, A. Eimon 2, E. Mussano 1, A. Alvarez 2, D. Dubinsky 2, S. Magri 2, D. Pereira 2, R. Quintana 4, M. de la Sota 2, Gr. Gomez
2, S. Agüero 5, M. Larroude 2, A. Ortiz 4, E. Scheines 2, A. Bertoli 1, G. Seleme 3, M. Apaz 1, F. Risueño 2, C. Battagliotti 1, N. Garrone 3, J. Barreira 2, L. Martinez 2, G. Casado 2 and BIOBADASAR GROUP.
1Sociedad Argentina Reumatología, Córdoba, 2Sociedad Argentina Reumatología, Buenos Aires, 3Sociedad Argentina Reumatología, Tucumán, 4Sociedad Argentina Reumatología, Santa Fé, 5Sociedad Argentina Reumatología, Catamarca, Argentina.
40.19
60%
DISCONTINUATION CAUSES
BY AGENT
ADVERSE EVENT
INEFFICACY
9.61
Severe
16%
49.35%
46.88%
41.41%
8.41
33.77%
Neoplasms
Lab
tests
58%
4.27
34.48%
31.31%
32%
Non Severe
84%
3.70
ADVERSE
EVENTS
Adalimumab Abatacept Etanercept Infliximab
Conclusions: This is the BIOBADASAR report showing the reality of biological treatments in Argentina. The patients of
LatinAmerican countries could show some differences with other countries using the same treatments due to differences in
regional diseases, vaccination or tolerability to pathogen agents. This topics might be studied and reported in the near
future.