Background/Purpose:
Several European registries have pooled data of patients (pts) who received Abatacept (ABA) for rheumatoid arthritis (RA) to acquire new knowledge about performance of ABA in clinical care in different settings.
The objective of this study was to analyze potential heterogeneity in pts initiating ABA across different European countries.
Methods:
Methods:
This is a cohort study of 8 longitudinal, observational, national RA registries from different European countries: ARTIS (Sweden), ATTRA (Czech Republic), BIOBADASER (Spain), DANBIO (Denmark), GISEA (Italy), NORDMARDS (Norway), ORA (France), SCQM (Switzerland), which have been described elsewhere. Inclusion criteria for this project were a diagnosis of RA and registered initiation of treatment with ABA. Key demographic variables, disease characteristics at ABA initiation, time on ABA treatment and reasons for discontinuation were collected from all registries and analyzed using descriptive statistics. Crude ABA drug retention was analyzed using Kaplan-Meier curves and log rank test.
Results:
A total of 4041 pts were included, contributing 5980 pt-yrs of follow-up (median 1 year per patient; interquartile range [IQR]: 0.40-2.3). Pts in the different national registries had similar demographic characteristics (Table). More heterogeneity existed for RA disease characteristics: disability (by HAQ ranged from 0.9 (NORDMARDS) to 1.5 (ATTRA)) and disease activity (by DAS28 ranged from mean 4.2(SCQM) to mean 5.7(ATTRA)). The greatest difference across registries existed regarding treatment history prior to ABA initiation: the median number of prior inadequate responses (IR) on conventional DMARDs varied between a median of 1 ([IQR: 1-2], SCQM) and 4 ([IQR: 2-5 or 6], ATTRA, DANBIO); the number of prior IR on Biologics (90%anti-TNF agents) before first ABA initiation also varied between a median of 1 (SCQM) and 3 (DANBIO).
|
Registers (N) |
NORDMARD (52) |
SCQM (506) |
ATTRA (215) |
GISEA (375) |
ORA (1032) |
ARTIS (1019) |
DANBIO (315) |
BIOBADASER (487 + 40) |
|
Follow-up (pt-years) |
49.9 |
332.9 |
340.5 |
476.4 |
1748.5 |
1531.4 |
411.4 |
1089 |
|
Male % |
13.5 |
21.0 |
20.9 |
13.3 |
20.9 |
20.7 |
19.0 |
19.7 |
|
Age (Yr), (Mean±SD) |
51.3±12.6 |
59.0±13.2 |
50.1±12.5 |
56.5±12.8 |
58.1±13.7 |
58.6±12.4 |
56.0±12.5 |
57.1±12.7 |
|
RF % |
59.6 |
71.6 |
70.1 |
73.6 |
71.3 |
– |
84.3 |
87.3 |
|
Anti-CCP % |
48.9 |
63.2 |
74.7 |
81.5 |
69.8 |
– |
59.3 |
_ |
|
Disease Duration (Yr), (Mean±SD) |
14.8±9.7 |
9.5 ±13.2 |
11.2±8.4 |
10.6±8.5 |
15.6±10.1 |
9.6±12.4 |
11.4±9.6 |
13.4±11.2 |
|
Disability (HAQ), (Mean±SD) |
0.9±0.5 |
1.1±0.5 |
1.5±0.5 |
1.4±0.8 |
1.2±0.7 |
1.3 ±0.7 |
1.4 ±0.7 |
_ |
|
DAS28-ESR, (Mean±SD) |
5.4±1.1 |
4.2±1.0 |
5.7±1.1 |
5.0±1.3 |
5.3±1.3 |
5.1±1.4 |
4.9 ±1.2 |
_ |
|
Smoker % |
23.1 |
24.0 |
22.8 |
22.3 |
9.8 |
– |
63.5 |
11.5 |
|
BMI (kg/m2), (Mean±SD) |
24.0±4.1 |
25.9±5.1 |
25.5±4.9 |
25.8±5.0 |
– |
24.8±1.5 |
26.3±5.6 |
_ |
|
CRP (mg/l), (Mean±SD) |
24.2±34.2 |
13.9±16.3 |
25.7±29.3 |
3.9±6.6 |
2.5±3.3 |
19.6±26.5 |
– |
– |
|
ESR (mm/h), (Mean±SD) |
36.4±28.1 |
25.9±20.3 |
38.3±24.3 |
34.4±23.4 |
35.6±27.7 |
30.4±23.0 |
_ |
_ |
|
N° past c. DMARDs, (Median [IQR]) |
3 [2-4] |
1 [0-2] |
4 [2-5] |
2 [2-3] |
3 [2-4] |
1 [1-2] |
4 [3-6] |
_ |
|
N° past Biologics , (Median [IQR]) |
2 [2-3] |
1 [0-2] |
_ |
1 [1-2] |
2 [1-3] |
2 [1-3] |
3[2-4] |
2 [1-4] |
|
ABA drug retention (yrs), (Median [IQR]) |
0.9 |
0.9 |
3.1 |
> 4 |
1.8 |
1.0 |
1.3 |
2.6 |
We found significant differences in drug survival for ABA (p< 0.001; log rank test). The median drug retention ranged from > 4 years in GISEA, to around 1 year in SCQM, NORDMARDs or ARTIS. When examining only drug discontinuation for ineffectiveness the same trends were found (not shown).
Conclusion:
Patient characteristics at ABA initiation varied across European countries, probably reflecting differences in eligibility criteria and prescription patterns. There were also large differences in ABA drug retention, with a trend to shorter ABA maintenance in countries with relatively liberal access to biologics. National differences need to be accounted for when analyzing pooled data from several national registries.
Disclosure:
D. Neto,
None;
A. Finckh,
BMS, Pfizer,
2,
Roche, Abbvie, Pfizer, BMS,
8;
F. Iannone,
BMS, Pfizer, Abbvie, UCB, Merck,
5,
Roche, Actelion, Merck,
2;
E. Loza,
Roche Pharmaceuticals,
5;
E. Lie,
Pfizer, Abbvie, Roche,
5,
BMS, Pfizer, Abbvie, Roche,
8;
P. L. C. Van Riel,
None;
M. L. Hetland,
Roche Pharmaceuticals,
5,
MSD, Pfizer,
8;
K. Pavelka,
Roche, BMS, Pfizer, MSD, AbbVie,
8;
J. E. Gottenberg,
Pfizer, Roche,
2,
Abbvie, BMS,MSD, Pfizer, Roche,
5;
X. Mariette,
Pfizer, Roche,
2,
BMD, GSK, LFB, Pfizer, Roche,
5;
C. Turesson,
Abbvie, Pfizer, Roche,
2,
Abbvie, BMS, Janssen, MSD, Pfizer, Roche, UCB,
5.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/differences-in-abatacept-use-in-rheumatoid-arthritis-patients-across-europe-a-pan-european-database-analysis-of-abatacept-in-european-ra-registries/