Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
During the last fifteen years, the role of biologics in the management of RA, the number of available biologics, and the recommendations of use, have changed. Moreover, several observational experiences pointed out a suboptimal adherence to the principles of treat-to-target.
The aim of this study is to assess differences in baseline characteristics of patient who started a first line biologic agent over time in a multicentric observational cohort (the LORHEN Registry) from 1999 until today.
Methods
In the LORHEN Registry, we identified all adult RA patients starting a first line biologic agent between 1 January 1999 and 31 May 2014. For the purpose of our analysis, we divided the patients in three time groups, according to the date of assessment of baseline disease variables: from 1999 to 2004 [99-04], from 2005 to 2010 [05-10] and from 2011 to May 2014 [11-14]. The comparison of baseline demographics, disease characteristics and previous treatments with csDMARDs in the 3 subgroups was performed.
Results
A total of 2373 RA patients from eight different rheumatologic centers were included. Patients treated in the [11-14] time group had a statistically significant lower baseline DAS28 and HAQ compared with previous time group. DAS28 at first switch was significantly lower in [11-14] patients, shrinking to mean values of moderate disease activity from those of high disease activity observed for patients in the [05-11] group. Disease duration and time before first switch did not differed significantly between groups.
Conclusion
The disease activity status at which RA patient starts biological treatment has progressively reduced: clinicians are now aiming at tighter control of RA activity.
The vast majority of patients starts biologic treatment only after years of csDMARDs, with an established disease, in conflict with the principles of treat-to-target. The incomplete availability of biological drugs over territory and economical concerns, in addition to incomplete adherence to international recommendations, might at least in part explain this occurrence.
The observation that real life population treated with biological drugs significantly differs for duration of disease from those selected in the majority of clinical trials should be taken into account when applying inferences from randomized controlled trials to everyday clinical practice.
|
|
Total |
1999-2004 |
2005-2010 |
p with 1999-2004 |
2011-2014 |
p with 1999-2004 |
p with 2005-2011 |
|
Patients, num |
2373 |
837 |
997 |
|
539 |
|
|
|
Female, num (%) |
1942 (80,61%) |
697 (79,84%) |
813 (80,15%) |
|
432 (80,15%) |
|
|
|
Age in years, mean (±sd) |
54,32 (±13,54) |
54,81 (±13,48) |
53,181 (±13,70) |
ns * |
55,68 (13,19) |
ns * |
ns * |
|
Disease duration in year, median (IQR) |
5,06 (1,74 – 11,85) |
5,83 (1,26 – 12,61) |
5,03 (1,83 – 11,14) |
ns • |
4,74 (1,96 – 10,95) |
ns • |
ns • |
|
Previous csDMARDs, median (IQR) |
2 (2 – 3) |
3 (2 – 4) |
2 (1 – 3) |
<0,05 • |
2 (1 – 3) |
<0,05 • |
ns • |
|
DAS28, mean (±sd) |
5,59 (±1,25) |
5,93 (±1,04) |
5,26 (±1,27) |
<0,05 • |
5,07 (±1,28) |
<0,05 • |
<0,05 • |
|
HAQ, median (IQR) |
1,25 (0,875 – 1,875) |
1,375 (1,000 – 2,000) |
1,25 (0,875 – 1,625) |
<0,05 • |
1,125 (0,625 – 1,625) |
<0,05 • |
<0,05 • |
Table 1. Patients at baseline. IQR: interquartile range. *Student’ T test. • Wilcoxon-Mann-Whitney’ test
|
|
Total |
2005-2010 |
2011-2014 |
p |
|
Patients, num |
626 |
394 |
232 |
|
|
Months before first bDMARD discontinuation, mean (±sd) |
28,77 (±28,69) |
26,90 (±24,70) |
31,94 (±34,25) |
ns • |
|
DAS28, mean (±sd) |
4,97 (±0,70) |
5,15 (±1,30) |
4,68 (±1,34) |
<0,05 • |
|
HAQ, median (IQR) |
1,125 (0,625 – 1,625) |
1,250 (0,750 – 1,750) |
1,125 (0,625 – 1,500) |
ns • |
Table 2. Disease variables at first switch. IQR: interquartile range. *Student’ T test. • Wilcoxon-Mann-Whitney’ test
Disclosure:
V. Grosso,
None;
R. Gorla,
None;
P. Sarzi-Puttini,
None;
F. Atzeni,
None;
R. Pellerito,
None;
E. Fusaro,
None;
G. Paolazzi,
None;
P. A. Rocchetta,
None;
E. G. Favalli,
None;
A. Marchesoni,
None;
R. Caporali,
None.
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