Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Tocilizumab (TCZ) is efficacious in monotherapy and in combination with methotrexate (MTX) or other DMARDs. However, longitudinal data from large registry populations are missing. To examine the effectiveness of TCZ administered alone or in combination with DMARDs in the TOcilizumab Collaboration of European Registries in RA (TOCERRA).
Methods: All RA patients treated with TCZ having a baseline (BL) visit were considered. Patients were assigned to groups: TCZ monotherapy (TCZ), TCZ+MTX, TCZ+MTX+other DMARDs (TCZ+MTX+other), and TCZ+other DMARDs based on BL information. Effectiveness was measured in terms of percentages of patients achieving DAS28 and CDAI remission and according to changes in DAS28 and CDAI at around 6 and 24 months post TCZ start. Groups were compared by time point using Fisher’s exact test or a Kruskal-Wallis test. A covariate-adjusted non-linear mixed effects model with an exponential decrease over time was fitted to the longitudinal DAS28 and CDAI data for patients with complete covariate information, including country, sex, age, disease duration, number of prior biologics, corticosteroid use, seropositivity and use of co-DMARDs.
Results: 1515 RA patients with 1537 treatment courses (TCs) were retrieved. 26% were treated with TCZ, 52% with TCZ+MTX, 9% with TCZ+MTX+other, and 13% with TCZ+other. Group frequencies varied significantly among countries (P=0.0005). For 78% of TCs DMARD co-therapy did not change over time. Median TCZ treatment duration was 0.75 years (IQR: 0.31 – 1.60 years, max: 4.25 years). BL characteristics of patients are described in Table 1. Number of TCs with a value for DAS28 and CDAI were 631 and 470 at 6 and 170 and 148 at 24 months. DAS28 and CDAI remission at 6 and 24 months in the different groups ranged from 47 to 52% and from 62 to 73% for DAS28 and from13 to 21% and from 18 to 30% for CDAI, respectively. Differences were not significant (all P>0.05). In all groups mean DAS28 and CDAI had decreased rapidly (to 2.7-3.0 and 9.8-14.1, respectively) by 6 months and leveled off thereafter, at 2.4-2.5 and 8.2-10.0 by 24 months, respectively (all P>0.05). There was no indication for an effect of DMARD use on the decrease of DAS28 and CDAI from the mixed effects analysis including 7096 and 6050 observations from 1251 and 985 TCs (with comparable percentages of groups as above), respectively (both P>0.05). However, country as well as use of prior biologics (in terms of none, 1, or ³ 2) were found to significantly affect DAS28 and CDAI decrease (all P<0.001).
Conclusion: The results from a large cohort of patients followed longitudinally indicate that TCZ has similar effectiveness when used in monotherapy or in combination with different synthetic DMARDs.
|
All
|
TCZ
|
TCZ+MTX
|
TCZ+MTX+ other (N=143) |
TCZ+other
|
P
|
|
|
Age (yrs), mean ± sd (N)
|
54.7±13.3 (1531) |
57.7±13.8 (391) |
53.9±12.9 (783) |
51.7±13.3 (143) |
55.6±12.2 (193) |
< 0.0001 * |
|
Disease duration (yrs), mean ± sd (N)
|
11.4±9.7 (1453) |
12.9±10.8 (353) |
11.3±9.5 (755) |
8.4±7.5 (136) |
12.3±9.1 (188) |
< 0.0001 * |
|
Female, n/N (%) |
1200/1532 (78.3) |
314/391 (80.3) |
601/784 (76.7) |
112/143 (78.3) |
156/193 (80.8) |
= 0.41 ¤ |
|
Prior bDMARDs use, n (%) 0 1 ³ 2 |
329 (21.5) 355 (23.2) 849 (55.4) |
87 (22.2) 84(21.5) 220 (56.3) |
143 (18.2) 191 (24.3) 451 (57.5) |
45 (31.5) 35 (24.5) 63 (44.1) |
34 (17.6) 45 (23.3) 114 (59.1) |
= 0.01 ¤ |
|
RF positive, n/N (%) |
1035/1340 (77.2) |
270/330 (81.8) |
537/687 (78.2) |
98/129 (76) |
130/173 (75.1) |
= 0.26 ¤ |
|
Anti-CCP positive, n/N (%)
|
420/619 (67.8) |
82/120 (68.3) |
242/362 (66.8) |
48/68 (70.6) |
48/69 (69.6) |
= 0.93 ¤ |
|
RF or anti-CPP positive, n/N (%)
|
1094/1357 (80.6) |
274/334 (82) |
576/697 (82.6) |
108/130 (83.1) |
136/175 (77.7) |
= 0.49 ¤ |
|
Corticosteroid use, n/N (%) |
649/1501 (43.2) |
141/386 (36.5) |
347/781 (44.4) |
70/142 (49.3) |
91/192 (47.4) |
= 0.009 ¤ |
|
DAS28, mean ± sd (N)
|
5.0±1.3 (1441) |
4.8±1.3 (363) |
5.1±1.4 (744) |
5.0±1.3 (134) |
5.0±1.4 (179) |
= 0.0075 * |
|
DAS28-CRP, mean ± sd (N)
|
4.8±1.2 (1415) |
4.6±1.2 (355) |
4.9±1.2 (732) |
4.8±1.1 (133) |
4.7±1.4 (174) |
= 0.03 * |
|
CDAI, mean ± sd (N)
|
29.7±14.4 (980) |
27.2±12.5 (228) |
31.4±15.4 (528) |
27.4±12.4 (104) |
28.7±14.0 (120) |
= 0.0016 * |
|
HAQ, mean ± sd (N)
|
1.4±0.7 (1273) |
1.5±0.7 (299) |
1.4±0.7 (674) |
1.3±0.7 (132) |
1.6±0.8 (168) |
= 0.02 * |
Table 1: Baseline demographic and disease characteristics
Numbers shown represent numbers of treatment courses (TCs). P-values are from Kruskal-Wallis test (*) or Fisher’s exact test (¤)
bDMARDs, biological DMARDs; sd, standard deviation; yrs, years
Disclosure:
C. Gabay,
Roche Pharmaceuticals,
5;
M. Riek,
None;
M. L. Hetland,
Roche Pharmaceuticals,
5,
Merck Pharmaceuticals,
5,
Pfizer Inc,
5;
U. Tarp,
None;
K. Pavelka,
None;
M. Tomsic,
None;
H. Canhao,
None;
K. Chatzidionysiou,
None;
R. F. van Vollenhoven,
Roche Pharmaceuticals,
5;
G. Lukina,
None;
E. Nasonov,
None;
D. C. Nordström,
None;
E. Lie,
None;
I. Ancuta,
None;
E. Loza Santamaria,
None;
P. Van Riel,
None;
T. K. Kvien,
None.
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