Background/Purpose
The aim of this registry is to determine: (1) the real-life use of various biological targeted treatments in Takayasu arteritis (TA) in France; (2) to compare the efficacy of different biologics among them; (3) to evaluate the tolerance.
Methods
French practionners from the departments of internal medicine, of vascular medicine and rheumatology were contacted to declare the patients with TA under biologics. Complete response was defined as the NIH<2 with prednisone<10 mg/day, the partial response as NIH and prednisone decrease at least at 50%.
Results
Forty eight patients with TA (age 42 years [20-55], 38 women) were included with 74 treatment lines including various biologics. The biologics were mostly used in second-line (n=21; 29%) and third-line regimen (n=27; 37%) for steroid dependence, non-response or relapses. At the initiation of the biologics, the vascular symptoms were present in 39 (67%) cases, constitutional signs in 25 (46%), with radiological activity in 37 (64%) of cases. NIH was ≥2 in 62 (93%) cases.
Among the biologics, most of the patients were treated by infliximab (59%), and etanercept (8%), adalimumab (8%), tocilizumab (19%), anakinra (3%) and rituximab (3%). The biologics duration was 1.8±1.1 year, with the mean follow-up of 3±1.5 years. A complete/partial response to biologics was shown in 15 (39%) and 17 (44%) of patients at 3 months, and 23 (62%) and 4 (11%) at 6 months, whereas a non-response was noted in 7 (18%) and 10 (27%), respectively. During the follow-up, NIH, C-reactive protein levels and prednisone amount significantly decreased (p<0.001). Only 58% of patients were still under steroids at 3 years versus 82% before biologics.
The comparison of patients treated with TNFa antagonists (n=55) to patients with tocilizumab (n=14) showed that the number of partial/complete responses was similar at 3 and 6 months, as were the NIH scale and the associated immunosuppressive agents.
Six infusion related reactions were noted (infliximab in 5 cases and tocilizumab in one), one EBV reactivation (infliximab) and 5 severe infections (3 with infliximab, one with etanercept and tocilizumab, respectively). One patient under tocilizumab experienced severe neutropenia (<500/mm3), but without any infection or antibiotics needs in relation with tocilizumab. Two neoplasms occurred during the biologics treatment, one lung cancer (infliximab) and one breast cancer (tocilizumab).
Conclusion
This is the first nationwide registry of TA treated by biologics which show an overall response rate to biologics, with similar response rates between TNFa antagonists and tocilizumab.
|
|
Before Biologics N=74
|
At 3 months N=42
|
At 6 months N=32
|
At 12 months N=39
|
At 18 months N=31
|
At 3 years N=19
|
|
NIH
|
2.5 [2-3] |
0 [0-1] |
0.5 [0-2] |
0 [0-1] |
0 [0-2] |
1 [1-3] |
|
C reactive protein (mg/l)
|
30 [15-63] |
6.5 [2-17] |
5 [2-18] |
6 [15-21] |
5 [1-22] |
18 [11-25] |
|
Prednisone (n;%)
|
61 (82%) |
37 (88%) |
28 (88%) |
35 (89%) |
26 (84%) |
11 (58%) |
|
Prednisone amount (mg/day)
|
15 [10-24] |
12.5 [7-16] |
10 [7-14] |
7.7 [5-10] |
5 [5-10] |
5 [1-6] |
|
Other immunosupressive agent (n;%)
|
55 (65%) |
35 (83%) |
23 (72%) |
33 (85%) |
10 (32%) |
16 (84%) |
|
Biologics (n;%)
|
74 |
42 (97%) |
31 (97%) |
33 (85%) |
24 (77%) |
13 (68%) |
Disclosure:
A. Mekinian,
None;
C. Comarmond,
None;
M. Resche Regon,
None;
T. Mirault,
None;
J. E. Kahn,
None;
M. Lambert,
None;
J. Sibilia,
None;
A. Neel,
None;
M. Hié,
None;
E. Messas,
None;
P. Cohen,
None;
G. Muller,
None;
S. Berthier,
None;
Z. Amoura,
None;
I. Marie,
Genzyme Corporation,
6;
C. Lavigne,
None;
M. A. Vandenhende,
None;
H. Devilliers,
None;
S. Abad,
None;
L. Guillevin,
None;
M. Hamidou,
None;
B. Godeau,
None;
P. Cacoub,
Astra Zeneca, Bayer, Boehringer Ingelheim, Gilead, Glaxo Smith Kline, Janssen, Merck Sharp Dohme, Roche, Servier, Vifor.,
5;
O. Fain,
None;
D. Saadoun,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/biologics-in-takayasu-arteritis-preliminary-data-from-the-french-registry/