Session Information
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: GiACTA study is a randomized, phase III controlled clinical trial of tocilizumab (TCZ) in giant cell arteritis (GCA) (1,2). Our aim was to compare GiACTA trial data from those of a national multicenter series of patients with GCA from the clinical practice, focusing on the baseline characteristics of the patients.
Methods: Differences between the GiACTA study and clinical practice series were assessed. In the latter, the diagnosis of GCA was established by the ACR-1990 criteria and in the GiACTA trial by the ACR modified criteria. In the clinical practice study TCZ was used at standard IV dose (8 mg/kg/month) while in the GiACTA trial it was given subcutaneously (162 mg every 1 or 2 weeks). Quantitative variables were expressed as mean±SD and they were compared by the Student’s t-test. Dichotomous variables were expressed as percentages and compared using the chi-square test.
Results: At TCZ onset, in the clinical practice series there were a significantly greater (TABLE): a) duration of GCA, b) polymyalgia rheumatica frequency, c) ESR, and d) previous conventional immunosuppressants (mainly MTX). There was also a non-statistically significant lower sustained remission. The mean dose of prednisone at the TCZ onset was lower in patients from the clinical practice. In comparing only GiACTA patients with relapsing-GCA versus those of the clinical practice these differences remained unchanged, except for the GCA duration. PET/CT was performed more frequently in the series of the clinical practice.
Conclusion: Patients receiving TCZ in the clinical practice study have several baseline clinical and laboratory differences when compared to those included in the GiACTA trial.
TABLE
|
GiACTA overall (n= 251) |
GiACTA (only relapsing-GCA; n=132) |
Clinical Practice (n= 49) |
GiACTA (overall) vs Clinical Practice p |
GiACTA (relapsing) vs Clinical Practice p |
|
|
Women / men |
188/63 |
99/33 |
39/10 |
0.60 |
0.65 |
|
Age, mean (SD) |
69 (8.2) |
69.1 (8) |
73 (9) |
0.002 |
0.005 |
|
Inclusion criteria |
ACR 1990 modified |
ACR 1990 modified |
ACR 1990 |
||
|
Newly diagnosed GCA/ recurrent GCA |
119/132 |
0/132 |
0/49 |
<0.0001 |
<0.0001 |
|
Time (months) from GCA diagnosis, mean (SD) |
9.1 (16.8) |
16.9 (20.3) |
26.4 (30.9) |
0.0004 |
0.05 |
|
Signs/symptoms of GCA at TCZ onset# |
98 (39) |
59 (44.7) |
31 (63.3) |
0.003 |
0.04 |
|
PMR, n (%) |
49 (19.5) |
40 (30.3) |
31 (63.3) |
<0.0001 |
0.0001 |
|
Unilateral blindness, n (%) |
4 (1.6) |
4 (3) |
1 (4.5) |
0.69 |
0.88 |
|
Bilateral blindness, n (%) |
1 (0.4) |
1 (0.8) |
1 (4.5) |
0.74 |
0.95 |
|
Amaurosis fugax, n (%) |
2 (0.8) |
1 (0.8) |
1 (2.0) |
0.98 |
0.95 |
|
Blurred vision, n (%) |
14 (5.6) |
10 (7.6) |
0 (0) |
0.19 |
0.11 |
|
ESR, mean (SD) |
24 (19.4); n= 246 |
26.8 (19.6) |
44.3 (33.8) |
0.0002 |
0.001 |
|
CRP, mean (SD) |
7.5 (13.4); n= 250 |
8.4 (15.4) |
4.2 (6.8) |
0.01 |
0.01 |
|
Positive TAB, n (%) |
156 (62.1) |
82 (62.1) |
32 (65.3) |
0.78 |
0.82 |
|
Imaging techniques, n (%) |
138 (55) |
70 (53) |
29 (59.2) |
0.70 |
0.57 |
|
Positive MRA, n (%) |
8 (3.2) |
4 (3) |
3 (6.1) |
0.56 |
0.60 |
|
Positive CT scan, n (%) |
13 (5.2) |
7 (5.3) |
1 (2.0) |
0.98 |
0.59 |
|
Positive PET/CT scan, n (%) |
97 (38.7) |
42 (31.8) |
26 (53.1) |
0.08 |
0.01 |
|
Patients on corticosteroids at study onset, n (%) |
251 (100) |
132 (100) |
48 (98.0) |
0.36 |
0.60 |
|
Dosage of prednisone at TCZ onset, mean (SD) |
recent GCA: 40 (13.1) relapsing GCA: 30.2(12) |
30.2 (12) |
22.8 (17.6) |
<0.0001 |
0.008 |
|
Patients who had received traditional immunosuppressant agents, n (%) |
27 (10.8) |
23 (17) |
43 (87.7) |
<0.0001 |
<0.0001 |
|
Patients who had received biologic therapy, n (%) |
– |
– |
2 (4.1) |
||
|
TCZ route |
SC |
SC |
IV |
||
|
Sustained remission, n (%) § |
82 (54.6) |
– |
19 (38.8) |
0.51 |
|
|
Severe infection, n (%)§ |
9/150 (6) |
– |
5 (10.2) |
0.49 |
# includes localized headache, TA, or scalp tenderness, jaw claudication, new or worsened extremity claudication.
§ In RCT patients with active TCZ therapy were only considered
*p<0.05
References:
1.- Stone J et al. Arthritis Rheumatol.2016; 68 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-tocilizumab-in-patients-with-giant-cell-arteritis-primary-and-secondary-outcomes-from-a-phase-3-randomized-double-blind-placebo-controlled-trial/.
2.- Tuckwell K et al. Semin Arthritis Rheum. 2016 Nov 15. pii: S0049-0172(16)30275-X
To cite this abstract in AMA style:
Vegas-Revenga N, Loricera J, Mera A, Pérez- Pampín E, Castañeda S, Domínguez-Casas LC, Martín-Varillas JL, Atienza-Mateo B, Gonzalez-Vela M, Hernández JL, González-Gay MA, Blanco R. Comparison between Giacta Trial and a Multicenter Series of Giant Cell Arteritis Patients from Clinical Practice with Tocilizumab [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/comparison-between-giacta-trial-and-a-multicenter-series-of-giant-cell-arteritis-patients-from-clinical-practice-with-tocilizumab/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-between-giacta-trial-and-a-multicenter-series-of-giant-cell-arteritis-patients-from-clinical-practice-with-tocilizumab/