Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Canadian provincial reimbursement policies in regards with infliximab coverage status have evolved in the last decade. The objective of this study was to describe and compare over time the demographics and disease parameters at infliximab treatment initiation and to assess the effectiveness of treatment at 6 and 12 months in Canadian AS patients.
Methods: BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with infliximab or golimumab as first biologics or after having been treated with a biologic for less than six months. People with AS treated with infliximab who were enrolled between 2002 and 2013 were included in this analysis (N=303) and stratified to two groups (2005-2007: n=135; 2008-2013: n=168) based on the year of enrolment in the registry.
Results: Table 1 summarizes the patient characteristics at infliximab initiation by period of enrolment in BioTRAC. Patient demographics were comparable in the two cohorts with a mean (SD) age of 45.72 (11.74) years and the majority being males (62.4%). A significant change in the geographic distribution of patients enrolled in the BioTRAC registry was observed (P=0.001) and more patients with provincial coverage were enrolled in 2008-2013 compared to 2005-2007 (P=0.012). A trend towards earlier initiation of infliximab was observed in more recent years as indicated by the shorter disease duration (11.12 vs. 8.24 years; P=0.013) and the lower number of prior traditional DMARDs used (0.83 vs. 0.59; P=0.078). Furthermore, overall, patients recruited in 2008-2013 had lower disease activity compared to those enrolled in 2005-2007. ESR (29.96 vs. 19.91 mm/hr; P<0.001), physician global assessment (MDGA; 6.99 vs. 6.26; P=0.001) were significantly lower in the 2008-2013 cohort while a statistical trend was observed in morning stiffness (78.96 vs. 70.11 minutes; P=0.064) and ASDAS (3.90 vs. 3.70; P=0.103).
Treatment for 6 months resulted in a greater proportion of patients in the 2008-2013 cohort achieving inactive disease (ASDAS<1.3) without reaching statistical significance (20.7% vs. 34.9%; P=0.140).
Conclusion: The results of this analysis show that the profile of the AS patient population in the BioTRAC registry has changed over time towards lower disease activity and earlier initiation in the patient management process. These results may reflect differences in patient management over time or may be related to earlier access to care. Irrespective of enrolment period, 6-month treatment with infliximab was effective in reducing disease activity in Canadian AS patients.
Table 1. Demographics and Patient Characteristics at IFX Initiation by Enrolment Period
|
Parameter |
Enrolment Period |
P-Value |
|
|
2005-2007 (N=135) |
2008-2013 (N=168) |
||
|
Age (years), mean (SD) |
45.58 (11.61) |
45.65 (11.89) |
0.958 |
|
Male gender, n (%) |
82 (60.7%) |
107 (63.7%) |
0.634 |
|
Disease duration (years), mean (SD) |
11.12 (10.77) |
8.24 (9.18) |
0.013 |
|
Province |
|
|
|
|
Maritime |
4 (3.0%) |
9 (5.4%) |
0.001 |
|
Quebec |
53 (39.3%) |
53 (31.5%) |
|
|
Ontario |
50 (37.0%) |
96 (57.1%) |
|
|
Manitoba |
3 (2.2%) |
0 (0.0%) |
|
|
Saskatchewan |
2 (1.5%) |
1 (0.6%) |
|
|
Alberta |
3 (2.2%) |
1 (0.6%) |
|
|
British-Colombia |
20 (14.8%) |
8 (4.8%) |
|
|
Coverage |
n=135 |
n=160 |
|
|
Provincial |
38 (28.1%) |
67 (41.9%) |
0.012 |
|
Private |
71 (52.6%) |
70 (43.8%) |
|
|
Provincial and private |
10 (7.4%) |
16 (10.0%) |
|
|
Other |
16 (11.9%) |
7 (4.4%) |
|
|
Infliximab dose (mg/kg), mean (SD) |
4.31 (1.02) |
4.43 (1.19) |
0.372 |
|
Previous use of DMARD, n (%) |
56 (41.5%) |
56 (33.3%) |
0.144 |
|
Number of previous DMARDs, mean (SD) |
0.83 (1.12) |
0.59 (0.86) |
0.078 |
|
Concomitant use of DMARDs, n (%) |
37 (27.4%) |
50 (29.8%) |
0.653 |
|
Morning stiffness (minutes), mean (SD) |
78.96 (38.86) |
70.11 (42.42) |
0.064 |
|
HAQ-DI, mean (SD) |
1.26 (0.58) |
1.19 (0.59) |
0.318 |
|
ESR (mm/hr), mean (SD) |
29.96 (23.07) |
19.91 (18.09) |
<0.001 |
|
CRP (mg/L), mean (SD) |
20.43 (23.85) |
16.68 (25.66) |
0.243 |
|
MDGA (NRS: 0-10), mean (SD) |
6.99 (1.56) |
6.26 (2.05) |
0.001 |
|
ASDAS, mean (SD) |
3.90 (0.87) |
3.70 (1.06) |
0.103 |
|
ASDAS Disease Activity, n (%) |
n=103 |
n=130 |
|
|
Inactive (ASDAS < 1.3) |
0 (0.0%) |
4 (3.1%) |
0.160 |
|
Moderate (1.3 ≤ ASDAS <2.1) |
1 (1.0%) |
3 (2.3 %) |
|
|
High (2.1 ≤ ASDAS ≤ 3.5) |
34 (33.0 %) |
50 (38.5 %) |
|
|
Very High (ASDAS > 3.5) |
68 (66.0%) |
73 (56.2 %) |
|
|
BASDAI, mean (SD) |
6.54 (1.90) |
6.37 (2.16) |
0.490 |
|
BASFI, mean (SD) |
6.30 (2.23) |
6.09 (2.48) |
0.447 |
Disclosure:
D. Choquette,
None;
M. Starr,
None;
M. M. Khraishi,
Hoffman-La Roche Canada, Amgen and Pfizer Canada, and Abbott Canada.,
2;
W. G. Bensen,
None;
S. A. Shaikh,
None;
J. F. Rodrigues,
None;
D. E. Sholter,
None;
M. K. Sheriff,
None;
J. Vaillancourt,
JSS ,
3;
J. S. Sampalis,
None;
A. J. Lehman,
Janssen Canada,
3;
S. M. Otawa,
Janssen Canada,
3;
F. Nantel,
None;
M. Shawi,
Janssen Canada,
3.
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