Session Information
Date: Sunday, November 8, 2015
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose:
The prevalence of ankylosing spondylitis (AS) is 2-3 times higher in men compared to women. Recent studies have suggested that clinical differences exist between both genders with women experiencing a higher burden of disease. This analysis examined gender-specific differences with respect to patient and disease parameters at initiation of infliximab (IFX) or golimumab (GLM) for the treatment of AS in a Canadian routine clinical practice setting.
Methods: Biologic Treatment Registry Across Canada (BioTRAC) is an ongoing, prospective registry of patients (pts) initiating treatment for rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis with IFX or GLM. Pts with AS treated with IFX who were enrolled since 2002 or with GLM enrolled since 2010 were included in this analysis. Between group differences were assessed with the Fisher’s Exact test or the independent samples t-test, while linear regression was used to assess the independent association of gender with HAQ-DI, ASDAS, BASDAI, and BASFI improvements at 12 months.
Results:
A total of 539 AS pts were included in this analysis; 188 (34.9%) pts were treated with GLM and 351 (65.1%) with IFX. The majority of pts were male (61.8%). Mean age and disease duration were comparable between genders for both GLM and IFX (Table 1). Overall, disease parameters were similar for GLM with the exception of BASDAI where higher disease severity was observed among females. Among pts treated with IFX, between gender differences were observed for CRP with significantly lower levels in female pts; however BASDAI and HAQ-DI where significantly higher in females compared to males.
|
Table 1: Patient Characteristics at Baseline by Gender |
|||
|
Parameter Mean (SD) / % |
Male |
Female |
P-Value |
|
AS-GLM |
n=115 |
n=73 |
|
|
Age: years |
46.3 (15.2) |
44.4 (11.8) |
0.498 |
|
Disease duration: years |
5.2 (10.0) |
6.0 (10.6) |
0.704 |
|
C-Reactive Protein (CRP): mg/L |
12.6 (15.2) |
17.5 (50.5) |
0.389 |
|
ESR: mm/hr |
18.0 (16.6) |
22.0 (16.2) |
0.152 |
|
Patient Global (PtGA): VAS mm |
52.7 (28.5) |
60.7 (21.2) |
0.058 |
|
Physician Global (MDGA): NRS 0-10 |
5.2 (2.4) |
5.6 (1.9) |
0.172 |
|
Morning stiffness: min |
56.4 (45.2) |
60.1 (47.1) |
0.603 |
|
HAQ-DI |
1.02 (0.62) |
1.08 (0.58) |
0.489 |
|
ASDAS |
3.3 (1.0) |
3.5 (0.8) |
0.126 |
|
BASDAI |
5.6 (2.3) |
6.5 (1.7) |
0.007 |
|
BASFI |
5.2 (2.6) |
5.3 (2.2) |
0.587 |
|
Prior biologic (<6 months) |
6.1% |
2.7% |
0.486 |
|
Concomitant DMARD |
7.0% |
5.5% |
0.769 |
|
Concomitant NSAID |
23.5% |
31.5% |
0.240 |
|
AS-IFX |
n=218 |
n=133 |
|
|
Age: years |
45.1 (12.0) |
47.0 (10.8) |
0.163 |
|
Disease duration: years |
9.6 (10.3) |
8.8 (9.6) |
0.505 |
|
C-Reactive Protein (CRP): mg/L |
19.2 (26.9) |
12.5 (17.6) |
0.012 |
|
ESR: mm/hr |
23.5 (21.3) |
24.5 (20.6) |
0.672 |
|
Patient Global (PtGA): VAS mm |
58.1 (27.0) |
59.2 (28.3) |
0.864 |
|
Physician Global (MDGA): NRS 0-10 |
6.3 (2.1) |
6.3 (2.1) |
0.881 |
|
Morning stiffness: min |
84.5 (115.9) |
87.5 (131.8) |
0.824 |
|
HAQ-DI |
1.11 (0.58) |
1.27 (0.63) |
0.019 |
|
ASDAS |
3.7 (1.0) |
3.6 (1.0) |
0.482 |
|
BASDAI |
6.0 (2.1) |
6.6 (2.1) |
0.013 |
|
BASFI |
5.9 (2.5) |
6.1 (2.5) |
0.458 |
|
Prior biologic (<6 months) |
6.4% |
8.3% |
0.527 |
|
Concomitant DMARD |
26.1% |
24.8% |
0.802 |
|
Concomitant NSAID |
56.4% |
51.9% |
0.440 |
Regression analysis showed that, upon adjusting for baseline levels, female gender (ΔBASDAI=0.603; P=0.035) was associated with increased BASDAI at 12 months of treatment as compare to males. HAQ-DI, ASDAS, and BASFI, on the other hand, at 12 months were comparable between genders.
Conclusion:
Overall, at anti-TNF initiation, female AS pts experience greater disease activity relative to men at initiation of biologic therapy. Whether this represents a gender bias in prescribing, concomitant fibromyalgia, a gender based difference in the acceptance of biologic treatment or disease assessment, requires additional research.
To cite this abstract in AMA style:
Starr M, Zummer M, Choquette D, Haraoui B, Rahman P, Sheriff M, Jones N, Rampakakis E, Psaradellis E, Osborne B, Lehman AJ, Maslova K, Nantel F, Tkaczyk C. Gender Specific Differences in Ankylosing Spondylitis at Treatment Initiation in Patients Treated with Infliximab or Golimumab [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/gender-specific-differences-in-ankylosing-spondylitis-at-treatment-initiation-in-patients-treated-with-infliximab-or-golimumab/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/gender-specific-differences-in-ankylosing-spondylitis-at-treatment-initiation-in-patients-treated-with-infliximab-or-golimumab/