Are There Gender Specific Differences in Patient Characteristics at Initiation of Biologic Treatment in Ankylosing Spondylitis and Psoriatic Arthritis?

John Kelsall¹, William Bensen², Wojciech Olszynski³, Niall Jones⁴, Isabelle Fortin⁵, Andrew Chow⁶, Milton Baker⁷, Saeed Shaikh⁸, Denis Choquette⁹, Emmanouil Rampakakis¹⁰, John S. Sampalis¹⁰, May Shawi¹¹, Francois Nantel¹¹, Susan Otawa¹² and Allen J Lehman¹², ¹The Mary Pack Arthritis Centre, Vancouver, BC, Canada, ²St Josephs Hospital and McMaster University, Hamilton, ON, Canada, ³University of Saskatchewan, Saskatoon, SK, Canada, ⁴Dept of Rheumatology, University of Alberta, Edmonton, AB, Canada, ⁵Centre de Rhumatologie de l'Est du Québec, Rimouski, QC, Canada, ⁶McMaster University, Hamilton and Credit Valley Hospital, Mississauga, ON, Canada, ⁷University of Victoria, Victoria, BC, Canada, ⁸McMaster University, Hamilton, ON, Canada, ⁹Rheumatology, Institut de rhumatologie de Montréal (IRM), Montréal, QC, Canada, ¹⁰JSS Medical Research, Montreal, QC, Canada, ¹¹Janssen Inc., Toronto, ON, Canada, ¹²Medical Affairs, Janssen Inc., Toronto, ON, Canada

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: ankylosing spondylitis (AS) and psoriatic arthritis, Biologics

Session Information

Title: Spondyloarthropathies and Psoriatic Arthritis - Clinical Aspects and Treatment II

Session Type: Abstract Submissions (ACR)

Background/Purpose

The prevalence of ankylosing spondylitis (AS) is 2-3 times higher in men compared to women whereas psoriatic arthritis (PsA) is generally considered a disease affecting both genders equally. Recent studies have suggested that clinical differences exist between men and women with the latter experiencing a higher burden of disease (1-4). This analysis examined gender-specific differences with respect to patient and disease parameters at initiation of the first anti-TNF agent (infliximab; IFX) for the treatment of AS and PsA in a Canadian routine clinical practice setting.

Methods

BioTRAC is an ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA) with IFX or golimumab as first biologics or after having been treated with a biologic for <6 months. Patients with AS and PsA treated with IFX who were enrolled between 2005 and 2012 were included in this analysis.

Results

Among the 303 AS patients and 91 PsA patients, 189 (62.4%) and 49 (53.3%) were male, respectively. Mean age and disease duration at initiation of IFX treatment were comparable between genders (Table 1). Overall, disease parameters in AS patients were similar between genders with the exception of CRP which was significantly lower in female patients and HAQ-DI which was significantly higher (Table 1). Among PsA patients, females reported a significantly greater functional disability and showed a higher DAS28 compared to men.

Table 1: Patient Characteristics at Baseline by Gender
Parameter Mean (SD) / %	Male	Female	P-Value
AS	n=189	n=114
Age: years	44.8 (12.2)	46.9 (10.8)	0.142
Disease duration: years	9.9 (10.3)	8.8 (9.4)	0.360
C-Reactive Protein (CRP): mg/L	20.9 (27.4)	14.3 (19.9)	0.044
Patient Global (PtGA): VAS mm	61.4 (26.8)	64.7 (23.4)	0.751
Physician Global (MDGA): NRS 0-10	6.5 (1.9)	6.7 (1.8)	0.635
Morning stiffness: min	73.5 (42.3)	75.2 (38.9)	0.736
HAQ-DI	1.16 (0.56)	1.32 (0.62)	0.018
ASDAS	3.8 (1.0)	3.7 (1.0)	0.238
BASDAI	6.3 (2.0)	6.7 (2.0)	0.101
BASFI	6.1 (2.4)	6.3 (2.3)	0.529
Prior biologic (<6 months)	7.4%	13.2%	0.099
Concomitant DMARD	28.6%	37.7%	0.098
Concomitant NSAID	78.4%	86.0%	0.098
PsA	n=49	n=42
Age: years	48.6 (10.8)	48.9 (8.9)	0.862
Disease duration: years	6.9 (7.4)	6.8 (10.8)	0.980
C-Reactive Protein: mg/L	11.1 (14.4)	15.7 (23.8)	0.342
Patient Global: VAS mm	46.6 (27.0)	55.0 (28.9)	0.168
Physician Global: NRS 0-10	5.6 (2.0)	6.0 (2.3)	0.369
Pain: VAS mm	43.9 (25.6)	49.1 (26.1)	0.355
Morning stiffness: min	61.4 (48.1)	55.2 (42.2)	0.527
HAQ-DI	0.92 (0.58)	1.43 (0.66)	<0.001
TJC28	5.0 (5.0)	6.8 (5.4)	0.105
SJC28	3.9 (4.0)	4.0 (3.6)	0.939
PASI	4.2 (5.6)	2.4 (5.7)	0.188
DAS28	3.8 (1.6)	4.6 (1.5)	0.036
Prior biologic (<6 months)	23.8%	14.3%	0.245
Concomitant DMARD	71.4%	78.6%	0.434
Concomitant corticosteroid	11.9%	4.1%	0.163

Conclusion

Overall, some significant differences in disease parameters were observed between genders in AS and PsA at anti-TNF initiation. Female AS patients experience greater functional impairment compared to men. Female PsA patients, in addition to higher HAQ, also show greater disease activity as measured by DAS28. These results suggest that female patients appear to be receiving their first biologics at a higher level of disease activity. Whether this represents a gender bias in prescribing, or a gender based difference in the acceptance of biologic treatment, requires additional research.

References

1. Lee W et al. Ann Rheum Dis. 2007 May;66(5):633-8.

2. van der Horst-Bruinsma IE et al. Ann Rheum Dis. 2013 Jul;72(7):1221-4.

3. Queiro R et al. Clin Dev Immunol. 2013;2013:482691.

4. Eder L et al. Ann Rheum Dis. 2013 Apr;72(4):578-82.

Disclosure:

J. Kelsall,

Janssen Inc.,

W. Bensen,

Janssen Inc,

W. Olszynski,

Janssen Inc.,

N. Jones,
None;

I. Fortin,

Janssen Inc.,

A. Chow,

Janssen Inc.,

M. Baker,

Janssen Inc.,

S. Shaikh,

Janssen Inc.,

D. Choquette,

Notre-Dame Hospital, Quebec, Canada,

AbbVie,

Amgen,

Celgene,

BMS Canada,

Janssen Pharmaceutica Product, L.P.,

Pfizer Inc,

E. Rampakakis,
None;

J. S. Sampalis,
None;

M. Shawi,

Janssen Inc.,

F. Nantel,

Janssen Inc.,

S. Otawa,

Janssen Inc.,

A. J. Lehman,

Janssen Inc.,

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