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Abstract Number: 248

Is the Basdai Score Driven By Pain in Ankylosing Spondylitis Patients Treated with Anti-TNF?

Proton Rahman1, Algis Jovaisas2, William Bensen3, Wojciech Olszynski4, Anna Jaroszynska5, Philip Baer6, Maqbool Sheriff7, Dalton Sholter8, Eliofotisti Psaradellis9, John S. Sampalis9, Francois Nantel10, Allen J Lehman11, Susan Otawa11 and May Shawi10, 1Faculty of Medicine, Memorial University of Newfoundland, St. John's, NF, Canada, 2194 Main Street, University of Ottawa, Ottawa, ON, Canada, 3Division of Rheumatology, McMaster University, Hamilton, ON, Canada, 4University of Saskatchewan, Saskatoon, SK, Canada, 5Private Practice, Burlington, ON, Canada, 6Private Practice, Scarborough, ON, Canada, 7Nanaimo Regional General Hospital, Nanaimo, BC, Canada, 8University of Alberta, Edmonton, AB, Canada, 9JSS Medical Research, Montreal, QC, Canada, 10Janssen Inc., Toronto, ON, Canada, 11Medical Affairs, Janssen Inc., Toronto, ON, Canada

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: Ankylosing spondylitis (AS), anti-TNF therapy, infliximab, pain and registry

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Session Information

Session Title: Pain: Basic and Clinical Aspects

Session Type: Abstract Submissions (ACR)

Background/Purpose The present standard for measuring disease activity in AS is the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) which focuses on five major symptoms including fatigue, axial pain, peripheral pain, enthesitis and morning stiffness (severity and duration). Given that the BASDAI instrument contains two pain questions, the objective was to assess whether pain symptoms are the main drivers of BASDAI scores among AS patients treated with anti-TNFs in routine clinical practice. 

Methods BioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, AS, or PsA with infliximab (IFX) or golimumab (GLM) as first biologics or after having been treated with a biologic for <6 months. Patients with AS treated with IFX or GLM and enrolled between 2005 and 2014 were included in this analysis. A modified weighted BASDAI score (m-BASDAI) was calculated excluding the axial (Q2) and peripheral (Q3) pain questions of the BASDAI. The correlation of BASDAI, each of its components, and the modified BASDAI (m-BASDAI) was assessed with the Pearson correlation coefficient. BASDAI low disease activity (LDA) and m-BASDAI LDA were defined as a score ≤3. The association between the number of administered analgesics (0, 1, >1) and BASDAI/m-BASDAI was assessed with one-way ANOVA. 

Results A total of 413 AS patients with 1,709 assessments were included in this analysis. Correlation analysis showed a strong correlation between the full BASDAI and m-BASDAI scores (r=0.98, P<0.001). With respect to the individual BASDAI questions, a strong positive linear correlation was observed between all questions and the BASDAI score as well as the m-BASDAI score (Table 1). As expected, a lower correlation was observed between Q2 and Q3 with the m-BASDAI relative to BASDAI. Axial pain was most strongly correlated with the severity of morning stiffness, whereas the highest correlation of peripheral pain was observed with localized tenderness. The cross-tabulation of BASDAI LDA and m-BASDAI LDA showed a strong measure of agreement (kappa=0.871, P<0.001). Omission of the pain questions from BASDAI resulted in a comparable proportion of LDA cases (41.7% vs. 40.9%) when using the same LDA definition.

Increased use of analgesics (0 vs. 1 vs. >1) over 2 years of follow-up was associated with significantly (P<0.05) higher mean scores in BASDAI, m-BASDAI, and each of the BASDAI components. No significant association was observed between increased use of analgesics and treatment retention.   

 

Table 1: Correlation between individual BASDAI Questions and BASDAI Outcomes

BASDAI Question

BASDAI*

m-BASDAI*

Q2:Spinal Pain*

Q3: Joint Pain / Swelling*

Q1: Fatigue

0.85

0.88

0.76

0.61

Q2: Spinal pain

0.92

0.87

–

0.68

Q3: Joint pain/ Swelling

0.84

0.75

0.68

–

Q4: Areas of localized tenderness

0.89

0.89

0.76

0.73

Q5: Morning stiffness severity

0.89

0.90

0.82

0.67

Q6: Morning stiffness duration

0.75

0.78

0.64

0.55

P<0.001 for all correlations

 

Conclusion Higher levels of AS pain are significantly associated with a higher BASDAI score and increased use of analgesic medications among patients treated with anti-TNFs.  In addition to pain, fatigue, tenderness, and morning stiffness are likewise important contributing components in the BASDAI score and the disease burden of AS. 


Disclosure:

P. Rahman,

Consulting fees for Abbott, AbbVie, Amgen, BMS, Celgene, Janssen, Novartis, Pfizer and Roche,

5;

A. Jovaisas,

Janssen Inc.,

5;

W. Bensen,

Janssen Inc.,

5;

W. Olszynski,

Janssen Inc.,

5;

A. Jaroszynska,

Janssen Inc.,

5;

P. Baer,

Janssen Inc.,

5;

M. Sheriff,

Janssen Inc.,

5;

D. Sholter,

Janssen Inc.,

5;

E. Psaradellis,
None;

J. S. Sampalis,
None;

F. Nantel,

Janssen Inc.,

3;

A. J. Lehman,

Janssen Inc.,

3;

S. Otawa,

Janssen Inc.,

3;

M. Shawi,

Janssen Inc.,

3.

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