TNF inhibitor efficacy in axial spondyloarthritis varies greatly by sex via BASDAI score
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Key takeaways:
- TNF inhibitor efficacy according to BASDAI score varies significantly between men and women with axial SpA.
- Sex differences between scores could impact judgment of treatment response in practice.
The effectiveness of TNF inhibitors for axial spondyloarthritis varies significantly between men and women based on BASDAI score, but not ASDAS, according to data published in Arthritis Research & Therapy.
After 1 year of treatment, men were more likely to demonstrate effective response according to the Bath Ankylosing Spondylitis Disease Activity Score (BASDAI), while there was no significant difference in response between men and women under the Ankylosing Spondylitis Disease Activity Score (ASDAS).
“Different disease characteristics of [axial SpA] between sexes have been recognized,” Seulkee Lee, MD, PhD, of the Sungkyunkwan University School of Medicine, in Seoul, South Korea, and colleagues wrote. “Various recommendations suggest utilizing disease activity scores, such as the BASDAI or ASDAS, as criteria for [TNF inhibitor] initiation and assessment of treatment efficacy. Despite the differences in reporting of disease activity scores between sexes, the criteria for both males and females remained the same, which could potentially impact the assessment of medication efficacy.”
To examine possible sex differences in disease activity scores — and their potential impacts on whether treatment is deemed effective — Lee and colleagues analyzed data from the prospective, nationwide Korean College of Rheumatology Biologics and Targeted Therapy Registry. The team examined 1,753 adult patients with axial SpA (mean age, 39.69 years; 76.6% male) who started TNF inhibitors at baseline between December 2012 and August 2021, and had at least 1 year of follow-up. Their analysis compared baseline disease activity scores according to BASDAI and ASDAS with scores assessed at 1 year.
“Historically, the BASDAI has been widely used as a clinical measure for assessing disease activity in [axial SpA],” Lee and colleagues wrote. “However, it is a fully patient-oriented metric that is not specific to the inflammatory response, does not reflect the importance of each variable, and does not account for redundancies between variables. The ASDAS was developed more recently than the BASDAI. The ASDAS is expected to be more objective than the BASDAI because it includes inflammatory markers.”
Treatment efficacy under BASDAI was defined as a score reduction of 50% or more, or a reduction of two or more. Meanwhile, ASDAS efficacy was defined as a score reduction of 1.1 or more. Between-sex comparisons were conducted using multivariate linear regression, with positive beta coefficients indicating that men saw greater change in the disease activity measure.
According to the researchers, the analysis demonstrated that BASDAI and PGA changes were independently associated with sex (BASDAI beta coefficient = 0.343; PGA beta coefficient = 0.491), while ASDAS had no significant association with sex (beta coefficient = 0.079). At 1 year, BASDAI was more likely to meet efficacy criteria in men (OR = 1.7; 95% CI, 1.2-2.406), while there was no significant difference for ASDAS (OR = 0.993; 95% CI, 0.678-1.455).
“This study shows that there were differences in changes in disease activity measured by BASDAI and ASDAS between sexes in real-world settings and that these differences may lead to different judgments of treatment response between sexes in practice,” Lee and colleagues wrote. “Disease activity changes before and after [TNF inhibitor] use were significantly different between male and female patients, as measured by the BASDAI, but not by the ASDAS.”
Perspective
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David A. McLain, MD, MACR, FACP, FRCP
The use of disease activity indexes (DAIs) has become standard in rheumatology, facilitated by the widespread adoption of electronic health records and the requirement by pharmacy benefit managers (PBMs) for such measures to approve or recertify medications. However, the influence of sex on the accuracy of these DAIs has been largely overlooked, despite their extensive use in assessing rheumatoid arthritis and axial spondyloarthritis.
The Disease Activity Score with 28 joints (DAS28) using erythrocyte sedimentation rate (ESR), DAS28 using C-reactive protein (DAS28-CRP), the Clinical Disease Activity Index (CDAI), and the Simplified Disease Activity Index (SDAI) are commonly employed and recommended for evaluating RA disease activity. Nevertheless, these indices are susceptible to influences from factors such as sex, age and body mass index.
In various studies, DAS28-ESR has exhibited higher values in female patients compared with males in remission, with the only difference in the index being a higher ESR in females. Moreover, tender joint count, patient global assessment values, and ESR are consistently higher in females compared with males. In DAS28-CRP and SDAI, 28-tender joint count was higher, while CRP was lower in females compared with males. Pain may contribute to these sex differences in composite measures.
Previous studies have shown an independent association of sex with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in axial SpA, while the Ankylosing Spondylitis Disease Activity Score (ASDAS) has not shown such association. Sex differences in patients with axial SpA include distinct disease manifestations, with females experiencing significantly worse disease activity and quality of life, as assessed by BASDAI and the Ankylosing Spondylitis Quality of Life index (ASQoL).
Furthermore, evidence suggests that the response to treatment varies by sex, with female patients exhibiting lower response rates, reduced survival and adherence to treatments such as tumor necrosis factor inhibitors. Among patients with axial SpA and syndesmophytes, males tend to have significantly higher levels of IL-18, whereas females show elevated IL-6 levels.
The relationship between sex and disease manifestations, treatment response, and scoring of disease activity, is an area warranting further investigation.
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