Volume 74, October 2025, 152777Author links open overlay panel, , , , , , , , , , , AbstractObjective

To test the discriminating capacity of different thresholds of the Assessment of SpondyloArthritis international Society Health Index (ASAS HI) in placebo-controlled trials of patients with axial spondyloarthritis (axSpA), including radiographic (r-axSpA) and non-radiographic (nr-axSpA) subtypes.

Methods

The discriminating capacities of absolute (≥2.0–≥4.0 points) and relative (≥20%–≥50%) ASAS HI improvement thresholds were evaluated in patients with axSpA from three COAST trials (COAST-V, COAST-W, and COAST-X) of ixekizumab every 4 weeks (IXE Q4W) vs. placebo. Threshold-based response rates at Week 16 were compared between trial arms using Fisher’s exact test. Odds ratios and phi coefficients were used to evaluate how strongly each improvement threshold was associated with treatment allocation in a given trial. Missing data were handled using non-responder imputation.

Results

ASAS HI data were available at baseline and Week 16 for 587 patients in IXE Q4W and placebo arms. The ASAS HI ≥30% improvement threshold effectively discriminated treatment allocation in all trials; significant differences were observed between IXE Q4W and placebo in r-axSpA (COAST-V: p = 0.026; COAST-W: p = 0.023) and nr-axSpA (COAST-X: p = 0.040). Lower absolute (≥2.0–≥3.0 points) and relative (≥20%–≥30%) thresholds discriminated effectively in COAST-W, whereas higher absolute (≥3.5–≥4.0 points) and relative (≥30%–≥50%) thresholds discriminated effectively in COAST-V. In COAST-X, ≥30%, ≥40%, and ≥50% thresholds discriminated effectively. Phi coefficients were small (<0.3) across all trials and thresholds.

Conclusions

Several ASAS HI improvement thresholds discriminated axSpA patients in treatment vs. placebo arms at Week 16. The ASAS HI ≥30% improvement threshold discriminated across all three COAST trials.

Graphical abstractDownload: Download high-res image (458KB)Download: Download full-size imageKeywords

Axial spondyloarthritis

Psychometrics

Outcomes assessment

Patient outcome assessment

Patient reported outcome measures

Quality of life

Validation study

Data availabilityhttps://www.vivli.org (Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at .)

© 2025 The Authors. Published by Elsevier Inc.