Abstract

<b>Introduction:</b> Diagnostic guidelines recommend that patients with suspected IPF undergo AAb testing during initial evaluation; however, the clinical implications of elevated AAbs are unknown. <b>Aims and Objectives:</b> To assess clinical characteristics and outcomes in placebo-treated patients with IPF in ASCEND (NCT01366209) by AAb status. <b>Methods:</b> Baseline characteristics were assessed in three groups: 1) antinuclear antibody+ (ANA+) high; 2) rheumatoid factor+ (RF+) and/or anti-cyclic citrullinated peptide+ (CCP+); and 3) AAb–. Categorical forced vital capacity (FVC) decline and progression-free survival (PFS; first occurrence of death, ≥10% decline from baseline in %FVC or ≥50m decline from baseline in 6-minute walk distance) over 52 weeks were compared in ANA+ high vs AAb– patients. <b>Results:</b> In total, 34 (12.3%) patients were ANA+ high, 27 (9.7%) were RF+ and/or CCP+, and 143 (51.6%) were AAb–. Baseline characteristics are in the Table. A higher proportion of ANA+ high vs AAb– patients had a decline of ≥10% in %FVC or death at Week 52 (55.9% [n=19/34] vs 42.0% [n=60/143]). The PFS hazard ratio (95% confidence interval) for ANA+ high vs AAb– was 1.22 (0.69, 2.17). <b>Conclusions:</b> Some baseline characteristics differed between groups. Patients with IPF who are ANA+ high may have worse outcomes vs AAb– patients. Further research is required due to this small sample size.

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