Achievement rate and predictive factors of the recommended therapeutical target in patients with axial spondyloarthritis who remain on biological therapy: a prospective cohort study in Spain

Abstract

Objectives: To determine the frequency of sustained remission (R) or low diseas activity (LDA) in patients with axial spondyloarthritis (axSpA) undergoing long-term biological therapy and to analyse predictive factors for achieving these outcomes.

Design: Prospective, observational cohort study.

Setting: Spanish hospital.

Participants: Patients with axSpA who initiated biological treatment between 2003 and 2017.

Intervention: Assessment of demographic and clinical characteristics at the beginning of treatment and disease activity every 6 months up to a maximum of 2 years.

Main outcome measures: Disease activity was measured by Ankylosing Spondylitis Disease Activity Score (ASDAS) and Bath Ankylosing Spondylitis Disease Activity Index and C reactive protein (BASDAI&CRP). Sustained R was defined as ASDAS<1.3 and/or BASDAI <2 and normal CRP while sustained LDA was defined as ASDAS <2.1 and/or BASDAI <4 and normal CRP on at least three consecutive visits.

Results: In total 186 patients (66.1% men and 75.3% with radiographic sacroiliitis) were included. Overall, 76.8% of patients achieved ASDAS R/LDA (R53.2%/LDA23.6%) in at least one visit. Forty per cent (R17.6%/LDA22.4%) of the patients fulfilled the sustained ASDAS R/LDA state, whereas only 30.8% maintained this status (R14.8%/LDA15.9%) according to BASDAI&CRP. In the multivariate analysis, male sex (OR=4.01), younger age at the beginning of biological therapy (OR=0.96) and an HLA*B27 positive status (OR=4.30) were associated with achieving sustained ASDAS R/LDA.

Conclusions: In clinical practice, around one-third of patients on biological disease-modifying antirheumatic drugs achieve a sustained R/LDA status, but these rates drop to less than one in five when targeting remission, preventing the use of the latter as a feasible target. Male sex, HLA*B27 positivity and younger age at the beginning of biological therapy are the main predictors for achieving sustained R/LDA.

Keywords: axial spondyloarthritis; bDMARDs; low-disease activity; remission.

Figure 1

Patient disposition during the 2-year follow-up. axSpA, axial spondyloarthritis; bDMARDs, biological disease-modifying antirheumatic drugs.

Figure 2

Momentary and sustained outcomes (remission and low disease activity). ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CRP, C reactive protein; LDA, low disease activity; REM, remission.

Figure 3

Momentary and sustained outcomes (remission or low disease activity (REM/LDA), as measured by ASDAS-CRP) stratified by gender. *P<0.001; #p<0.05. ASDAS, Ankylosing Spondylitis Disease Activity Score; CRP, C reactive protein.