Maintained improvement in patient-reported outcomes in early axial spondyloarthritis following certolizumab pegol dose reduction: findings from the randomised period of a phase 3b trial.

BACKGROUND

In the phase 3b C-OPTIMISE study (ClinicalTrials.gov, NCT02505542), approximately 80% of patients with early active axial spondyloarthritis (axSpA) remained flare-free from week (W)48 to W96 with full-dose and reduced-dose certolizumab pegol (CZP) after gaining sustained remission (Axial Spondyloarthritis Disease Activity Score <1.3 at W32/36, and W48; if <1.3 at W32, <2.1 was required at W36, or vice versa). Patient-reported outcomes (PROs) are presented throughout the maintenance period for patients in sustained remission at W48.

METHODS

After open-label CZP through W48, patients were double-blind randomised 1:1:1 to full-dose CZP (200 mg every 2 weeks [Q2W]), reduced-dose CZP (Q4W), or placebo. Prespecified PROs: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI). Post hoc: Patient's Global Assessment of Disease Activity (PtGADA), nocturnal spinal pain (NSP), and Ankylosing Spondylitis Quality of Life (ASQoL).

RESULTS

At W48, 43.9% of patients (323/736) achieved sustained remission. At timepoints from W48 through W96, PRO scores were maintained with full-dose and reduced-dose CZP, vs rapid increases (worsening) with placebo. At W96, least squares mean score change from W48 with full-dose and reduced-dose CZP vs placebo (P < .001) was: BASDAI total 0.56 and 0.78 vs 3.02; BASDAI morning stiffness 0.58 and 0.73 vs 3.56; BASDAI fatigue 0.52 and 0.70 vs 2.12; BASFI 0.32 and 0.46 vs 1.90; PtGADA 0.67 and 0.98 vs 3.65; NSP 0.62 and 0.80 vs 2.60; and ASQoL 0.54 and 0.86 vs 4.28.

CONCLUSIONS

In patients who achieved remission at W48, reduced-dose and full-dose CZP maintained axSpA in remission without impacting PROs through W96.