FRI0391 NETAKIMAB IMPROVES PATIENT-RELATED OUTCOMES IN PATIENTS WITH RADIOLOGICAL AXIAL SPONDYLOARTHRITIS: RESULTS FROM RANDOMISED PHASE 3 TRIAL (ASTERA)

Abstract

Background: Chronic pain, stiffness, fatigue and limited spinal mobility significantly affect quality of life (QoL) in patients (pts) with axial spondylarthritis (axSpA). There is increasing evidence that IL‐17 blockade is highly effective in this pts' population and show benefits in terms of multiple patient‐reported outcomes (PROs) in both non‐radiological (nr) and radiological (r) axSpA. Objectives: To evaluate early effects of netakimab (NTK) on PROs in pts with active r‐axSpA, based on data of 16‐week observation from ongoing phase 3 ASTERA study (NCT03447704). Methods: ASTERA is a phase 3 international double‐blind placebo(PBO)‐controlled clinical study. After completion of screening 228 eligible adult pts with r‐axSpA (mNew York criteria, 1984), which remained active (BASDAI > 4.0) despite the standard non‐steroidal anti‐inflammatory drugs (NSAIDs), were randomly assigned (1:1) to receive 120 mg NTK or placebo (PBO) at Week (Wk) 0, 1, 2 and then q2wk through Wk 16. After Wk 16 all patients will continue/be switched to receive NTK up to week 52. PROs were total back pain (10‐item numerical range scale), BASDAI, BASFI. Work productivity and QoL were also assessed by Work Productivity and Activity Impairment (WPAI) and 36‐item Short Form Health Survey (SF‐36), respectively. Results: Baseline characteristics were similar between treatment arms. The mean age at baseline was 39.14±9.99 years, 75.88% of patients were male and the mean symptoms duration was 4.3±4.48 years. All patients had active (mean BASDAI: 6.21±1.55) r‐axSpA, 76.8% of patients were naïve to any biological treatment. Mean total back pain score at baseline was 6.7±1.6 in NTK group and 6.8±1.5 in PBO arm. At Wk1 the difference in total back pain score between study arms became statistically significant (Figure 1). At Wk 16 use of NTK was associated with statistically significant improvements from baseline in BASDAI (‐2.8 vs 0.2, p<0.0001), BASFI (‐0.9 vs 0.9, p<0.0001) and physical component of SF36 (6.3 vs.‐2.6, p<0.0001) (Figure 2). WPAI response in NTK arm was significantly better at Wk 16, as compared with PBO (Table 1). Conclusion: NTK in treatment of patients with r‐axSpA showed rapid mprovement in PRO, WP and QoL and was accompanied with improvement in physical function and disease activity.