FRI0391 NETAKIMAB IMPROVES PATIENT-RELATED OUTCOMES IN PATIENTS WITH RADIOLOGICAL AXIAL SPONDYLOARTHRITIS: RESULTS FROM RANDOMISED PHASE 3 TRIAL (ASTERA). (June 2019)

• Record Type: Journal Article
• Authors: Gaydukova, Inna; Mazurov, V; Erdes, Shandor; Dubinina, Tatiana; Nesmeyanova, Olga; Ilivanova, Elena; Kundzer, Alena; Soroka, Nikolaj; Dokukina, Ekaterina; Eremeeva, Anna; Chernyaeva, Ekaterina; Ivanov, Roman
• Is Part Of: Annals of the rheumatic diseases. Volume 78(2019)Supplement 2
• Page Start: 880
• Page End: 881
• Publication Date: 2019-06
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2019-eular.6791
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: chronic pain, stiffness, fatigue and limited spinal mobility significantly affect quality of life (QoL) in patients (pts) with axial spondyloarthritis (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 improvement in PRO, WP and QoL and was accompanied with improvement in physical function and disease activity. Disclosure of Interests: Inna Gaydukova Grant/research support from: JSC BIOCAD, Speakers bureau: paiment from Pfizer, Novartis, Abbvie, Biocad, Selgene, MSD, Sanofy does not exceed 10 000 euros, V Mazurov Grant/research support from: JSC BIOCAD, Shandor Erdes Grant/research support from: JSC BIOCAD, Speakers bureau: JSC BIOCAD, Tatiana Dubinina: None declared, Olga Nesmeyanova Grant/research support from: JSC BIOCAD, Elena Ilivanova Grant/research support from: JSC BIOCAD, Alena Kundzer: None declared, Nikolaj Soroka: None declared, Ekaterina Dokukina Employee of: JSC BIOCAD, Anna Eremeeva Grant/research support from: JSC BIOCAD, Ekaterina Chernyaeva Employee of: JSC BIOCAD, Roman Ivanov Employee of: JSC BIOCAD