ABSTRACT
INTRODUCTION: SB4 is the first approved biosimilar of etanercept, a biologic tumor necrosis factor inhibitor, to treat various autoimmune diseases including axial spondylarthritis (axSpA), rheumatoid arthritis (RA), psoriatic arthritis (PsA), and plaque psoriasis (PsO). This post-marketing surveillance (PMS) study of SB4 investigated safety and effectiveness in routine clinical practice and is part of the drug approval process in Korea. METHODS: This prospective, multi-center, open-label, observational, phase IV PMS study was designed to enroll patients with axSpA, RA, PsA, and PsO in Korea from September 2015 to September 2019. Both etanercept-naïve patients or patients switched from reference etanercept were included. SB4 was administered weekly via subcutaneous injections using pre-filled syringes. Safety was assessed by the incidence of adverse events (AEs), adverse drug reactions (ADRs) and serious adverse events (SAE). Effectiveness was assessed by the change from baseline of investigator-rated Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with ankylosing spondylitis (AS) and disease activity score-28 (DAS28) in patients with RA. RESULTS: Among 316 enrolled patients, 314 were included in the safety analysis (176 with AS and 138 with RA). The overall incidence of AEs, ADRs and serious AEs were 17.8, 9.9, and 1.3%, respectively. Most AEs were mild (66.7%) or moderate (31.1%) and not related to SB4 (58.9%). Most common AEs were injection site pruritus (1.9%) and injection site rash (1.3%). At week 24, mean disease activity scores significantly decreased compared to baseline in naïve patients with AS and RA (BASDAI 2.7 vs. 6.2, p < 0.0001; DAS28 3.8 vs. 5.7, p < 0.0001) and in switched patients with AS and RA (BASDAI 1.0 vs. 1.3, p = 0.0018; DAS28 2.4 vs. 2.9, p = 0.0893). CONCLUSION: This first real-world evidence of SB4 from a phase IV PMS study in Korea shows comparable effectiveness to historical SB4 real-world evidence without any new significant safety signals.
ABSTRACT
BACKGROUND: There is limited guidance on which biologic therapies should be prioritised for the treatment of moderate-to-severe psoriasis, amongst the many available options. New mode-of-action biologics, as well as recently available biosimilars for existing biologics, continue to be developed making the choice of treatment sequence increasingly complex. OBJECTIVES: The aim of this analysis was to develop a cost-effectiveness model to determine the optimal placement of biologic therapies on the treatment pathway for psoriasis in the UK. METHODS: A cohort-based Markov model was developed in Microsoft Excel, from the perspective of the National Health Service and Personal and Social Services in the UK. The model followed a hypothetical cohort of patients over a lifetime. The health states in the model were defined by Psoriasis Area and Severity Index response. In the model, patients could receive a total of four separate treatments, including three active interventions and best supportive care. RESULTS: A fully incremental analysis was undertaken on a subset of commonly used treatment sequences. The results of the list price analyses determined the most cost-effective sequence to be adalimumab biosimilar followed by ustekinumab, secukinumab, then best supportive care. This sequence is associated with total costs of £78,731 and total quality-adjusted life-years of 14.74 over a patient's lifetime. CONCLUSIONS: This research suggests that the optimal first-line treatment in the UK is adalimumab biosimilar. The optimal second-line and third-line treatments depend on the magnitude of confidential discounts applied to the biologic treatments.
