A randomised, double-blind study of the effect of Simponi (golimumab) in treating patients with active non-radiographic axial spondyloarthritis (nr-axial SpA) has posted positive results, it has been announced.
The data from the GO-AHEAD study revealed that the clinical benefit and predictable tolerability profile of golimumab that was observed in the 16-week placebo-controlled study were sustained over a full year. The patients who received golimumab in the study were continued on open-label Simponi 50mg every 4 weeks for the extension study. These patients experienced continued benefits in disease activity through 52 weeks of therapy.
Nr-axial SpA and ankylosing spondylitis (AS) come under the umbrella term of axial spondyloarthritis (axial SpA), which is a painful and potentially progressive condition that mainly affects the spine and pelvic joints, commonly characterised by chronic lower back pain and stiffness. AS patients have evidence of radiographic damage, whereas nr-axial SpA patients do not. The burden of disease in nr-axial SpA is similar to AS.
The announcement regarding the efficacy of golimumab follows on from survey data into nr-axial SpA from the Disease Specific Programme (DSP), a multi-national survey of patients and rheumatologists that highlights the burden of illness in patients with nr-axial SpA, and the financial burden of this condition on employers and society due to productivity loss. The survey results also suggest a need for more consistent classification of nr-axial SpA.
The database analysis, which looked at the experiences of 5 European countries, including the UK, found that nr-axial SpA patients may suffer from various chronic and acute pain symptoms, and that their condition often affected productivity at work. It is greater for those not treated with a biologic medicine; productivity-loss associated with biologic-naïve patients compared with biologic-treated patients equates to €10,834.92 from the employer perspective, per patient.
The survey also showed that there is inconsistency in how physicians classify nr-axial SpA in real world practice, which suggests a gap in accurate classification that could affect optimal treatment decisions for patients. According to the physicians surveyed, in more than half of their patients (52.5%), the nr-axSpA diagnosis was made using the ASAS criteria, yet 29.5% were diagnosed without any form of classification criteria.
“There is a substantial burden associated with nr-axSpA to employers and the economy overall. Some of this burden may be avoidable and could be addressed by better classification of nr-axSpA in real-world practice, supported by treatments that offer sustained treatment efficacy,” said Sumesh Kachroo, Director of Outcomes research at MSD and DSP Survey author. “The results from the GO-AHEAD open-label extension study are therefore particularly timely when viewed in light of the ongoing needs highlighted in the DSP Survey.”
NICE is currently reviewing the guidelines for the diagnosis and management of spondyloarthritic conditions, including nr-axial SpA.