MSD (Merck & Co., Inc., Kenilworth, New Jersey, USA), recently announced long-term tolerability and efficacy results from the open-label extension1 of the GO-AHEAD study, a randomised, double-blind study on the effect of Simponi® (golimumab) in treating patients with active non-radiographic axial spondyloarthritis (nr-axial SpA).2
MSD also released data from the nr-axial SpA Disease Specific Programme (DSP),3,4,5 a multi-national survey of patients and rheumatologists, funded by MSD, which highlights the burden of illness in patients with nr-axial SpA3, and the financial burden of this condition on employers and society due to productivity loss.4 The survey results also suggest a need for more consistent classification of nr-axial SpA.5
Nr-axial SpA and ankylosing spondylitis (AS) come under the umbrella term of Axial Spondyloarthritis (axial SpA)6, 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.7 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.8
GO-AHEAD shows sustained efficacy and tolerability through 52 weeks
The results from the study show that the clinical benefit and predictable tolerability profile of Simponi observed in the 16-week placebo-controlled study2 were sustained over a full year.1
The patients who received Simponi in the 16-week study were continued on open-label Simponi 50 mg every 4 weeks for the extension study. These patients experienced continued benefits in disease activity through 52 weeks of Simponi therapy, measured as ASAS 20, ASAS 40, BASDAI 50 and ASAS PR.1 The patients who received placebo in the 16-week study were switched to open-label Simponi 50 mg every 4 weeks for the extension study. These patients showed notable improvements in disease activity after switching to Simponi, in the measures of ASAS 20, ASAS 40, BASDAI 50 and ASAS PR, and the improvements in this group were also maintained through the end of the extension study.1 For ASDAS-C (Ankylosing Spondylitis Disease Activity Score using the CRP level), for the Week 52 results compared with the Week 16 results, the mean reductions from baseline at each timepoint were similar or better in the continuing-Simponi group (-2.2 compared with -1.7) and were improved in the switch-to-Simponi group (-1.7 compared with -0.6).1
"Effective and sustained suppression of inflammation in nr-axial SpA can considerably improve not only the disease activity but quality of life outcome parameters", explains Dr Marwan Bukhari, Consultant Rheumatologist at the Royal Lancaster Infirmary. "The study findings point to the need for early and consistent treatment in helping to reduce the burdens associated with this disease."
In the UK, NICE (National Institute for Health and Care Excellence) is reviewing the guidelines for the diagnosis and management of spondyloarthritic conditions, including nr-axial SpA.9
GO-AHEAD shows Improvements in quality of life measures through 52 weeks
Improvements in quality of life (measured by EQ-5D Health State VAS score) were maintained at Week 52, as seen by the mean change from baseline of 3.2 cm and 2.3 cm in the continuing-Simponi and switch-to-Simponi groups, respectively.1 In addition, at week 52, the mean change from baseline for percentage of work impairment while working (measured by WPAI) was -28.1% in the continuing-Simponi group and -22.8% in the switch-to-Simponi group.1
There were no notable differences in the number/types of adverse events (AEs) between the placebo-Simponi switch group and the continuing-Simponi group.1 A total of 14.8% of patients experienced a treatment-related AE in the GO-AHEAD open-label extension, with 1.6% discontinuing treatment due to an AE. The most commonly reported AEs were nasopharyngitis, upper respiratory tract infection, and headache.1
Unmet needs in nr-axial SpA
The burden of nr-axial SpA was further highlighted by real-world data presented from the nr-axial SpA Disease Specific Programme (DSP),3,4,5 for which surveys were completed by patients and their rheumatologists in five European countries, including the UK. It was shown that the UK has the lowest mean number of consultations within both primary and secondary care.3
The database analysis also shows that nr-axial SpA patients may suffer from various chronic and acute pain symptoms3, and that the work productivity-loss related to their condition is substantial.4 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.4
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.5 According to the physicians surveyed, in over half (52.5%) of their patients, the nr-axSpA diagnosis was made using the ASAS criteria, however, 29.5% were diagnosed without any form of classification criteria.5
"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" comments 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."
GO-AHEAD was a 16-week, Phase 3b double-blind, randomised, placebo-controlled trial of Simponi conducted in patients 18 to 45 years of age with active nr-axial SpA, diagnosed according to the Assessment of SpondyloArthritis international Society (ASAS) criteria.2
Of the 198 patients randomised, 197 received treatment in the 16-week double-blind study, and 189 entered the open-label extension phase, and received Simponi 50 mg every 4 weeks in a 44-week extension (36-week treatment period; 8-week safety follow-up). Patients taking Simponi in the 16-week study remained on Simponi for the extension study (93 patients), and those taking placebo were switched to Simponi (96 patients). In total, 176 patients (89%) completed all visits. 1 (GLM/GLM, n=87; PBO/GLM, n=89)
Efficacy evaluations during the open-label extension included ASAS 20, ASAS 40, BASDAI 50, ASAS partial remission, and ASDAS-C at weeks 20, 24, 32, 40, and 52. Quality of life evaluations included EQ-5D and percentage of work impairment (WPAI) at weeks 16 and 52.1
The placebo-treated patients in the 16-week study showed notable improvement in all efficacy measures after switching to Simponi in the extension study, while the proportions of responders in the patients who continued Simponi from the 16-week study remained consistent throughout the 52 weeks.1 For ASDAS-C at Week 52 versus Week 16, mean changes from baseline were similar or better in the continuing-Simponi group (-2.2 vs. -1.7), and were improved in the group switched from placebo to Simponi (-1.7 vs. -0.6).1
Improvements in quality of life were maintained at Week 52, as seen by the mean change from baseline in EQ-5D Health State VAS score of 3.2 cm and 2.3 cm in the continuing-Simponi and switch-to-Simponi groups, respectively. In addition, the mean change from baseline for percentage of WPAI was -28.1% in the continuing-Simponi group and -22.8% in the switch group.1
Safety evaluations included the incidence/severity of adverse events (AEs). There were no notable differences in the number and types of AEs between the continuing- Simponi group and the switch-to-Simponi group.1
About the Disease Specific Programme (DSP)
The Disease Specific Programme (DSP) is a cross-sectional, multi-national survey of nr-axSpA patients and their rheumatologists in France, Germany, Italy, Spain and the UK.
A total of 631 patients were included in the Burden of Illness on patients survey3, 310 in the Burden of Illness from an employers' perspective survey4, and 631 in the Standards of Classification survey.5
About Axial Spondyloarthritis
Axial spondyloarthritis is a painful and potentially progressive form of inflammatory arthritis that mainly affects the spine and pelvic joints and most commonly results in chronic lower back pain.7 It typically begins in the late teens and early twenties and in severe cases can result in complete fusion of the spinal vertebrae and cause structural damage to hips and other joints.7 The term axial spondyloarthritis covers both non-radiographic axial spondyloarthritis and ankylosing spondylitis. In patients with non-radiographic axial spondyloarthritis, patients experience symptoms but damage to the joints is not yet visible on X-ray.6 A proportion of these patients will move on to ankylosing spondylitis with typical radiographic changes.10 Often misdiagnosed as "just back pain" in the early stages11, axial spondyloarthritis is a systemic inflammatory disease that, in addition to its effect on the spine, can affect other areas such as peripheral joints, eyes, and the bowel.7
About SIMPONI® (golimumab)12
Golimumab is a human monoclonal antibody that targets and neutralises tumour necrosis factor (TNF)-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. Licensed indications for golimumab include: moderate to severe, active rheumatoid arthritis in adults, in combination with methotrexate, when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including methotrexate has been inadequate; severe, active and progressive rheumatoid arthritis, in combination with methotrexate, in adults not previously treated with methotrexate; active and progressive psoriatic arthritis in adult patients, alone or in combination with methotrexate, when the response to previous DMARD therapy has been inadequate; and severe, active ankylosing spondylitis in adults who have responded inadequately to conventional therapy. Golimumab is also the first and only four-weekly, subcutaneous biologic therapy approved for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. SIMPONI® is available either through the SmartJect autoinjector/prefilled pen or a prefilled syringe as a SC administered injection.
SIMPONI® is a Registered Trademark owned by Johnson & Johnson and licensed to Merck and Co., Inc. (known as MSD outside the US), Kenilworth, New Jersey, USA.