New data on quality of life benefits of SIMPONI® in treating patients with active nr-axial SpA

Merck Sharp & Dohme (MSD), known as Merck in the United States and Canada, announced additional data from a subanalysis (1) of the multicentre, randomised, double-blind, placebo-controlled GO-AHEAD study on the effect of SIMPONI® (golimumab) in treating patients with non-radiographic axial spondyloarthritis (nr-axial SpA). (2)

Merck Sharp & Dohme (MSD), known as Merck in the United States and Canada, announced additional data from a subanalysis (1) of the multicentre, randomised, double-blind, placebo-controlled GO-AHEAD study on the effect of SIMPONI® (golimumab) in treating patients with non-radiographic axial spondyloarthritis (nr-axial SpA). (2)

Quality of Life (QoL) (1) findings from the GO-AHEAD study, published at EULAR Congress this week, showed that patients with nr-axial SpA treated with SIMPONI® had greater improvements than those treated with placebo. At week 16, SIMPONI® patients had greater improvements from baseline QoL than those receiving placebo against all scales of the Ankylosing Spondylitis Quality of Life (ASQoL), EuroQoL 5-Dimension (EQ-5D), and the 36-item Short Form Health Survey (SF-36). (1)

Patients treated with SIMPONI® also experienced greater percentage improvements in measures of overall work impairment at week 16 versus placebo-treated patients (-21.1 versus -11.7, respectively; P=0.0391), as well as in activity impairment at week 16 (-24.9 versus -8.6, respectively; P<0.0001) as evaluated by the Work Productivity and Activity Impairment (WPAI) questionnaire. (1)

Axial spondyloarthritis (axial SpA), which encompasses both nr-axial SpA and ankylosing spondylitis (AS), (3) is a painful and potentially progressive condition that mainly affects the spine and pelvic joints, commonly characterised by chronic lower back pain and stiffness. (4)

“The burden of disease is similar in axial SpA and AS, and effective suppression of inflammation can result in a considerable improvement of quality of life outcome parameters”, explains study author Professor Joachim Sieper, consultant and head rheumatologist at the Charité University Hospital, Berlin. “Such a good effect on disease activity and quality of life was nicely shown in the current study of the TNF-blocker golimumab in nr-axial SpA patients compared to the group of patients treated with placebo.”

The key results of the GO-AHEAD study, also presented at the EULAR 2015 Congress (2) and previously presented at the American College of Rheumatology (ACR) Congress, November 2014, (5) demonstrated the efficacy of SIMPONI® in patients with nr-axial SpA. (2) The primary endpoint data showed that 71.1% of patients treated with SIMPONI® achieved ASAS 20, at 16 weeks compared with 40 per cent of placebo-treated patients (P<0.0001). (2) The ASAS (ASsessments in Ankylosing Spondylitis) assess symptomatic outcomes across domains including physical function, pain, global disease assessment, spinal stiffness and inflammation.

Adverse events occurred in 41% and 47% of patients treated with SIMPONI® and placebo, respectively. Serious adverse events occurred in one SIMPONI® patient (female partner-reported foetal death) and two placebo patients (presence of gallstones and back pain). There were no events of serious infections, serious opportunistic infections, active tuberculosis, malignancies, serious systemic hypersensitivity, or deaths during the placebo-controlled part of the study up to week 16. (2)

In May 2015, SIMPONI® received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of nr-axial SpA. (6) If approved by the European Commission, the new indication will mean that SIMPONI® will be available as a once monthly  treatment option for adult patients with severe, active nr-axial SpA with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs). Subsequent to the CHMP opinion, the EU Commission Decision will mark the implementation of this addition to the existing approved indications in rheumatology: AS, psoriatic arthritis (PsA) and rheumatoid arthritis (RA). SIMPONI® is also approved for the treatment of ulcerative colitis (UC). (7)

NICE and spondyloarthritis
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. (8) Additionally, a NICE Multiple Technology Appraisal (MTA) is in progress evaluating the use of adalimumab, certolizumab, etanercept, infliximab and golimumab for the treatment of ankylosing spondylitis and nr-axial SpA, with publication anticipated in September 2015. (9)

References:

1. Maksymowych WP et al. Quality of life in patients with active nonradiographic axial spondyloarthritis after 16 weeks of golimumab treatment. Abstract 3046. The 16th EULAR Annual European Congress of Rheumatology 2015, Rome, 10–13 June, 2015. Accessed June 2015.
2. Sieper J et al. A randomized, double-blind, placebo-controlled, 16-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Abstract 2114. The 16th EULAR Annual European Congress of Rheumatology 2015, Rome, 10–13 June, 2015. Accessed June 2015.
3. National Anklyosing Spondylitis society website. Available at: nass.co.uk. Accessed May 2015.
4. American College of Rheumatology (ACR). Spondylarthritis (Spondylarthropathy) website. Available at: www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Spondylarthritis_(Spondylarthropathy). Accessed April 2015.
5. Sieper J et al. A randomized, double-blind, placebo-controlled, 16-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Abstract 2938. American College of Rheumatology, Boston, 15–19 November, 2014. Accessed May 2015.
6. Committee for Medicinal Products for Human Use. Summary of opinion (post authorisation): Simponi. Available at: www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500187055. Accessed May 2015.
7. SIMPONI. Summary of product characteristics. Available at: www.medicines.org.uk/EMC/medicine/23766/SPC/Simponi+50+mg+solution+for+injection. Accessed May 2015.
8. NICE. Spondyloarthritis: the diagnosis and management of spondyloarthritis. Available at: www.nice.org.uk/guidance/indevelopment/gid-cgwave0688. Accessed June 2015.
9. NICE. Ankylosing spondylitis and axial spondyloarthritis (non-radiographic) – adalimumab, etanercept infliximab and golimumab (incl rev TA 143 and TA 233). Available at: www.nice.org.uk/guidance/indevelopment/gid-tag355. Accessed June 2015.
10. Poddubnyy D et al. Rates and predictors of radiographic sacroiliitis progression over 2 years in patients with axial spondyloarthritis. Ann Rheum Dis 2011;70(8):1369–74.
11. The University of Oxford. Axial spondylitis. Available at: www.ndorms.ox.ac.uk/clinicaltrials.php?trial=axspond. Accessed July 2014.