MSD, known as Merck & Co., Inc. in the United States and Canada, announced that SIMPONI® (golimumab) has received CHMP positive opinion for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (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 nonsteroidal anti-inflammatory drugs (NSAIDs). (1) Once the EU commission issues their EC decision, and if approved, nr-axial SpA patients can be considered for the once-monthly subcutaneous injection with SIMPONI® (golimumab).
The CHMP positive opinion was based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with golimumab, compared with patients treated with placebo, over 16 weeks. (2)
“The indication of SIMPONI® in non-radiographic axial spondyloarthritis will add to a number of existing indications in rheumatology and gastroenterology”, explains Dr Sean Curtis, VP, Immunology Clinical Research at MSD, “physicians will have an option to help address the treatment needs of a significant group of their patients.”
The term 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 in nr-axial SpA is similar to AS. (5)
Once approved, SIMPONI® will become available as a treatment option for patients with severe active nr-axial SpA. This will add 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. (6)
- Committee for Medicinal Products for Human Use. Summary of opinion (post authorisation): Simponi. Available at: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500187055. Accessed May 2015.
- 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. http://acrabstracts.org/abstracts/a-randomized-double-blind-placebo-controlled-16-week-study-of-subcutaneous-golimumab-in-patients-with-active-nonradiographic-axial-spondyloarthritis/. Accessed May 2015.
- National Anklyosing Spondylitis society website. Available at: http://nass.co.uk/. Accessed May 2015.
- American College of Rheumatology (ACR). Spondyloarthritis (Spondylarthropathy) website. Available at: https://www.rheumatology.org/Practice/Clinical/Patients/Diseases_And_Conditions/Spondylarthritis_(Spondylarthropathy)/. Accessed April 2015.
- Kiltz U et al. Do patients with non-radiographic axial spondyloarthritis differ from patients with ankylosing spondylitis? Arthritis Care Res 2012;64(9):1415–22.
- SIMPONI. Summary of product characteristics. Available at: http://www.medicines.org.uk/emc/medicine/23766. Accessed May 2015.
- Colbert RA. Early axial spondyloarthritis Curr Opin Rheumatol 2010;22(5):603–7.
- 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.