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SIMPONI® (golimumab) gains positive opinion from CHMP for the treatment of nr-axial SpA

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)



  1. Committee for Medicinal Products for Human Use. Summary of opinion (post authorisation): Simponi. Available at: Accessed May 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 2938. American College of Rheumatology, Boston, 15–19 November 2014. Accessed May 2015.
  3. National Anklyosing Spondylitis society website. Available at: Accessed May 2015.
  4. American College of Rheumatology (ACR). Spondyloarthritis (Spondylarthropathy) website. Available at: Accessed April 2015.
  5. 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.
  6. SIMPONI. Summary of product characteristics. Available at: Accessed May 2015.
  7. Colbert RA. Early axial spondyloarthritis Curr Opin Rheumatol 2010;22(5):603–7.
  8. 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.

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