MSD (Merck & Co., Inc.), a global healthcare leader working to help the world be well, announced that the European Commission approved Simponi (golimumab) for the treatment of adult patients with severe, active non-radiographic axial spondyloarthritis (nr-axial SpA). This follows CHMP positive opinion issued in May 2015, which was based on the findings from the GO-AHEAD study, which demonstrated significant clinical improvement in patients with active nr-axial SpA treated with Simponi, compared with patients treated with placebo, over 16 weeks.
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 is similar in nr-axial SpA and AS, and effective suppression of inflammation results in a considerable improvement of pain, stiffness, function, and more general quality of life outcome parameters," explains GO-AHEAD study author Professor Joachim Sieper, Consultant and Head Rheumatologist at the Charité University Hospital, Berlin. "These results in this early phase of axial spondyloarthritis were at least as good as in the more established ankylosing spondylitis in previous trials."
European Commission approval in the nr-axial SpA indication means that Simponi is now - in addition to the already existing approval for ankylosing spondylitis - a treatment option for adult patients with severe, active nr-axial SpA with objective signs of inflammation (OSI), 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).
"The indication of Simponi in non-radiographic axial spondyloarthritis adds to a number of existing indications in rheumatology and gastroenterology," explains Dr Sean Curtis, VP, Immunology Clinical Research at MSD. "Physicians now have an option to help address the treatment needs of a significant group of their patients."
In rheumatology, Simponi is already indicated for AS, psoriatic arthritis and rheumatoid arthritis. Simponi is also approved for the treatment of ulcerative colitis.
Axial spondyloarthritis (axial SpA) 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. 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. The term axial spondyloarthritis covers both non-radiographic axial spondyloarthritis (nr-axial SpA) and ankylosing spondylitis (AS). In patients with nr-axial SpA, patients experience symptoms but damage to the joints does not fulfill the modified New York Criteria for AS on X-ray. The burden of disease in nr-axial SpA is similar to AS. A proportion of these nr-axial SpA patients may progress to AS with typical radiographic changes. Often misdiagnosed as "just back pain" in the early stages, axial SpA 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.
Simponi 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 Simponiinclude: moderate to severe, active rheumatoid arthritis (RA) 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 RA, 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 AS in adults who have responded inadequately to conventional therapy. Simponi is now also indicated for the treatment of adults with severe active nr-axial SpA with OSI as indicated by elevated CRP and/or MRI evidence, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Simponiis also the first and only subcutaneous anti-tumor necrosis factor (TNF)-alpha treatment administered as an every-four-week maintenance therapy 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.
Janssen Biotech, Inc. discovered and developed Simponi and markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific.
In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to Simponi to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights for Simponi to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, USA.
GO-AHEAD was a Phase 3b double-blind, randomised, placebo-controlled trial conducted in patients 18 to 45 years of age with active non-radiographic axial spondyloarthritis (nr-axial SpA), diagnosed according to the ASsessment in Ankylosing Spondylitis (ASAS) criteria.