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New Biological Drug for Ankylosing Spondylitis

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The experimental drug ‘secukinumab’ may offer patients with ankylosing spondylitis – a type of autoimmune, inflammatory arthritis that primarily affects the spine and pelvis – a much-needed alternative for symptom relief, according to the results of several studies presented at this year’s American College of Rheumatology (ACR) Annual Meeting in Boston.

Secukinumab belongs to a new class of inflammation-fighting drugs and has already been shown to relieve skin lesions caused by psoriasis, an autoimmune, inflammatory skin disorder. Other research unveiled at the ACR conference suggests that this medication could have additional uses, too.

Ankylosing spondylitis – or AS – is usually treated with nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs) and with tumor necrosis factor (TNF) inhibitor, which block a protein, interrupting the inflammatory process. Yet some patients don’t respond to these medicines. Notably, up to 50 percent of AS patients treated with TNF inhibitors don’t get adequate relief of their symptoms.

The search for new medicines to treat these and other inflammatory diseases has led researchers to other inflammation-producing targets, including one called interleukin-17A, or IL-17A. This small protein (known as a cytokine) is a key player in the immune system, the body’s defense network. Members of the IL-17 family help protect against bacteria and other germs, but these cytokines can turn rogue, produce uncontrolled inflammation, and promote various immune system disorders, including AS. Scientists have identified several compounds that block the action of IL-17A, including secukinumab.

To learn whether blocking IL-17A could ease AS symptoms, an international team of researchers funded by the pharmaceutical company Novartis recruited 371 patients with the disease, more than two-thirds of them male, to participate in a clinical trial. The typical participant was about 40 years old, had been living with AS for six to eight years, and was unable to control symptoms of the disease despite taking medications such as NSAIDs, DMARDs and/or TNF inhibitors. On a standard evaluation of disease activity, known as the BASDAI, the average participant scored between 6.0 and 6.5, an indication that their medications weren’t relieving their pain and other symptoms.

Each patient was randomly placed in one of three groups. Members of two groups received three initial infusions of secukinumab at a clinic, spaced two weeks apart, then injected themselves with the drug (either 75 milligrams or 150 milligrams) once a month at home. A third set of patients received inactive (placebo) infusions and injections, and served as a comparison group (though they were later given secukinumab, too).

After four months of treatment, patients given the placebo infusions showed little or no improvement, while those receiving either dose of secukinumab had improved significantly; their BASDAI scores dropped more than two points, on average. “This improvement … would mean significantly less pain, less stiffness and less fatigue” for patients, says rheumatologist Atul Deodhar, medical director of rheumatology clinics at Oregon Health & Science University in Portland, and a coauthor of the study. Novartis plans to seek FDA approval in 2015.

A second, smaller study found that AS patients who didn’t receive the initial infusions and simply self-injected secukinumab got significant relief, too, but only at the 150 milligram dose. Separately, other researchers at the ACR conference presented optimistic results from two studies examining secukinumab for the treatment of another form of spondyloarthropathy, called psoriatic arthritis, which occurs in up to 30 percent of people who have psoriasis. Investigators are also studying whether secukinumab and related drugs could have a role in treating other inflammatory diseases, including rheumatoid arthritis.

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This web site is run by an Arthritis Specialist based in Dubai, United Arab Emirates. On this site you will find news about the latest in arthritis, information about research results in the field, tips and information and diet and exercise, and much more.



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