FDA Approves Lilly’s Taltz for the Treatment of Active Ankylosing Spondylitis

Eli Lilly‘s Taltz (ixekizumab) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis.

Taltz is a biological therapy, or a biological disease-modifying antirheumatic drug (bDMARD), that blocks interleukin-17A (IL-17A), which is an immune protein or cytokine that plays a role in inflammation.

The medication is given as an under-the-skin, or subcutaneous, injection and is available at a dose of 80 mg/ml. It may be administered alone or in combination with a conventional disease-modifying antirheumatic drug (DMARD), corticosteroid, non-steroidal anti-inflammatory drug (NSAID), and/or pain killer.

“Ankylosing spondylitis is a challenging disease that can cause severe back pain and if left untreated, can significantly impact patient mobility,” Rebecca Morison, vice president of U.S. Immunology at Lilly, said in a news release. “We are excited to now offer Taltz as a treatment option for people in need of relief from the symptoms of AS.”

Taltz was first approved by the FDA in 2016 for the treatment of moderate to severe plaque psoriasis in adult patients and then in 2017 for the treatment of adults with active psoriatic arthritis, two chronic inflammatory diseases.

“This approval is an important milestone for patients and physicians who are looking for a much-needed alternative to address symptoms of AS,” said Philip Mease, MD, from Swedish Medical Center/Providence St. Joseph Health, and the University of Washington.

The efficacy and safety of Taltz in patients with AS was demonstrated in two Phase 3 studies that included 657 adults with active disease: COAST-V (NCT02696785) and COAST-W (NCT02696798). COAST-V evaluated the medication in patients who had never taken a biological DMARD, while COAST-W enrolled patients who failed to respond or were intolerant to TNF inhibitors, a type of biologic widely used for arthritis.

Both trials showed that treatment with Taltz led to early and sustained reductions in pain, fatigue, and inflammation, as well as significant improvements in sleep and quality of life.

At 16 weeks, 48% of patients treated with Taltz versus 18% of those receiving a placebo showed significant improvements in the COAST-V study. In COAST-W, significant benefits were noted in 25% of the Talz group versus 13% in the placebo group.

Additionally, in both studies, 64% (COAST-V) and 48% (COAST-W) of patients treated with Taltz achieved ASAS20 versus 40% (COAST-V) and 30% (COAST-W) of placebo-treated individuals.

Assessment in SpondyloArthritis International Society (ASAS) 20 is a validated measure of disease activity and reflects the number of patients that show a minimum improvement/reduction of 20% in at least three out of four domains: patient global assessment of disease, pain, function, and inflammation.

Overall, the safety profile of Taltz was consistent with that known for psoriasis patients taking the medication.

“Results from the Phase 3 clinical trial program in ankylosing spondylitis show that Taltz helped reduce pain and inflammation and improve function in patients who had never been treated with a bDMARD as well as those who previously failed TNF inhibitors,” said Mease.

Cassie Shafer, CEO of the Spondylitis Association of America, added: “Having new treatment options for the ankylosing spondylitis community is truly encouraging. The ongoing focus to help people impacted by the disease will hopefully lead us to an eventual cure.”

In its release, Lilly states that Taltz should not be used in patients with a history of serious hypersensitivity to ixekizumab or to any of its excipients. The medication may also increase the risk of infection. Other precautions include pre-treatment evaluation for tuberculosis, hypersensitivity, inflammatory bowel disease, and immunizations.