FDA Approves Taltz for Non-radiographic Axial Spondyloarthritis

Eli Lilly‘s Taltz (ixekizumab) has been approved in the U.S. to treat non-radiographic axial spondyloarthritis (nr-axSpA) in people who have objective signs of inflammation.

“This approval reflects Lilly’s continued growth and commitment to supporting rheumatologists and people with autoimmune conditions, including nr-axSpA,” Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines, said in a press release.

The medication had previously received regulatory approval by the U.S. Food and Drug Administration (FDA) for ankylosing spondylitis (AS), plaque psoriasis, and active psoriatic arthritis.

nr-axSpA and AS are two forms of axial spondyloarthritis, a type of arthritis that mainly affects the joints of the spine. The condition is called AS if joint damage is visible through X-rays and nr-axSpA when no such changes can be seen with this approach.

“There are limited treatment options that can address both AS and nr-axSpA symptoms, and people living with these conditions are often underdiagnosed and undertreated,” said Cassie Shafer, CEO of the Spondylitis Association of America. “This approval represents an important milestone in providing relief to patients where there has been a significant unmet need.”

Taltz is a biological disease-modifying anti-rheumatic drug that works by blocking the activity of interleukin-17A (IL-17A), a signaling molecule that promotes inflammation. With the FDA approval, Taltz becomes the first IL-17A blocker available for people with nr-axSpA, Eli Lilly said.

The decision was based on data from the company-sponsored Phase 3 trial COAST-X (NCT02757352), which enrolled 303 adults with previously untreated nr-axSpA. Participants were randomly assigned to receive subcutaneous (under-the-skin) injections of Taltz or a placebo, given every two or four weeks. The initial dose of Taltz was 80 or 160 mg, with subsequent doses at 80 mg.

In COAST-X, the efficacy of Taltz was assessed by the percentage of participants achieving ASAS40 — Assessment in SpondyloArthritis International Society — which refers to a 40% improvement or reduction in at least three of four domains at weeks 16 and 52 (one year): patient global assessment of disease, pain, function, and inflammation.

After one year of treatment, significantly more participants given Taltz achieved ASAS40 than those on the placebo: 31% of those treated every two weeks, 30% of patients treated every four weeks, and 13% of those on placebo. Similar results were seen after 16 weeks of treatment.

Taltz treatment also improved health-related quality of life, reduced disease activity on multiple measures, and eased inflammation in the sacroiliac joints as assessed by MRI.

Safety results were consistent with those of prior trials of Taltz in other conditions. The most commonly reported adverse events included injection site reactions, upper respiratory tract infection, nausea, and tinea infections, known as ringworm.

“The study results indicate that Taltz is safe and effective in patients [with nr-axSpa],” said COAST-X investigator Atul Deodhar, MD, a professor at Oregon Health & Science University. “Today’s FDA approval provides patients with a much-needed treatment option targeting IL-17A to improve the signs and symptoms of nr-axSpA.”

Eli Lilly said it will work with insurers, providers, and healthcare systems to enable patients to access the medication, recognizing that the ongoing COVID-19 pandemic may limit the ability to afford therapies. The company offers a program, Taltz Together, to help people pay the lowest possible cost and get medications delivered directly to their homes. Additional information about insurance support for Taltz can be found here.