Health Canada Approves Taltz for Treatment of Active Ankylosing Spondylitis

Health Canada approved Taltz (ixekizumab) for the treatment of adults with active ankylosing spondylitis (AS) who have responded poorly to or are unable to tolerate conventional therapies.

Eli Lilly‘s Taltz is a disease-modifying antirheumatic drug (DMARD) that works by blocking the activity of interleukin-17A, a signaling molecule that helps drive inflammation. Because it is an antibody, Taltz is more specifically classified as a biological DMARD. It is administered via subcutaneous (under-the-skin) injection, and can be used alone or in combination with other medications.

“We are very pleased that Taltz is now approved for the treatment of AS in Canada,” Doron Sagman, MD, vice president of R&D and medical affairs at Eli Lilly Canada, said in a press release.

“We are pleased to learn that a new medication to treat ankylosing spondylitis has been approved by Health Canada. Timely and equitable access to diverse treatment options are essential for patients living with this painful and debilitating condition,” said Graeme Reed, interim president of the Canadian Spondylitis Association.

Taltz was approved by Health Canada for the treatment of moderate-to-severe plaque psoriasis in 2016, and was approved for psoriatic arthritis in 2018.

Health Canada based its approval on data from two Phase 3 studies that included a total of 657 adults with active disease: COAST-V (NCT02696785) and COAST-W (NCT02696798). The U.S. Food and Drug Administration approved Taltz for AS in 2019, based on the same studies.

COAST-V included participants who had never been treated with a biological DMARD, while COAST-W enrolled patients who had previously failed treatment (either due to lack of tolerability or response) with TNF inhibitors, a type of biologic therapy commonly used to treat arthritis and other inflammatory conditions.

Results from both trials showed that Taltz significantly lessened pain, fatigue, and inflammation, while improving sleep and quality of life.

Both trials aimed to measure the percentage of participants who achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) at 16 weeks of treatment — defined as improvement of at least 40% in at least three out of four categories: global assessment of disease, pain, function, and inflammation.

In both studies, more people treated with Taltz achieved ASAS40 than in the group receiving a placebo: 48% compared with 18% in COAST-V and 25% versus 13% in COAST-W.

Taltz also helped more people achieve ASAS20 (a similar measurement, but using 20% as the cutoff). In COAST-V, 64% of participants on Taltz got to ASAS20, compared with 40% of those on placebo. In COAST-W, the rates were 48% with Taltz and 30% with placebo.

The medication’s safety profile in the trials was consistent with previous data in people with psoriasis.

“Health Canada’s approval is helpful for physicians who are looking for alternative treatment options, and significant for our patients with AS,” said Proton Rahman, MD, a professor at Memorial University and investigator on the COAST-W study.