TGA approves Ixekizumab for AS

2 minute read

Ixekizumab has shown promise in phase III trials, though the risk of infection must be borne in mind.

The TGA has approved the monoclonal antibody ixekizumab for ankylosing spondylitis, following promising research results.

Up to one in 200 Australians has AS, and the first-line treatment is with nonsteroidal anti-inflammatory drugs, along with exercise and lifestyle modifications.

Ixekizumab (Taltz, Eli Lilly) is currently the second IL17a inhibitor approved for use in psoriasis and psoriatic arthritis, and has been approved for use in the US for patients with AS since late last year.

But now the injection is now also available to Aussie adults with AS, Eli Lilly has confirmed.

Patients with the condition are recommended to have an 80mg subcutaneous injection every four weeks, and may continue to take their other medication, including cDMARDs, NSAIDs and other pain-killers, at the same time.

Two phase III trials have found patients treated with the drug have significantly fewer symptoms after being treated for 16 weeks than those taking a placebo.

In one study of more than 300 participants, only one in five of the controls had at least a 40% reduction in AS symptoms, compared to half the group taking ixekizumab.

In another multicentre trial of more than 280 participants, treatment with the drug led to twice as many people having a significant reduction in symptoms compared to the placebo group. More than one in four patients taking ixekizumab reached the primary endpoint at 16 weeks, compared to one in eight in the placebo group.

The TGA warned that the drug had been tied to higher rates of infection such as upper respiratory tract infection, oral candidiasis, conjunctivitis and tinea.

“Taltz should be used with caution in patients with clinically important chronic or active infection,” according to the product information. Patients should be encouraged to see their doctor if they have signs of an infection, and the drug discontinued until serious infection resolves.

Patients should also be monitored closely for signs of tuberculosis during or after treatment.

“Exercise caution when prescribing Taltz to patients with inflammatory bowel disease, including Crohn’s disease and ulcerative colitis, as new cases or exacerbations have been reported,” according to the product information. “Patients treated with Taltz and have inflammatory bowel disease should be monitored closely.”

Patients who are known to have a serious hypersensitivity to the medication or the accompanying agents should not be given the drug, the TGA said.

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