New Citrate-free Taltz Becoming Available for AS Patients in US
New formulation intended to ease injection-site reactions
A new and citrate-free formulation of Taltz (ixekizumab) is being made available to treat adults with active ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA) patients who have signs of inflammation.
Symptoms of nr-axSpA are similar to AS, but without X-ray evidence of inflammation.
This formulation of the Eli Lilly therapy was shown in trials to significantly ease injection site pain, experienced by some patients, the company reported in a press release. It has also demonstrated safety similar to the original treatment.
The new formulation is being shipped across the U.S. and expected to be available to all patients there by month’s end, becoming available in additional markets shortly thereafter, Lilly reported. It was approved in by the U.S. Food and Drug Administration (FDA) in May and by the European Medicines Agency in December 2021.
Taltz works to ease pain and stiffness of ankylosing spondylitis
Patients do not need a new prescription for citrate-free Taltz, also available as an 80 mg/ml injection. According to Lilly, people using Taltz should not experience any gap in their treatment, with the original formulation available until it is replaced by the new one.
Citrate-free Taltz has the same active ingredient as the original formulation. In two Phase 1 trials in healthy adults — study A (NCT03848403) and study B (NCT04259346) — its use was associated with a significant lessening of injection-site pain immediately after injection, researchers reported.
Specifically, the new formulation showed an 86% decrease in injection-site pain compared with the original formulation, as measured by a visual analog scale (VAS) of pain, Lilly reported. This is a validated, subjective measure for acute and chronic pain, whose scores range from zero (no pain) to 100 (worst imaginable pain).
Taltz in its original formulation was FDA-approved for ankylosing spondylitis patients, to help alleviate the arthritic pain and stiffness caused by inflammation, in 2019. It works by blocking the activity of interleukin-17A (IL-17A), a signaling molecule that promotes inflammation.
“Today is an exciting milestone for the nearly 30 million people around the world who live with the challenging symptoms of these autoimmune diseases that affect the skin and joints,” said April Armstrong, MD, a professor of dermatology and associate dean of clinical research at Keck School of Medicine at the University of Southern California.
“In my six years of prescribing Taltz, I’ve seen firsthand the significant impact Taltz has had for patients across multiple indications. The availability of Taltz as a citrate-free formulation represents an important advance in patient care that will allow … less injection-site pain,” Armstrong added.
It also was FDA-approved to treat people with moderate to severe plaque psoriasis in 2016 and adults with active psoriatic arthritis in 2017.
“Taltz has long delivered effective treatment with a well-established safety profile that addresses symptoms for people living with plaque psoriasis, psoriatic arthritis, AS and nr-axSpA,” said Ashley Diaz-Granados, vice president of U.S. immunology at Lilly.
“This new formulation provides yet another reason to choose Taltz, and we look forward to introducing it to patients … and providing a seamless transition,” Diaz-Granados added.