Taltz Eases Disease Activity, Improves Quality of Life in nr-axSpA Patients, Phase 3 Trial Shows

Treatment with the anti-rheumatic drug Taltz (ixekizumab) leads to early and sustained reductions in pain, fatigue, and inflammation in people with non-radiographic axial spondyloarthritis (nr-axSpA), a Phase 3 trial shows.

It also significantly improves quality of life for these patients, data show.

The data were presented at the 2019 American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting, held recently in Atlanta.

Eli Lilly’s Taltz is a type of therapy known as a biological disease-modifying anti-rheumatic drug (bDMARD). It is an engineered antibody against interleukin-17A (IL-17A), a molecule with a key role in inflammation. By blocking IL-17A, Taltz is intended to reduce inflammation.

The therapy was originally approved by the U.S. Food and Drug Administration (FDA) to treat adults with severe plaque psoriasis and active psoriatic arthritis. In September 2019, it was also approved for adults with active ankylosing spondylitis (AS), one of the two forms of axial spondyloarthritis.

Yet, it is still not indicated for people with nr-axSpA, the other subset of this type of arthritis. It differs from AS in its lack of visible joint damage on X-rays.

The now-completed COAST-X trial (NCT02757352) assessed whether Taltz also would be beneficial for 303 previously untreated adults with nr-axSpA.

Participants were randomly assigned to receive 80 mg Taltz every 2 weeks (102 patients) or every 4 weeks (96 participants) or a placebo (105 participants), all delivered subcutaneously, or under the skin. Those given Taltz received a starting dose of 80 mg or 160 mg.

The therapy’s effectiveness was measured by ASAS40 — Assessment in SpondyloArthritis International Society — which determines the percentage of patients who achieved at least a 40% improvement or reduction in at least three of four domains, or categories, at weeks 16 and 52 (one year) of treatment. Those domains are patient global assessment of disease, pain, function, and inflammation.

The results showed that 40% of patients treated every two weeks, and 35% of those treated every four weeks achieved ASAS40 response with Taltz at week 16. Only 19% of the participants on placebo achieved such a response at this time point.

After one year of treatment, 31% of participants receiving Taltz every two weeks, and 30% of those taking the therapy every four weeks achieved ASAS40. In contrast, only 13% of patients in the placebo group showed this response.

Taltz also significantly reduced disease activity, as assessed with the Ankylosing Spondylitis Disease Activity Score (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

Patients treated with Taltz achieved low disease activity on ASDAS and a clear improvement of sacroiliac joint inflammation — inflammation in the joint between the spine and hip — as assessed with magnetic resonance imaging (MRI).

“In the COAST-X study, Taltz improved the signs and symptoms of non-radiographic axSpA as measured by ASAS40, as well as reduced inflammation on MRI, an important objective measure of disease activity,” Atul Deodhar, MD, professor of medicine at Oregon Health & Science University and clinical investigator in the Eli Lilly-sponsored COAST program, said in a press release.

Taltz had a similar safety profile with this patient population to that seen in previous trials. The most frequent side effects included injection site reactions, upper respiratory tract infections, nausea, and tinea infections, commonly known as ringworm.

Deodhar presented these results in a talk titled “Ixekizumab in Non-Radiographic Axial Spondyloarthritis: Primary Results from a Phase 3 Trial.”

Results from the Physical Component Summary Score of the Short-Form 36 (SF-36) questionnaire, used to evaluate health-related quality of life, showed that Taltz had a positive impact as early as week 4 of treatment. The benefits were maintained until week 52 when compared with the placebo group.

Jessica Walsh, a rheumatologist from University of Utah School of Medicine, presented these findings in a poster titled “Ixekizumab Significantly Improves Self-reported Overall Health as Measured by Short-Form-36 in Patients with Active Non-radiographic Axial Spondyloarthritis: 16- and 52-Week Results of a Phase 3 Randomized Trial (COAST-X).”

Based on these results, Eli Lilly requested the approval of Taltz for the treatment of active nr-axSpA in the U.S.

“We’re pleased to share these positive results from the COAST-X trial, which support our belief that Taltz could be an effective treatment option for patients with non-radiographic axSpA,” said Rhonda Pacheco, global brand development leader for immunology at Eli Lilly. “We look forward to working with regulatory authorities towards our goal of making Taltz the first IL-17A antagonist approved for non-radiographic axSpA.”

“If approved for this patient population,” added Deodhar, “Taltz could be an important treatment option to help address chronic, debilitating symptoms.”

Besides COAST-X, the COAST Phase 3 program for Taltz includes COAST-V (NCT02696785), COAST-W (NCT02696798), and the long-term extension study COAST-Y (NCT03129100).