Ixekizumab Curbs Disease Activity, Improves Quality of Life in Axial Spondyloarthritis

By Reuters Staff

December 12, 2019

NEW YORK (Reuters Health) - Treatment with the interleukin-17 inhibitor ixekizumab (Taltz, Lilly) significantly improves signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSpA), according to results of the COAST-X study.

The results of the phase-3 randomized controlled trial were presented in November during a plenary session at the American College of Rheumatology (ACR) annual meeting and are now published in The Lancet.

The manufacturer-funded study enrolled 303 adults with active nr-axSpA, objective signs of inflammation (determined by MRI or CRP) and an inadequate response or intolerance to non-steroidal anti-inflammatory drugs. They were randomly allocated to receive ixekizumab 80 mg subcutaneously every four weeks or every two weeks or placebo.

Significantly more patients on ixekizumab achieved the primary endpoint of improvement in the signs and symptoms of nr-axSpA as measured by Assessment of Spondyloarthritis International Society 40 (ASAS40).

At week 16, 35% of patients treated with ixekizumab every four weeks and 40% of patients treated with the drug every two weeks achieved ASAS40 response, compared to 19% of patients treated with placebo.

At week 52, 30% of patients receiving ixekizumab every four weeks and 31% receiving the drug every two weeks achieved ASAS40 response, compared to 13% of patients treated with placebo.

Ixekizumab also met the major secondary endpoints in the study at week 16 and week 52, including significant improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of patients achieving low disease activity (ASDAS <2.1), sacroiliac joint inflammation as assessed by MRI (Week 16) and 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score.

The overall safety profile of ixekizumab, including reports of adverse events, was similar to that seen in prior studies, with no new or unexpected safety findings.

In the U.S., ixekizumab is currently approved for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as adults with active psoriatic arthritis and active ankylosing spondylitis.

Based on the COAST-X results, Lilly has submitted for U.S. regulatory approval for adults with active non-radiographic axial spondyloarthritis.

"If approved for this patient population, Taltz could be an important treatment option to help address chronic, debilitating symptoms for people living with non-radiographic axSpA," Dr. Atul Deodhar of Oregon Health and Science University, in Portland, clinical investigator for the COAST program, said in a Lilly news release.

SOURCE: http://bit.ly/2sZBmrn The Lancet, online December 5, 2019.

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