Results from the COAST-X trial show that patients treated with Taltz (ixekizumab, Eli Lilly and Company) achieved improvement in the signs and symptoms of non-radiographic axial spondyloarthritis (nr-axSp).
COAST-X is a multi-centre, randomised, double-blind, placebo-controlled 52-week study evaluating the efficacy and safety of Taltz for the treatment of non-radiographic axial spondyloarthritis in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. The study showed that Taltz met the primary and all major secondary endpoints. Results from the COAST-X study were presented at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) annual meeting (ACR/ARP 2019; 8–13 November; Atlanta, USA) as a plenary presentation.
“Currently, there are limited biological treatments for patients living with non-radiographic axSpA,” said Proton Rahman, (Eastern Health; Newfoundland; Canada). “The results of COAST-X demonstrated that Taltz improved the signs and symptoms of this debilitating disease, and therefore, could be an important treatment option for this patient population.”
axSpA is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the spine and is estimated to affect 4.5 million adults worldwide. AxSpA is recognised as a single disease entity, with one patient subset defined by the presence of radiographically defined structural damage of the sacroiliac joints (radiographic axSpA or ankylosing spondylitis [AS]) and a second patient subset without clearly detectable structural damage radiographically (nr-axSpA).
“Given the nature of non-radiographic axial spondyloarthritis and the impact it has on a patient’s quality of life, there is a clear need for more treatment options,” said Doron Sagman, vice president, R&D and Medical Affairs, Lilly Canada. “Lilly is committed to fulfilling this need and we are very pleased that Taltz has met all primary and major secondary endpoints in the COAST-X study.”
Under the trial, 303 adult patients with active nr-axSpA were randomised to receive Taltz 80mg subcutaneously every four weeks or every two weeks (following 80mg or 160mg starting dose at Week 0) or placebo.
The proportion of patients achieving the primary endpoint of improvement in the signs and symptoms of nr-axSpA as measured by Assessment of Spondyloarthritis International Society 40 (ASAS40) response was superior for Taltz compared to placebo with statistically significant difference (P<0.01). At Week 16, 35% of patients treated with Taltz every four weeks and 40% of patients treated with Taltz every two weeks achieved ASAS40 response, compared to 19% of patients treated with placebo.
At Week 52, 30% of patients treated with Taltz every four weeks and 31% of patients treated with Taltz every two weeks achieved ASAS40 response, compared to 13% of patients treated with placebo.
Taltz 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), improvement in Bath Ankylosing Spondylitis Disease Activity (BASDAI), proportion of patients achieving low disease activity (ASDAS <2.1), significant improvement in sacroiliac joint inflammation as assessed by MRI (week 16) and significant improvement in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) score.
The overall safety profile of Taltz was consistent with previously reported results, with no new or unexpected safety findings.