ACR 2019: Lilly presents positive new data from COAST-X, a Phase 3 study of TALTZ® (ixekizumab) in patients with non-radiographic axial spondyloarthritis
Based on these positive results, Lilly has submitted for U.S. regulatory approval for adults with active non-radiographic axial spondyloarthritis
TORONTO, ON – November 26, 2019 - Eli Lilly and Company presented detailed results from the COAST-X study at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting in Atlanta as a plenary presentation. COAST-X is a 52-week placebo-controlled Phase 3 study, evaluating the safety and efficacy of TALTZ for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. The study showed that TALTZ® (ixekizumab) met the primary and all major secondary endpoints.
"Currently, there are limited biological treatments for patients living with non-radiographic axSpA," says Dr. Proton Rahman, Rheumatologist, Eastern Health, St. Johns, Newfoundland. "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.”
Axial spondyloarthritis (axSpA) is a chronic inflammatory disease affecting predominantly the sacroiliac joints and the spine skeleton and is estimated to affect 4.5 million adults worldwide. 1,2,3 AxSpA is recognized 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). 4 While these two patient subsets share a similar burden of disease and similar clinical features, such as inflammation in the axial skeleton, which result in chronic inflammatory back pain and fatigue, the biologic treatment options for patients with nr-axSpA are much more limited. 5,6
“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,” says Dr. 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.”
A total of 303 adult patients with active nr-axSpA were randomized to receive TALTZ 80 mg subcutaneously every 4 weeks or every 2 weeks (following 80 mg or 160 mg 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), significant 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.
Van der Heijde D, et al. Lancet 2018; RHBV (COAST-V) Primary 24-Week Results
Deodhar A, et al. Arthritis Rheumatol 2019; RHBW (COAST-W) Primary 24-Week Results
Dougados M, et al. Ann Rheum Dis 2019 (Epub ahead of print); COAST-V and COAST-W 52-Week Results
TALTZ (ixekizumab) is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. 7 IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. TALTZ inhibits the release of pro-inflammatory cytokines and chemokines. 7
COAST-X is a multicenter, randomized, double-blind, placebo-controlled 52-week study evaluating the efficacy and safety of TALTZ (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) in patients who are biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve. Patients were required to have an established diagnosis of nr-axSpA and active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Numeric Rating Scale (NRS) score ≥4 and total back pain ≥4 at screening and baseline, and were required to have objective signs of inflammation as shown by the presence of sacroiliitis on MRI or the presence of elevated CRP.
About the TALTZ Program in axSpA
The COAST-X study is part of a clinical development program that aims to evaluate the efficacy and safety of ixekizumab across various population subsets of patients with axSpA. The COAST program includes three registration studies each of one year duration: COAST-V in patients with Ankylosing Spondylitis (AS)/radiographic axSpA who are bDMARD-naïve; COAST-W in patients with AS/radiographic axSpA who previously had an inadequate response or were intolerant to TNF inhibitors; and COAST-X in patients with non-radiographic axSpA who are bDMARD-naïve. Patients may enroll into a long-term extension study (COAST-Y) after completion of any of these registration studies to receive ixekizumab treatment for up to an additional two years.
About Lilly in Rheumatology
Lilly in rheumatology aims to create a brighter future for people with debilitating rheumatologic diseases through innovative discoveries and patient-centered solutions.
About Eli Lilly Canada
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people’s needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.
Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto, which eventually produced the world’s first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.
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Spondyloarthritis. Arthritis Foundation. https://www.arthritis.org/about-arthritis/types/spondyloarthritis/. Accessed October 16, 2019.
Strand V, Rao SA, Shillington AC, et al. Prevalence of axial spondyloarthritis in United States rheumatology practices: Assessment of SpondyloArthritis International Society criteria versus rheumatology expert clinical diagnosis. Arthritis Care Res. 2013;65(8):1299-306.
Kiltz U, Baraliakos X, Karakostas P, et al. Do patients with non-radiographic axial spondylarthritis differ from patients with ankylosing spondylitis? Arthritis Care Res. 2012;64(9):1415-22.
Deodhar A, Reveille JD, van den Bosch F, et al. The concept of axial spondyloarthritis: joint statement of the spondyloarthritis research and treatment network and the Assessment of SpondyloArthritis International Society in response to the US Food and Drug Administration's comments and concerns. Arthritis Rheumatol. 2014;66(10):2649-2656.
Baraliakos X, Braun J. Non-radiographic axial spondyloarthritis and ankylosing spondylitis: what are the similarities and differences? RMD Open. 2015;1:e000053.
Taurog JD, Chhabra A, Colbert RA. Ankylosing spondylitis and axial spondyloarthritis. N Engl J Med. 2016,374(26):2563-74.
TALTZ Product Monograph January 8, 2019.