Eli Lilly's IL-17 Inhibitor Taltz Demonstrates Long-Term Efficacy, Meeting Primary Endpoints in Two Phase 3 Trials for PsA and nr-axSpA

Today, Eli Lilly and Company announced that its IL-17 inhibitor Taltz (ixekizumab) met both the primary endpoints and all key secondary endpoints in two clinical trials involving patients with active psoriatic arthritis (PsA) and non-radiographic axial spondyloarthritis (nr-axSpA), further confirming the long-term efficacy and safety of Taltz. These data were presented at the American College of Rheumatology Annual Meeting.

Psoriatic arthritis and non-radiographic axial spondyloarthritis are both chronic inflammatory diseases. Psoriatic arthritis can lead to irreversible joint deformity and disability. It is estimated that there are over 50 million patients with psoriatic arthritis worldwide. Axial spondyloarthritis (axSpA) primarily affects the sacroiliac joints and axial skeleton, with approximately 4.5 million adult patients globally. Among these, non-radiographic axial spondyloarthritis (nr-axSpA) is often difficult to diagnose, and many patients struggle to receive appropriate treatment.

Eli Lilly and Company’s monoclonal antibody, Taltz, selectively binds to interleukin-17A (IL-17A) and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine involved in normal inflammatory and immune responses. By inhibiting IL-17 receptor-mediated signaling pathways, Taltz suppresses the release of pro-inflammatory cytokines and chemokines, thereby alleviating symptoms of inflammatory diseases. Previously, Taltz has been approved for the treatment of active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

In the phase 3b/4 SPIRIT-H2H clinical trial, patients with active psoriatic arthritis who were naive to biologic therapy were randomized to receive either Taltz or the common comparator adalimumab, with concomitant use of conventional disease-modifying antirheumatic drugs (DMARDs) permitted. The results demonstrated that at 52 weeks, 39% of patients in the Taltz group achieved both a 50% reduction in disease activity (ACR50) and complete clearance of skin symptoms (PASI 100), compared with 26% in the active control group.

▲Proportion of patients treated with Taltz who simultaneously achieved ACR50 and PASI 100 in the SPIRIT-H2H trial (Image source: Reference [3])

“Taltz is the first and only IL-17 inhibitor with superior therapeutic performance compared to adalimumab. The 52-week results from the SPIRIT-H2H trial demonstrate that Taltz maintains efficacy in alleviating both joint and skin symptoms for up to one year,” said Dr. Lotus Mallbris, Vice President of Immunology Development at Eli Lilly and Company. “These data further underscore the potential of Taltz as a first-line therapy for patients with active psoriatic arthritis.”

▲Proportion of patients treated with Taltz who achieved ASAS40 and ASDAS responses in the COAST-X trial (Image source: Reference [4])

In this Phase 3 clinical trial, named COAST-X, patients with non-radiographic axial spondyloarthritis (nr-axSpA) who had not previously been treated with biologic disease-modifying antirheumatic drugs (bDMARDs) received either Taltz or placebo. The trial data showed that after 52 weeks of treatment, the proportion of patients achieving an Assessment of SpondyloArthritis international Society 40% improvement response (ASAS40) was 30% in the group receiving treatment every four weeks and 31% in the group receiving treatment every two weeks, compared to 13% in the placebo group.

“The positive results from the COAST-X trial demonstrate the potential of Taltz to become an effective treatment option for patients with nr-axSpA,” said Ms. Rhonda Pacheco, Head of Global Immunology Product Development at Eli Lilly and Company. “We look forward to continuing our collaboration with regulatory authorities, with the hope that Taltz will become the first IL-17A antagonist approved in the United States for the treatment of patients with nr-axSpA.”

References:

[1] ACR 2019: Lilly Presents 52-Week Head-to-Head (SPIRIT-H2H) Data from Taltz® (ixekizumab) Versus Humira® (adalimumab) Trial in Psoriatic Arthritis, Retrieved November 12, 2019, from https://investor.lilly.com/news-releases/news-release-details/acr-2019-lilly-presents-52-week-head-head-spirit-h2h-data-taltzr

[2] ACR 2019: Lilly Presents Positive New Data from COAST-X, a Phase 3 Study of Taltz® (ixekizumab) in Patients with Non-Radiographic Axial Spondyloarthritis，Retrieved November 12, 2019, from https://www.prnewswire.com/news-releases/acr-2019-lilly-presents-positive-new-data-from-coast-x-a-phase-3-study-of-taltz-ixekizumab-in-patients-with-non-radiographic-axial-spondyloarthritis-300954995.html

[3] A Head-to-Head Comparison of Ixekizumab and Adalimumab in Biologic-Naïve Patients with Active Psoriatic Arthritis: Efficacy and Safety Outcomes from a Randomized, Open-Label, Blinded Assessor Study Through 52 Weeks，Retrieved November 12, 2019, from https://acrabstracts.org/abstract/a-head-to-head-comparison-of-ixekizumab-and-adalimumab-in-biologic-naive-patients-with-active-psoriatic-arthritis-efficacy-and-safety-outcomes-from-a-randomized-open-label-blinded-assessor-study-th/

[4] Ixekizumab in Non-Radiographic Axial Spondyloarthritis: Primary Results from a Phase 3 Trial，Retrieved November 12, 2019, from https://acrabstracts.org/abstract/ixekizumab-in-non-radiographic-axial-spondyloarthritis-primary-results-from-a-phase-3-trial/

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