On August 23, 2019, the U.S. Food and Drug Administration (FDA) approved Lilly’s Taltz® (ixekizumab) injection 80 mg/mL for the treatment of adults with active ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). Taltz is also approved to treat adults with active psoriatic arthritis and to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Approximately 1.6 million people in the U.S. suffer from AS, a chronic, progressive inflammatory disease that causes pain in the back, pelvis and other joints. 1 Currently, it is estimated that only 40 percent of people living with AS in the U.S. are using medication to manage the disease. 2
The approval of Taltz was based on findings from COAST-V and COAST-W – two Phase 3, multicenter, randomized, double-blind clinical trials designed to evaluate the safety and efficacy of Taltz compared to placebo in 657 adult patients with active AS. COAST-V studied patients who were biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve and COAST-W studied patients who previously had an inadequate response or were intolerant to one or two TNF inhibitors (TNFi).
In both studies, Taltz demonstrated significant and clinically meaningful improvements in signs and symptoms of AS, defined by the primary endpoint of Assessment of Spondyloarthritis International Society 40 (ASAS40) compared to placebo at week 16 . Taltz is the first and only approved AS treatment to achieve ASAS40 as a primary endpoint.
- COAST-V: 48 percent of patients treated with Taltz (80 mg) every four weeks achieved ASAS40 response at week 16 versus 18 percent of patients treated with placebo ( P<0.0001)
- COAST-V: 25 percent of patients treated with Taltz (80 mg) every four weeks achieved ASAS40 response at week 16 versus 13 percent of patients treated with placebo ( P<0.05)
Overall, the safety profile observed in patients with AS treated with Taltz (80 mg) was consistent with the safety profile in patients with plaque psoriasis. Taltz should not be used in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Taltz may increase the risk of infection. Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations. See Important Safety Information below.
“Taltz is an effective treatment option for people with active ankylosing spondylitis because it addresses the signs and symptoms of the disease as demonstrated by its efficacy in achieving ASAS40 response,” said Atul Deodhar, M.D., Professor of Medicine, Oregon Health & Science University and clinical trial investigator for the Taltz AS clinical trial program.
In the clinical trial program, patients treated with Taltz also demonstrated statistically significant improvements in key secondary endpoints, including the proportion of patients at 16 weeks achieving ASAS20 at the following response rates:
- COAST-V: 64 percent of patients treated with Taltz (80 mg) every four weeks versus 40 percent of patients treated with placebo ( P=0.0015)
- COAST-W: 48 percent of patients treated with Taltz (80 mg) every four weeks versus 30 percent of patients treated with placebo ( P<0.01)
“Taltz was studied in people with AS who had not previously taken a biologic, as well as those who had failed or couldn’t tolerate one or two TNF inhibitors,” said Dr. Deodhar. “ Data from COAST-V and COAST-W demonstrate that Taltz works well in reducing symptoms of AS across both of these patient groups. ”
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Taltz is approved for the treatment of adults with active ankylosing spondylitis. Taltz is also approved for the treatment of adults with active psoriatic arthritis and adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
IMPORTANT SAFETY INFORMATION
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
Taltz may increase the risk of infection. In clinical trials of patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of patients with psoriatic arthritis and ankylosing spondylitis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.
Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.
Inflammatory Bowel Disease
During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz 80 mg Q2W group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn’s disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn’s disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.
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1. Reveille JD, Weisman MH. The epidemiology of back pain, axial spondyloarthritis and HLA-B27 in the United States. Am J Med Sci . 2013 Jun;345(6):431-436.
2. DRG, Axial Spondyloarthritis- Epidemiology- Mature Markets- DR PatientBase201510.
PP-IX-US-2798 11/2019 ©Lilly USA, LLC 2019. All rights reserved.
Taltz® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.