Taltz® Showed Consistent, Long-Term Improvement in Key Signs and Symptoms of Axial Spondyloarthritis Through Two Years in Phase 3 Study
AxSpA is recognized as a single disease entity, with two subtypes which are defined depending on the presence (radiographic axSpA, or r-axSpA) or absence (non-radiographic axSpA, or nr-axSpA) of defined structural damage of the sacroiliac joints on plain x-ray films as per the modified
"Patients living with axial spondyloarthritis deal with a range of chronic, debilitating symptoms, including inflammatory back pain, and are in need of treatment options that can provide long-term efficacy," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at
Taltz Showed Sustained Long-Term Improvements in axSpA Through Two Years
In COAST-Y, Taltz showed consistent and sustained long-term improvements in signs and symptoms, functionality and quality of life in patients with r- and nr-axSpA. In this study, more than half of patients (56.7%) treated continuously with Taltz (80 mg every four weeks, n=157) through two years achieved Assessment of SpondyloArthritis international Society 40% response (ASAS40).
Among those treated continuously with Taltz every four weeks for two years:
- 43.9% of patients achieved low disease activity status, as measured by Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1. Mean change from baseline (3.9) in ASDAS score was -1.6.
- 19.7% achieved ASAS partial remission status.
- Mean change from baseline (6.6) in Bath Ankylosing Spondylitis Functional Index (BASFI) was -2.8.
- Mean change from baseline (33.9) in Medical Outcomes Survey Short Form 36 Physical Component Summary (SF-36 PCS) was 8.4.
The safety profile of Taltz was consistent with previously published safety data, and no new safety signals were observed after up to two years of treatment.
For methodology, see the "About the Analyses" section below. Additional results from the Phase 3 COAST-Y study were also recently published in the Annals of the Rheumatic Diseases.
Most Patients Treated with Taltz Did Not Show Bone Damage Progression of r-axSpA Up to Two Years
An analysis of two Phase 3 studies in r-axSpA (COAST-V and COAST-W) and the long-term extension trial (COAST-Y), found that 9 out of 10 patients treated with Taltz (89.6%, n=206) did not show radiographic progression for up to two years, as measured by mean change from baseline of modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) <2. Overall mean rates of progression were low among patients treated with Taltz. These results were similar among patients who were previously treated with anti-TNF therapy (88%, n= 106) and those who had not previously been treated with a biologic (91%, n=100). For methodology, see the "About the Analyses" section below.
"If left uncontrolled, individuals living with active radiographic axSpA can experience severe, chronic pain and structural damage in the spine that can lead to fusion of the spine and loss of mobility," said
- Baseline Characteristics and Treatment Response to Ixekizumab Categorized by Sex in Radiographic and Non-radiographic Axial Spondyloarthritis Patients Through 52 Weeks: Data From 3 Phase 3 Randomized Controlled Trials
- Ixekizumab Shows a Distinct Pattern of Pain Improvement Beyond Inflammation in Radiographic Axial Spondyloarthritis
- Ixekizumab Efficacy on Spinal Pain, Disease Activity and Quality of Life in Patients with Psoriatic Arthritis Presenting with Symptoms Suggestive of Axial Involvement
More than 175,000 patients have been treated with Taltz worldwide since launch, giving healthcare providers confidence in making informed prescribing decisions for the treatment of adults with active psoriatic arthritis, active ankylosing spondylitis, active nr-axSpA and moderate to severe plaque psoriasis.
About the Analyses
- Long-term Treatment with Ixekizumab in Patients with Axial Spondyloarthritis: 2-year Results from COAST-Y
- COAST-Y is the two-year extension of the COAST-V, COAST-W and COAST-X trials. Upon completion of the initial trials, 773 patients continued with the dose received at the end of the originating trial at Week 52, either with 80 mg Taltz every two weeks or four weeks. Patients who had been assigned to adalimumab or placebo were re-randomized to Taltz every two weeks or every four weeks at Week 16 in COAST-V and COAST-W. Patients who had received placebo for 52 weeks in COAST-X were switched to Taltz every four weeks in COAST-Y. For this analysis, only patients continuously treated with Taltz since the originating studies were included. All other patients were analyzed separately.
- Standardized efficacy measures were used. Missing data were handled by non-responder imputation for categorical data and modified baseline observation carried forward for continuous data. Safety data were analyzed for all patients who received ≥1 dose of Taltz.
- Evaluation of Spinal Radiographic Progression in Patients with Radiographic Axial Spondyloarthritis Receiving Ixekizumab Therapy over 2 Years
- These analyses included biologic-naïve patients with active r-axSpA (COAST-V) or patients with prior inadequate response or intolerance to one or two TNF inhibitors (COAST-W) who received 80 mg Taltz every two weeks or four weeks for two years (108 weeks, of which 56 weeks were the COAST-Y long-term extension study).
- Mean change from baseline of mSASSS (average score from two selected readers, blinded for time order) for patients treated with Taltz for two years with data at both baseline and year 2 is presented (n=230; 54% of total randomized patients). Of the 657 patients who entered COAST-V or -W, 527 patients re-consented to enter COAST-Y; however, 104 patients had either baseline or Year 2 mSASSS data missing. Of 423 patients with baseline and Year 2 mSASSS data, 230 (54%) were treated with Taltz for at least two years. Of these, 110 were biologic-naïve and 120 were TNFi-experienced.
INDICATIONS AND USAGE FOR TALTZ
Taltz is approved for the treatment of patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and for the treatment of adults with active psoriatic arthritis, active ankylosing spondylitis, or active non-radiographic axial spondyloarthritis with objective signs of inflammation.
IMPORTANT SAFETY INFORMATION FOR TALTZ
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Taltz may increase the risk of infection. In clinical trials of adult 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 adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. 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
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.
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, oropharingeal pain and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis (also common). Adverse drug reactions in patients with radiographic axial spondyloarthritis (ankylosing spondylitis) were similar with the exception of inflammatory bowel disease (common) and rhinitis (common). In patients with non-radiographic axial spondyloarthritis, adverse events were also similar to inflammatory bowel disease (common), influenza (common) and conjunctivitis (common).
IX HCP ISI 07MAY2020
Taltz is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. 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.
About Axial Spondlyoarthritis
Axial spondyloarthritis (axSpA), which includes both radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA), is a disease predominantly affecting the sacroiliac joints and the spine. Common symptoms include chronic inflammatory back pain, fatigue and stiffness.1,2,3 It is estimated that 2.3 million people in the
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) as a treatment for ankylosing spondylitis, radiographic and non-radiographic axial spondylorarthritis, and psoriatric arthritis, and reflects
1 Reveille JD, et al. Prevalence of axial spondylarthritis in
2 Strand V, et al. Prevalence of axial spondyloarthritis in
3 Kiltz U, et al. Do patients with non-radiographic axial spondylarthritis differ from patients with ankylosing spondylitis? Arthritis Care Res. 2012;64(9):1415-22.
5 Deodhar A, et al. The concept of axial spondyloarthritis: joint statement of the spondyloarthritis research and treatment network and the Assessment of
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