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Taltz is indicated for adults with active ankylosing spondylitis (AS), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and for adults with active psoriatic arthritis (PsA). Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
Difference between ASAS40 and ASAS20
AS Biologic-Naive Results
The first and only approved AS treatment to achieve ASAS40 as a primary endpoint1,2
COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare the efficacy between these products.
*P<.0001 vs placebo.
†P=.0053 vs placebo.
Primary endpoint=ASAS40 at week 16.
ASAS improvement criteria assess improvement in signs and symptoms of AS. Criteria include spinal pain, physical function, global assessment, and inflammation.
Patients with missing data were counted as nonresponders.
Nonresponder imputation (NRI) of intent-to-treat population through week 16.
AS=ankylosing spondylitis; ASAS40/20=Assessment of Spondyloarthritis International Society response criteria, ≥40%/≥20% improvement.
Among biologic-naive patients, 64% of those receiving Taltz, 59% of those receiving Humira, and 40% of those receiving placebo achieved ASAS20 at week 16.
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INFECTIONS
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.
ASAS 40 results as fast as 16 weeks and consistent through week 521-4
COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare the efficacy between these products.
*Nominal P value: Taltz P=.003, Humira P=.001 vs placebo. Not controlled for type-I error; therefore, no statistical conclusions can be made between active treatment arms. Results at week 2: Taltz=20%, Humira=21%, Placebo=5%.
†P<.0001 vs placebo at week 16.
‡P=.0053 vs placebo at week 16.
Primary endpoint=ASAS40 at week 16.
The extended treatment period of the study (weeks 16-52) has limitations (ie, no placebo comparison, patients remaining in the extension phase may be those more responsive to Taltz treatment).
ASAS scores measure degrees of spinal pain, physical function, patient global assessment, and inflammation.
NRI of intent-to-treat population through weeks 16 and 52.
Among biologic-naive patients, 64% receiving Taltz, 59% receiving Humira, and 40% receiving placebo achieved ASAS20 at week 16. At week 52, 65% of patients receiving Taltz achieved ASAS20.
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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.
ASAS Component Scores
Taltz showed improvement in ASAS components vs placebo1,5
COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare the efficacy between these products.
LSM change from baseline at week 16: Inflammation (stiffness)*
Taltz | Humira | Placebo | |
|---|---|---|---|
| Mean baseline | Taltz6.51 | Humira6.58 | Placebo6.76 |
| Change from baseline | Taltz-3.18 | Humira-2.67 | Placebo-1.27 |
LSM change from baseline at week 16: Spinal pain
Taltz | Humira | Placebo | |
|---|---|---|---|
| Mean baseline | Taltz7.2 | Humira7.0 | Placebo7.4 |
| Change from baseline | Taltz-3.2 | Humira-2.7 | Placebo-1.7 |
LSM change from baseline at week 16: Patient’s Global Assessment Score
Taltz | Humira | Placebo | |
|---|---|---|---|
| Mean baseline | Taltz6.9 | Humira7.1 | Placebo7.1 |
| Change from baseline | Taltz-2.5 | Humira-2.6 | Placebo-1.4 |
LSM change from baseline at week 16: Function (BASFI)
Taltz | Humira | Placebo | |
|---|---|---|---|
| Mean baseline | Taltz6.06 | Humira6.06 | Placebo6.35 |
| Change from baseline | Taltz-2.39 | Humira-2.14 | Placebo-1.16 |
*Mean of BASDAI questions 5 and 6 (morning stiffness duration and morning stiffness severity).
Nominal P value: Individual component scores were not controlled for type-I error; therefore, no statistical comparisons can be made for either treatment arm.
†P<.001 vs placebo.
‡P=.008 vs placebo.
§P=.009 vs placebo.
‖P=.001 vs placebo.
Primary endpoint=ASAS40 at week 16.
BASDAI scores measure 5 clinical domains through a patient questionnaire.
BASFI is measured using a visual analog scale questionnaire focused on the patient's ability to perform specific functional tasks.
BASDAI range 0-10; spinal pain range 0-10; Patient's Global Assessment score range 0-10; BASFI range 0-10.
BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; LSM=least-squares mean.
ADDITIONAL WEEK 16 RESULTS FROM COAST-W TRIAL, MMRM1,6
In COAST-W (TNFi-experienced) (Taltz 80 mg every 4 weeks n=114; placebo n=104), mean percentage change from baseline in morning stiffness at week 16 was 32% for patients receiving Taltz and 5% for placebo, and mean percentage change from baseline in BASFI was 18% for patients receiving Taltz and 7% for placebo. Mean percentage change from baseline in spinal pain at week 16 was 30% for patients receiving Taltz and 11% for placebo and mean percentage change from baseline in Patient’s Global Assessment score at week 16 was 31% for patients receiving Taltz and 6% for placebo.
Among TNFi-experienced patients, change from baseline in inflammation at week 16 was -2.42 (baseline 7.21) for patients receiving Taltz and -0.70 (baseline 7.20) for placebo, and change from baseline in BASFI at week 16 was -1.69 (baseline 7.35) for patients receiving Taltz and -0.64 (baseline 7.01) for placebo, and change from baseline in spinal pain was -2.4 (baseline 7.9) for patients receiving Taltz and -1.0 (baseline 7.8) for placebo, and change from baseline in Patient’s Global Assessment score at week 16 was -2.4 (baseline 8.0) for patients receiving Taltz and -0.7 (baseline 7.8) for placebo.
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HYPERSENSITIVITY
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.
AS TNFi-Experienced Results
Significantly more TNFi-experienced patients achieved ASAS40 and ASAS20 with Taltz vs placebo1,7
*P<.05 vs placebo.
†P<.01 vs placebo.
Primary endpoint=ASAS40 at week 16.
ASAS improvement criteria assess improvement in signs and symptoms of AS. Criteria include spinal pain, physical function, global assessment, and inflammation.
Patients with missing data were counted as nonresponders.
NRI of intent-to-treat population through week 16.
TNFi=tumor necrosis factor inhibitor.
Additional week 52 results from COAST-W trial, NRI1,7,8
In COAST-W (TNFi-experienced) (Taltz 80 mg every 4 weeks n=114; placebo n=104), 34% of patients receiving Taltz achieved ASAS40 and 53% of patients receiving Taltz achieved ASAS20 at week 52.
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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 exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.
References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axia spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392:2441-2451. 3. Data on file. Lilly USA, LLC. DOF-IX-US-0155. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0157. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0158. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0163. 7. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71:599-611. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0162.
INDICATIONS
Taltz is indicated for adults with active psoriatic arthritis (PsA), for adults with active ankylosing spondylitis (AS), and for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
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
Infections
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.
Hypersensitivity
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.
Immunizations
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.
ADVERSE REACTIONS
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 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.
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IX HCP ISI 07MAY2020