The first and only AS treatment with ASAS40 as a primary endpoint in its label

Taltz is indicated for adults with active ankylosing spondylitis (AS). Taltz is indicated for adults with active psoriatic arthritis. In addition, Taltz is indicated for adults with moderate to severe plaque psoriasis 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.

Now Approved for Ankylosing Spondylitis.

Ankylosing Spondylitis Efficacy

COAST-V: ASAS40 at week 16



FOR BIOLOGIC-NAIVE PATIENTS WITH ANKYLOSING SPONDYLITIS

The first and only approved AS treatment to achieve ASAS40 as a primary endpoint1,2

COAST-V was not designed to test for noninferiority or superiority against Humira® (adalimumab)

COAST-V BIOLOGIC-NAIVE: ASAS40 RESPONSE RATES AT WEEK 16, NRI. Primary endpoint for Taltz in biologic-naïve patients at 16 weeks.

*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.

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.

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.

AS=ankylosing spondylitis; ASAS40/20=Assessment of Spondyloarthritis International Society response criteria, ≥40%/≥20% improvement.

Trial Design


SELECT IMPORTANT SAFETY INFORMATION
INFECTIONS

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.

FOR TNFi-EXPERIENCED PATIENTS WITH ANKYLOSING SPONDYLITIS

Significantly more TNFi-experienced patients achieved ASAS40 and ASAS20 with Taltz vs placebo3

COAST-W (TNFi-EXPERIENCED): ASAS40 AND ASAS20 RESPONSE RATES AT WEEK 16, NRI

*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.

Trial Design


SELECT IMPORTANT SAFETY INFORMATION
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.

FOR BIOLOGIC-NAIVE PATIENTS WITH ANKYLOSING SPONDYLITIS

ASAS40 results in as fast as 16 weeks and maintained through week 521,2,4,5

COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira

Taltz efficacy maintained through 52 weeks for biologic-naïve patients

*Nominal P value: Taltz P=.003, Humira P=.001 vs placebo. Not controlled for type-I error; therefore, no 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.

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.

Additional week 52 results from COAST-W trial, NRI1, 3, 6

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.

Trial Design


SELECT IMPORTANT SAFETY INFORMATION
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.

ASAS Component Scores


FOR BIOLOGIC-NAIVE PATIENTS WITH ANKYLOSING SPONDYLITIS

Taltz showed improvement in ASAS components vs placebo1,7

COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira

Taltz subjective measures for patient improvement in morning stiffness and spinal pain
Taltz subjective measures for patient improvement in patient global assessment and function

*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.

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.

ADDITIONAL WEEK 16 RESULTS FROM COAST-W TRIAL, MMRM1,8

In COAST-W, 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.

Trial Design


SELECT IMPORTANT SAFETY INFORMATION
INFLAMMATORY BOWEL DISEASE

During Taltz treatment, monitor patients for onset or exacerbation 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.


References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019. 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 axial 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. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteenweek results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response or intolerance to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019; 71: 599 - 611. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0155. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0157. 6. Data on file. Lilly USA, LLC. DOF-IXUS-0162. 7. Data on file. Lilly USA, LLC. DOF-IX-US-0158. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0163.

Indications and Important Safety Information
Indications

Taltz is indicated for your adult patients with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

Taltz is also indicated for your adult patients 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 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.

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
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.

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 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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IX HCP ISI 23AUG2019