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 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 patients with psoriatic arthritis and ankylosing spondylitis, 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.

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.

Indications and Important Safety Information
Indications

Taltz is indicated for patients as young as age 6 with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Taltz is also indicated for adult patients with active psoriatic arthritis (PsA). Taltz is also indicated for adult patients with active ankylosing spondylitis (AS).

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 and ankylosing spondylitis, 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 and ankylosing spondylitis 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 26MAR2020