The first IL-17A antagonist now approved for adult patients across the spectrum of axSpA (nr-axSpA, AS)  

Dactylitis

Taltz showed improvement in patients with preexisting dactylitis2,3,10

SPIRIT-P1 BIOLOGIC-NAIVE: POST HOC ANALYSIS: COMPLETE RESOLUTION OF DACTYLITIS (LDI-B=0) AT WEEK 24 AMONG PATIENTS WITH LDI-B>0 AT BASELINE, NRI

Mean baseline LDI-B was 73.0 for Taltz and 62.7 for placebo.

In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=28, mean baseline=31.5; placebo n=14, mean baseline=37.3), 75% of Taltz patients had complete resolution of dactylitis at week 24 vs 21% for placebo.

The data presented were from post hoc analyses and were not type-I error-controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.

Inadequate responders (<20% in tender and in swollen join counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.

LDI-B=Leads Dactylitis Index-Basic.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Post hoc analysis: resolution of dactylitis (LDI-B=0) through week 1083,11

Double-blind and open-label extension periods, ITT population, mNRI and observed
Patients with dactylitis (LDI-B>0) at baseline
Mean baseline score-73

SPIRIT-P1 BIOLOGIC-NAIVE: RESOLUTION OF DACTYLITIS (LDI-B=0) THROUGH WEEK 108, OBSERVED

Primary endpoint=ACR20 response at week 24.

mNRI, a preferred method for analyzing long term efficacy, imputes missing data due to study drug (e.g., inadequate response, adverse event, or lack of efficacy), as nonresponse; whereas, missing data due to other reasons (e.g., missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.

Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.

After week 24, patients knew they were taking active treatment, but remained blind to the dose until the last patient completed week 24. The uncontrolled extension period of the study has limitations (e.g., no placebo comparisons, patients remaining in the study may be those with better results).

LDI-B=Leeds Dactylitis Index-Basic.

mNRI=modified nonresponder imputation.

Trial design


SELECT 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.

Indications and Important Safety Information
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