Taltz has the best access in the IL-17A antagonist class in psoriasis*
*Based on the number of covered lives across commercial and Part D plans

Pediatric Dermatology Efficacy

Hypothetical Patient

Taltz is the first IL-17A antagonist approved for the treatment of pediatric patients as young as age 6 with moderate to severe plaque psoriasis (PsO)¹

Taltz is 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 also indicated for adults with active psoriatic arthritis (PsA), for adults with active ankylosing spondylitis (AS), and for adults with active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

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.

FOR PEDIATRIC PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Half of Taltz pediatric patients achieved PASI 100 at week 12¹

PASI 100 results consistent with adult registration trials

IXORA-PEDS: Week 12 efficacy, NRI

IXORA-PEDS: Week 12 pediatric patient efficacy chart

In an NRI analysis of IXORA-PEDS (Taltz n=115; placebo n=56), at week 12, 89%^* of patients receiving Taltz achieved PASI 75 vs 25% for placebo; 78%^* of patients receiving Taltz achieved PASI 90 vs 5% for placebo; and 50%^* of patients receiving Taltz achieved PASI 100 vs 2% for placebo.

^*P<.001 vs placebo at week 12.
Co-primary endpoints=PASI 75 at week 12 and sPGA 0,1 at week 12.

Week 12 results from patients treated with a weight-based dose of 160 mg, 80 mg, or 40 mg of Taltz at week 0, followed by 80 mg, 40 mg, or 20 mg every 4 weeks through week 60.²

ADDITIONAL RESULTS AT WEEK 12
81% of patients taking Taltz achieved sPGA 0,1 vs 11% who received placebo.³

PASI=Psoriasis Area Severity Index; NRI=nonresponder imputation; sPGA=static Physician's Global Assessment.

IXORA-PEDS trial design

Adult PsO Registration trial data

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 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.

Pediatric Safety

FOR PEDIATRIC PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Safety profile of Taltz in IXORA-PEDS is consistent with adult psoriasis trials: no new safety signals observed^2,4

Clinically relevant adverse events of special interest through week 12^2,4

IXORA-PEDS: Adverse events during double-blind treatment period through week 12

TODO — Adverse Reaction
Taltz (n=115) n (%)
Placebo (n=56) n (%)

Infections Taltz (n=115)
n (%): 37 (32%) Placebo (n=56)
n (%): 14 (25%)

Injection site reactions* Taltz (n=115)
n (%): 14 (12%) Placebo (n=56)
n (%): 1 (2%)

Allergic reactions/hypersensitivies Taltz (n=115)
n (%): 6 (5%) Placebo (n=56)
n (%): 1 (2%)

Non-anaphylaxis Taltz (n=115)
n (%): 6 (5%) Placebo (n=56)
n (%): 1 (2%)

Potential anaphylaxis Taltz (n=115)
n (%): 0 Placebo (n=56)
n (%): 0

Crohn's disease Taltz (n=115)
n (%): 1 (0.9%) Placebo (n=56)
n (%): 0

Ulcerative colitis Taltz (n=115)
n (%): 0 Placebo (n=56)
n (%): 0

Adverse Reaction	Taltz (n=115) n (%)	Placebo (n=56) n (%)
Infections	Taltz (n=115) n (%): 37 (32%)	Placebo (n=56) n (%): 14 (25%)
Injection site reactions*	Taltz (n=115) n (%): 14 (12%)	Placebo (n=56) n (%): 1 (2%)
Allergic reactions/hypersensitivies	Taltz (n=115) n (%): 6 (5%)	Placebo (n=56) n (%): 1 (2%)
Non-anaphylaxis	Taltz (n=115) n (%): 6 (5%)	Placebo (n=56) n (%): 1 (2%)
Potential anaphylaxis	Taltz (n=115) n (%): 0	Placebo (n=56) n (%): 0
Crohn's disease	Taltz (n=115) n (%): 1 (0.9%)	Placebo (n=56) n (%): 0
Ulcerative colitis	Taltz (n=115) n (%): 0	Placebo (n=56) n (%): 0

^*The most frequent injection site reactions were erythema and pain. All injection site reactions were mild to moderate in severity and did not lead to discontinuation of Taltz.

List is not all-inclusive.

Overall, the safety profile observed in pediatric patients with PsO treated with Taltz every 4 weeks is consistent with the safety profile in adult patients with PsO, with the exception of the frequencies of conjunctivitis (3%), influenza (2%), and urticaria (2%) in the pediatric population.

Crohn’s disease occurred at a greater frequency in the Taltz group (0.9%) than the placebo group (0%) during the 12-week, placebo-controlled period. Crohn’s disease occurred in a total of 4 Taltz treated subjects (2.0%) through 48 weeks.

References: 1. Data on file. Lilly USA, LLC. DOF-IX-US-0207. 2. Taltz. Prescribing Information. Lilly USA, LLC. 3. Data on file. Lilly, USA, LLC. DOF-IX-US-0213. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0217.

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.

Please see Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 07MAY2020

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.