Our lowest doses, now available in a prefilled syringe for PsO pediatric patients as young as 6

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: IMMUNIZATIONS
Prior to initiating Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

FOR PEDIATRIC PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Half of Taltz pediatric patients achieved PASI 100 at week 12²

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 60.¹

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: 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.

Pediatric Safety

FOR PEDIATRIC PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Safety Profile of Taltz in IXORA-PEDS: no new safety signals observed through week 12 and 48^{1, 4-12}

Consistent with data from adult psoriasis trials¹

Clinically relevant adverse events of special interest through week 12^1,4

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

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/hypersensitivities 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/hypersensitivities	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.

IXORA-PEDS: Adverse events of special interest through week 48

chart of infections to total Taltz population (n=196) n (%) — Total Taltz Population* (n=196) n (%)

Infections 129 (66%)

Upper respiratory tract infections 35 (18%)

Nasopharyngitis 34 (17%)

Pharyngitis 17 (9%)

Conjunctivitis 15 (8%)

Tonsillitis 15 (8%)

Impetigo 13 (7%)

Serious infections 2 (1%)

Otitis media acute 1 (1%)

Tonsillitis 1 (1%)

Injection site reactions 39 (20%)

Injection site reaction 32 (16%)

Pain 7 (4%)

Erythema 5 (3%)

IBD (adjudicated) 4 (2%)

Crohn’s disease^† 4 (2%)

Ulcerative colitis 0

List is not all-inclusive.

	Total Taltz Population* (n=196) n (%)
Infections	129 (66%)
Upper respiratory tract infections	35 (18%)
Nasopharyngitis	34 (17%)
Pharyngitis	17 (9%)
Conjunctivitis	15 (8%)
Tonsillitis	15 (8%)
Impetigo	13 (7%)
Serious infections	2 (1%)
Otitis media acute	1 (1%)
Tonsillitis	1 (1%)
Injection site reactions	39 (20%)
Injection site reaction	32 (16%)
Pain	7 (4%)
Erythema	5 (3%)
IBD (adjudicated)	4 (2%)
Crohn’s disease^†	4 (2%)
Ulcerative colitis	0

^*Includes all patients who received at least one dose of ixekizumab.

Overall, the safety profile observed in pediatric patients with plaque psoriasis treated with Taltz every 4 weeks is consistent with the safety profile in adult patients with plaque psoriasis, with the exception of the frequencies of conjunctivitis (3%), influenza (2%), and urticaria (2%).¹¹

The most frequent injection site reactions were pain (4%) and erythema (3%). All injection-site reactions were mild to moderate in severity. All patients treated with Taltz who had an injection site reaction continued treatment.⁸

The joint American Academy of Dermatology–National Psoriasis Foundation pediatric guidelines cite that the prevalence rate of IBD in children with psoriasis is thought to be 3 to 4 times higher than in children without psoriasis. Additionally, the guidelines suggest that pediatric patients with psoriasis have a higher prevalence rate of Crohn’s disease versus ulcerative colitis.¹²

^†The 4 cases included a 9-year-old female who reported symptoms of gastrointestinal inflammation and abdominal pain at the time of randomization in the double-blind treatment period. Adverse event occurred approximately 60 days after starting Taltz therapy. She discontinued the study at physician’s direction. The 3 additional cases occurred in a 9-year-old female, a 13-year-old female, and a 14-year-old male. One of the patients had a risk factor of additional autoimmune inflammatory diseases. None of the patients reported a family history of IBD. The 4 patients discontinued.

IBD=inflammatory bowel disease.

References: 1. Taltz. Prescribing Information. Lilly USA, LLC 2. Data on file. Lilly USA, LLC. DOF-IX-US-0207. 3. Data on file. Lilly, USA, LLC. DOF-IX-US-0213. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0217. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0096. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0088. 7. Data on file. Lilly USA, LLC. DOF-IX-US-0105. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0216. 9. Data on file. Lilly USA, LLC. DOF-IX-US-0218. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0208. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0215. 12. Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82:161-201.

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. Serious infections have occurred. 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 placebocontrolled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. In the post-marketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving IL-17 inhibitors, including Taltz. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and 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. Consider anti-TB therapy prior to initiating Taltz in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving Taltz should be monitored closely 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.

Eczematous Eruptions
In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving Taltz; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of Taltz. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing Taltz.

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.

Taltz is available as an 80 mg/mL, 40 mg/0.5mL, 20 mg/0.25mL injection.

IX HCP ISI 20AUG2024

INDICATIONS

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 non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.