In PsA, AS, and nr-axSpA, Taltz is the preferred IL-17A antagonist on 2 out of the 3 largest PBMs (Express Scripts NPF^® and Optum Rx^®)

Hypothetical Patient

For patients with active nonradiographic axial spondyloarthritis (nr-axSpA)

Non-Radiographic Axial Spondyloarthritis Efficacy

An IL-17A antagonist for patients across the spectrum of axSpA

See data below

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

Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

Unmet Need

In the US, nr-axSpA is underdiagnosed and undertreated^2-5

50-50 split, lower diagnosis rate, and fewer patients treated icons — Comparison of nr-axSpA and AS statistics. Of the 2.3 million patients in the United States that have axSpA, half have nr-axSpA and half have AS. There is a lower diagnosis rate in nr-axSpA compared to AS. Fewer nr-axSpA patients are adequately treated due to lower diagnosis rates and fewer approved treatment options. The disease burden (pain, BASDAI, BASFI) is similar in patients with AS or nr-axSpA.

nr-axSpA Biologic-Naive Results

Significant improvement in nr-axSpA symptoms achieved through week 52^1,6

COAST-X (BIOLOGIC-NAIVE): ASAS40 RESPONSE RATES AT WEEK 16, NRI

^*P<.01 vs placebo at week 16.

^†P=.0045 vs placebo at week 52.

Primary endpoint=ASAS40 at week 52.

Starting at week 16 and up to week 44, changes could be made to non-biologic background therapy and/or patients could be transitioned to open-label Taltz 80 mg Q2W at the investigators' discretion. Patients who either switched to Taltz 80 mg Q2W, were missing week 16 or week 52 data, or discontinued double-blind treatment were considered non-responders. Taltz 80 mg Q2W is not an approved dose for nr-axSpA.

In a post hoc analysis of the patients in the Q4W arm that switched to open-label therapy (n=40), 25% had achieved ASAS40 at the last visit before switching; these patients were counted as non-responders in the primary outcome analysis at week 52⁸.

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.

References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021. 2. Strand V, et al. Prevalence of axial spondyloarthritis in United States rheumatology practices: Assessment of SpondyloArthritis International Society criteria versus rheumatology expert clinical diagnosis. Arth Care Res. 2013;65:1299-1306. 3. U.S. Census Bureau, Population Estimates Program (PEP), Quick Facts. https://www.census.gov/quickfacts/fact/table/US. Accessed April 30, 2020. 4. Robinson PC, et al. Non-Radiographic Axial Spondyloarthritis (nr-axSpA): Advances in Classification, Imaging and Therapy. Rheumatol Ther. 2019;6:165- 177. 5. Rudwaleit M, et al. The early disease stage in axial spondylarthritis: results from the German Spondyloarthritis Inception Cohort. Arthritis Rheum. 2009;60:717-727. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0225. 7. Deodhar A, et al. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020; 395:53-64.

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 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 moderateto-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.