Think Taltz across the spectrum of axSpA (nr-axSpA, AS)

Taltz is indicated for adults with active ankylosing spondylitis (AS), 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.

nr-axSpA Biologic-Naive Results

Unmet Need

In the US, nr-axSpA is underdiagnosed and undertreated2-5

50-50 split, lower diagnosis rate, and fewer patients treated icons

Significant improvement in nr-axSpA symptoms achieved through week 521,6

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 527.

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 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.

References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 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.

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