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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®)

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For patients with active ankylosing spondylitis (AS)

Taltz is for Today and Tomorrow

An IL-17A antagonist with rapid and sustained efficacy in the spine1-13

See efficacy data below

Rapid ASAS40 response seen as early as Week 2 in some patients4,16-18

COAST-V (BIOLOGIC-NAIVE): ASAS40 response rates through week 52, NRI

COAST-V ASAS40 respsonse rates through 52 weeks chart

*Nominal P value: Taltz P=.003, Humira P=.001 vs placebo. Not controlled for type-I error; therefore, no statistical conclusions can be made. Results at week 2: Taltz=20%; Humira=21%; placebo=5%.
†P<.0001 vs placebo at week 16.
‡P=.0053 vs placebo at week 16.
Primary endpoint=ASAS40 at week 16.
NRI of ITT population through weeks 16 and 52.

COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare the efficacy between these products.

The extended treatment period of the study (weeks 16-52) has limitations (i.e., no placebo comparison, patients remaining in the extension phase may be those more responsive to treatment).

Additional week 16 and 52 results from COAST-W trial4,19,20

In COAST-W (TNFi-experienced) (Taltz 80 mg every 4 weeks n=114; placebo n=104), 25% of patients receiving Taltz achieved ASAS40 at week 16 vs 13% of patients receiving placebo. At week 52, 34% of patients receiving Taltz achieved ASAS40.

Click here for COAST-V and -W trial designs

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 biologic-naive patients with active ankylosing spondylitis (AS)

Rapid BASDAI50 response seen as early as Week 2 in some patients20

BASDAI50 Response Rates Through Week 16, NRI

BASDAI50 response rate at week 2 was not controlled for type 1 error; therefore, statistical conclusions cannot be made.

BASDAI50 is ≥50% improvement in the BASDAI score from baseline. BASDAI baseline mean: Taltz=6.8, Humira=6.7, PBO=6.8.

COAST-V was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare the efficacy between these products.

Primary endpoint=ASAS40 at week 16.

See COAST-V Trial Design.

For biologic-naive patients with AS

ASDAS-Low Disease Activity response through Week 1621

COAST-V Post Hoc Analysis: ASDAS <2.1 (Low Disease Activity)—Response Rate Through Week 16, NRI

Data are from a post hoc analysis and were not type-I error-controlled; therefore, statistical conclusions cannot be made.

ASDAS low disease activity is defined as a score of <2.1.

Primary endpoint=ASAS40 at week 16.

See COAST-V Trial Design.

For biologic-naive patients with AS

ASAS40 response sustained through 3 years22,23

In an NRI analysis of patients receiving Taltz, ASAS40 results were 48% at week 16, 53% at week 52, 53% at week 116, and 37% at week 156.

The open-label extension period of the study has limitations (e.g., no placebo comparisons, patients remaining in the study may be those with better results).

COAST-V Primary endpoint=ASAS40 at week 16.

See COAST-V Trial Design.

For patients with AS

The majority of Taltz patients had no radiographic progression* through 2 years.21

COAST-Y: Proportion of radiographic non-progressors at year 2

TODO

*Defined as a change from baseline in mSASSS ≤0.

mSASSS mean change from baseline (10.6) was 0.4 at 2 years.

Results from 2-year COAST-Y extension study. This analysis included patients from COAST-V and -W who have AS and continued Taltz 80 mg Q4W (n=115) uninterrupted.

The open-label extension has limitations (e.g., no placebo comparison, patients remaining in the extension phase may be those with better results). Patients in the extension period population were all patients administered Taltz on or after week 24.

Radiographic progression was a prespecified secondary endpoint in COAST-Y.

See COAST 2-Year Radiographic Progression Analysis Design

References:

  1. Data on file. Lilly USA, LLC. DOF-IX-US-0304.
  2. Mease P, van der Heijde D, Ritchlin CT, et al; on behalf of SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76:79-87.
  3. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase III trial. Lancet. 2017;389:2317-2327.
  4. Taltz. Prescribing Information. Lilly USA, LLC.
  5. Data on file. Lilly USA, LLC. DOF-IX-US-0013.
  6. Chandran V, van der Heijde D, Fleischmann RM, et al. Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology. 2020;59:2774-2784.
  7. Data on file. Lilly USA, LLC. DOF-IX-US-0247.
  8. Data on file. Lilly USA, LLC. DOF-IX-US-0308.
  9. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase III trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
  10. Data on file. Lilly USA, LLC. DOF-IX-US-0102.
  11. Data on file. Lilly USA, LLC. DOF-IX-US-0012.
  12. Data on file. Lilly USA, LLC. DOF-IX-US-0278.
  13. Orbai A, Gratacós J, Turkiewicz A, et al. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021;8:199-217. https://doi.org/10.1007/s40744-020-00261-0.
  14. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying antirheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392:2441-2451.
  15. Data on file. Lilly USA, LLC. DOF-IX-US-0155.
  16. Data on file. Lilly USA, LLC. DOF-IX-US-0157.
  17. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71:599-611.
  18. Data on file. Lilly USA, LLC. DOF-IX-US-0162.
  19. van der Heijde D, Østergaard M, Reveille JD, et al. Spinal radiographic progression and predictors of progression in patients with radiographic axial spondyloarthritis receiving ixekizumab over 2 years. J. Rheumatol. 2022;49:265-273
  20. Data on file. Lilly USA, LLC. DOF-IX-US-0172
  21. Data on file. Lilly USA, LLC. DOF-IX-US-0321.
  22. Data on file. Lilly USA, LLC. DOF-IX-US-0323.
  23. Deodhar A, Poddubnyy D, Rahman P, et al. Long-term safety and efficacy of ixekizumab in patients with axial spondyloarthritis: 3-year data from the COAST program. J Rheumatol. 2023:50(8):1020-1028. doi:10.3899/jrheum.221022. Epub 2023 Feb 15.

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.