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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TALTZ vs HUMIRA® (adalimumab)

The first and only IL-17A antagonist to demonstrate superiority in a head-to-head trial against Humira in PsA1-5

As measured by the percentage of patients who simultaneously achieved both ACR50 and PASI 100 at week 24.1

PsA=psoriatic arthritis.

Humira® is a registered trademark of AbbVie Biotechnology Ltd.

Scroll down to see the data.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Superiority vs Humira at week 24: Simultaneous achievement of ACR50 and PASI 100 at week 24, with consistency at week 526

*P<.05 vs Humira at week 24.

P≤.001 vs Humira at week 52. Nominal P value: Week 52 measure of ACR50 + PASI 100 was not controlled for type-I error; therefore, no statistical comparisons can be made.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing for moderate to severe PsO.8

See SPIRIT-H2H trial design

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 PSORIATIC ARTHRITIS

ACR50 responses that rivaled Humira at week 24 and were consistent at week 528,9

In an NRI analysis, 69% and 70% of patients taking Taltz vs 72% and 69% of patients taking Humira achieved ACR20 at weeks 24 and 52, respectively. Additionally, 32% and 35% of patients taking Taltz vs 26% and 34% of patients taking Humira achieved ACR70 at weeks 24 and 52, respectively.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.8

Major secondary objective met: demonstrated noninferiority of Taltz vs Humira in ACR50 response at 24 weeks (95% CI [−4.3%, 12.1%]) for noninferiority with −12.0% margin.8,9

ACR20 and ACR70 at week 24 and all responses at week 52 were prespecified but not type-I error-controlled; therefore, results cannot be regarded as statistically significant.8

See SPIRIT-H2H trial design

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.

Rapid minimal disease activity (MDA) response seen as early as Week 4 in some patients, with consistent results through Week 52 10,11

SPIRIT-H2H
MDA Response Rates through Week 52, NRI

MDA was prespecified but not controlled for type-1 error; therefore, results cannot be reported as statistically significant.

Patients are classified as having MDA if they fulfill at least 5 of 7 outcome measures: tender joint count ≤1; swollen joint count ≤1; PASI score ≤1 or BSA ≤3%; patient pain VAS score ≤15; patient global disease activity VAS score ≤20; HAQ-DI score ≤0.5; and tender entheseal points ≤1.12

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.

See SPIRIT-H2H Trial Design .

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz vs Humira: Complete resolution of enthesitis at weeks 24 and 5213

Enthesitis data were prespecified but not type-I error-controlled; therefore, results cannot be regarded as statistically significant.

A subset of patients from SPIRIT-H2H with enthesitis (LEI >0) at baseline.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.8

Mean baseline LEI scores were 2.5 for Taltz and 2.7 for Humira.8

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, and sPGA ≥3 followed the dosing regimen indicated for moderate to severe PsO.

See SPIRIT-H2H trial design

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 BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz vs Humira: Complete resolution of dactylitis at weeks 24 and 5214

Dactylitis data were prespecified but not type-I error-controlled; therefore, results cannot be regarded as statistically significant.

A subset of patients from SPIRIT-H2H with dactylitis (LDI-B >0) at baseline.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.8

Mean baseline LDI-B scores were 40 for Taltz and 56 for Humira.8

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, and sPGA ≥3 followed the dosing regimen indicated for moderate to severe PsO.

See SPIRIT-H2H 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.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Superior PASI 100 response vs Humira at week 24, with consistency at week 5215

*P≤.001 vs Humira at week 24 for PASI 100.15

P≤.001 vs Humira at week 52 for PASI 100.12 Nominal P value: Week 52 was not controlled for type-I error; therefore, no statistical comparisons can be made.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.8

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, and sPGA ≥3 followed the dosing regimen indicated for moderate to severe psoriasis.8

See SPIRIT-H2H trial design

SELECT IMPORTANT SAFETY INFORMATION:
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.

IN BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Safety profile of Taltz in SPIRIT-H2H is consistent with registration trials; no new safety signals were observed8,16,17

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

SPIRIT-H2H: Taltz vs Humira

TALTZ DEMONSTRATED POSITIVE RESULTS:

  • Superiority vs Humira in the percentage of patients who achieved both ACR50 and PASI 100 at week 24, with consistency at week 521,6
  • Complete resolution in key domains of PsA2-4,10-12 (Enthesitis, dactylitis, plaque psoriasis)
    Click here for data
  • Safety consistent with registration trials5,8,13,14
    Click here for data

See SPIRIT-H2H trial design

SPIRIT-P1 and P2 registration trial data

TALTZ HAS NO BOXED WARNING.14

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. Data on file. Lilly USA, LLC. DOF-IX-US-0121.
  2. Data on file. Lilly USA, LLC. DOF-IX-US-0122.
  3. Data on file. Lilly USA, LLC. DOF-IX-US-0123.
  4. Data on file. Lilly USA, LLC. DOF-IX-US-0124.
  5. Data on file. Lilly USA, LLC. DOF-IX-US-0125.
  6. Data on file. Lilly USA, LLC. DOF-IX-US-0190.
  7. Data on file. Lilly USA, LLC. DOF-IX-US-0119.
  8. Mease PJ, Smolen JS, Behrens F, et al. A head-to-head comparison of the efficacy and safety of ixekizumab and adlimumab in biologic-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2020;79:123-131.
  9. Data on file. Lilly USA, LLC. DOF-IX-US-0189.
  10. Smolen JS, Mease P, Tahir H, et al. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis. 2020;79:1310-1319.
  11. Smolen JS, Mease P, Tahir H, et al. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52. Supplementary material. Ann Rheum Dis. 2020;79:1310-1319.
  12. Coates LC, Fransen J, Helliwell PS. Defining minimal disease activity in psoriatic arthritis: a proposed objective target for treatment. Ann Rheum Dis. 2010;69:48-53.
  13. Data on file. Lilly USA, LLC. DOF-IX-US-0194.
  14. Data on file. Lilly USA, LLC. DOF-IX-US-0195.
  15. Data on file. Lilly USA, LLC. DOF-IX-US-0191.
  16. Data on file. Lilly USA, LLC. DOF-IX-US-0188.
  17. Taltz. Prescribing Information. Lilly USA, LLC.
  18. Mease P, van der Heidje 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(suppl):1-30.
  19. 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.
  20. 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.

Humira® is a registered trademark of AbbVie Biotechnology Ltd.

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.