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More insurance plans than ever are offering Taltz as the Preferred IL-17A antagonist across Commercial and Part D.

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Taltz is for Today and Tomorrow

An IL-17A antagonist with rapid and sustained efficacy in the joints and skin1-13

Rapid ACR20 response seen as early as Week 2 in some patients with active psoriatic arthritis, regardless of TNFi experience1-4,9

SPIRIT-P1 (BIOLOGIC-NAIVE): ACR20 response rates through week 24, NRI

SP1 response rate in Taltz and placebo by week 24

*P≤.001 vs placebo at weeks 12 and 24.

SPIRIT-P2 (TNFi-EXPERIENCED): ACR20 response rates through week 24, NRI3,4

SP2 response rate in Taltz and placebo over the course of 24 weeks

†P<.0001 vs placebo at weeks 12 and 24.

ACR20 at week 2 was not controlled for type 1 error; therefore, statistical conclusions cannot be made.

Additional Week 24 Data, NRI:
In SPIRIT-Pl and SPIRIT-P2, 40% and 35% of patients receiving Taltz achieved ACR50 vs 15% and 5% for placebo, and 23% and 22% of Taltz patients achieved ACR70 vs 6% and 0% for placebo (P<.001 vs placebo).

NRI of intent-to-treat population through week 24.

Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.

Primary endpoint=ACR20 response at week 24.

Click here for SPIRIT-P1 and SPIRIT-P2 Trial Designs

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.

FOR PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Joint symptom results sustained for 3 years, regardless of TNFi experience4-7,13

SPIRIT-P1 (BIOLOGIC-NAIVE): ACR response rates during double-blind and uncontrolled extension periods, observed5,6

SPIRIT-P1 ACR response rates through 156 weeks during double-blind and uncontrolled extension periods

SPIRIT-P2 (TNFi-EXPERIENCED): ACR response rates during double-blind and uncontrolled extension periods, observed4,7,13

SPIRIT-P2 ACR response rate chart over three years

*Nx = observed population at week 156. Nx values are different due to missing data.

In SPIRIT-P1, in an mNRI analysis of patients receiving Taltz, ACR20 results were 76% at week 52, 71% at week 108, and 70% at week 156, ACR50 results were 60% at week 52, 52% at week 108, and 52% at week 156. ACR70 results were 40% at week 52, 27% at week 108, and 33% at week 156.

mNRI of ITT population through week 156.

Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.

In SPIRIT-P2 (TNFi-experienced), in a modified nonresponder imputation (mNRI) analysis of patients receiving Taltz, ACR20 results were 70% at week 52, 60% at week 108, and 55% at week 156. ACR50 results were 47% at week 52, 46% at week 108, and 40% at week 156. ACR70 results were 29% at week 52, 23% at week 108, and 23% at week 156.

After week 24, patients knew they were taking active treatment, but remained blind to the dose until the last patient completed week 24. The uncontrolled extension period of the study has limitations (e.g., no placebo comparisons, patients remaining in the study may be those with better results).

mNRI, a method for analyzing long term efficacy, imputes missing data due to study drug (e.g., inadequate response, adverse event, or lack of efficacy), as nonresponse; whereas missing data due to other reasons (e.g., missed visits, lost to follow-up) is included as a predicted value based on statistical modeling of observed data.

Click here for SPIRIT-P1 and SPIRIT-P2 Trial Designs

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.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Rapid PASI 75 and PASI 90 responses seen as early as week 2 in some patients2-4,8-10

SPIRIT-P1 (BIOLOGIC-NAIVE): PASI 75 response rates through week 24 in PsA patients with plaque psoriasis ≥3% BSA, NRI

Skin response rate in taltz patients versus placebo over 24 week period

*P≤0.001 vs placebo for PASI 75 at week 12.

SPIRIT-P1 (BIOLOGIC-NAIVE): PASI 90 response rates through week 24 in PsA patients with plaque psoriasis ≥3% BSA, NRI

Skin response rate over 24 weeks in taltz patients compared to placebo

PASI 75 response rates at week 2 and 24 and PASI 90 response rates were not controlled for type 1 error; therefore, statistical conclusions cannot be made.

In SPIRIT-P1 (biologic-naive), among patients with sPGA≥3 at baseline (Taltz 80 mg every 4 weeks n=52; placebo n=41) 75% of patients receiving Taltz achieved sPGA 0,1 at week 12 vs 7% of patients who received placebo and 65% of patients receiving Taltz achieved sPGA 0,1 at week 24 vs 17% of patients who received placebo.10

ADDITIONAL WEEK 12 RESULTS FROM SPIRIT-P2 TRIAL

In SPIRIT-P2 (TNFi-experienced, ≥3% BSA) (Taltz 80 mg every 4 weeks n=68, placebo n=67), 57% of patients receiving Taltz achieved PASI 75 at week 12 vs 10% for placebo. And, 38% of patients receiving Taltz achieved PASI 90 at week 12 vs 6% for placebo. Among patients with sPGA ≥3 at baseline (Taltz 80 mg every 4 weeks n=60, placebo n=55), 63% of patients receiving Taltz achieved sPGA 0,1 at week 12 vs 4% of patients who received placebo.10

Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.

Primary endpoint=ACR20 at week 24.

Click here for SPIRIT-P1 and SPIRIT-P2 Trial Designs

SELECT IMPORTANT SAFETY INFORMATION:
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 exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

FOR PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Skin symptom results sustained for 3 years, regardless of TNFi experience4,6,11-13

SPIRIT-P1 (BIOLOGIC-NAIVE): PASI response rates, observed

Psoriatic Arthritis SPIRIT-P1 PASI Response Rate chart

SPIRIT-P2 (TNFi-EXPERIENCED): PASI response rates, observed

PASI response rate over 156 week period

*Nx=observed population at week 156.

In SPIRIT-P1 (biological-naive, BSA ≥3%), in an mNRI analysis of patients receiving Taltz 80 mg every 4 weeks (n=73), PASI 75 results were 80% at week 52, 69% at week 108, and 64% at week 156. PASI 90 results were 67% at week 52, 61% at week 108, and 51% at week 156. PASI 100 results were 56% at week 52, 47% at week 108, and 44% at week 156.

In SPIRIT-P2 (TNFi-experienced), in an mNRI analysis of patients receiving Taltz 80 mg every 4 weeks (n=68), PASI 75 results were 67% at week 52, 65% at week 108, and 58% at week 156. PASI 90 results were 56% at week 52, 55% at week 108, and 47% at week 156. PASI 100 results were 44% at week 52, 39% at week 108, and 37% at week 156.

Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.

After week 24, patients knew they were taking active treatment, but remained blind to the dose until the last patient completed week 24. The uncontrolled extension period of the study has limitations (e.g., no placebo comparisons, patients remaining in the study may be those with better results).

mNRI, a method for analyzing long-term efficacy, imputes missing data due to study drug (e.g., inadequate response, adverse event, or lack of efficacy) as nonresponse; whereas missing data due to other reasons (e.g., missed visits, lost to follow up) is included as a predicted value based on statistical modeling of observed data.

A subset of patients with plaque psoriasis involving ≥3% BSA.

Click here for SPIRIT-P1 and SPIRIT-P2 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.

Radiographic response

Dactylitis

Enthesitis

Concomitant MTX use

References:

  1. Data on file. Lilly USA, LLC. DOF-IX-US-0304.
  2. Mease PJ, 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. Data on file. Lilly USA, LLC. DOF-IX-US-0276.
  15. Data on file. Lilly USA, LLC. DOF-IX-US-0156.
  16. Data on file. Lilly USA, LLC. DOF-IX-US-0151.
  17. Data on file. Lilly USA, LLC. DOF-IX-US-0127.
  18. van der Heijde D, Gladman DD, Kishimoto M, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase III study (SPIRIT-P1). J Rheumatol. 2018;45:367-377.
  19. Coates LC, Kishimoto M, Gottlieb A et al. Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. RMD Open. 2017;3(2):e000567. doi:10.1136/rmdopen-2017-000567.
  20. Data on file. Lilly USA, LLC. DOF-IX-US-0128.

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.