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Taltz Citrate-Free: The same active ingredient with significantly less injection site pain vs the original formulation1*
*P<.0001; 3.5 vs 25.2 based on VAS 0-100

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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

See efficacy data

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 spondylarthritis (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.

FOR YOUR PATIENTS WITH PsA AND axSpA (nr-axSpA, AS)

Consider Taltz as your preferred IL-17A antagonist

TODO

Michelle* has psoriatic arthritis

  • Presenting with joint pain and bothersome skin plaques

Daniel* has ankylosing spondylitis

  • Experiencing spinal pain and morning stiffness

Michelle and Daniel are frustrated their current treatment is not working.

Taltz offers rapid results for Today and sustained efficacy for Tomorrow so that Michelle and Daniel can participate in everyday moments that matter.

*Hypothetical patient profiles.

Click here for PsA efficacy data

Click here for AS efficacy data

TODO

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.

Taltz is for today and tomorrow1-18

RAPID

  • ACR20 response seen as early as Week 2 in some patients with active PsA, regardless of TNFi experience ( See Rapid ACR data )
  • PASI 75 and PASI 90 responses seen as early as Week 2 in some biologic-naive patients with active PsA ( See Rapid PASI data )
  • Improvement in back pain, function, and inflammation seen as early as Week 2 in some biologic-naive patients with AS ( See Rapid AS data )

SUSTAINED

Week 2 and year 3 data were not controlled for type-1 error; therefore, statistical conclusions cannot be made.

See SPIRIT-P1 and SPIRIT-P2 trial designs

See COAST-V and W trial designs

TODO

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 thatn 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 patinets with plaque psoriasis. Seroius 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.

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 spondylarthritis (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.

FOR YOUR PATIENTS WITH PsA AND axSpA (nr-axSpA, AS)

Consider Taltz as your preferred IL-17A antagonist

TODO

Michelle* has psoriatic arthritis

  • Presenting with joint pain and bothersome skin plaques
TODO

Daniel* has ankylosing spondylitis

  • Experiencing spinal pain and morning stiffness

Michelle and Daniel are frustrated their current treatment is not working.

Taltz offers rapid results for Today and sustained efficacy for Tomorrow so that Michelle and Daniel can participate in everyday moments that matter.

*Hypothetical patient profiles.

Click here for PsA efficacy data

Click here for AS efficacy data

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.

Taltz is for today and tomorrow1-18

RAPID

  • ACR20 response seen as early as Week 2 in some patients with active PsA, regardless of TNFi experience ( See Rapid ACR data )
  • PASI 75 and PASI 90 responses seen as early as Week 2 in some biologic-naive patients with active PsA ( See Rapid PASI data )
  • Improvement in back pain, function, and inflammation seen as early as Week 2 in some biologic-naive patients with AS ( See Rapid AS data )

SUSTAINED

Week 2 and year 3 data were not controlled for type-1 error; therefore, statistical conclusions cannot be made.

See SPIRIT-P1 and SPIRIT-P2 trial designs

See COAST-V and W trial designs

TODO

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 thatn 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 patinets with plaque psoriasis. Seroius 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.

Explore

Psoriatic arthritis efficacy

Ankylosing spondylitis efficacy

Non-radiographic axial spondyloarthritis efficacy

Support resources

Abbreviations:
ACR=American College of Rheumatology; ACR20=American College of Rheumatology 20% response; ACR50=American College of Rheumatology 50% response; ACR 20/50=American College of Rheumatology 20%/50% response; ACR20/50/70=American College of Rheumatology 20%/50%/70% response; AE=adverse event; AS=ankylosing spondylitis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, ≥40% improvement; axSpA=axial spondyloarthritis; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; BSA=body surface area; CD=Crohn’s disease; cDMARD=conventional disease-modifying antirheumatic drug; H2H=head-to-head; IBD=inflammatory bowel disease; IL-17A=interleukin-17A; IR=inadequate responder; ITT=intent-to-treat; LSM=least squares mean; MACE=major adverse cardiovascular event; MMRM=mixed-effect model of repeated measure; mNRI=modified nonresponder imputation; n=total number of patients entering the study or extension period; nr-axSpA=nonradiographic axial spondyloarthritis; NRI=nonresponder imputation; NSAID=non-steroidal anti-inflammatory drug; Nx=observed population; PA=prior authorization; PASI=Psoriasis Area and Severity Index; PASI 75/90/100=75%/90%/100% improvement from baseline in PASI criteria; PASI 100=100% improvement from baseline in PASI criteria; PsA=psoriatic arthritis; PsO=psoriasis; r-axSpA=radiographic axial spondyloarthritis; Rx=prescription; sPGA=Static Physician Global Assessment; TEAE=treatment-emergent adverse event; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis; VAS=visual analogue scale.

References:

  1. Data on file. Lilly USA, LLC. DOF-IX-US-0304.
  2. 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;76:79-87.
  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, Gladman DD, Kishimoto M, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase II study (SPIRIT-P1) J Rheumatol. 2018;45:367-377.
  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, Possubnyy 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.

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 patient s 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 infect ion 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.