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
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.
Powerful and consistent results within the spectrum of SpA2-15
For patients with PsA
SPIRIT-P1 (biologic-naive) trial results
Taltz | Placebo | |
|---|---|---|
|
ACR50 % achieving response at week 24
Click here for more, including SPIRIT-P2 results See SPIRIT-P1 and SPIRIT-P2 trial designs | Taltz40%* | Placebo15%
Click here for more, including SPIRIT-P2 results See SPIRIT-P1 and SPIRIT-P2 trial designs |
| ACR50 % achieving response at week 156 NRI Click here for more | Taltz52% | Placebo Click here for more |
*P≤.001 vs placebo.
Primary endpoint=ACR20 response at week 24.
The uncontrolled extension period of the study (weeks 24-156) has limitations (eg, no placebo comparison; patients remaining in the extension phase may be those more responsive to treatment).
See SPIRIT-P1 and SPIRIT-P2 trial designsSPIRIT-H2H (biologic-naive) trial results
Taltz | Humira | |
|---|---|---|
| ACR50 + PASI 100 % achieving response at week 24 | Taltz36%§ | Humira28% |
| ACR50 % achieving response at week 24 | Taltz51% | Humira47% |
| ACR70 % achieving response at week 24 | Taltz32% | Humira26% |
§P<.05 vs Humira at week 24.
All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing for moderate-to-severe PsO.10
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.10
Major secondary objective met: demonstrated noninferiority of Taltz vs Humira on ACR50 response at 24 weeks (95% CI [-4.3%, 12.1%]) for noninferiority with -12.0% margin.
ACR70 at week 24 was prespecified but not type-l error-controlled; therefore, results cannot be regarded as statistically significant.
See SPIRIT-H2H trial designFor patients with AS
COAST-V (biologic-naive) trial results
Taltz | Placebo | |
|---|---|---|
| ASAS40 % achieving response at week 16 | Taltz48%† | Placebo18% |
| ASAS40 % achieving response at week 52 Click here for more, including COAST-W results | Taltz53% | Placebo Click here for more, including COAST-W results |
†P≤.0001 vs placebo.
Primary endpoint=ASAS40 at week 16.
The extended treatment period of the study (weeks 16-52) has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those more responsive to treatment).
See COAST-V and COAST-W trial designsFor patients with nr-axSpA
COAST-X (biologic-naive) trial results
Taltz | Placebo | |
|---|---|---|
| ASAS40 % achieving response at week 16 | Taltz35%* | Placebo19% |
| ASAS40 % achieving response at week 52 Click here for more | Taltz30%† | Placebo13%
Click here for more |
*P<.01 vs placebo at week 16.
†P=0.0045 vs placebo at week 52.
Primary endpoint=ASAS40 at week 52.
Starting at week 16 and up to week 44, changes could b made to non-biologic background therapy and/or patients could be transitioned to open-label Taltz 80mg every 2 weeks at the investigators' discretion. Patients who switched to Taltz 80mg every 2 weeks, were missing week 16 or week 52 data, or discontinued double-blind treatment were considered nonresponders. Taltz 80mg every 2 weeks is not an approved dose for nr-axSpA.
See COAST-X trial designSELECT 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.
References: 1. Chabra S, Gill BJ, Gallo G, et al. Ixekizumab citrate-free formulation: results from two clinical trials. Adv Ther. 2022;Epub (Incl Suppl Inf):1-11, 1-4. https://doi.org/10.1007/s12325-022-02126-0 . 2. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 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 3 trial. Lancet. 2017;389:2317-2327. 4. 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. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0013. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0015. 7. Genovese MC, Combe B, Kremer J, et al. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology. 2018. doi:10.1093/rheumatology/key182. 8. Data on file. Lilly USA, LLC. TAL20171026B. 9. Data on file. Lilly USA, LLC. DOF-IX-US-0017. 10. 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. 11. 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 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix. 12. Data on file. Lilly USA, LLC. TAL04022018A. 13. Data on file. Lilly USA, LLC. TAL20171002A. 14. Data on file. Lilly USA, LLC. TAL04022018B. 15. Data on file. Lilly USA, LLC. TAL20170919A.
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