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 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 SpA1-14
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.9
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.9
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.