Results at week 264
FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Consistent range of response through 5 years, mNRI and observed30
Induction period and open-label extension
*Nx=observed population.
Analysis presented is post hoc. UNCOVER-3 was not powered for this analysis, nor was the analysis error-controlled. Therefore, treatment differences observed cannot be regarded as statistically significant.
A subset of patients from UNCOVER-3 who received a 160 mg starting dose of Taltz at week 0, followed by 80 mg every 2 weeks through week 12, followed by 80 mg every 4 weeks, is shown.
After week 60, dosing could be increased from 80 mg ixekizumab Q4W to 80 mg ixekizumab Q2W if it was determined by the patient and investigator the patient needs additional study drug.
Patients and site personnel were blinded to study treatment until all patients completed week 12 or discontinued. The open-label phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).
In an mNRI analysis of patients receiving Taltz at week 60, 89% of patients achieved PASI 75, 78% of patients achieved PASI 90, and 59% of patients achieved PASI 100. In an mNRI analysis of patients receiving Taltz at weeks 108, 156, 204, and 264, 84%, 82%, 83%, and 79% of patients, respectively, achieved PASI 75; 71%, 69%, 66%, and 67% of patients, respectively, achieved PASI 90; and 50%, 49%, 48%, and 46% of patients, respectively, achieved PASI 100.
mNRI of intent-to-treat population through week 264.
mNRI analysis imputes missing data due to study drug (eg, inadequate response, adverse event, lack of efficacy) as nonresponse; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) are included as a predicted value based on statistical modeling of observed data.
mNRI=modified nonresponder imputation.
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 clearance by week 12 that was sustained through week 26431
Excludes subjects whose dose escalated to Q2W dosing after week 60 (n=86).
In UNCOVER-1, patients receiving Taltz achieved a mean PASI of 1.9 (an 88% improvement from the mean baseline score of 20.1) at week 12. Patients receiving placebo achieved a mean PASI of 18.9 (a 3% improvement from the mean baseline score of 20.3) at week 12.
In UNCOVER-2, patients receiving Taltz achieved a mean PASI of 1.7 (a 91% improvement from the mean baseline score of 19.4) at week 12. Patients receiving placebo achieved a mean PASI of 19.1 (a 7% improvement from the mean baseline score of 20.6) at week 12.
A subset of patients from UNCOVER-3 who received a 160 mg starting dose of Taltz at week 0, followed by 80 mg every 2 weeks through week 12, followed by 80 mg every 4 weeks, is shown. Patients and site personnel were blinded to study treatment until all patients completed week 12 or discontinued. Data collected weeks 12 to 108 during the long-term extension phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).
Analysis presented is post hoc. UNCOVER-3 was not powered for this analysis, nor was the analysis type-I error-controlled. Therefore, treatment differences observed cannot be regarded as statistically significant.
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.