Taltz

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Psoriasis
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Taltz Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Ixekizumab 80mg/mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-17A antagonist.

    How Supplied

    Single-dose prefilled autoinjector—1, 2, 3; Single-dose prefilled syringe—1

    How Supplied

    Taltz injection is a sterile, preservative free, clear and colorless to slightly yellow solution available as 80 mg ixekizumab in a single-dose prefilled autoinjector in a 1-, 2-, or 3-count carton or a single-dose prefilled syringe in a 1-count carton. 

    Storage

    Taltz is sterile and preservative-free. Discard any unused portion. Taltz must be protected from light until use. Store refrigerated at 2°C to 8°C (36°F to 46°F).

    If needed, patients/caregivers may store Taltz at room temperature up to 30°C (86°F) for up to 5 days in the original carton to protect from light. Once Taltz has been stored at room temperature, do not return to the refrigerator and discard, if unused, within 5 days. 

    Record the date when Taltz is first removed from the refrigerator in the spaces provided on the carton. 

    For the 2 or 3 autoinjector pack, remove a single autoinjector at a time leaving the remaining autoinjector(s) in the original carton in the refrigerator. Ensure the unrefrigerated Taltz is protected from light. 

    Do not freeze. Do not use Taltz if it has been frozen. Do not shake. 

    Discard the Taltz single-dose autoinjector or syringe after use in a puncture-resistant container. Not made with natural rubber latex.

    Manufacturer

    Eli Lilly and Company

    Generic Availability

    NO

    Taltz Indications

    Indications

    Active psoriatic arthritis. Active ankylosing spondylitis. Active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

    Taltz Dosage and Administration

    Prior to Treatment Evaluations

    • Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Skyrizi. Treatment initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiating Taltz.

    • Complete all age-appropriate vaccinations as recommended by current immunization guidelines.

     

    Adult

    Give by SC inj into upper arms, thighs, or any quadrant of abdomen; rotate inj sites. ≥18yrs: Psoriatic arthritis: 160mg (two 80mg injs) at Week 0, then 80mg every 4 weeks; may be given alone or in combination with a conventional DMARD. With coexistent plaque psoriasis: 160mg (two 80mg injs) at Week 0, then 80mg at Weeks 2, 4, 6, 8, 10, and 12, then 80mg every 4 weeks. Ankylosing spondylitis: 160mg (two 80mg injs) at Week 0, then 80mg every 4 weeks. nr-axSpA: 80mg every 4 weeks.

    Children

    <18yrs: not established.

    Taltz Contraindications

    Not Applicable

    Taltz Boxed Warnings

    Not Applicable

    Taltz Warnings/Precautions

    Warnings/Precautions

    May increase risk of infections. If a serious infection develops, monitor closely and discontinue until resolved. Active TB infection: do not initiate until resolved. Evaluate for TB infection and treat latent TB prior to initiating. Monitor for active TB during and after therapy. History of latent or active TB without confirmed adequate course of treatment: consider anti-TB therapy prior to initiation. Monitor for inflammatory bowel disease; discontinue and treat if occurs. Discontinue immediately and treat if a serious hypersensitivity reaction occurs. Complete all age appropriate immunizations based on current guidelines prior to initiating. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Infections

    • May increase the risk of infection.

    • Seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.

    • If a serious infection develops or is not responding to standard therapy, monitor closely and discontinue until resolved. 

    Pre-treatment Evaluation for Tuberculosis

    • Active TB infection: do not initiate until resolved. Evaluate for TB infection and treat latent TB prior to initiating. Monitor closely for active TB during and after therapy. 

    • History of latent or active TB without confirmed adequate course of treatment: consider anti-TB therapy prior to initiation. 

    Hypersensitivity

    • If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

    Inflammatory Bowel Disease

    • May be at increased risk of inflammatory bowel disease (eg, Crohn disease, ulcerative colitis).

    • Monitor for onset or exacerbation of inflammatory bowel disease (IBD). 

    • Discontinue Taltz and initiate appropriate medical management if IBD occurs.

    Immunizations

    • Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines.

    • Avoid use of live vaccines.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • Pregnant women exposed to Taltz are encouraged to enroll in the Taltz Pregnancy Registry by calling 1-800-284-1695. Contact information for the registry is also available on https://www.taltz.com. 

    Risk Summary

    • Insufficient data  to evaluate the use of Taltz in pregnant women for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

    • Human IgG is known to cross the placental barrier; therefore, Taltz may be transmitted from the mother to the developing fetus. 

    Nursing Mother Considerations

    Risk Summary

    • Limited published literature has described the presence of interferon beta-1a products in human milk at low levels. Consider the developmental and health benefits of breastfeeding with the mother’s clinical need for Taltz and any potential adverse effects on the breastfed infant from Taltz or from the underlying maternal condition.

    Pediatric Considerations

    • The safety and effectiveness of Taltz have been established in pediatric subjects aged 6 years to less than 18 years with moderate-to-severe plaque psoriasis. 

    • The safety and effectiveness of Taltz in other pediatric indications and for pediatric subjects less than 6 years of age have not been established.

    Taltz Pharmacokinetics

    Absorption

    Following a single subcutaneous dose of 160 mg in subjects with plaque psoriasis, ixekizumab reached peak mean (±SD) serum concentrations (Cmax) of 16.2 ±6.6 mcg/mL by approximately 4 days post dose. Steady-state concentrations were achieved by Week 8 following the 160 mg starting dose and 80 mg every 2 weeks dosing regimen; the mean ±SD steady-state trough concentration was 9.3 ±5.3 mcg/mL. Steady-state concentrations were achieved approximately 10 weeks after switching from the 80 mg every 2 weeks dosing regimen to the 80 mg every 4 weeks dosing regimen at Week 12. The mean ±SD steady-state trough concentration was 3.5 ±2.5 mcg/mL.

    Distribution

    The mean (geometric CV%) volume of distribution at steady-state was 7.11 L (29%) in subjects with plaque psoriasis.

    Elimination

    The metabolic pathway of ixekizumab has not been characterized. As a humanized IgG4 monoclonal antibody ixekizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The mean systemic clearance was 0.39 L/day (37%) and the mean (geometric CV%) half-life was 13 days (40%) in subjects with plaque psoriasis. 

    Taltz Interactions

    Interactions

    Avoid concomitant live vaccines.

    Taltz Adverse Reactions

    Adverse Reactions

    Inj site reactions, upper respiratory tract infections, nausea, tinea infections.

    Taltz Clinical Trials

    Clinical Trials

    Psoriatic Arthritis

    • The safety and efficacy of Taltz was evaluated in 679 patients in 2 randomized, double-blind, placebo-controlled studies (PsA1 and PsA2) in adults, age 18 years and older with active psoriatic arthritis (at least 3 swollen and at least 3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease modifying anti-rheumatic drug (DMARD) therapy. 

    • The PsA1 Study (NCT01695239) included 417 biologic-naive patients, who were treated with either Taltz 160 mg at Week 0 followed by 80 mg every 2 weeks (Q2W) or 4 weeks (Q4W), adalimumab 40 mg every 2 weeks, or placebo. The PsA2 Study (NCT02349295) included 363 anti-TNFα experienced patients, who were treated with Taltz 160 mg at Week 0 followed by 80 mg every 2 or 4 weeks, or placebo. Patients receiving placebo were re-randomized to receive Taltz (80 mg every 2 or 4 weeks) at Week 16 or Week 24 based on responder status.

    • The primary endpoint was the percentage of patients achieving an ACR20 response at week 24.

    • In PsA1, patients treated with Taltz 80 mg every 4 weeks achieved the following clinical responses compared with placebo , respectively:

      • ACR20 response 

        • Week 12: 57% vs 31% (difference from placebo, 26% [95% CI, 13-39])

        • Week 24: 58% vs 30% (difference from placebo, 28% [95% CI, 15-41])

      • ACR50 response 

        • Week 12: 34% vs 5% (difference from placebo, 29% [95% CI, 19-39])

        • Week 24: 40% vs 15% (difference from placebo, 25% [95% CI, 14-37])

      • ACR70 response 

        • Week 12: 15% vs 0% (difference from placebo, 29% [95% CI, 19-39])

        • Week 24: 23% vs 6% (difference from placebo, 18% [95% CI, 9-27])

    • In PsA2, patients treated with Taltz 80 mg every 4 weeks achieved the following clinical responses compared with placebo , respectively:

      • ACR20 response 

        • Week 12: 50% vs 2% (difference from placebo, 28% [95% CI, 16-40])

        • Week 24: 53% vs 20% (difference from placebo, 34% [95% CI, 22-45])

      • ACR50 response 

        • Week 12: 31% vs 3% (difference from placebo, 28% [95% CI, 19-37])

        • Week 24: 35% vs 5% (difference from placebo, 30% [95% CI, 21-40])

      • ACR70 response 

        • Week 12: 15% vs 2% (difference from placebo, 13% [95% CI, 6-20])

        • Week 24: 22% vs 0% (difference from placebo, 22% [95% CI, 15-30])

    • For patients with pre-existing dactylitis or enthesitis, treatment with Taltz resulted in improvement in dactylitis and enthesitis.

    • For patients with PsA, treatment with Taltz 80mg every 4 weeks achieved improvement in psoriatic skin lesions.

    • Additionally, in PsA1, treatment with Taltz inhibited the progression of structural joint damage at week 16 compared with placebo. Both studies showed that treatment with Taltz achieved improvement in physical function compared with placebo as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 12 and 24.

     

    Psoriatic Arthritis

    • The safety and efficacy of Taltz were assessed in 567 patients, in 2 randomized, double-blind, placebo-controlled studies (AS1 and AS2) in adult patients, age 18 years and older with active ankylosing spondylitis. Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid, or disease modifying anti-rheumatic drug (DMARD) therapy.

    • AS1 Study (NCT02696785) included 341 biologic-naive patients who received either Taltz 80 mg or 160 mg at Week 0 followed by 80 mg every 2 weeks (Q2W) or 4 weeks (Q4W), adalimumab 40 mg every 2 weeks, or with placebo. Patients receiving placebo were re-randomized at Week 16 to receive Taltz (160 mg starting dose, followed by 80 mg Q2W or Q4W). Patients receiving adalimumab were re-randomized at Week 16 to receive Taltz (80 mg Q2W o rQ4W).

    • AS2 Study (NCT02696798) included 316 TNF-inhibitor experienced patients (90% were inadequate responders and 10% were intolerant to TNF inhibitors). All patients were treated with Taltz 80 or 160 mg at Week 0 followed by 80 mg Q2W or Q4W, or with placebo. Patients receiving placebo were re-randomized at Week 16 to receive Taltz (160 mg initial dose, followed by 80 mg Q2W or Q4W). 

    • The primary endpoint in both studies was the percentage of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16.

    • In both studies, patients treated with Taltz 80 mg every 4 weeks achieved greater improvements in ASAS40 and ASAS20 responses at week 16 compared with placebo, respectively:

      • ASAS20 response 

        • AS1: 64% vs 40% (difference from placebo, 24% [95% CI, 9-39])

        • AS2: 48% vs 30% (difference from placebo, 18% [95% CI, 6-31])

      • ASAS40 response 

        • AS1: 48% vs 18% (difference from placebo, 30% [95% CI, 16-43])

        • AS2: 25% vs 13% (difference from placebo, 13% [95% CI, 3-23])

    • For patients with pre-existing dactylitis or enthesitis, treatment with Taltz resulted in improvement in dactylitis and enthesitis.

    • For patients with PsA, treatment with Taltz 80mg every 4 weeks achieved improvement in psoriatic skin lesions.

    • Additionally, in PsA1, treatment with Taltz inhibited the progression of structural joint damage at week 16 compared with placebo. Both studies showed that treatment with Taltz achieved improvement in physical function compared with placebo as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 12 and 24.

    • In both studies, treatment with Taltz improved the main components of the ASAS40 response criteria and other measures of disease activity at week 16, including BASFI, BASDAI score, BASMI, and high sensitivity C-reactive protein (hsCRP). 

     

    Non-radiographic Axial Spondyloarthritis

    • The efficacy and safety of Taltz were assessed in a randomized, double-blind, 52-week placebo-controlled study (nr-axSpA1) (NCT02757352) in patients ≥18 years of age with active axial spondyloarthritis for at least 3 months. Patients were required to be intolerant to or had an inadequate response to at least 2 NSAIDs.

    • Patients were randomly assigned to receive either placebo or Taltz 80 mg or 160 mg at Week 0, followed by either 80 mg every 2 weeks or 80 mg every 4 weeks. The primary endpoint was the percentage of patients achieving an Assessment of Spondyloarthritis International Society (ASAS40) response at week 52. The ASAS40 response was also evaluated at week 16 as a major secondary endpoint.

    • At week 52, 30.2% of patients treated with Taltz 80 mg every 4 weeks achieved ASAS40 response compared with 13.3% of those treated with placebo (difference from placebo, 16.9% [95% CI, 5.6-28.1]).

    • At week 16, 35.4% of patients treated with Taltz 80 mg every 4 weeks achieved ASAS40 response compared with 19% of those treated with placebo (difference from placebo, 16.4% [95% CI, 4.2-28.5]).

    • In both studies, treatment with Taltz improved the main components of the ASAS40 response criteria and other measures of disease activity at week 16, including BASFI, BASDAI score, BASMI, and high sensitivity C-reactive protein (hsCRP). 

    Taltz Note

    Not Applicable

    Taltz Patient Counseling

    Patient Counseling

    • Provide guidance to patients and caregivers on proper subcutaneous injection technique, including aseptic technique, and how to use the autoinjector or prefilled syringe correctly. 

    • Taltz may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider, and contacting their healthcare provider if they develop any symptoms of infection. 

    • Seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions. 

    • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Taltz during pregnancy. Advise patients to contact the registry at 1-800-284-1695 to enroll.  

    Cost Savings Program

    Taltz Patient Support

    Taltz Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Ixekizumab 80mg/mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Interleukin-17A antagonist.

    How Supplied

    Single-dose prefilled autoinjector—1, 2, 3; Single-dose prefilled syringe—1

    How Supplied

    Taltz injection is a sterile, preservative free, clear and colorless to slightly yellow solution available as 80 mg ixekizumab in a single-dose prefilled autoinjector in a 1-, 2-, or 3-count carton or a single-dose prefilled syringe in a 1-count carton. 

    Storage

    Taltz is sterile and preservative-free. Discard any unused portion. Taltz must be protected from light until use. Store refrigerated at 2°C to 8°C (36°F to 46°F).

    If needed, patients/caregivers may store Taltz at room temperature up to 30°C (86°F) for up to 5 days in the original carton to protect from light. Once Taltz has been stored at room temperature, do not return to the refrigerator and discard, if unused, within 5 days. 

    Record the date when Taltz is first removed from the refrigerator in the spaces provided on the carton. 

    For the 2 or 3 autoinjector pack, remove a single autoinjector at a time leaving the remaining autoinjector(s) in the original carton in the refrigerator. Ensure the unrefrigerated Taltz is protected from light. 

    Do not freeze. Do not use Taltz if it has been frozen. Do not shake. 

    Discard the Taltz single-dose autoinjector or syringe after use in a puncture-resistant container. Not made with natural rubber latex.

    Manufacturer

    Eli Lilly and Company

    Generic Availability

    NO

    Taltz Indications

    Indications

    Moderate to severe plaque psoriasis in patients who are candidates for systemic therapy or phototherapy.

    Taltz Dosage and Administration

    Prior to Treatment Evaluations

    • Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Skyrizi. Treatment initiation is not recommended in patients with active TB infection. Initiate treatment of latent TB prior to initiating Taltz.

    • Complete all age-appropriate vaccinations as recommended by current immunization guidelines.

     

    Adult

    Give by SC inj into upper arms, thighs, or any quadrant of abdomen; rotate inj sites. ≥18yrs: 160mg (two 80mg injs) at Week 0, then 80mg at Weeks 2, 4, 6, 8, 10, and 12, then 80mg every 4 weeks.

    Children

    <6yrs: not established. Give by SC inj into upper arms, thighs, or any quadrant of abdomen; rotate inj sites. ≥6yrs (<25kg): initially 40mg (0.5mL) at Week 0, then 20mg (0.25mL) every 4 weeks; (25–50kg): initially 80mg at Week 0, then 40mg every 4 weeks; (>50kg): initially 160mg (two 80mg injs) at Week 0, then 80mg every 4 weeks.

    Taltz Contraindications

    Not Applicable

    Taltz Boxed Warnings

    Not Applicable

    Taltz Warnings/Precautions

    Warnings/Precautions

    May increase risk of infections. If a serious infection develops, monitor closely and discontinue until resolved. Active TB infection: do not initiate until resolved. Evaluate for TB infection and treat latent TB prior to initiating. Monitor for active TB during and after therapy. History of latent or active TB without confirmed adequate course of treatment: consider anti-TB therapy prior to initiation. Monitor for inflammatory bowel disease; discontinue and treat if occurs. Discontinue immediately and treat if a serious hypersensitivity reaction occurs. Complete all age appropriate immunizations based on current guidelines prior to initiating. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Infections

    • May increase the risk of infection.

    • Seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.

    • If a serious infection develops or is not responding to standard therapy, monitor closely and discontinue until resolved. 

    Pre-treatment Evaluation for Tuberculosis

    • Active TB infection: do not initiate until resolved. Evaluate for TB infection and treat latent TB prior to initiating. Monitor closely for active TB during and after therapy. 

    • History of latent or active TB without confirmed adequate course of treatment: consider anti-TB therapy prior to initiation. 

    Hypersensitivity

    • If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

    Inflammatory Bowel Disease

    • May be at increased risk of inflammatory bowel disease (eg, Crohn disease, ulcerative colitis).

    • Monitor for onset or exacerbation of inflammatory bowel disease (IBD). 

    • Discontinue Taltz and initiate appropriate medical management if IBD occurs.

    Immunizations

    • Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines.

    • Avoid use of live vaccines.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • Pregnant women exposed to Taltz are encouraged to enroll in the Taltz Pregnancy Registry by calling 1-800-284-1695. Contact information for the registry is also available on https://www.taltz.com. 

    Risk Summary

    • Insufficient data  to evaluate the use of Taltz in pregnant women for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

    • Human IgG is known to cross the placental barrier; therefore, Taltz may be transmitted from the mother to the developing fetus. 

    Nursing Mother Considerations

    Risk Summary

    • Limited published literature has described the presence of interferon beta-1a products in human milk at low levels. Consider the developmental and health benefits of breastfeeding with the mother’s clinical need for Taltz and any potential adverse effects on the breastfed infant from Taltz or from the underlying maternal condition.

    Pediatric Considerations

    • The safety and effectiveness of Taltz have been established in pediatric subjects aged 6 years to less than 18 years with moderate-to-severe plaque psoriasis. 

    • The safety and effectiveness of Taltz in other pediatric indications and for pediatric subjects less than 6 years of age have not been established.

    Taltz Pharmacokinetics

    Absorption

    Following a single subcutaneous dose of 160 mg in subjects with plaque psoriasis, ixekizumab reached peak mean (±SD) serum concentrations (Cmax) of 16.2 ±6.6 mcg/mL by approximately 4 days post dose. Steady-state concentrations were achieved by Week 8 following the 160 mg starting dose and 80 mg every 2 weeks dosing regimen; the mean ±SD steady-state trough concentration was 9.3 ±5.3 mcg/mL. Steady-state concentrations were achieved approximately 10 weeks after switching from the 80 mg every 2 weeks dosing regimen to the 80 mg every 4 weeks dosing regimen at Week 12. The mean ±SD steady-state trough concentration was 3.5 ±2.5 mcg/mL.

    Distribution

    The mean (geometric CV%) volume of distribution at steady-state was 7.11 L (29%) in subjects with plaque psoriasis.

    Elimination

    The metabolic pathway of ixekizumab has not been characterized. As a humanized IgG4 monoclonal antibody ixekizumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. The mean systemic clearance was 0.39 L/day (37%) and the mean (geometric CV%) half-life was 13 days (40%) in subjects with plaque psoriasis. 

    Taltz Interactions

    Interactions

    Avoid concomitant live vaccines.

    Taltz Adverse Reactions

    Adverse Reactions

    Inj site reactions, upper respiratory tract infections, nausea, tinea infections.

    Taltz Clinical Trials

    Clinical Trials

    Adult Plaque Psoriasis

    • Efficacy was evaluated in 3 multicenter, randomized, double-blind, placebo-controlled trials Trials 1, 2, and 3 (NCT01474512, NCT01597245, NCT01646177), which enrolled a total of 3866 subjects 18 years of age and older with plaque psoriasis who had a minimum BSA involvement of 10%, a static Physician Global Assessment (sPGA) score of ≥3 in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 5, a Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for phototherapy or systemic therapy. 

    • In all 3 trials, patients were randomly assigned to placebo or Taltz 80mg every 2 weeks for 12 weeks following a 160mg starting dose. In active comparator Trials 2 and 3, patients also received etanercept 50mg twice weekly for 12 weeks.

    • The 2 coprimary endpoints were: 1) PASI 75, the proportion of subjects who achieved at least a 75% reduction in the PASI composite score that takes into consideration both the percentage of body surface area affected and the nature and severity of psoriatic changes (induration, erythema and scaling) within the affected regions, and 2) sPGA of “0” (clear) or “1” (minimal), the proportion of subjects with an sPGA 0 or 1 and at least a 2-point improvement.

    • At week 12, patients treated with Taltz achieved the following results vs those treated with placebo, respectively:

      • sPGA of “0” or “1”: [Trial 1] 82% vs 3%; [Trial 2] 83% vs 2%; [Trial 3] 81% vs 7%

      • sPGA of “0”: [Trial 1] 37% vs 0%; [Trial 2] 42% vs 1%; [Trial 3] 40% vs 0%

      • PASI 75: [Trial 1] 89% vs 4%; [Trial 2] 90% vs 2%; [Trial 3] 87% vs 7%

      • PASI 90: [Trial 1] 71% vs 1%; [Trial 2] 71% vs 1%; [Trial 3] 68% vs 3%

      • PASI 100: [Trial 1] 35% vs 0%; [Trial 2] 40% vs 1%; [Trial 3] 38% vs 0%

      • Itch NRS (≥4 point improvement): [Trial 1] 86% vs 16%; [Trial 2] 85% vs 14%; [Trial 3] 83% vs 21%

     

    Pediatric Plaque Psoriasis

    • The randomized, double-blind, multicenter, placebo-controlled trial (IXORA-Peds, NCT03073200) included 171 pediatric subjects 6 to <18 years of age, with moderate-to-severe plaque psoriasis (as defined by a sPGA score ≥3, involving ≥10% of the BSA, and a PASI score ≥12) who were candidates for phototherapy or systemic therapy or were inadequately controlled on topical therapy. 

    • Patients were randomly assigned to receive placebo or Taltz with dosing stratified by weight:

      • <25kg: 40mg at Week 0 followed by 20mg every 4 weeks

      • 25kg–50kg: 80mg at Week 0 followed by 40mg every 4 weeks

      • >50kg: 160mg at week 0 followed by 80mg every 4 weeks

    • The coprimary endpoints were the proportion of patients who achieved an sPGA score of “0” (clear) or “1” (almost clear) with at least a 2-point improvement from baseline and the proportion of subjects that achieved a reduction in PASI score of at least 75% (PASI 75) from baseline. Response to treatment was assessed at 12 weeks of therapy. 

    • At week 12, patients treated with Taltz achieved the following clinical responses compared with those treated with placebo:

      • sPGA “0” or “1”: 81% vs 11%

      • sPGA “0”: 52% vs 2%

      • PASI 75: 89% vs 25%

      • PASI 90: 78% vs 5%

      • PASI 100: 50% vs 2%

      • Itch NRS (≥4 point improvement): 71% vs 20%

    • At week 4, patients treated with Taltz achieved the following clinical responses compared with those treated with placebo:

      • sPGA “0” or “1”: 48% vs 7%

      • PASI 75: 54% vs 9%

    Taltz Note

    Not Applicable

    Taltz Patient Counseling

    Cost Savings Program

    Taltz Patient Support

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