Head-to-head results in 2 disease states8-12

Adult Plaque Psoriasis

IXORA-R
(Results available now)

The primary endpoint was the proportion of patients achieving completely clear skin at week 12.

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ClinicalTrials.gov Identifier: NCT03573323

IXORA-S
(Taltz showed superiority in the primary endpoint)

The primary endpoint was the proportion of patients achieving PASI 90 at week 12.

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ClinicalTrials.gov Identifier: NCT02561806

UNCOVER-2 and -3
(Taltz showed superiority)

The co-primary outcome measures of these trials were the proportion of patients with sPGA 0, 1 with ≥2-point improvement from baseline, and proportion of patients achieving PASI 75 at week 12.

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ClinicalTrials.gov Identifier: NCT01597245, NCT01646177

Adult Psoriatic Arthritis

Taltz has the first head-to-head study to test superiority vs Humira

SPIRIT-H2H
(Taltz showed superiority in the primary endpoint)

The primary outcome measure of this trial was the proportion of patients simultaneously achieving both ACR50 and PASI 100 at week 24.

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ClinicalTrials.gov Identifier: NCT03151551

*US - approved Enbrel.

Please refer to the Prescribing Information of each agent for indication, dosage, and administration.

The brands listed are registered trademarks of their respective owners.


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 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.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz established superiority to Tremfya across all efficacy endpoints through week 1213

Tremfya key efficacy endpoints

Secondary efficacy endpoint, PASI 100 at week 24, was type-I error controlled but did not achieve superiority. Noninferiority analysis of PASI 100 at week 24 was prespecified and achieved with a noninferiority margin of -11.4%, but not type-I error controlled (Taltz vs Tremfya treatment difference of -2.3% with 95% CI[-8.4, 3.8]). At week 24, 50% of patients taking Taltz and 52% of patients taking Tremfya achieved PASI 100.

*Primary and secondary endpoints were analyzed according to a prespecified graphical multiplicity adjustment approach.

All patients were ≥18 years of age and had plaque psoriasis with BSA ≥10%, sPGA ≥3, and a PASI score ≥12, and were candidates for phototherapy and/or systemic therapy.

Trial design

Registration Trial Results


SELECT IMPORTANT SAFETY INFORMATION
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.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz was superior to Tremfya in the percentage of patients achieving completely clear skin (PASI 100) at week 1213

PASI 100 results at week 12 were consistent with registration trials

IXORA-R Primary Endpoint

*P<.001 vs Tremfya at weeks 4, 8, and 12.

PASI 100 at week 12 was the primary endpoint.

All patients were ≥18 years of age and had plaque psoriasis with BSA ≥10%, sPGA ≥3, and a PASI score ≥12, and were candidates for phototherapy and/or systemic therapy.

PASI 100 (defined by blinded assessor) is a measure that denotes 100% clearance of skin plaques (a 100% improvement from baseline). Patients achieving PASI 100 have achieved complete resolution of all skin plaques.

Trial design

Registration Trial Results


SELECT IMPORTANT SAFETY INFORMATION
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.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz was superior to Tremfya in providing rapid and visible skin clearance (PASI 75) at week 213

IXORA-R Secondary Endpoint

*P<.001 vs Tremfya at week 2.

PASI 75 response at week 2 was a secondary endpoint.

Prespecified analysis was conducted for PASI 75 at week 12 (Taltz: 87%, Tremfya: 83%). The data were not type-I error-controlled; therefore, results cannot be regarded as statistically significant.

Trial design

Registration Trial Results


SELECT IMPORTANT SAFETY INFORMATION
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 exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz was superior to Stelara in the percentage of patients who achieved PASI 90 and PASI 100 at week 1214

Results at weeks, 12, 24, and 52

Dermatology efficacy ixora h2h

Trial design


SELECT IMPORTANT SAFETY INFORMATION
IMMUNIZATIONS

Prior to initiating Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz showed superiority in 2 head-to-head trials vs US-approved Enbrel1

Dermatology efficacy uncover-2-3-12w bar

Trial design


SELECT IMPORTANT SAFETY INFORMATION
ADVERSE EVENTS AND DISCONTINUATION RATES FOR TALTZ COMPARED TO US-APPROVED ETANERCEPT

The rate of serious adverse events during the controlled induction period (weeks 0-12) was 0.7% for US-approved etanercept and 2% for Taltz and the rate of discontinuation from adverse events was 0.7% for US-approved etanercept and 2% for Taltz. The incidence of infections was 18% for US-approved etanercept and 26% for Taltz. The rate of serious infections was 0.3% for both US-approved etanercept and Taltz.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz was superior to Humira in the percentage of patients who simultaneously achieved both PASI 100 and ACR50 at week 24, with consistency at week 5215.

Primary Endpoint

*P<.05 vs Humira at week 24.

P≤.001 vs Humira at week 52.

Nominal P value: Week 52 measure of ACR50 + PASI 100 was not controlled for type-I error; therefore, no statistical comparisons can be made.

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing for moderate to severe plaque psoriasis.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.

SPIRIT-P1 and -P2: ACR response rates at week 241
In SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=107; placebo n=106) and SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=122; placebo n=118), 58% and 53% of Taltz patients, respectively, achieved ACR20 vs 30% and 20% for placebo. Additionally, 40% and 35% of patients receiving Taltz achieved ACR50 vs 15% and 5% for placebo.

Primary endpoint=ACR20 response at week 24.
Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.
NRI of intent-to-treat population through week 24.

SPIRIT-P1 and -P2: PASI results at week 12
In SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=73; placebo n=67), among PsA patients with plaque psoriasis ≥3% BSA, 75% of patients receiving Taltz achieved PASI 75 at week 12 vs 8% of patients who received placebo. 32% of patients receiving Taltz achieved PASI 100 at week 12 vs 2% of patients who received placebo.16 In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=68; placebo n=67), among PsA patients with plaque psoriasis ≥3% BSA, 57% of patients receiving Taltz achieved PASI 75 at week 12 vs 10% for placebo. Additionally, 19% of patients receiving Taltz achieved PASI 100 at week 12 vs 6% for placebo.17
Among patients with sPGA ≥3 at baseline, in SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=52; placebo n=41), 75% of patients receiving Taltz achieved sPGA 0,1 at week 12 vs 7% for placebo.13 Additionally, in SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=60; placebo n=55), 63% of patients receiving Taltz achieved sPGA 0,1 vs 4% for placebo.17,18

NRI of intent-to-treat population through week 12.

PASI=Psoriasis Area Severity Index; ACR20/50=American College of Rheumatology 20%/50% response; NRI=nonresponder imputation; BSA=body surface area; sPGA=static Physician’s Global Assessment.

SPIRIT-H2H Trial Design

SPIRIT-P1 and -P2 Registration Trial Design


SELECT IMPORTANT SAFETY INFORMATION
IMMUNIZATIONS

Prior to initiating Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz demonstrated superiority to Humira in the percentage of patients achieving PASI 100 at week 2419

Primary Endpoint

P=.001 vs Humira at week 24 for PASI 100.
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.
All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing regimen indicated for moderate to severe plaque psoriasis.


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.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz provided comparable improvement in ACR50 to Humira at week 24, NRI15

In SPIRIT-H2H, 51% of patients receiving Taltz (n=283) achieved ACR50 at week 24 vs 47% for Humira (n=283)

Major secondary objective met: demonstrate noninferiority of Taltz vs Humira on ACR50 response at 24 weeks (50.5% vs 46.6%, respectively, 95% CI [-4.3% , 12.1%]) for noninferiority with -12.0% margin.

SPIRIT-H2H Trial Design

SPIRIT-P1 and -P2 Registration Trial Design


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.

Indications and Important Safety Information
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.

Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.
IX HCP ISI 07MAY2020