Head-to-head results in 2 disease states

Plaque psoriasis

IXORA-R
(Results available 2019)

The primary outcome measure of this trial is the proportion of patients with moderate to severe plaque psoriasis achieving completely clear skin, as measured by PASI 100 at week 12.

IXORA-R is a 24-week, randomized, blinded, parallel-group study comparing the efficacy and safety of ixekizumab to guselkumab in patients with moderate to severe plaque psoriasis.

To learn more about this trial, visit ClinicalTrials.gov Identifier: NCT03573323.

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

The primary outcome measure of this trial was the proportion of patients reaching PASI 90 at week 12.2 The proportion of patients achieving complete resolution of nail psoriasis (NAPSI 0) over 52 weeks was also measured.3

Click here for data

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.

Click here for data

ClinicalTrials.gov Identifier: NCT01597245, NCT01646177

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.

SPIRIT-H2H was a 52-week, randomized, open-label study evaluating the efficacy and safety of Taltz vs Humira in patients with psoriatic arthritis who were biologic naive.

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ClinicalTrials.gov Identifier: NCT03151551

*US - approved etanercept.

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

The brands listed are registered trademarks of their respective owners.

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 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 1211

Results at weeks, 12, 24, and 52

Dermatology efficacy ixora h2h

Trial design


SELECT IMPORTANT SAFETY INFORMATION
INFLAMMATORY BOWEL DISEASE

During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis.

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 2412

Primary Endpoint

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.13 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.14
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.14,15

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 2416

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.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz provided comparable improvement in ACR50 to Humira at week 24, NRI12

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
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 profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.

Indications and Important Safety Information
Indications

Taltz is indicated for your adult patients with active psoriatic arthritis (PsA).

Taltz is also indicated for your adult patients 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 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 patients with psoriatic arthritis. 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
During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis.

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 profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.

Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.
IX HCP ISI 01DEC2017