Challenging body areas



FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Dermatology efficacy tough-to-treat

Subgroup analyses presented for nail, scalp, and palmoplantar psoriasis are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Data presented for nail are from the UNCOVER-3 open-label extension period.

Please see below tabs for full data.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Post hoc subgroup analyses of patients with scalp psoriasis20,21*

PSSI 100 response rates at weeks 12 and 60 (induction period and open-label extension)

Dermatology efficacy uncover-3 pasi


ADDITIONAL RESULTS

In UNCOVER-1 (Taltz n=210; placebo n=215) and UNCOVER-2 (Taltz n=144; placebo n=77), 68% and 71% of patients who received Taltz 80 mg every 2 weeks, respectively, achieved PSSI 100 at week 12 vs 3% and 3% for placebo.

Subgroup analyses presented are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Baseline severity was not specified in the inclusion criteria.

Trial design


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 patients with psoriatic arthritis and ankylosing spondylitis, 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

Post hoc subgroup analyses of patients with nail psoriasis22,23*

NAPSI 0 response rates at weeks 12 and 60 (induction period and open-label extension)

Dermatology efficacy uncover-3 napsi


ADDITIONAL RESULTS

In UNCOVER-1 (Taltz n=172; placebo n=168) and UNCOVER-2 (Taltz n=131; placebo n=72), 7% and 8%, respectively, of patients who received Taltz 80 mg every 2 weeks achieved NAPSI 0 at week 12 vs 0% and 4% for placebo.

Subgroup analyses presented are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Baseline severity was not specified in the inclusion criteria.

Trial design


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

More than half of patients achieved sPGA-G 0 by week 1224,25

At week 12, 73% of patients receiving Taltz achieved sPGA-G 0,1 vs 8% of patients receiving placebo.21,25

sPGA-G 0 was a prespecified, exploratory endpoint. It was not controlled for multiplicity; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.

sPGA-G 0,1=primary endpoint.

Dermatology efficacy ixora-q-spga-o-line

NRI of intent-to-treat population through week 12.25

sPGA-G=static Physician’s Global Assessment of Genitalia.

Trial design


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

Post hoc subgroup analyses of patients* with palmoplantar psoriasis26,27

PPASI 100 response rate at week 12

Dermatology efficacy uncover-1-2-3-ppasi


ADDITIONAL RESULTS

In UNCOVER-1 (Taltz n=45; placebo n=47), UNCOVER-2 (Taltz n=31; placebo n=18), and UNCOVER-3 (Taltz n=38; placebo n=20), 53%, 52%, and 50%, respectively, of patients who received Taltz 80 mg every 2 weeks achieved PPASI 100 at week 12 vs 9%, 6%, and 10% for placebo.

Subgroup analyses presented are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Baseline severity was not specified in the inclusion criteria.

Trial design


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.

Indications and Important Safety Information
Indications

Taltz is indicated for patients as young as age 6 with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Taltz is also indicated for adult patients with active psoriatic arthritis (PsA). Taltz is also indicated for adult patients with active ankylosing spondylitis (AS).

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 and ankylosing spondylitis, 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 and ankylosing spondylitis 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 26MAR2020