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Adult Dermatology Safety

Data at week 12


IN ADULT PLAQUE PSORIASIS TRIALS

Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo in plaque psoriasis registration trials1

Safety adverse 12 week
Safety infections 12 week

The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity and did not lead to discontinuation of Taltz.


SAFETY DATA FROM SPIRIT-P1 AND -P2 TRIALS

Overall, patients with psoriatic arthritis had a safety profile consistent with that of adult patients with plaque psoriasis in UNCOVER-1, -2, and -3 trials, except for frequency of influenza (Taltz 1.3%, placebo 0.4%) and conjunctivitis (Taltz 1.3%, placebo 0%).


ADDITIONAL ACTIVE COMPARATOR SAFTEY INFORMATION

In the 2 clinical trials that included Enbrel, an active comparator, the rate of serious adverse events during weeks 0 to 12 was 2% with Taltz and 0.7% with US-approved Enbrel, and the rate of discontinuation from adverse events was 2% with Taltz and 0.7% with US-approved Enbrel.

Data at week 60


IN ADULT PLAQUE PSORIASIS TRIALS

Adverse events during weeks 0 to 60 with Taltz vs placebo from plaque psoriasis trials1

Safety adverse 0-60

Among those treated with Taltz, the exposure-adjusted incident rates of adverse events from 13 to 60 weeks were lower than the exposure-adjusted incidence rates from 0 to 12 weeks (1.0 vs 2.5 per subject-year of follow-up).

Long-term data


Safety in Taltz clinical trial adult participants studied for up to 6 years2-4

In the adult plaque psoriasis and psoriatic arthritis safety population, 6989 patients across 15 clinical trials received Taltz, with a total exposure of 16,586 patient-years (PY).

  • In psoriatic arthritis trials, the average duration of exposure was 449 days, with 258 patients having at least 2 years’ exposure
  • In adult plaque psoriasis trials, the average duration of exposure was 946 days, with 2981 patients having at least 3 years’ exposure
Safety long term siae

The safety profile observed in patients with psoriatic arthritis who were treated with Taltz is consistent with the safety profile in patients with adult plaque psoriasis. The exceptions include frequencies of influenza (1.3%) and conjunctivitis (1.3%).

Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk. Lilly is conducting continued long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Taltz.

The reported safety population includes all dosing arms of the phase 1-3 psoriasis clinical trials. Not all patients received the recommended dosing regimen consistent with the FDA-approved label.

References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Data on file. Lilly USA, LLC. TAL20171211A. 3. Data on file. Lilly USA, LLC. DOF-IX-US-0019. 4. Mease P, Roussou E, Burmester GR, et al. Safety of ixekizumab in patients with psoriatic arthritis: results from a pooled analysis of three clinical trials. Arth Care Res. 2018 (Epub). doi:10.1002/acr.23738.

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.

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IX HCP ISI 26MAR2020

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SPIRIT-H2H: Trial design9

Taltz icon

SPIRIT-H2H (N=566) was a phase 4, randomized, open-label, blinded-assessor study evaluating the efficacy and safety of Taltz vs Humira in biologic-naive patients with active psoriatic arthritis and plaque psoriasis BSA ≥3.

Patients who met the trial design criteria for moderate to severe psoriasis (BSA ≥10%, PASI ≥12, and sPGA ≥3) in addition to psoriatic arthritis followed the psoriasis dosing regimen: Taltz patients (n=49) received an initial dose of 160 mg (two 80 mg injections), followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks thereafter. Humira patients (n=52) received an initial dose of 80 mg, then 40 mg every other week starting 1 week after the initial dose. For Taltz patients with psoriatic arthritis only (n=234), the initial dose (160 mg as 2 injections) was followed by 80 mg every 4 weeks. Humira patients (n=231) received 40 mg every other week and no initial dose.

SPIRIT-H2H: Trial design1

SPIRIT-H2H (N=566) was a phase 4, randomized, open-label, blinded-assessor study evaluating the efficacy and safety of Taltz vs Humira® (adalimumab) in biologic-naive patients with active psoriatic arthritis and plaque psoriasis BSA ≥3%. The primary efficacy endpoint was the proportion of patients simultaneously achieving ACR50 and PASI 100 at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints with an inadequate response to ≥1 cDMARD. Patients were randomized (1:1) to Taltz or Humira and allowed to continue a stable dose of concomitant cDMARD during the study. For Taltz patients with psoriatic arthritis only (n=234), the initial dose (160 mg as 2 injections) was followed by 80 mg every 4 weeks. Humira patients (n=231) received 40 mg every other week and no initial dose. Patients who met the trial design criteria for moderate to severe psoriasis (BSA ≥10%, PASI ≥12, and sPGA ≥3) in addition to psoriatic arthritis followed the psoriasis dosing regimen: Taltz patients (n=49) received an initial dose of 160 mg (two 80 mg injections), followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks thereafter. Humira patients (n=52) received an initial dose of 80 mg, then 40 mg every other week starting 1 week after the initial dose.

Reference:1. Data on file. Lilly USA, LLC. DOF-IX-US-0119.

BSA=body surface area; ACR50=American College of Rheumatology 50% response;
PASI=Psoriasis Area Severity Index; cDMARD=conventional disease-modifying antirheumatic drug; sPGA=static Physician's Global Assessment.

SPIRIT-P1 and -P2 Trial Design1-4

SPIRIT-P1 (N=417) and -P2 (N=363) were phase 3, randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz compared with placebo in patients with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic-naive. Patients in SPIRIT-P2 were tumor necrosis factor inhibitor (TNFi)-experienced, having had an inadequate response and/or intolerance to 1 or 2 prior TNFis. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints. Patients were randomized to placebo or Taltz 80 mg every 2 or 4 weeks following a 160 mg starting dose. In SPIRIT-P1, an active reference arm of Humira® (adalimumab) 40 mg every 2 weeks was included. Patients in all study arms were allowed to continue taking stable background medications during the trial. Inadequate responders (as defined by blinded criteria of <20% improvement in tender and in swollen joint counts) at week 16 received rescue therapy and were analyzed as nonresponders after week 16 until the primary endpoint. After receiving rescue therapy, inadequate responders in the placebo and Humira arms were re-randomized to Taltz 80 mg every 2 or 4 weeks. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses during the double-blind treatment period.

Reference: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase 3 trial SPIRIT-P1. Ann Rheum Dis. 2017;76(suppl):1-30. 3. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. 4. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.

ACR20=American College of Rheumatology 20% response.

SPIRIT-P1 and -P2: Trial design12-15

Registration Trials

SPIRIT-P1 (N=417) and SPIRIT-P2 (N=363) were phase 3, randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz compared with placebo in patients with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic-naive. Patients in SPIRIT-P2 were tumor necrosis factor inhibitor (TNFi)-experienced, having had an inadequate response and/or intolerance to 1 or 2 prior TNFis. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints. Patients were randomized to placebo or Taltz 80 mg every 2 or 4 weeks following a 160 mg starting dose. In SPIRIT-P1, an active reference arm of adalimumab 40 mg every 2 weeks was included. Patients in all study arms were allowed to continue taking stable background medications during the trial. Inadequate responders (as defined by blinded criteria of <20% improvement in tender and in swollen joint counts) at week 16 received rescue therapy and were analyzed as nonresponders after week 16 until the primary endpoint. After receiving rescue therapy, inadequate responders in the placebo and adalimumab arms were re-randomized to Taltz 80 mg every 2 or 4 weeks. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses during the double-blind treatment period.

IXORA-PEDS TRIAL DESIGN

IXORA-PEDS (N=171) is an ongoing, multicenter, randomized, double-blind, placebo-controlled phase 3 study designed to evaluate the efficacy and safety of Taltz in pediatric patients aged 6 to <18 years with moderate to severe plaque psoriasis. All patients have a diagnosis of moderate to severe plaque psoriasis for at least 6 months, with a body surface area (BSA) of ≥10%, a static Physician’s Global Assessment (sPGA) score ≥3, and a Psoriasis Area Severity Index (PASI) score ≥12, and are candidates for systemic therapy or phototherapy. Patients were randomized to receive Taltz every 4 weeks (n=115), with dosing based on body weight, or placebo (n=56). Of patients receiving Taltz, those weighing <25 kg were randomized to Taltz 20 mg every 4 weeks following a 40 mg starting dose, those weighing 25 to 50 kg were randomized to Taltz 40 mg every 4 weeks following an 80 mg starting dose, and those weighing >50 kg were randomized to Taltz 80 mg following a starting dose of 160 mg. Co-primary efficacy endpoints were the percentage of patients achieving PASI 75 and sPGA 0,1 at week 12. Secondary endpoints were the percentage of patients achieving the following measures: PASI 75 at week 4, sPGA 0,1 at week 4, PASI 90 at week 12, PASI 100 at week 12, sPGA 0 at week 12, and Itch Numeric Rating Scale (I-NRS) ≥4-point improvement at week 12. Nonresponder imputation methods (NRI) were used for categorical efficacy analyses.

Following the double-blind treatment period, patients are allowed to transition to an open-label maintenance period (weeks 12-60) and extension period (weeks 60-108) where all patients, regardless of initial treatment, will receive Taltz every 4 weeks through week 108. Patients who were taking placebo were initiated to Taltz with the appropriate weight-based starting dose, followed by the appropriate weight-based Q4W dose.

References: 1.Data on file. Lilly USA, LLC. DOF-IX-US-0211.