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Psoriatic Arthritis Safety

Data at weeks 24 and 52

IN PSORIATIC ARTHRITIS TRIALS

Common adverse events in pooled SPIRIT-P1 and -P2 trials that occurred through week 521,2

Overall, the safety profile in patients with psoriatic arthritis (PsA) treated with Taltz is consistent with the safety profile in patients with plaque psoriasis (PsO). The exception is the higher frequency of influenza (Taltz=1.3%, placebo=0.4%) and conjunctivitis (Taltz=1.3%, placebo=0%) in the PsA safety population vs the plaque psoriasis (PsO) safety population.

*The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity. Discontinuation due to injection site reactions at 24 weeks in the Taltz Q4W arm were 0.4% and 0.4% for placebo.

Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection. Pooled safety data from SPIRIT-P1 and SPIRIT-P2 clinical trials.

IN PSORIATIC ARTHRITIS TRIALS

Adverse events of special interest from pooled SPIRIT-P1 and -P2 trials through week 521,3,4

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.

Pooled safety data from SPIRIT-P1 and SPIRIT-P2 clinical trials.

No confirmed cases of anaphylaxis in clinical trials. All incidents of allergic reactions/hypersensitivity were non-anaphylactic.

Includes all patients with ≥1 Treatment Emergent Adverse Event (TEAE), including nonmelanoma skin cancer (NMSC) and prostate cancer.

§Incidents of inflammatory bowel disease events were reported in the plaque psoriasis trial safety population with Taltz.

Patients with uncontrolled Ulcerative Colitis (UC) or Crohn's disease were excluded from the studies; however, patients with a personal or family history of UC/Crohn's were allowed in the study.

MACE=major adverse cerebrocardiovascular event.

Long-term data

Safety in Taltz clinical trial participants studied for up to 6 years5-7

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).

Taltz-Treated Population:

  • 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

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.

*No confirmed cases of anaphylaxis in clinical trials; events reported here are based on potential identifiers using Sampson criteria.

n=5697; 10 trials in psoriasis.

References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. Data on file. Lilly USA, LLC. TAL20171016A. 3. Data on file. Lilly USA, LLC. TAL20171026D. 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. 5. Data on file. Lilly USA, LLC. TAL20171211A 6. Data on file. Lilly USA, LLC. DOF-IX-US-0019. 7. 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

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.

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IX HCP ISI 07MAY2020