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

Safety adverse 24 week
Safety adverse 52 week
Safety infections 24 week

Overall, the safety profile in patients with psoriatic arthritis treated with Taltz is consistent with the safety profile in patients with plaque psoriasis. 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 safety population.

IN PSORIATIC ARTHRITIS TRIALS

Adverse events of special interest from pooled SPIRIT-P1 and -P2 trials through week 52 1,3,4

Safety siae 24 week

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.

MACE=major adverse cerebrocardiovascular event.

Long-term data



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

In the 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 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 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; 2019. 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 and Important Safety Information
Indications

Taltz is indicated for your adult patients with active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).

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 and ankylosing spondylitis. 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 80 mg Q2W group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn’s disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn’s disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.

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 patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.
IX HCP ISI 23AUG2019