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SAFETY

Week 12 Data

In Plaque Psoriasis Trials

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

Adverse Reactions Through Week 12 Adverse Reactions Through Week 12

*US-approved etanercept.

Upper respiratory tract infections include nasopharyngitis and rhinovirus infection.

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.

Infections Through Week 12 Infections Through Week 12

*US-approved etanercept.

SAFETY DATA FROM SPIRIT-P1 AND -P2 TRIALS

Overall, patients with psoriatic arthritis had a safety profile consistent with that of 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 SAFETY INFORMATION

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

Week 60 Data

In Plaque Psoriasis Trials

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

Adverse Events Weeks 0-60 Adverse Events Weeks 0-60

*Safety population includes all patients who received Taltz every 2 weeks in the induction phase and every 4 weeks in the maintenance phase. The placebo group received placebo for the duration of the trial. Data based on 541 total person-years for the Taltz group and 190 total person-years for the placebo group.

Exposure-adjusted rates.

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

In Plaque Psoriasis Trials

Safety in Taltz plaque psoriasis clinical trial participants studied for up to 6 years2

In the psoriasis safety population, 5871 patients across 11 clinical trials* received Taltz, with a total exposure of 15,213 patient years (PY) as of September 2017.

  • 3201 patients had at least 2 years’ exposure to Taltz
  • Average duration of exposure to Taltz was 946 days
  • Median duration of exposure to Taltz was 1142 days

*Phase 1-3 clinical trials.

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

n=5697; 9 trials.

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.

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.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  2. Data on file. Lilly USA, LLC. TAL20171211A

WEEKS 24 AND 52 DATA

In PSORIATIC ARTHRITIS TRIALS

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

Adverse Reactions Through Week 24 Adverse Reactions Through Week 24 Adverse Reactions Through Week 52 Adverse Reactions Through Week 52

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

*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.3

Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection.1

Infections Through Week 24 and 52 Infections Through Week 24 and 52

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.1

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

ADVERSE EVENTS OF SPECIAL INTEREST–WEEKS 24 AND 52 DATA

In PSORIATIC ARTHRITIS TRIALS

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

ADVERSE EVENTS OF SPECIAL INTEREST–WEEKS 24 and 52 ADVERSE EVENTS OF SPECIAL INTEREST–WEEKS 24 and 52

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 nonanaphylactic.

Includes all patients with ≥1 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.4

Certain adverse effects, 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.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  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.
Indication and Important Safety Information

Psoriatic Arthritis:

Taltz is indicated for the treatment of adult patients with active psoriatic arthritis.

Plaque Psoriasis:

Taltz is indicated for the treatment of adult patients with moderate to severe plaque psoriasis 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.

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IX HCP ISI 01DEC2017