Taltz Citrate-Free: The same active ingredient with significantly less injection site pain vs the original formulation1*
*P<.0001; 3.5 vs 25.2 based on VAS 0-100
FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Trust the Taltz long-term safety data2-8
Five years of established safety experience with this IL-17A antagonist
Across 15 global PsO clinical trials
6000+ PsO patients treated in adult studies
17,000+ patient-years of exposure to Taltz
NO BOXED WARNINGS OR ROUTINE LAB MONITORING REQUIRED*
Adjudicated IBD events were LOW AND INFREQUENT (0.5%)†
Rate of oral candidiasis was 2.2% and did not lead to treatment discontinuation
*During Taltz treatment, monitor patients for signs and symptoms of infection and for onset or exacerbation of IBD. During and after treatment with Taltz, monitor patients for active tuberculosis infection.
†There were 5 additional patients with adjudicated IBD that weren’t considered TEAEs. Total adjudicated IBD, n=31 patients (0.5%).
Long-term safety data was evaluated using an integrated data set comprising 15 phase 1, 2, 3, and 4 studies in adult patients with moderate to severe plaque psoriasis.
This analysis includes data from the beginning of the studies to the March 2020 cutoff for integrated safety data.
IL-17A=interleukin-17A; PsO=psoriasis; ISR=injection site reaction; IBD=inflammatory bowel disease; TEAE=treatment-emergent adverse event.
SELECT IMPORTANT SAFETY INFORMATION
Taltz is contraindicated in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
Warnings and precautions include infections, pre-treatment evaluation for tuberculosis, hypersensitivity, inflammatory bowel disease, and immunizations. The most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.
FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Safety profile established in UNCOVER registration trials: Week 123
Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo
INTEGRATED SAFETY: UNCOVER registration trials
ADVERSE REACTIONS THROUGH WEEK 12
Taltz 80 mg original formation every 2 weeks (n=1167) | Enbrel® (etaerncept)* 50 mg twice weekly (n=287) | Placebo (n=791) | |
|---|---|---|---|
| Injection site reactions | Taltz 80 mg original formation every 2 weeks (n=1167): 17% | Enbrel® (etaerncept)* 50 mg twice weekly (n=287): 11% | Placebo (n=791): 3% |
| Upper respiratory tract infections† | Taltz 80 mg original formation every 2 weeks (n=1167): 14% | Enbrel* 50 mg twice weekly (n=287): 8% | Placebo (n=791): 13% |
| Nausea | Taltz 80 mg original formation every 2 weeks (n=1167): 2% | Enbrel* 50 mg twice weekly (n=287): <1% | Placebo (n=791): 1% |
| Tinea infections | Taltz 80 mg original formation every 2 weeks (n=1167): 2% | Enbrel* 50 mg twice weekly (n=287): 0% | Placebo (n=791): <1% |
INFECTIONS THROUGH WEEK 12
Taltz 80 mg original formation every 2 weeks (n=1167) | Enbrel* 50 mg twice weekly (n=287) | Placebo (n=791) | |
|---|---|---|---|
| Infections | Taltz 80 mg original formation every 2 weeks (n=1167): 27% | Enbrel* 50 mg twice weekly (n=287): 18% | Placebo (n=791): 23% |
| Serious infections | Taltz 80 mg original formation every 2 weeks (n=1167): 0.4% | Enbrel* 50 mg twice weekly (n=287): 0.3% | Placebo (n=791): 0.4% |
*US-approved Enbrel (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.
ADDITIONAL ACTIVE COMPARATOR SAFETY INFORMATION FROM UNCOVER-2 AND -3
In the 2 clinical trials that included US-approved 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 Enbrel, and the rate of discontinuation from adverse events was 2% with Taltz and 0.7% with US-approved Enbrel.
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%).
TALTZ PSORIASIS CLINICAL TRIALS
Demonstrated long-term safety data for half a decade and counting2,3
Over 6000 patients across 15 clinical trials
ADVERSE EVENTS OF SPECIAL INTEREST: INCIDENCE RATES PER 100 PYS
Total PY=17,599 | Year 1 PY=5688 | Year 2 PY=3390 | Year 3 PY=3108 (n) | Year 4 PY=2882 (n) | Year 5 PY=2375 (n) | |
|---|---|---|---|---|---|---|
| Serious infections | Total PY=17,599: 1.3 | Year 1 PY=5688: 1.3 | Year 2 PY=3390: 1.4 | Year 3 PY=3108 (n): 1.7 | Year 4 PY=2882 (n): 1.4 | Year 5 PY=2375 (n): 1.3 |
| Candida infections | Total PY=17,599: 1.9 | Year 1 PY=5688: 3.2 | Year 2 PY=3390: 2.2 | Year 3 PY=3108 (n): 2.1 | Year 4 PY=2882 (n): 2.3 | Year 5 PY=2375 (n): 2.0 |
| Hypersensitivity (non-anaphylaxis) | Total PY=17,599: 5.1 | Year 1 PY=5688: 9.8 | Year 2 PY=3390: 5.0 | Year 3 PY=3108 (n): 4.4 | Year 4 PY=2882 (n): 4.2 | Year 5 PY=2375 (n): 3.5 |
| Hypersensitivity (potential anaphylaxis*) | Total PY=17,599: 0.1 | Year 1 PY=5688: 0.2 | Year 2 PY=3390: 0.1 | Year 3 PY=3108 (n): 0.0 (0) | Year 4 PY=2882 (n): 0.0 (0) | Year 5 PY=2375 (n): 0.0 (0) |
| Crohn’s disease† | Total PY=17,599: 0.1 | Year 1 PY=5688: 0.1 | Year 2 PY=3390: 0.1 | Year 3 PY=3108 (n): 0.0 (1) | Year 4 PY=2882 (n): 0.0 (1) | Year 5 PY=2375 (n): 0.1 |
| Ulcerative colitis† | Total PY=17,599: 0.1 | Year 1 PY=5688: 0.2 | Year 2 PY=3390: 0.1 | Year 3 PY=3108 (n): 0.0 (1) | Year 4 PY=2882 (n): 0.0 (0) | Year 5 PY=2375 (n): 0.1 |
| Malignancy-related (Nonmelanoma skin cancer) | Total PY=17,599: 0.3 | Year 1 PY=5688: 0.5 | Year 2 PY=3390: 0.2 | Year 3 PY=3108 (n): 0.4 | Year 4 PY=2882 (n): 0.2 | Year 5 PY=2375 (n): 0.2 |
| Malignancy-related (Malignancies excluding NMSCs) | Total PY=17,599: 0.5 | Year 1 PY=5688: 0.5 | Year 2 PY=3390: 0.6 | Year 3 PY=3108 (n): 0.5 | Year 4 PY=2882 (n): 0.6 | Year 5 PY=2375 (n): 0.6 |
| Injection site reactions | Total PY=17,599: 5.5 | Year 1 PY=5688: 16.1 | Year 2 PY=3390: 4.2 | Year 3 PY=3108 (n): 2.2 | Year 4 PY=2882 (n): 2.3 | Year 5 PY=2375 (n): 1.7 |
*After review of potential cases, no confirmed cases of anaphylaxis in clinical trials.9
†Data on all suspected IBD, as identified by events potentially indicative of ulcerative colitis or Crohn’s disease, were adjudicated according to EPIMAD criteria by an external clinical review committee of gastroenterologists with IBD expertise.
When incidence rates equal 0.0, the n value is added; n=number of events.
The average and median Taltz exposure durations were 996.7 days and 718 days, respectively.10
Certain adverse events, such as malignancy, require longer observation periods and larger patient exposure to ascertain risk. In the reported safety population of the psoriasis clinical trials, not all patients received the recommended dosing regimen consistent with the FDA-approved label.
PY=patient-year; NMSC=nonmelanoma skin cancer; IBD=inflammatory bowel disease; EPIMAD=Registre Epidemiologique des Maladies de l’Appareil Digestif.
References: 1. Chabra S, Gill BJ, Gallo G, et al. Ixekizumab citrate-free formulation: results from two clinical trials. Adv Ther. 2022;Epub (Incl Suppl Inf):1-11, 1-4. https://doi.org/10.1007/s12325-022-02126-0 . 2. Data on file. Lilly USA, LLC. DOF-IX-US-0251. 3. Data on file. Lilly USA, LLC. DOF-IX-US-0256. 4. Taltz [package insert]. Indianapolis, IN: Lilly LLC, USA. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0291. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0265. 7. Data on file. Lilly USA, LLC. DOF-IX-US-0288. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0289. 9. Data on file. Lilly USA, LLC. DOF-IX-US-0267. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0255.
INDICATIONS
Taltz is indicated for patients aged 6 years or older 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), adult patients with active ankylosing spondylitis (AS), and adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
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