00:00-00:48
[Taltz logo with dosage and ISI disclaimers appear on screen.]
Caption:
[On-screen]
SELECT IMPORTANT SAFETY INFORMATION
INDICATIONS
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. 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.
CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients. Full Important Safety Information is available at the conclusion of the video.
00:49-00:55
Caption:
Patient Manifestations to Consider When Choosing Taltz for Moderate-to-Severe Plaque Psoriasis
00:56-1:04
[On-screen patient “Taylor” sitting in an armchair.]
Caption:
Not an actual patient.
1:05-1:12
[Plaques appear on Taylor's arms and scalp. His nails are discolored. Icons appear to highlight his scalp and nail psoriasis.]
Caption:
Not an actual patient.
1:13-1:22
[Taylor looks longingly out the window, where he sees a cityscape and individuals walking in a public park.]
Caption:
Not an actual patient.
1:23-1:38
[A paper being uncrumpled to reveal Taylor sitting in a chair. Cutouts of clothing float next to him before covering up his body and his plaques. The scene shifts to reveal Taylor is sitting in the waiting room of his dermatologist.]
Caption:
Not an actual patient.
1:39-2:12
[Taltz UNCOVER-1, -2, -3 trial designs.]
Caption:
[Title and subheadings]
TALTZ REGISTRATION TRIALS:
Multicenter, randomized, double-blind, placebo-controlled1,2
UNCOVER-1: UNCOVER-2, UNCOVER-3
FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
[Graph labels]
SCREENING RANDOMIZATION
12-WEEK INDUCTION PERIOD
UNCOVER-1 (N=864)
Taltz 80 mg every 2 weeks* (n=433)
Placebo (n=431)
UNCOVER-2 (N=877)
Taltz 80 mg every 2 weeks* (n=351)
Enbrel§ 50 mg twice weekly (n=358)
Placebo (n=168)
UNCOVER-3 (N=960)
Taltz 80 mg every 2 weeks* (n=385)
Enbrel§ 50 mg twice weekly (n=382)
Placebo (n=193)
RE-RANDOMIZATION
At Week 12: Taltz Responders (sPGA, 0,1)Re-Randomized To Taltz Q4W(n=221) and PBO (n=211)
MAINTENANCE PERIOD
Taltz 80 mg every 4 weeksUNCOVER-1 (n=119)†UNCOVER-2 (n=102)†
Placebo every 4 weeksUNCOVER-1 (n=117)UNCOVER-2 (n=94)
OPEN-LABEL, LONG-TERM EXTENSION PERIOD
Taltz 80 mg every 4 weeks (n=362)
At Week 12: ALL patients went to Q4W Taltz
Week 0
Week 12
Week 60
Week 264
Co-primary efficacy endpoints at Week 12
- Proportion of patients achieving PASI 75
- Proportion of patients with sPGA 0,1 with at least a 2-point improvement from baseline
*Taltz-treated patients received a 160 mg starting dose
†Intent-to-Treat population: patients RANDOMIZED to receive 160 mg starting dose, 80 mg every 2 weeks for 12 weeks, and 80 mg every 4 weeks in the in the maintenance period. §US-approved etanerceptPASI=Psoriasis Area Severity Index; sPGA=static Physician Global Assessment.
2:13-2:53
[Taltz UNCOVER-1, -2, -3 skin clearance results.]
Caption:
[Title and subheading] TALTZ DEMONSTRATED COMPLETE AND CONSISTENT CLEARANCE1
UNCOVER-1, UNCOVER-2, UNCOVER-3
FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
PASI RESPONSE at Week 12, NRI
UNCOVER-1
Taltz (n=433)
PBO (n=431)
UNCOVER-2
Taltz (n=351)
PBO (n=168)
UNCOVER-3
Taltz (n=385)
PBO (n=198)
PATIENTS ACHIEVEING RESPONSE (%)
0, 25, 50, 75, 100
PASI 75
TALTZ, 89 (UNCOVER-1), 90 (UNCOVER-2), 87 (UNCOVER-3)
PBO, 4 (UNCOVER-1), 2 (UNCOVER-2), 7 (UNCOVER-3)
PASI 90
TALTZ, 71 (UNCOVER-1), 71 (UNCOVER-2), 68 (UNCOVER-3)
PBO, 1 (UNCOVER-1), 1 (UNCOVER-2), 3 (UNCOVER-3)
PASI 100
TALTZ, 35 (UNCOVER-1), 40 (UNCOVER-2), 38 (UNCOVER-3)
PBO, 0 (UNCOVER-1), 1 (UNCOVER-2), 0 (UNCOVER-3)
sPGA 0,1 at Week 12, NRIUNCOVER-182% of patients on Taltz vs 3% on PBOUNCOVER-283% of patients on Taltz vs 2% on PBOUNCOVER-381% of patients on Taltz vs 7% on PBOIn the maintenance period of UNCOVER-1 and -2, 75% of the patients on Taltz who achieved sPGA 0,1 at Week 12 maintained that response at Week 60 (n=181*) vs 7% of patients on PBO (n=203*) (NRI analysis).1
Patients who achieved clear or almost clear skin (sPGA 0,1) after initial treatment with Taltz 80 mg every 2 weeks were rerandomized at Week 12 to receive either Taltz 80 mg every 4 weeks (n=181*) or placebo (n=203*). *Evaluable patients at Week 60. NRI = non-responder imputation, PASI = Psoriasis Area Severity Index; PBO = placebo; sPGA = static Physical Global Assessment
2:54-3:10
[Taltz UNCOVER-3 PASI 90 and 100 results through 5 years.]
Caption:
RAPID IMPROVEMENT AT 12 WEEKS SUSTAINED THROUGH 5 YEARS3
UNCOVER-3: PATIENTS ACHIEVING PASI 90 and 100, OBSERVED4
FOR ADULTS WITH MODERATE TO SEVERE PSORIASIS
RAPID RESPONSE at Week 12
[Graph copy]
PATIENTS ACHIEVING RESPONSE (%)
0 20 40 60 80 100
PASI 90, PASI 100
WEEK 12 (Nx=365*), 40%, 72%
YEAR 1 (60 weeks Nx=335*), 64%, 84%
YEAR 2 (108 weeks Nx=305*), 58%, 81%
YEAR 3 (156 weeks Nx=248*), 65%, 87%
YEAR 4 (204 weeks Nx=222*), 67%, 88%
YEAR 5 (264 weeks Nx=194*), 66%, 90%
Induction Period
Open-Label Extension Period
[Table copy]
PATIENTS ACHIEVING RESPONSE (%), mNRI
PASI 90, PASI 100
WEEK 12, 70%, 39%
WEEK 60, 78%, 59%
WEEK 108, 71%, 50%
WEEK 156, 69%, 49%
WEEK 204, 66%, 48%
WEEK 264, 67%, 46%
[Footnotes]
*Nx=observed population
fdThese were post hoc analyses of ITT population throughout Week 264.The open-label phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results)
3:11-3:15
[Taylor stands, covered from head to toe in his clothes. The clothes then transition away from his body, revealing clearance of his psoriasis, except for some faint remaining plaques on his arms.]
Caption:
Not an actual patient.
3:16-3:42
[Taltz complete clearance in scalp and nail psoriasis.]
Caption:
[Box 1]
COMPLETE CLEARANCE IN SCALP PSORIASIS
87% PSSI=0 at Year 5, observed
Nx=1733 mNRI=69%
Mean baseline PSSI=20
[Box 2]
COMPLETE CLEARANCE IN NAIL PSORIASIS
77% NAPSI=0 at Year 5, observed
Nx=1273 mNRI=64%
Mean baseline NAPSI=27
Patients with nail and scalp PsO have a 3x and 4x greater risk of developing PsA.5,6 Nail and scalp data are from UNCOVER-3 and are post hoc, subgroup analyses of patients who had nail and scalp psoriasis at baseline. The open-label phase of the studies after Week 12 has limitations (eg., no placebo comparison, patients remaining in the extension phase may be those with better results). At Week 12, 10% of patients on placebo achieved PSSI=0 (observed); mNRI=9% (Nx=167 for observed population, n=176 for mNRI, mean baseline=18). At Week 12, 4% of patients on placebo achieved NAPSI=0 (observed); mNRI=4% (Nx=113 observed population, n=116 for mNRI, mean baseline=25).7
Caption: Not an actual patient.
[Footnotes]
mNRI = modified nonresponder imputation; NAPSI = Nail Psoriasis Severity Index; NRI = nonresponder imputation; Nx = observed population; PsA = psoriatic arthritis; PsO = psoriasis; PSSI = Psoriasis Scalp Severity Index.
3:43-3:46
[Taylor stands, holding the prescription box that Taltz is packaged in. The Taltz logo is in the background, along with a molecular chemical structure.]
Caption:
Not an actual patient.
3:47-4:14
[Taltz adverse reactions and infections through Week 12.]
Caption:
FOR ADULTS WITH MODERATE-TO-SEVERE PLAQUE PSORIASIS
ADVERSE REACTIONS AND INFECTIONS1 through Week 12
Adverse reactions that occurred in ≥1% of Taltz patients and more frequently than with placebo
Taltz 80 mg every 2 weeks (n=1167)
Placebo (n=791)
ADVERSE REACTIONS
17%, Injection site reactions, PBO = 3%
14%, Upper respiratory tract infections*, PBO = 13%
2%, Nausea, PBO = 1%
2%, Tinea infections, PBO <1%
INFECTIONS
27%, Infections, PBO = 23%
0.4%, Serious infections, PBO = 0.4%
[Footnote]
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.
*Upper respiratory tract infections include nasopharyngitis and rhinovirus infection.
4:15-4:31
[Taylor stands in front of a park background, smiling confidently as he takes off his jacket to reveal his arms where his psoriasis plaques have mostly cleared.]
Caption:
Not an actual patient.
For more information on Taltz, visit Taltz.com/HCP.
4:32-7:33
[Taltz logo with dosage and remainder of the ISI disclaimers appear on screen.]
Caption:
INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TALTZ (IXEKIZUMAB)
INDICATIONS
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. 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.
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. Serious infections have occurred. 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. In the post-marketing setting, serious bacterial, viral, and fungal opportunistic infections have been reported in patients receiving IL-17 inhibitors, including Taltz. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a serious infection or is not responding to standard therapy, monitor the patient closely and 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. Consider anti-TB therapy prior to initiating Taltz in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving Taltz should be monitored closely 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.
Eczematous Eruptions
In the postmarketing setting, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma were reported in patients receiving Taltz; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of Taltz. Treatment may need to be discontinued to resolve the eczematous eruption. Some patients with limited psoriasis treatment options were successfully treated for eczema while continuing Taltz.
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.
Please see Prescribing Information and Medication Guide. See Instructions for Use included with the device.
Taltz is available as an 80 mg/mL, 40 mg/0.5 mL, 20 mg/0.25 mL injection.
IX HCP ISI 20AUG2024
9:09-9:11
[Reference list progresses on screen]
References
- Taltz. Prescribing Information. Lilly USA, LLC.
- Data on file. Lilly USA, LLC. DOF-IX-US-0183.
- Data on file. Lilly USA, LLC. DOF-IX-US-0183.
- Blauvelt A, Lebwohl MG, Mabuchi T, et al. Long-term efficacy and safety of ixekizumab: a 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021;85:360-368.
- Blauvelt A, Lebwohl MG, Mabuchi T, et al. Long-term efficacy and safety of ixekizumab: a 5-year analysis of the UNCOVER-3 randomized controlled trial. Supplementary material. J Am Acad Dermatol. 2021;85:360-368.
- Ventura A, Mazzeo M, Gaziano R, Galluzzo M, Bianchi L, Campione E. New insight into the pathogenesis of nail psoriasis and overview of treatment strategies. Drug Des Devel Ther. 2017;11:2527-2535.
- Wilson FC, et al. Incidence and Clinical Predictors of Psoriatic Arthritis in Patients With Psoriasis: A Population-Based Study. Arthritis Rheum. 2009;61(2):233-239.
- Data on file. Lilly USA, LLC. DOF-IX-US-0271.
9:12-9:14
[Text fades to white. Lilly logo appears.]
Caption:
Lilly PP-IX-US-6948 09/2024 ©Lilly USA 2024. All rights reserved.
