00:00-00:05
[Lilly A Medicine Company logo appears on the screen]
00:06-00:11
[On screen visual of a physician in an office helping a patient break through a wall. On the other side of the wall, the patient is going a cannonball into a swimming pool in the presence of friends.]
Caption: Real Patient Stories: A Taltz Experience with Dr. Mark Jackson
Caption: Taltz A Lilly Medicine Logo (remains on screen throughout the entire video)
Caption: PP-IX-US-7064 10/2024 © Lilly USA, LLC 2024. All rights reserved.
Caption: Taltz® and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
Caption: Other company and product names are trademarks of their respective owners.
00:12-00:35
[Dr. Mark Jackson looks directly at the camera and introduces himself. He is wearing a business suit and tie.]
Caption: DR. MARK JACKSON
Caption: Clinical professor of medicine and dermatology at the University of Louisville Division of Dermatology Member of Forefront Dermatology in Louisville, Kentucky
Dr. Mark Jackson: Hello, I'm Dr. Mark Jackson. I'm a clinical professor of medicine and dermatology at the University of Louisville Division of Dermatology and also a member of Forefront Dermatology in Louisville, Kentucky. Today, I’ll be sharing a patient case from my clinical practice on behalf of Lilly USA, LLC. This program is being presented consistent with FDA guidelines and is not approved for continuing education credit.
00:36-02:26
[Scene cuts from Dr. Jackson to Taltz Indications and Important Safety Information]
Caption: Indications and Important Safety Information for Taltz (ixekizumab)
Caption: 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.
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.
Caption: Please note this is not the full Safety Information for Taltz. The rest of the Safety Information will be covered later in the video.
02:27-03:00
[Dr. Jackson reappears on screen.]
Dr. Mark Jackson: I've been in practice for nearly 25 years, and it's been a lot of fun seeing the advent of new therapies come into our armamentarium. During this time, I've been actively involved in teaching, clinical research and actually had the good fortune of being involved with the clinical trial program with Taltz. Today, I want to highlight a patient case that really impacted me in a major way. I think this patient depicts a fairly typical scenario with the ones that I've seen in the Taltz clinical trials and also in my clinic, but this gentleman stood out for me for a few reasons, and I think you'll see why as we discuss this case.
03:01-03:42
[Screen splits to Dr. Jackson on the left and relevant data shown on the right.]
Caption: Patient Clinical Description
Dr. Mark Jackson: He's a 35-year-old man who presented to me with a ten-year history of psoriasis, with a Body Surface Area of 16% and a Physician Global Assessment of 3. He came to me, having only been on topicals in the past but now was having worsening of his disease on his scalp, his face, his trunk, groin, as well as his arms and legs. He also had what he calls “dirty nails” and was very bothered by this because of their visual appearance. I usually ask about joint issues with my psoriasis patients, even if they just present with skin disease and I noted stiffness in his fingers and a couple of his toes. When I inquired, he says it was more bothersome in the morning and did improve throughout the day, but he had noticed that it was worsening over time as well.
Caption: Patient Clinical Description
| Measures | Baseline |
| BSA | 16% |
| sPGA | 3 |
| Location of Plaques | Scalp, face, trunk, groin, arms, legs, nails |
| Joint Involvement | Yes |
Caption: BSA=Body Surface Area; sPGA=static Physician’s Global Assessment.
03:43-04:41
[The table on the right of the screen fades to patient demographic information.]
Dr. Mark Jackson: This patient had recently married, moved to Louisville, and started a new job, so a lot of life changes happening. Six months after the move, his wife was actually diagnosed with breast cancer. So, he'd been under a lot of stress already and noticed his disease had worsened, especially since his wife’s diagnosis. He'd done the usual trial of multiple over-the-counter agents that friends and family had told him about with no benefit. He didn't like using topical steroids, and he really didn't want to use them on his face or groin area. So, when I saw him, I realized he was beyond what I think would be controlled with topical therapy, so we reviewed the different traditional systemics, as well as biologic therapies. Although we discussed that UVB might be an option based on his skin disease, his complaints were consistent with what we see with early psoriatic joint disease, and UVB would obviously not address his joints. I preferred that he not take methotrexate due to his age and the other potential risks with this and the long period of time with which he might need to be on therapy.
Caption: Patient Description
- Occupation: Sales
- Marital Status: Married
- High Levels of Stress
- Previous Tx History: OTC, topical steroids, bio-naïve
Caption: OTC=Over The Counter; Tx=Treatment.
04:42-05:13
[Camera zooms in on Dr. Jackson, still on the left side of the screen. New information explain why to choose Taltz appears on the right side. Camera zooms out on Dr. Jackson during his explanation.]
Dr. Mark Jackson: And so, I chose Taltz for him due to the severity of his skin, as well as his joint disease. I also chose Taltz because of the speed of onset that I'd seen in clinical trials and with other patients in my practice. And I knew that Taltz had a durability of response that would give him benefit over the years if he needed that as well. He was amenable to this, especially with his history of psoriasis and with Taltz being indicated for both psoriasis and psoriatic arthritis, I thought Taltz would be a nice option for him. He had some psoriasis plaques on his face and scalp, so the rapid onset of action was of great interest to him.
Caption: Why Taltz
- High PASI clearance
- Rapid response
- Durability of response
- Efficacy in PsA
- Efficacy in nail, scalp, and genital PsO
Caption: PASI=Psoriasis Area and Severity Index; PsA=Psoriatic Arthritis.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
05:14-05:50
[UNCOVER clinical trial data appears on the right side of the screen while Dr. Jackson remains on the left side.]
Dr. Mark Jackson: You can see here several of the Taltz clinical trials that I considered when thinking about treatment options for this patient and why they ultimately influenced my decision to start Taltz. UNCOVER-1, -2, and -3 are the registration trials for Taltz. They were randomized, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of Taltz in adults with moderate to severe plaque psoriasis. The co-primary efficacy endpoints of the trials were proportion of patients with an sPGA of 0,1 and at least a 2- point improvement from baseline and proportion of patients achieving PASI 75 at week 12.
Caption: Robust Clinical Trial Profile in PsO1-2
Caption: UNCOVER-1, -2, -3
Caption: Adult PsO
Caption: Multicenter, randomized, double blind, PBO controlled*
Caption: *Patients originally randomized to Taltz who were responders at week 12 (ie, PGA 0,1) in UNCOVER-1 and -2 were re-randomized to either Taltz 80 mg Q4W or PBO. In UNCOVER-3, after week 12, all patients received open-label Taltz 80 mg Q4W injections. In all UNCOVER trials, any patient who relapsed (sPGA ≥3) at any time during the maintenance period were classified as nonresponders.
Caption: Nonresponder imputation (NRI) methods were used for categorical efficacy analyses.
Caption: PBO=placebo.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive Clues: A table with three columns appears on the screen detailing UNCOVER trial patients, dosing and endpoints.
The first column in the table describes the trial participants. They were patients 18 years of age or older who had plaque psoriasis with BSA greater than or equal to 10 percent, sPGA score greater than or equal to three, and PASI score greater than or equal to 12 and were candidates for phototherapy or systemic therapy.
The middle column describes dosing in the trial. Taltz 80 mg was given every 2 weeks to 433 patients, 351 patients and 385 patients. The corresponding PBO groups included 431 patients, 168 patients and 193 patients. In UNCOVER -2 and -3:
- US-approved Enbrel® (etanercept) 50 mg biweekly (n=358) (n=382)
- Patients randomized to Taltz received a 160 mg starting dose
The third column details the trial endpoints. Coprimary efficacy endpoints:
- Proportion of patients achieving PASI 75 at 12 weeks
- Proportion of patients with sPGA 0,1 with ≥2-point improvement from baseline at 12 weeks
05:51-06:11
[The camera zooms in on Dr. Jackson as IXORA-R data appears on the screen.]
Dr. Mark Jackson: IXORA-R was a 24-week, multicenter, randomized, double-blind, parallel-group study comparing the efficacy and safety of Taltz versus Tremfya in interleukin-23 antagonist-naive adults with moderate to severe plaque psoriasis. The primary endpoint was the proportion of patients achieving PASI 100 at week 12.
Caption: Robust Clinical Trial Profile in PsO1-2
Caption: IXORA-R
Caption: H2H Study vs. Tremfya® (guselkumab)
Caption: Adult PsO
Caption: Multicenter, randomized, double blind, parallel group (N=1027)
Caption: Nonresponder imputation (NRI) methods were used for categorical efficacy analyses.
Caption: PBO=placebo.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive Clues: A table with three columns appears on the screen detailing UNCOVER trial patients, dosing and endpoints.
The first column in the table describes the trial participants. They were patients 18 years of age or older who had plaque psoriasis with BSA greater than or equal to 10 percent, sPGA score greater than or equal to three, and PASI score greater than or equal to 12 at screening and baseline.
The middle column describes dosing in the trial. 520 patients received Taltz 80 mg every 2 weeks until 12 weeks then 80 mg every 4 weeks thereafter. Patients randomized to Taltz received a 160 mg starting dose. 507 patients received Tremfya 100 mg at week 0 and week 4 and 100 mg every 8 weeks thereafter.
The third column details the trial endpoints. The primary efficacy endpoint was the proportion of patients achieving PASI 100 at week 12.
06:12-07:00
[A bar graph showing PASI response rates at Week 12 takes over the entire screen while Dr. Jackson continues to narrate.]
Dr. Mark Jackson: In the UNCOVER trials, Taltz demonstrated complete and consistent clearance, as shown by these data. Here we see that patients receiving Taltz consistently achieved greater PASI 75, 90, and 100 response rates versus placebo by week 12 across all 3 of these pivotal trials. By week 12, around 90% of patients receiving Taltz achieved PASI 75, around 70% achieved PASI 90, and around 40% achieved PASI 100. Up to 83% of patients on Taltz achieved an sPGA score of 0 or 1 by week 12. In the maintenance period of UNCOVER-1 and -2, 75% of the patients on Taltz who achieved an sPGA score of 0 or 1 at week 12 maintained that response at week 60 vs 7% of patients on placebo.
Caption: Taltz Demonstrated Complete and Consistent Clearance1
Caption: PASI response at week 12, NRI
Caption: For adults with moderate to severe plaque PsO
Caption: SPGA 0,1 at Week 12, NRI
Caption: UNCOVER-1 82% of patients on Taltz vs 3% on PBO
Caption: UNCOVER-2 83% of patients on Taltz vs 2% on PBO
Caption: UNCOVER-3 81% of patients on Taltz vs 7% on PBO
Caption: In 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).2
Caption: Examination of age, sex, race, body weight, and previous treatment with a biologic did not identify differences in response to Taltz among these subgroups at week 12.2
Caption: *Evaluable patients at week 60.
Caption: NRI=nonresponder imputation.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive Clues: A group of bar charts describing the percentage of patients achieving a particular PASI response at Week 12, NRI, in the UNCOVER-1, -2, and –3 trials. There are 18 bars, 6 each for the percentages of patients achieving PASI 75, 90, and 100. In each group of 6, one bar each represents the results of UNCOVER-1, -2, and –3, for Taltz and placebo respectively. In UNCOVER-1 89 percent of patients on Taltz achieved PASI 75 versus four percent of patients on placebo, 71 percent of patients on Taltz achieved PASI 90 versus one percent of patients on placebo and 35 percent of patients on Taltz achieved PASI 100 versus zero percent of patients on placebo. In UNCOVER-2, 90 percent of patients on Taltz achieved PASI 75 versus two percent of patients on placebo, 71 percent of patients on Taltz achieved PASI 90 versus one percent of patients on placebo and 40 percent of patients on Taltz achieved PASI 100 versus one percent of patients on placebo. In UNCOVER-3, 87 percent of patients achieved on Taltz PASI 75 versus seven percent of patients on placebo, 68 percent of patients on Taltz achieved PASI 90 versus three percent of patients on placebo and 38 percent of patients on Taltz achieved PASI 100 versus zero percent of patients on placebo.
07:01-07:36
[Dr. Jackson continues to narrate while a line graph representing long term results appears on the screen.]
Dr. Mark Jackson: This slide presents the percentage of patients treated with Taltz (both observed and modified nonresponder imputation) in the open label extension period of UNCOVER-3 sustaining PASI 75, 90 and 100 response rates through week 264. It demonstrates that patients taking Taltz achieved a rapid response at week 12 and maintained durable response through 5 years. The chronic nature of psoriasis and the duration of this patient’s disease really underscores the importance of this long-term data, as well as the rapid onset of action that I know he wanted.
Caption: Taltz Provided a Consistent Range of Response Through 5 Years5-7
Caption: UNCOVER-3
Caption: PASI 75/90/100 RESULTS AT WEEKS 12, 60, 108, 156, 204, AND 264, OBSERVED
Caption: FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PsO
Caption: These were post hoc analyses of the ITT population through week 264.
Caption: The open-label phase of the study has limitations (eg, no PBO comparison; patients remaining in the extension phase may be those with better results).
UNCOVER-3: PASI 75/90/100 at Weeks 12, 60, 108, 156, 204, and 264, mNRI
Caption: AE=adverse event; ITT=intent-to-treat; mNRI=modified nonresponder imputation; Nx=observed population; PBO=placebo.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive Clues: A line graph depicts the percentage of patients receiving Taltz 80 mg every 4 weeks (n=385) achieving 75/90/100 PASI results at weeks 12, 60, 108, 156, 204 and 264 in the UNCOVER-3 trial. At week 12 (Nx=365) 92% of patients achieved PASI 75, 72% achieved PASI 90 and 40% achieved PASI 100. At week 60, (Nx=335) 96% of patients achieved PASI 75, 84% achieved PASI 90 and 64% achieved PASI 100. At week 108, (Nx=305) 94% of patients achieved PASI 75, 81% achieved PASI 90 and 58% achieved PASI 100. At week 156, (Nx=248) 97% of patients achieved PASI 75, 87% achieved PASI 90 and 65% achieved PASI 100. At week 204, (Nx=222) 98% of patients achieved PASI 75, 88% achieved PASI 90 and 67% achieved PASI 100. At week 264, (Nx=194) 97% of patients achieved PASI 75, 90% achieved PASI 90 and 66% achieved PASI 100.
Caption mNRI analysis imputes missing data due to the study drug (eg, inadequate response, AE, lack of efficacy) as nonresponse, whereas missing data due to other reasons (eg, missed visits, lost to follow-up) are included as a predicted value based on statistical modeling of observed data.
Caption: UNCOVER-3: PASI 75/90/100 at Weeks 12, 60, 108, 156, 204, and 264, mNRI
Caption:
| PASI score | Week 12 | Week 60 | Week 108 | Week 156 | Week 204 | Week 264 |
| 75 | 90% | 89% | 84% | 82% | 83% | 79% |
| 90 | 70% | 78% | 71% | 69% | 66% | 67% |
| 100 | 39% | 59% | 50% | 49% | 48% | 46% |
07:37-07:55
[Dr. Jackson continues to narrate while a table showing IXORA-R efficacy endpoints appears on the screen.]
Dr. Mark Jackson: Additionally, the results seen in the IXORA-R trial further supported my decision to initiate this patient on Taltz. Taltz showed superiority on the primary endpoint and all key secondary endpoints through week 12 versus Tremfya, including significant improvement as measured by PASI 75 at week 2.
Caption: Taltz Established Superiority to Tremfya Across All Key Efficacy Endpoints Through Week 123
Caption: For adults with moderate to severe plaque PsO
Caption: IXORA-R: Response rates of key efficacy endpoints, NRI
| Outcome measure, NRI* | Response Rate (%) | Significance |
|
Taltz
(n=520)
|
Tremfya
(n=507)
| P-value | Achieved |
| Primary efficacy endpoint | |
| PASI 100 at week 12 | 41 | 25 | <.001 | yes |
| Secondary efficacy endpoints | |
| PASI 50 at week 1 | 28 | 9 | <.001 | yes |
| PASI 75 at week 2 | 23 | 5 | <.001 | yes |
| PASI 90 at week 4 | 21 | 8 | <.001 | yes |
| PASI 90 at week 8 | 58 | 36 | <.001 | yes |
| PASI 100 at week 8 | 30 | 14 | <.001 | yes |
| sPGA 0 at week 12 | 42 | 25 | <.001 | yes |
Caption: The secondary efficacy endpoint, PASI 100 at week 24, was type-1 error controlled but did not achieve superiority. At week 24, 50% of patients taking Taltz and 52% of patients taking Tremfya achieved PASI 100.
Caption: *Primary and secondary endpoints were analyzed according to a prespecified graphical multiplicity adjustment approach.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
07:56-08:32
[Dr. Jackson reappears on the screen and continues narrating.]
Dr. Mark Jackson: All of these data, along with my experience with Taltz in clinical practice, highlight the complete and consistent clearance, the rapid rate of improvement, and the long-lasting results I’ve come to expect with Taltz. I also knew from experience that Taltz would work well in treating some of the more challenging body areas this patient was struggling with, such as his nails, scalp, and groin area. The nail and scalp data from the Uncover-3 trial and the data in treating genital psoriasis from the IXORA-Q trial, further supported my decision to initiate Taltz with this particular patient because of the effectiveness in treating these specific areas.
08:33-08:50
[Dr. Jackson continues to narrate off screen while a line grap describing long-term clearance of scalp psoriasis is shown on screen.]
Dr. Mark Jackson: This complete clearance of scalp psoriasis data comes from a post-hoc analysis of patients who had scalp psoriasis at baseline in UNCOVER-3. Nearly 9 out of 10 patients achieved or maintained a scalp psoriasis severity index of zero through week 264.
Caption: For adults with moderate to severe plaque psoriasis
Caption: Data on long-term complete clearance of scalp psoriasis5,8-9
Caption: Nearly 9 out of 10 patients achieved or maintained PSSI=0 through week 264
Caption: UNCOVER-3 post hoc analysis: PSSI=0 response rates through 5 years, observed
Caption: PSSI=0 response rates are for a subset of patients from UNCOVER-3 with baseline scalp psoriasis. The mean baseline PSSI score was 20 for Taltz.3
Caption: 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).
Caption: Please see Important Safety Information throughout this video and accompanying
Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Caption: *Nx=observed population
Caption: †Nx=observed population for placebo at week 12.
Caption: UNCOVER-3 post hoc analysis: PSSI=0 response rates through 5 years, mNRI
| Week 12 | Week 60 | Week 108 | Week 156 | Week 204 | Week 264 |
Taltz
(n=349)
| 78% | 81% | 78% | 74% | 64% | 69% |
Placebo
(n=176)
| 9% | |
Descriptive Clues:
The line graph shows the response rates of patients receiving Taltz 80 mg every 2 weeks (induction); then every 4 weeks (maintenance) at week 12, week 60, week 108, week 156, week 204, and week 264 were 18%, 68%, 71%, 79%, 76%, and 77%. The total number of observed patients at week 12, week 60, week 108, week 156, week 204, and week 264 were 221*, 211*, 184*, 154*, 145*, and 127*, respectively. On the other hand, the response rate of patients on Placebo at week 12 was 4%. The total number of observed patients at week 12 was 113†.
Caption: *Nx=observed population
Caption: †Nx=observed population for placebo at week 12.
08:51-09:00
[Data on screen switches to nail psoriasis]
Dr. Marc Jackson: And when looking at the post hoc analysis of patients who had baseline nail psoriasis in UNCOVER-3, we see that nearly 8 out of 10 patients achieved or maintained a NAPSI zero score through 5 years.
Caption: For adults with moderate to severe plaque psoriasis
Caption: Data on long-term complete clearance in nail psoriasis5,9-10
Caption: Nearly 8 out of 10 patients achieved or maintained NAPSI=0 through week 264
Caption: UNCOVER-3 post hoc analysis: NAPSI=0 response rates through 5 years, observed
Caption: NAPSI=0 response rates were for a subset of patients from UNCOVER-3 with baseline nail psoriasis. For nail psoriasis assessments, only fingernail psoriasis was assessed in UNCOVER-3. The mean baseline NAPSI score was 27 for Taltz.
Caption: 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).
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Caption: *Nx=observed population
Caption: †Nx=observed population for placebo at week 12.
Caption: UNCOVER-3 post hoc analysis: NAPSI=0 response rates through 5 years, mNRI
| Week 12 | Week 60 | Week 108 | Week 156 | Week 204 | Week 264 |
Taltz
(n=299)
| 18% | 65% | 65% | 70% | 60% | 64% |
Placebo
(n=116)
| 4% |
Descriptive Clues:
The line graph shows the response rates of the population (n=229) receiving Taltz 80 mg every 2 weeks (induction); then every 4 weeks (maintenance) were 18%, 68%, 71%, 79%, 76%, and 77% at week 12, week 60, week 108, week 156, week 204, and week 264, respectively. The observed population at week 12, week 60, week 108, week 156, week 204, and week 264 was 221*, 211*, 184*, 154*, 145*, and 127*, respectively. The response rate to placebo (Nx=113†) at week 12 was 4%.
09:01-09:09
[The camera zooms in on Dr. Jackson as he talks about the kind of therapy he needed for treating the patient’s genital psoriasis.]
Dr. Mark Jackson: To treat the patient’s genital psoriasis, I knew I needed a therapy that has demonstrated efficacy in treating this challenging area.
Caption: Robust clinical trial profile in PsO1,4
09:09-09:35
[IXORA-Q trial profile appears on screen. Dr. Mark Jackson appears back on screen to discuss the trial.]
Dr. Mark Jackson: To treat the patient’s genital psoriasis, I knew I needed a therapy that has demonstrated efficacy in treating this challenging area. The Taltz IXORA-Q trial gave me the specific information I was looking for. IXORA-Q is a placebo-controlled, randomized, double-blind study comparing the efficacy and safety of Taltz versus placebo in adults with moderate to severe genital psoriasis. The primary endpoint was the proportion of patients achieving a static Physician Global Assessment of the genitalia of clear or almost clear at week 12.
Caption: Robust clinical trial profile in PsO1,4
Caption: IXORA-Q
Caption: Adult genital PsO
Caption: Randomized, double blind, PBO controlled (N=149)
Caption: PBO=placebo
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive Clues: A table with three columns appears on the screen detailing IXORA-Q trial patients, dosing and endpoints.
The first column in the table describes the trial participants. They were patients 18 years of age or older who had plaque psoriasis with BSA greater than or equal to 1 percent, sPGA greater than or equal to three (moderate PsO), and sPGA-G greater than or equal to 3 (moderate genital PsO) and failed to respond to or were intolerant of one or more topical therapy for genital PsO (corticosteroids, calcineurin inhibitors, and/or vitamin D analogs) who were candidates for phototherapy and/or systemic therapy.
The middle column describes dosing in the trial. 75 patients received Taltz 80 mg every 2 weeks. Patients randomized to Taltz received a 160 mg starting dose.74 patients received PBO.
The third column details the trial endpoints. The primary endpoint was the proportion of patients achieving sPGA-0,1 at week 12.
09:36-10:02
[Dr. Jackson continues to explain the results of the IXORA-Q trial as a graphical representation appears on the screen.]
Dr. Mark Jackson: As you can see here, 73% of Taltz patients achieved the primary endpoint of sPGA-G 0,1 at week 12 compared to 8% with placebo, and Taltz provided complete clearance in genital psoriasis that was sustained over 1 year of treatment, with 6 out of 10 patients achieving an sPGA-G 0 through week 52. Genital psoriasis is tough to treat and seeing that Taltz could provide this level of efficacy was reassuring for me.
Caption: For adults with moderate to severe plaque psoriasis
Caption: More than half of patients achieved sPGA-G (0) by week 12, which was maintained through week 5211
Caption: 56% of Taltz-treated patients achieved sPGA-G (0) (completely clear genital skin) at week 12
Caption: IXORA-Q sPGA-G (0): Response rates through week 52, NRI
Caption: In NRI analysis, 73% of Taltz patients achieved sPGA-G (0,1) at week 12 compared to 8% of placebo (primary endpoint).
Caption: The open-label phase of the study has limitations (e.g. no placebo comparison, patients remaining in the extension phase may be those with better results).
Caption: sPGA-G (0) data were from a prespecified, exploratory endpoint and not controlled for type-1 error.
Caption: NRI of intent-to-treat population through week 52.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive Clues:
Line graph showing the percentage of patients achieving response at week 1, 2, 4, 8, 12, 16, 24, 28, 40, and 52 was 8%, 23%, 31%, 53%, 56%, 60%, 61%, 59%, 61%, and 60%, respectively, for Taltz 80 mg every 2 weeks (n=75). The percentage of patients achieving response at week 1, 2, 4, 8, and 12 for placebo (n=74) was 0%, 0%, 0%, 5%, and 5%.
10:03-10:18
[Dr. Jackson appears back on the screen and the camera zooms in about halfway through.]
Dr. Mark Jackson: And finally, because this patient also had psoriatic arthritis with joint involvement that was continuing to worsen, I knew I needed a therapy that was effective in treating the joints, as well as the skin. Knowing that Taltz is indicated for psoriatic arthritis, as well as psoriasis, helped me to make my treatment choice even easier.
10:19-11:02
[Dr. Jackson remains on the left side of the screen while the SPIRIT-P1 and SPIRIT-P2 profile appears on the right side.]
Dr. Mark Jackson: The Taltz psoriatic arthritis registration trials are SPIRIT-P1 and SPIRIT-P2. These were phase 3, randomized, double-blind, placebo-controlled trials. Patients in SPIRIT-P1 were biologic-naive. Patients in SPIRIT-P2 were TNF inhibitor experienced, having had an inadequate response and/or intolerance to 1 or 2 prior TNF inhibitors. In both trials, the primary efficacy endpoint was the proportion of patients achieving an ACR20 response at week 24. SPIRIT-P1 included an active reference arm of Humira 40 mg every 2 weeks. The study was not designed to test the noninferiority or superiority of Taltz against Humira.
Caption: Robust Clinical Trial Profile in PsA1,14-17
Caption: SPIRIT -P1, -P2
Caption: Adult PsA
Caption: Phase 3, randomized, double blind, PBO controlled
SPIRIT-P1 (bilologic naive, N=417)
SPIRIT-P2 (TNFi experienced, N=363)*
Caption: *Inadequate response and/or intolerance to 1 or 2 prior TNFis. †Taltz 80 mg Q2W is not an approved dose for PsA.
Caption: In SPIRIT- P1 and -P2, all IRs (as defined by blinded criteria of <20% improvement in tender and in swollen joint counts) at week 16 received rescue therapy and were analyzed as nonresponders after week 16 until the primary endpoint. After receiving rescue therapy, IRs in the PBO and Humira arms were rerandomized to Taltz 80 mg Q2W or Q4W. IRs from the PBO arm received their first dose of Taltz at week 16, while IRs from the Humira arm had an 8-week PBO washout period before beginning their first dose of Taltz at week 24
Caption: ACR20/50/70=American College of Rheumatology criteria for 20%/50%/70% improvement; IR=inadequate responder; TNFi=tumor necrosis factor inhibitor; Q2W=every 2 weeks; Q4W=every 4 weeks.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive clues: A table with three columns appears on the screen detailing SPIRIT-P1, -P2 trial patients, dosing and endpoints.
The first column in the table describes the trial participants. They were patients 18 years of age or older who had active PsA and 3 or more swollen and 3 or more tender joints.
The middle column describes dosing in the trial. Taltz 80 mg every 2 weeks (n=103) (n=123)† Taltz 80 mg every 4 weeks (n=107) (n=122) PBO (n=106) (n=118). SPIRIT-P1 had an active reference arm of Humira® (adalimumab) 40 mg every 2 weeks (n=101). The study was not powered to make direct comparisons between the Taltz and Humira arms. Patients randomized to Taltz received a 160 mg starting dose.
The third column details the trial endpoints. The primary efficacy endpoint was marked by the proportion of patients achieving ACR20 response at week 24.
11:03-11:13
[Dr. Jackson talks in the background and the screen displays two graphs from SPRINT-P1 and -P2 clinical trials.]
Dr. Mark Jackson: As you can see here, Taltz provided significant improvement in joint symptoms at week 24 in both trials.
Caption: Powerful Joint Symptom Improvement in PsA at week 24, NRI1,14-17
Caption: ACR response, NRI
Caption: For adults with PsA
Caption: SPIRIT-P1 was not designed to test the noninferiority or superiority of Taltz to Humira. Thus, these data should not be used to compare efficacy between these products.
Caption: SPIRIT-P1: Biologic-Naïve Patients
Caption: *P≤001 vs PBO25
Caption: SPIRIT-P2: TNFi-Experienced Patients
Caption: †P≤001 vs PBO17
Caption: Primary endpoint=ACR20 response at week 24.
Caption: Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive Clues:
Two bar graphs appear side by side showing the response rates for SPIRIT-P1 and SPIRIT-P2.
The first bar graph represents SPIRIT-P1, conducted on Biologic-Naive Patients. The study compares the efficacy of two drugs, Taltz (80 mg every 4 weeks) and Humira (40 mg every 2 weeks), against a placebo. The graph shows the percentage of patients achieving response levels ACR20, ACR50, and ACR70.
For ACR20, 58%* of patients responded to Taltz and 57%* to Humira, compared to 30% for the placebo. For ACR50, the response rates were 40%* for Taltz and 39%* for Humira, compared to 15% for the placebo. For ACR70, 23%* of patients responded to Taltz and 26%* to Humira, compared to just 6% for the placebo.
The total number of participants in the Taltz group was 107, Humira group was 101 and placebo group was 106.
The second bar graph represents SPIRIT-2, conducted on TNFi-experienced patients. It compares the percentage of patients achieving response levels ACR20, ACR50, and ACR70 between two groups: those treated with Taltz (80 mg every 4 weeks) (n=122) and those given a placebo (n=118).
For ACR20, approximately 53%† of patients treated with Taltz achieved this response, which is significantly higher than the approximate 20% in the placebo group. At the ACR50 level, about 35%† of Taltz-treated patients achieved a response, compared to about 5% for the placebo group. For ACR70, approximately 22%† of patients treated with Taltz achieved a response, while no patients in the placebo group did.
11:14-11:24
[Dr. Jackson continues narrating while the screen displays a graph describing inhibition of structural joint damage.]
Dr. Mark Jackson: And, Taltz also has structural joint damage inhibition data from the SPIRIT-P1 clinical trial, and you can see that Taltz significantly inhibited the progression of structural joint damage by week 16 versus placebo.
Caption: Taltz inhibited Progression of Structural Joint Damage in Patients with PsA as Early as Week 161,14,16,18
Caption: Adjusted mean change from baseline at week 16, MMRM2,17,52
Caption: For biologic-naive patients with active PsA
Caption: SPIRIT-P1 was not designed to test the noninferiority or superiority of Taltz vs Humira. Thus, these data should not be used to compare efficacy between these products.
Caption: Taltz 80 mg Q4W (n=107)
Mean baseline mTSS, 19.2
Caption: Humira 40 mg Q2W (n=101)
Mean baseline mTSS, 15.925
Caption: PBO (n=106)
Mean baseline mTSS, 17.6
Caption: Primary endpoint=ACR20 response at week 24.
Caption: Inhibition of progression of structural damage was assessed radiographically and expressed as adjusted mean change in mTSS and its components, joint space narrowing score and bone erosion score, at week 16 vs baseline.
Caption: SPIRIT-P2 (TNFi experienced) did not include assessment of radiographic progression.17
Caption: *P≤.05 vs PBO. †Assessed radiographically and modified for PsA by addition of hand distal interphalangeal joints.
Caption: MMRM=mixed-model for repeated measures; mTSS=modified total Sharp score.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
Descriptive Clues: The bar graph shows the adjusted mean change from baseline at week 16 concerning mTSS, joint space narrowing, and bone erosion for patients receiving Taltz, Humira and placebo. The mean change from baseline for mTSS† for Taltz was 0.13*, Humira was 0.12*, and PBO was 0.36. The mean change from baseline for the joint space narrowing score for Taltz was 0.02, Humira was 0, and PBO was 0.06. The mean change from baseline for the bone erosion score for Taltz was 0.11*, Humira was 0.11*, and PBO was 0.3.
11:25-11:57
[The screen has Dr. Jackson positioned at the left side of the screen while a table is displayed to the right side of the screen. The Talz logo is in the top right corner.]
Dr. Mark Jackson: Here, you see the adverse reactions that occurred in more than 1% of patients in the placebo-controlled period from UNCOVER 1,2, and 3. The most common adverse reactions were injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profile in patients with psoriatic arthritis from SPIRIT-P1 and P2 studies was consistent with this psoriasis safety profile, with the exception of higher frequencies of influenza and conjunctivitis in the psoriatic arthritis population.
Caption: Adverse Reactions and Infections Through Week 12 in PsO Registration Trials1
ADVERSE REACTIONS IN ≥1% OF PATIENTS ON TALTZ AND MORE OFTEN THAN WITH PBO (%)
Descriptive Clues:
Table depicts adverse reactions in 1% of patients on Taltz and more often than with PBO (%).
For the Taltz group (n=1167), 17% of patients experienced injection site reactions, 14% of patients had upper respiratory tract infections, 2% of patients reported nausea, and 2% of patients experienced tinea infections. For the placebo group (n=791), 3% of patients experienced injection site reactions, 13% of patients had upper respiratory tract infections, 1% of patients reported nausea, and less than 1% of patients experienced tinea infections.
For the Taltz group, 27% of patients experienced infections and 0.4% of patients reported serious infections. For the placebo group, 23% of patients experienced infections while 0.4% patients reported serious infections.
*Upper respiratory tract infections included nasopharyngitis and rhinovirus infection.
Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
11:58-12:16
[Dr. Jackson talks about long-term safety profile of Taltz in psoriasis patients. Text and a table in shades of green appears on a white translucent box.]
Dr. Mark Jackson: The established long-term safety profile for Taltz in psoriasis includes 5 years of data from more than 6000 patients, with more than 17 patient-years of exposure. This table shows adverse events of special interest across all 15 clinical trials. No new safety signals and no escalation of previous safety signals were observed.
Caption: Taltz Long-Term Safety Data in PsO Demonstrated for Half a Decade and Counting21-25
6449 TALTZ PATIENTS ACROSS 15 TRIALS AEs OF SPECIAL INTEREST: INCIDENCE RATES PER 100 PY
Descriptive Clues:
The table in the image provides a detailed overview of the incidence rates of various adverse events per 100 patient-years (PYs) over different periods.
The adverse events listed include ‘Serious infections’, ‘Candida infections’, ‘Hypersensitivity’, ‘Crohns disease’, ‘ulcerative colitis’, ‘Malignancy related NMSCs’, and ‘Malignancy excluding NMSCs’ and ISRs. For each adverse event, incidence rates are provided for different periods, ranging from ‘PY=5,688’ to ‘PY=2375’.
Over 6000 Adult
Patients on Taltz Across
15 Clinical Trials
The average and median Taltz exposure durations were 996.7 and 718 days, respectively.
*After review of potential cases, no confirmed cases of anaphylaxis were seen in clinical trials.59 †Data on all suspected IBD, as identified by events potentially indicative of UC or CD, were adjudicated according to EPIMAD criteria by an external clinical review committee of gastroenterologists with IBD expertise.
Certain AEs, such as malignancy, require longer observation periods and larger patient exposure to ascertain risk. In the reported safety population of the PsO clinical trials, not all patients received the recommended dosing regimen consistent with the FDA-approved label.
CD=Crohn's disease; EPIMAD=Registre Epidemiologique des Maladies de l'Appareil Digestif; NMSC=nonmelanoma skin cancer; PY=patient-year; UC=ulcerative colitis.
Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
12:17-13:02
[Next scene goes back to Dr. Jackson in the center of the screen with the Taltz logo in the top right corner. It then transitions to a close-up of him.]
Dr. Mark Jackson: Once I decided that Taltz was the right choice for this particular patient, I started discussing initiating Taltz with him. He was a little concerned about Taltz being an injection and was a little bit apprehensive about starting a therapy with a biologic, but after our conversation, he felt a little bit better. I explained that Taltz is a biologic and is a larger molecule that has to be injected and couldn’t be taken orally. Once he understood this, I think he felt more comfortable, especially after we talked about the potential for the speed of onset with Taltz. I administered his first two injections in the office, which helped him feel more comfortable and also gave him the injection training. I told him I would see him in a couple of weeks, and that he may notice some improvement even over that short period of time, which was amazing to him having had psoriasis for over ten years.
13:03-13:35
[The screen shows Dr. Jackson on the left while graphics appear on a white translucent background on the right. Taltz logo remains on the top right corner.]
Dr. Mark Jackson: I saw him two weeks later and clinically his PGA was down to a 1 and his facial plaques had improved. I told him that I felt like his psoriasis was at least 50% better and some of the areas on his face were barely noticeable. He agreed. I saw him at week 12 and he continued to clear; his body surface area was 1% and his PGA was a one. He had a few small 5-to-6 millimeter scaly plaques on his elbows, but that was it. His nails had improved, and he had noticed that he was not having as much stiffness in his hands in the morning as he had had in the past.
Caption: Week-2 Results
sPGA was down to one
Facial plaques were improved
His PsO was at least 50% better and some areas on his face were barely noticeable
Caption: Week 12 Results
Descriptive Clues: Table shows week 12 results which demonstrated BSA at 16% at baseline and 1% at week 12, sPGA at 3 at baseline and 1 at week 12, and the location of plaques at baseline was on Scalp, face, trunk, groin, arms, legs, nails and at week 12 it was a few 5-6 mm scaly plaques on his elbows.
Nails were 50% better
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
13:36-14:01
[Screen shows a close-up of Dr. Jackson on the left with text and a table appearing on the right. Taltz logo remains on the top right corner.]
Dr. Mark Jackson: And now he's two years out and I see him every six months, as I do with all of my biologic patients once they're doing okay. He has clear nails and all of his other areas are clear. He still has a couple of small residual plaques on his elbows, but they're barely noticeable. And he only notices it when I point them out just to show that there's still a little bit of involvement and that he needs to stay on his therapy. I think he's very happy with how he's doing, and nobody would even know he has psoriasis.
Caption: 2-Year Results
Clear nails, scalp and groin area
Descriptive Clue: The table below the caption shows the baseline values, results at week 12, and results at the end of 2 years for the Location of Plaques, BSA and sPGA. By the end of 2 years, there are only a couple of small residual plaques on his elbows, the BSA is <1% and the sPGA is 1.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
14:02-14:28
[Dr. Jackson is in the center of the screen. The Taltz logo remains at the top right of the screen.]
Dr. Mark Jackson: I highlighted this case as a patient that is consistent with what I’ve seen in my practice. Taltz shows a rapid and durable response that lasted with this patient, and then we see the improvement in the joint disease, as well. And I think it's really important that we factor that in because often times the joint disease postdates the diagnosis of psoriasis. And so, I think catching that early in him will hopefully impact his ability to continue to be a healthy freely moving adult with clear psoriasis over years to come.
14:29- 17:44
[Camera goes to a close up of Dr. Jackson as text appears to the right of him. Taltz logo remains at the top right of the screen. The next scene transitions to an all white background with scrolling text.]
Dr. Mark Jackson: Included here is some additional important safety information for Taltz.
Caption: Additional Important Safety Information
WARNINGS AND PRECAUTIONS
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/0.5mL, 20 mg/0.25mL injection.
This is not the complete Important Safety Information for Taltz. Additional Important Safety Information was given at the beginning of the video.
IX HCP ISI 20AUG2024
17:45-17:52
[Dr. Jackson appears on the screen with the Taltz logo in the top right corner. A white box drops down and the references text appears.]
Dr. Mark Jackson: Thanks for taking the time to watch this presentation.
Caption: References
1. Taltz. Prescribing information. Lilly USA, LLC. 2. Data on file. Lilly USA, LLC. DOF-X-US-0183. 3. Data on file. Lilly USA, LLC. DOF-X-US-0167. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0273. 5. Blauvelt A, Lebwohl MG, Mabuchi T, et al. Long-term efficacy and safety of ixeizumab: a 5-year analysis of the UNCOVER-3 randomized controlled trial. J Am Acad Dermatol. 2021;85(2):360-368. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0197. 7. Data on file. Lilly USA, LLC. DOF-IX-US-0209. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0264. 9. 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(2)(suppl):360-368. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0259. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0258. 12. Data on file. Lilly USA, LLC. DOF-IX-US-0119. 13. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of the SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase Ill trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1)(suppl):1-30. 14. 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. 15. 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. 16. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of the SPIRIT-P 1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naïve patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase Ill trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1): 79-87. 17. Data on file. Lilly USA, LLC. TAL20171127A. 18. Data on file. Lilly USA, LLC. TAL20171026B. 19. Shear NH, Paul C, Blauvelt A, et al. Safety and tolerability of ixekizumab: integrated analysis of injection-site reactions from 11 clinical trials. J Drugs Dermatol. 2018;17(2):200-206. 20. Data on file. Lilly USA, LLC. DOF-IX-US-0123. 21. Data on file. Lilly USA, LLC. DOF-IX-US-0251. 22. Data on file. Lilly USA, LLC. DOF-IX-US-0256. 23. Data on file. Lilly USA, LLC. DOF-IX-US-0255. 24. Data on file. Lilly USA, LLC. DOF-IX-US-0268. 25. Data on file. Lilly USA, LLC. DOF-IX-US-0267.
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
17:53-18:01
[Screen transitions to an all green background while a white Lilly logo appears on a white background. The logo then transitions onto an all green background.]
Caption:
Lilly A Medicine Company logo
