00:00-00:12
[On screen visual of a physician helping an adult break through a literal barrier, representative of breaking through social barriers presented by a psoriasis diagnosis. As a result of this breakthrough, the adult is enjoying a day at the pool with their family, liberated from any barriers, physical or social.]
Narrator: N/A
Caption: Real Patient Stories: A Taltz Experience with Dr. Mark Jackson
00:12-00:35
[Dr. Mark Jackson looks directly at the camera and introduces himself. He is seated comfortably and clothed in business formals.]
Narrator: 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.
Caption: DR. MARK JACKSON – Clinical professor of medicine and dermatology at the University of Louisville Division of Dermatology, Member of Forefront Dermatology in Louisville, Kentucky.
00:35-01:09
[The screen cuts from Dr. Jackson and fills up to display the Indication and Select Important Safety Information of Taltz with Taltz logo and dose information depicted on the top right corner of the screen.]
Narrator: Taltz is indicated for adults and pediatric patients 6 years of age or older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and also adults with active psoriatic arthritis, adults with active ankylosing spondylitis, and adults with active nonradiographic axial spondyloarthritis with objective signs of inflammation. Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of its excipients.
Caption: INDICATIONS
Taltz is indicated for:
- Adults and pediatric patients 6 years of age or older with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy
- Adults with active psoriatic arthritis (PsA)
- Adults with active ankylosing spondylitis (AS)
- 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 its excipients.
This is not the complete Important Safety Information for Taltz. Please see additional Important Safety Information at the end of this video.
01:09-01:50
[Dr. Jackson explains the possible warnings and precautions of using Taltz, including the risk of infections. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: 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 with 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.
Caption: 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.
This is not the complete Important Safety Information for Taltz. Please see additional Important Safety Information at the end of this video.
01:50-02:11
[Dr. Jackson emphasizes the importance of conducting a pre-treatment evaluation for tuberculosis as a precautionary measure.]
Narrator: Pre-treatment evaluation for tuberculosis should be conducted. Evaluate patients for tuberculosis 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.
Caption: 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.
This is not the complete Important Safety Information for Taltz. Please see additional Important Safety Information at the end of this video.
02:11-02:20
[Dr. Jackson explains where to find the full safety information for Taltz. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: Please note that this is not the full safety information for Taltz. The rest of the safety information will be covered later in the video.
Caption: This is not the complete Important Safety Information for Taltz. Please see additional Important Safety Information at the end of this video.
02:20-02:35
[Dr. Jackson shares a brief background of his involvement with the clinical trial program with Taltz and his extensive teaching and clinical research experience. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: 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.
Caption: N/A
02:35-02:54
[Dr. Jackson introduces a patient case that stood out for him. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: 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.
Caption: N/A
02:54-03:19
[The screen splits with Dr. Jackson describing the physiology of the patient in one half while the other half displays relevant metrics. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: 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.
Caption: Patient Clinical Description
| Measures | Baseline |
| BSA | 16% |
| sPGA | 3 |
| Location of Plaques | Scalp, face, trunk, groin, arms, legs, nails |
| Joint Involvement | Yes |
BSA= Body Surface Area
sPGA= static Physician’s Global Assessment
03:19-03:36
[Dr. Jackson speaks about the initial symptoms of the patient in question. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: 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 |
BSA= Body Surface Area
sPGA= static Physician's Global Assessment
03:36-03:58
[Dr. Jackson explains the patient's circumstances at the time of the diagnosis while the other half of the screen captures key elements of his life. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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.
Caption: Patient Description
Caption:
- Occupation: Sales
- Marital Status: Married
- High Levels of Stress
- Previous Tx History: OTC, topical steroids, bio-naïve
OTC= Over The Counter
Tx= Treatment
03:58-04:14
[Dr. Jackson describes the patient’s reaction to different therapy options. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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.
Caption: Patient Description
Caption:
- Occupation: Sales
- Marital Status: Married
- High Levels of Stress
- Previous Tx History: OTC, topical steroids, bio-naïve
OTC= Over The Counter
Tx= Treatment
04:14-04:34
[Dr. Jackson explains his rationale behind not recommending UVB as a treatment option. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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
Caption:
- Occupation: Sales
- Marital Status: Married
- High Levels of Stress
- Previous Tx History: OTC, topical steroids, bio-naïve
OTC= Over The Counter
Tx= Treatment
04:34-05:06
[Dr. Jackson explains why he chose Taltz with one-half of the screen highlighting the primary reasons driving his decision-making. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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
Caption:
- High PASI clearance
- Rapid response
- Durability of response
- Efficacy in PsA
- Efficacy in nail, scalp, and genital PsO
- PASI: Psoriasis Area and Severity Index
PsA= Psoriatic Arthritis
05:06-05:17
[Dr. Jackson speaks about the clinical trial data that convinced him to recommend Taltz as a treatment option. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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.
Caption: Robust Clinical Trial Profile in PsO1-2
Caption: UNCOVER-1, -2, -3
Caption: Adult PsO
Multicenter, randomized, double blind, PBO controlled*
*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.
Nonresponder imputation (NRI) methods were used for categorical efficacy analyses.
PBO=placebo.
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 the following data
PARTICIPANTS
Patients ≥18 years of age who had plaque PsO with BSA ≥10%, sPGA score ≥3, and PASI score ≥12 and were candidates for phototherapy or systemic therapy.
DOSING
Taltz 80 mg every 2 weeks (n=433, n=351, n=385) PBO (n=431) (n=168) (n=193)
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
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
05:17-05:43
[Dr. Jackson explains the trial design of the UNCOVER trials. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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*
*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.
Nonresponder imputation (NRI) methods were used for categorical efficacy analyses.
PBO=placebo.
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 the following information:
PARTICIPANTS
Patients ≥18 years of age who had plaque PsO with BSA ≥10%, sPGA score ≥3, and PASI score ≥12 and were candidates for phototherapy or systemic therapy.
DOSING
Taltz 80 mg every 2 weeks (n=433, n=351, n=385) PBO (n=431) (n=168) (n=193)
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
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
05:43-06:04
[The camera takes a close-up of Dr. Jackson’s face as he looks through more clinical trial profiles. Taltz logo and dose information remain static on the top right corner of the screen.]
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
Multicenter, randomized, double blind, parallel group (N=1027)
Nonresponder imputation (NRI) methods were used for categorical efficacy analyses.
PBO=placebo.
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 the following information:
PARTICIPANTS
Patients ≥18 years of age who had plaque PsO, with BSA ≥10%, sPGA score ≥3, and PASI score ≥12 at screening and baseline
DOSING
Taltz (n=520)
Taltz 80 mg every 2 weeks until 12 weeks
Taltz 80 mg every 4 weeks thereafter
Patients randomized to Taltz received a 160 mg starting dose
Tremfya® (guselkumab) (n=507)
Tremfya 100 mg at week 0 and week 4
Tremfya 100 mg every 8 weeks thereafter
TRIAL ENDPOINTS
Primary efficacy endpoint:
- Proportion of patients achieving PASI 100 at week 12
06:04-06:10
[The camera closes in on Dr. Jackson as he prepares to uncover the UNCOVER trials data. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: In the UNCOVER trials, Taltz demonstrated complete and consistent clearance, as shown by these data.
Caption: Taltz Demonstrated Complete and Consistent Clearance1
06:10-06:53
[The UNCOVER trials data fills up the screen as Dr. Jackson explains the figures in the background. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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: SPGA 0,1 at Week 12, NRI
Caption: UNCOVER-1
82% of patients on Taltz vs 3% on PBO
UNCOVER-2
83% of patients on Taltz vs 2% on PBO
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 PGA 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.
The data in these bar charts is as narrated.
06:53-07:29
[Dr. Jackson continues explaining the clinical trial data. Three line graphs showing the results of the UNCOVER-3 trial. A table with the data points of the same study appears below. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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: 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).
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: 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 group of line graphs depict the percentage of patients achieving the narrated PASI results at weeks 12, 60, 108, 156, 204, and 264, as observed. These results were for adults with moderate to severe plaque PsO. The data shown in the graphs is as follows:
At week 12, Nx = 365. 90% patients achieved PASI 75, 70% achieved PASI 90, and 39% achieved PASI 100.
At week 60, Year 1 Nx = 335. 89% of these patients achieved PASI 75, 78% achieved PASI 90, and 59% achieved PASI 100.
At week 108, Year 2 Nx = 305. 84% achieved PASI 75, 71% achieved PASI 90, and 50% achieved PASI 100.
At week 156, Year 3 Nx = 248. 82% achieved PASI 75, 69% achieved PASI 90, and 49% achieved PASI 100.
At week 204, Year 4 Nx = 222. 83% achieved PASI 75, 66% achieved PASI 90, and 48% achieved PASI 100.
At week 264, Year 5 Nx = 194. 79% achieved PASI 75, 67% achieved PASI 90, and 46% achieved PASI 100.
07:29-07:47
[Dr. Jackson explains the results observed in the IXORA-R trial as a table containing the response rates (in percentages) of key efficacy end points of Taltz and Tremfya appears on the screen. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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
Descriptive Clue:
The table contains three columns— outcome measures with NRI*, response rate (%), and significance. It contains information regarding the response rates (%) of Taltz (n=520) and Tremfya (n=507). The primary efficacy endpoint was PASI 100 at week 12 and secondary efficacy endpoints were PASI 50 at week 1, PASI 75 at week 2, PASI 90 at week 4, PASI 100 at week 4, PASI 90 at week 8, PASI 100 at week 8, and sPGA 0 at week 12.
The response rate (%) of Taltz was 41 whereas the response rate of Tremfya was 25 at the primary efficacy endpoint. The response rates of Taltz at the secondary end points were 28, 23, 21, 7, 58, 30, and 42 at PASI 50 at week 1, PASI 75 at week 2, PASI 90 at week 4, PASI 100 at week 4, PASI 90 at week 8, PASI 100 at week 8, and sPGA 0 at week 12, respectively. On the other hand, the response rates at the secondary efficacy endpoints for Tremfya, were 9, 5, 8, 1, 36, 14, and 25 at PASI 50 at week 1, PASI 75 at week 2, PASI 90 at week 4, PASI 100 at week 4, PASI 90 at week 8, PASI 100 at week 8, and sPGA 0 at week 12, respectively.
Caption: *Primary and secondary endpoints were analyzed according to a prespecified graphical multiplicity adjustment approach.
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: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
07:48-08:10
[Dr. Jackson appears on the screen and explains that the results seen in the clinical trials along with his experience with Taltz in clinical practice helped strengthen his trust in Taltz. The Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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.
Caption: N/A
08:11-08:25
[Dr. Jackson continues to explain the other factors that encouraged him to go ahead with his decision to start treatment with Taltz for this patient. The Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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.
Caption: N/A
08:26-08:53
[Dr. Jackson explains the UNCOVER-3 post-hoc analysis of patients who had scalp psoriasis as a line graph and a table appear on the screen. In the second frame, another line graph and table appear on the screen, as Dr. Jackson continues to explain the UNCOVER-3 post-hoc analysis of patients who had nail psoriasis. The Taltz logo and dose information remain static on the top right corner of the screen. A visual representation of a side-facing human face also appears on the left side of the Taltz logo.]
Narrator: 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. 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 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
Descriptive Clue:
In the line graph, the response rates of patients to Taltz 80 mg every 4 weeks at week 12, week 60, week 108, week 156, week 204, and week 264 were 80%, 87%, 87%, 88%, 87%, and 87%. The total number of observed patients at week 12, week 60, week 108, week 156, week 204, and week 264 was 332, 306, 273, 220, 199, and 173, respectively. On the other hand, the response rate of patients to Placebo at week 12 was 10%. The total number of observed patients at week 12 was 167.
In the table, the response rates of people to Taltz 80 mg every 4 weeks were 78%, 81%, 78%, 74%, 64%, and 69%. The total number of observed patients was 349. The response rate of patients to placebo was 9%. The total number of observed people was 176.
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 (e.g. 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: 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
Descriptive Clue: In the line graph, the response rates (%) of the observed population (221) to Taltz 80 mg every 2 weeks (induction); then every 4 weeks (maintenance) (n=229) 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 (n=113) at week 12 was 4%.
In the table, the response rates of the observed population to Taltz 80 mg every 2 weeks (induction); then every 4 weeks (maintenance) (n=229) were 18%, 65%, 65%, 70%, 60%, and 64% at week 12, week 60, week 108, week 156, week 204, and week 264, respectively. The response rate of the observed population to Placebo (n=116) was 4%.
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. 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: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
08:54-09:27
[The camera zooms in on Dr. Jackson as he talks about the kind of therapy he needed for treating the patient’s genital psoriasis. In the next frame, he describes the results of the Taltz IXORA-Q trial that compared the efficacy and safety of Taltz with placebo in adult patients with moderate to severe genital psoriasis as a tabular representation appears on the screen which is then followed by a split screen showing Dr. Jackson as well as the tabular representation. The Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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 (first frame): Robust Clinical Trial Profile in PsO1,4
Caption (second frame): Robust Clinical Trial Profile in PsO1,4
Caption: IXORA-Q Adult genital PsO Randomized, double blind, PBO controlled (N=149)
Descriptive Clue:
The image represents the summary of IXORA-Q trial, for patients on Taltz aimed at treating adult genital Psoriasis (PsO). The trial was a placebo-controlled, randomized, double-blind study involving 149 participants.
The participants were patients aged 18 years and above who had plaque PsO with Body Surface Area (BSA) ≥1%, static Physician’s Global Assessment (sPGA) ≥3, and genital Physician’s Global Assessment (PGA-G) ≥3 at baseline. These patients had failed to respond to, or were intolerant of topical therapy for genital PsO, including corticosteroids, calcineurin inhibitors, and/or vitamin D analogs, and were candidates for phototherapy and/or systemic therapy.
In terms of dosing, 75 patients were administered Taltz 80 mg every 2 weeks, while the remaining 74 received a placebo. Patients randomized to Taltz received a 160 mg starting dose.
The primary endpoint of the trial was the proportion of patients achieving sPGA-G 0 or 1 at week 12.
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.
09:28-09:54
[Dr. Jackson continues to explain the results of the IXORA-Q trial as a graphical representation appears on the screen. The Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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
Descriptive Clue:
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%.
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.
09:55-10:11
[Dr. Jackson is explaining why he chose Taltz for treating the patient. In the second part of the scene, the camera zooms in on Dr. Jackson. The Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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.
Caption: N/A
10:12-10:55
[Dr. Jackson explains regarding clinical trials SPIRIT-P1 and SPIRIT-P2 and a table appears on the screen. The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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
Adult PsA
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: Table shows information regarding participants: Patients ≥18 years of age who had active PsA and ≥3 swollen and ≥3 tender joints,
Dosing: 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.
Trial endpoints: Primary efficacy endpoint marked by the proportion of patients achieving ACR20 response at week 24.
10:55-11.05
[Dr. Jackson talks in the background and the screen displays two graphs from SPRINT-P1 and -P2 clinical trials. The data provides proof regarding the joint symptom improvement in PsA at week 24. The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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: 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:
The first bar graph in the image represents the results of a clinical study named 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 asterisks indicate that the differences in response rates for Taltz and Humira compared to the placebo are statistically significant (*PY<.001 vs PBO). This means that both Taltz and Humira are significantly more effective than the placebo in achieving various levels of patient response in this study. The total number of participants in the Taltz group was 107, Humira group was 101 and placebo group was 106. This graph is a clear demonstration of the superior efficacy of Taltz and Humira over the placebo in this clinical setting.
The second bar graph in the image is titled “SPIRIT-P2: TNFi-Experienced Patients” and 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.
The symbols above the Taltz bars indicate that the differences in response rates for Taltz compared to the placebo are statistically significant (†p≤0.001 vs PBO). This suggests that Taltz is significantly more effective than the placebo in achieving various levels of patient response in this study among TNFi-Experienced Patients. This graph provides a clear visual representation of the superior efficacy of Taltz over the placebo in this clinical setting.
11:05-11:18
[Dr. Jackson talks in the background and screen displays one graph regarding Taltz effect on progression of structural joint damage. The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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.
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.
SPIRIT-P2 (TNFi experienced) did not include assessment of radiographic progression.17
*P≤.05 vs PBO. †Assessed radiographically and modified for PsA by addition of hand distal interphalangeal joints.
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 in the image shows data from the SPIRIT-P1 clinical trial to testify that Taltz inhibited the progression of structural joint damage in biologic-naive patients with active PsA. The bar graph compares the adjusted mean change in baseline at week 16 as observed by administering Taltz (80 mg Q4W), Humira (40 mg Q2W) and PBO.
The total number of participants in the Taltz group was 107, the Humira group was 101 and the PBO group was 106.
The mean baseline mTSS for Taltz was 19.2, the mean baseline mTSS for Humira was 15.9, and the mean baseline mTSS for PBO was 17.6.
Please keep in mind that SPIRIT-P1 was not designed to test the noninferiority of Taltz vs Humira and these data should not be used to compare efficacy between these products.
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. According to the bar graph, mTSS for Taltz was 0.13*, Humira was 0.12*, and PBO was 0.36. The joint space narrowing score for Taltz was 0.02, Humira was 0, and PBO was 0.06. The bone erosion score for Taltz was 0.11*, Humira was 0.11*, and PBO was 0.3.
The asterisk indicates that the observed difference between Taltz and Humira as compared to the placebo group is statistically significant at the 0.05 significance level (P≤.05).
mTSS has been assessed radiographically and modified for PsA by the addition of hand distal interphalangeal joints.
11:18-11:49
[The screen has Dr. Jackson positioned at the left side of the screen explaining about Adverse reactions in patients treated with Taltz and PBO (Table displayed to the right side of the screen). The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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
Caption: ADVERSE REACTIONS IN ³1% OF PATIENTS ON TALTZ AND MORE OFTEN THAN WITH PBO (%)
Caption: *Upper respiratory tract infections included nasopharyngitis and rhinovirus infection.
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:
Table depicts adverse reactions in ³1% 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.
11:49-12:09
[Dr. Jackson talks about long-term safety profile of Taltz in psoriasis patients. The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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
Caption: 6449 TALTZ PATIENTS ACROSS 15 TRIALS AEs OF SPECIAL INTEREST: INCIDENCE RATES PER 100 PY
Caption: Over 6000 Adult
Patients on Taltz Across
15 Clinical Trials
Caption: The average and median Taltz exposure durations were 996.7 and 718 days, respectively.
Caption: *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.
Caption: 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.
Caption: CD=Crohn's disease; EPIMAD=Registre Epidemiologique des Maladies de l'Appareil Digestif; NMSC=nonmelanoma skin cancer; PY=patient-year; UC=ulcerative colitis.
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 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’.
12:09-12:24
[Dr. Jackson appears on the screen and explains about a patient whom he prescribed Taltz but the patient was little concerned regarding the treatment. The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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.
Caption: N/A
12:24-12:54
[Dr. Jackson appears on the screen and explains how he made the patient understand the potential of Taltz and initiated him with the Taltz treatment. The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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.
Caption: N/A
12:54-13.08
[Dr. Jackson discusses regarding the effect of Taltz treatment in patient. Week-2 results are displayed on the screen. The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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.
Caption: Week-2 Results
Caption: sPGA was down to one
Caption: Facial plaques were improved
Caption: His PsO was at least 50% better and some areas on his face were barely noticeable
Caption: Please see Important Safety Information throughout this video and accompanying Prescribing Information and Medication Guide. Instructions for Use are included with the device.
13:08-13:27
[Dr. Jackson explains the week 12 results after treating the patient and a table appears on the screen. The Taltz logo with the dosage strength is displayed in the top right corner of the screen.]
Narrator: 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 12 Results
Caption: 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.
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.
13:27- 13:52
[Dr. Jackson explains the 2-year results of the patient and the visible improvement the patient had after treatment with Taltz. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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
Caption: 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.
13:53- 14:20
[Dr. Jackson highlights the rapid and durable response seen with Taltz for this patient, not just for psoriasis but also for his joint disease. Taltz logo and dose information remain static on the top right corner of the screen.]
Narrator: 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.
Caption: N/A
14:21- 14:49
[Dr. Jackson explains the Additional Important Safety Information for Taltz highlighting on the risk of occurrence of Hypersensitivity reactions in patients taking Taltz. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: Included here is some additional important safety information for Taltz. Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, have been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.
Caption: Additional Important Safety Information
Caption: WARNINGS AND PRECAUTIONS
Caption: Hypersensitivity
Caption: Serious hypersensitivity reactions, including angioedema and urticaria (each <=0.1%), occurred in the Taltz group in the 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.
Caption: This is not the complete Important Safety Information for Taltz. Additional Important Safety Information was given at the beginning of the video.
Caption: IX HCP ISI 07MAY2020
14:50- 15:16
[Dr. Jackson continues explaining on the Additional Important Safety Information for Taltz highlighting on the increased risk of Inflammatory Bowel Disease in patients treated with Taltz. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: 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.
Caption: Additional Important Safety Information
Caption: WARNINGS AND PRECAUTIONS
Caption: Inflammatory Bowel Disease
Caption: 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.
Caption: This is not the complete Important Safety Information for Taltz. Additional Important Safety Information was given at the beginning of the video.
Caption: IX HCP ISI 07MAY2020
15:17- 15:28
[Dr. Jackson continues explaining the Additional Important Safety Information for Taltz highlighting on completion of age-appropriate immunizations and avoiding the use of live vaccines. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: 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.
Caption: Additional Important Safety Information
Caption: WARNINGS AND PRECAUTIONS
Caption: Immunizations
Caption: 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.
Caption: This is not the complete Important Safety Information for Taltz. Additional Important Safety Information was given at the beginning of the video.
Caption: IX HCP ISI 07MAY2020
15:29- 16:11
[Dr. Jackson continues explaining on the Additional Important Safety Information for Taltz highlighting on the other common adverse reactions associated with Taltz treatment. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: Most common adverse reactions (at ≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in the 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 patients, and conjunctivitis, influenza, and urticaria in pediatric psoriasis patients. Thanks for taking the time to watch this presentation.
Caption: Additional Important Safety Information
Caption: ADVERSE REACTIONS
Caption: 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.
Caption: This is not the complete Important Safety Information for Taltz. Additional Important Safety Information was given at the beginning of the video.
Caption: IX HCP ISI 07MAY2020
16:12- 16:21
[This slide displays the References used for the claims cited in this video. Taltz logo and dose information remains static on the top right corner of the screen.]
Narrator: N/A
Caption: References
1. Taltz. Prescribing information. Lilly USA, LLC.
2. Data on file. Lilly USA, LLC. DOF-IX-US-0183.
3. Data on file. Lilly USA, LLC. DOF-IX-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 ixekizumab: 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 P J, van der Heijde D, Ritchlin CT, et al; on behalf of the SPIRIT-Pl Study Group. lxekizumab, 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-Pl. Ann Rheum Dis. 2017;76(l)(suppl):l-30.
14. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. lxekizumab 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. lxekizumab 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-Pl Study Group. lxekizumab, an interleukin-I 7 A specific monoclonal antibody, for the treatment of biologic-na·ive 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-Pl. Ann Rheum Dis. 2017;76(1):79-87.
17. Data on file. Lilly USA, LLC. TAL20171127A.
18. Data on file. Lilly USA, LLC. TAL201710268.
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.
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