Taltz Citrate-Free: The same active ingredient with significantly less injection site pain vs the original formulation^1*
^*P<.0001; 3.5 vs 25.2 based on VAS 0-100

man and woman climbing a spiral of changing seasons in the clouds

Taltz is for Today and Tomorrow^1-18

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.

RAPID

ACR20 response seen as early as Week 2 in some patients with active PsA, regardless of TNFi experience ( See Rapid ACR data )

PASI 75 and PASI 90 responses seen as early as Week 2 in some biologic-naive patients with active PsA ( See Rapid PASI data )

Improvement in back pain, function, and inflammation seen as early as Week 2 in some biologic-naive patients with AS ( See Rapid AS data )

SUSTAINED

Joint symptom results sustained for 3 years, regardless of TNFi experience in patients with PsA ( See Sustained ACR data )

Skin symptom results sustained for 3 years, regardless of TNFi experience in patients with PsA ( See Sustained PASI data )

ASAS40 results sustained through week 52 in patients with AS ( See Sustained AS data )

Data were not controlled for type-1 error; therefore, statistical conclusions cannot be made.

See SPIRIT-P1 and SPIRIT-P2 trial designs

See COAST-V and W trial designs

SELECT IMPORTANT SAFETY INFORMATION:
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.

Real Patient Journeys

Letters from Patients to HCPs

00:10-00:15

Dear Dr. Yu, Being outdoors for me, it's like meditation.

00:25-29

Whether it was skiing, biking, or fishing; you name it, I loved it.

00:35-00:53

With the onset of Psoriatic Arthritis and its impact on my joints—my participation in these activities came to a halt. At my toughest time, you were there for me. You knew I couldn’t wait for fast and lasting relief. So, I'm writing you this letter to say thank you.

00:56-1:08

Aside from having bothersome skin plaques, I was at the top of my game when I started to feel the onset of pain and stiffness in some of my joints. And then, just like that, things started to go downhill.

01:11-01:19

Something as simple as putting my socks on was next to impossible, let alone gripping the handles on my bike.

01:19-01:27

Even cooling a cup of coffee in my hands, the pain was unbelievable. I could feel it just thinking about it.

01:30-01:42

The hardest part—it was affecting my family. My kids had school, but I could barely get out of bed to drive them there. My wife was mowing the lawn, but I couldn't get off the couch to help her. I was in tears many mornings.

01:44-01:50

Because I wasn't able to do what I loved, what I’d lived for, I didn't want to be around the circle of my friends.

01:55-2:13

As I thought of my future, I kept thinking: I've got to figure this out before joint damage sets in. I feared I would never return to my outdoor way of life, which is why I needed an expert on my team to help find a medication I could be on, long-term. And that expert was you.

02:18-02:24

From our first appointment, you understood my treatment goals. I talked about how my priority was to get fast relief.

02:26-02:29

You talked about finding a solution that would last.

02:32-02:43

I've never had anybody listen to me like you did that day, and every day since. You moved quickly to help get my joint pain and skin plaques under control.

02:43-02:56

I want you to know how lucky I feel to be in your care. While every day on the mountain might not be 100%, you got me back outside. And that's exactly where I belong. Sincerely thank you, Kirk.

03:12-04:12

SPIRIT-P1 and SPIRIT-P2 were phase 3, randomized, double-blind, placebo-controlled clinical trials designed to evaluate the efficacy and safety of Taltz vs placebo in adults with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic naive, while patients in SPIRIT-P2 had an inadequate response or were intolerant to 1 or 2 prior TNF inhibitors. Patients were randomized to placebo or Taltz 80 mg Q2W or Q4W following a 160-mg starting dose. In SPIRIT-P1, an active reference arm of Humira 40 mg Q2W was included. Taltz 80 mg every two weeks is not an approved dose for psoriatic arthritis. Only data from the Q4W arm will be shown. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24.

04:14-04:41

Both SPIRIT-P1 and -P2 reached their primary efficacy endpoints, where 58% of patients in SPIRIT-P1 and 53% of patients in SPIRIT-P2 achieved ACR20 at week 24 compared to 30% and 20% with placebo. As early as week 2, 39% of patients in SPIRIT-P1 and 38% of patients in SPIRIT-P2 achieved ACR20 with Taltz.

04:42-04:48

Patients sustained joint symptom response for 3 years, regardless of TNFi experience.

04:55-05:12

In biologic-naive patients at week 12, 75% and 52% of Taltz patients achieved PASI 75 and 90, and as early as week 2, 25% of patients achieved PASI 75, and 11% of patients achieved PASI 90 with Taltz.

05:14-05:26

Patients also reported improvement in physical function as assessed by HAQ-DI at week 16. Results were sustained through the open label extension period at week 156.

05:31-05:42

Taltz inhibited progression of structural joint damage in patients as early as week 16, with 74% of patients recording minimal radiographic progression at year 3.

05:48-06:05

Common adverse events from pooled SPIRTI-P1 and -P2 safety data through week 24 included injection site reactions, upper respiratory tract infection, headache, and sinusitis. Serious infections occurred in 0.4% of patients taking Taltz.

06:06-06:40

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, Adults with active psoriatic arthritis, Adults with active ankylosing spondylitis, Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

IMPORTANT SAFETY INFORMATION

Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

06:40-08:30

WARNINGS AND PRECAUTIONS

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. Evaluate patients for tuberculosis infection prior to initiating treatment with Taltz. Do not administer to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active tuberculosis during and after treatment. Serious hypersensitivity reactions, including angioedema and urticaria, (each less than or equal to 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. 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 inflammatory bowel disease occurs, discontinue Taltz and initiate appropriate medical management.

08:30-09:28

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 (greater than or equal to 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 accompanying Prescribing Information and Medication Guide linked on this site.

Please see Instructions for Use included with the device.

Meet Kirk - A Patient with PsA

"My priority was to get fast relief, and you talked about finding a solution that would last."

Abby (00:06):
Dear Dr. Steven,
Being active has been my escape and my therapy. Then all of a sudden—my outlet was gone.

(00:18):
My life turned upside down When I was first diagnosed with Ankylosing Spondylitis. I'm writing this letter because you typically only see me when I'm in a lot of pain, frustrated by my disease and not when I'm back to living my life and doing what I love.

(00:36):
Before my AS diagnosis, I was always go-go-go. I had big dreams—I was on my college dance team; I was studying to be a nurse—and then it all fell apart. When the pain in my back started to worsen and become unbearable, simple things became harder and harder. I couldn't move like I used to.

(00:56):
Before my AS diagnosis, my friends and I were always doing active things together. As the pain in my back became worse, those activities became impossible, and I saw my friends less.

(01:09):
Everything came to a pause and I couldn't help but think, is this going to be the rest of my life?

(01:16):
I needed something that would work fast. I needed something that would last so I could return to my life. I was scared and frustrated about putting my life on hold, but you really listened to me.

(01:30):
From the start, you could sense my impatience. I was desperate to find a medication that would work fast and would last. I didn't want to end up back in your office in search of another treatment.

(01:41):
I felt seen by you—and even better—when I was at my lowest, I knew you still believed I could get better. Of course, not every day will be perfect, but—because of you—I'm living my life again, back to doing the activities I love. Because of you. I'll be hiking with my friends this weekend. Thank you will never be enough. With ongoing gratitude, Abby.

(02:13)
COAST-V and COAST-W were phase 3, multicenter, randomized, double-blind clinical trials designed to evaluate the efficacy and safety of Taltz vs placebo in adults with active ankylosing spondylitis. Patients in COAST-V were biologic naive, while patients in COAST-W had an inadequate response or were intolerant to 1 or 2 prior TNF inhibitors.

Each trial included a treatment arm using Taltz 80 mg every 2 weeks or 4 weeks after being randomized to a starting dose of placebo, Taltz 80 mg or Taltz 160 mg. The approved AS dose for Taltz is 160 mg starting dose followed by Taltz 80 mg every 4 weeks.

The primary efficacy endpoint for COAST-V and -W was the proportion of patients achieving ASAS40 response at Week 16.

(03:03):
Both COAST-V and -W reached their primary efficacy endpoints, with 48% of patients in COAST-V and 25% of patients in COAST-W achieving ASAS40 at Week 16 compared to placebo.

(03:17):
Improvements in spinal pain, function as measured by mean change in BASFI score, and inflammation as measured by mean of BASDAI questions 5 and 6 were seen at week 16 with some patients experiencing improvements as early as week 2.

On the SF-36 Physical Component Score, both biologic-naïve and TNFi-experienced patients treated with Taltz showed greater improvement from baseline compared to placebo.

(03:42):
Common adverse events from both COAST-V and –W through week 16 included upper respiratory tract infection, injection site reactions, arthralgia, and diarrhea. Back pain and bronchitis were also reported during the extended treatment period.

(03:58):
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

IMPORTANT SAFETY INFORMATION
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

(04:30):
WARNINGS AND PRECAUTIONS
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.

(05:09):
Evaluate patients for tuberculosis infection prior to initiating treatment with Taltz. Do not administer to patients with active tuberculosis infection. Initiate treatment of latent tuberculosis prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active tuberculosis during and after treatment.

(05:27):
Serious hypersensitivity reactions, including angioedema and urticaria(each ≤ .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.

(05:51):
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 inflammatory bowel disease occurs, discontinue Taltz and initiate appropriate medical management.

(06:16):
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 accompanying Prescribing Information and Medication Guide linked on this site. Please see Instructions for Use included with the device.

Meet Abby - A Patient with AS

"When I was at my lowest, I knew you still believed I could get better."

FOR ADULT PATIENTS WITH PsA and axSpA (nr-axSpA, AS)

Consider Taltz as your preferred IL-17A antagonist

Michelle^* has psoriatic arthritis

Presenting with joint pain and bothersome skin plaques

Full body image of woman with psoriatic arthritis

Full body image of man with ankylosing spondylitis

Daniel^* has ankylosing spondylitis

Experiencing spinal pain and morning stiffness

^* Hypothetical Patient Profiles

Michelle and Daniel are frustrated their current treatment is not working and need a treatment that provides powerful and consistent efficacy.

Taltz offers rapid results for Today and sustained efficacy for Tomorrow so that Michelle and Daniel can participate in everyday moments that matter.

View PsA efficacy data View AS efficacy data

SELECT IMPORTANT SAFETY INFORMATION: CONTRAINDICATIONS
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

IL-17A=Interleukin-17A.

Explore

Abbreviations:
ACR=American College of Rheumatology; ACR20=American College of Rheumatology 20% response; ACR50=American College of Rheumatology 50% response; ACR 20/50=American College of Rheumatology 20%/50% response; ACR20/50/70=American College of Rheumatology 20%/50%/70% response; AE=adverse event; AS=ankylosing spondylitis; ASAS40=Assessment of Spondyloarthritis International Society response criteria, ≥40% improvement; axSpA=axial spondyloarthritis; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; BSA=body surface area; CD=Crohn’s disease; cDMARD=conventional disease-modifying antirheumatic drug; CI=confidence interval; HAQ-DI=Health Assessment Questionnaire Disability Index; H2H=head-to-head; IBD=inflammatory bowel disease; IL-17A=interleukin-17A; IR=inadequate responder; ITT=intent-to-treat; LSM=least squares mean; MACE=major adverse cardiovascular event; MDA=minimal disease activity; MMRM=mixed-effect model of repeated measure; mNRI=modified nonresponder imputation; n=total number of patients entering the study or extension period; mSASSS=modified Stroke Ankylosing Spondylitis Spinal Score; mTSS=modified Total Sharp Score; nr-axSpA=nonradiographic axial spondyloarthritis; NRI=nonresponder imputation; NSAID=non-steroidal anti-inflammatory drug; Nx=observed population; PA=prior authorization; PASI=Psoriasis Area and Severity Index; PASI 75/90/100=75%/90%/100% improvement from baseline in PASI criteria; PASI 100=100% improvement from baseline in PASI criteria; PsA=psoriatic arthritis; PBO=Placebo; PsO=psoriasis; Q4W=every 4 weeks; r-axSpA=radiographic axial spondyloarthritis; Rx=prescription; sPGA=Static Physician Global Assessment; TEAE=treatment-emergent adverse event; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis; VAS=visual analogue scale.

References:

Data on file. Lilly USA, LLC. DOF-IX-US-0304.
Mease P, van der Heidje D, Ritchlin CT, et al; on behalf of 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 III trial SPIRIT-P1. Ann Rheum Dis. 2017;76:79-87.
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 III trial. Lancet. 2017;389:2317-2327.
Taltz. Prescribing Information. Lilly USA, LLC.
Data on file. Lilly USA, LLC. DOF-IX-US-0013.
Chandran V, van der Heijde D, Fleischmann RM, et al. Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology. 2020;59:2774-2784.
Data on file. Lilly USA, LLC. DOF-IX-US-0247.
Data on file. Lilly USA, LLC. DOF-IX-US-0308.
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 III trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
Data on file. Lilly USA, LLC. DOF-IX-US-0102.
Data on file. Lilly USA, LLC. DOF-IX-US-0012.
Data on file. Lilly USA, LLC. DOF-IX-US-0278.
Orbai A, Gratacós J, Turkiewicz A, et al. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021;8:199-217. https://doi.org/10.1007/s40744-020-00261-0.
van der Heijde D, Gladman DD, Kishimoto M, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase II study (SPIRIT-P1) J Rheumatol. 2018;45:367-377.
Data on file. Lilly USA, LLC. DOF-IX-US-0155.
Data on file. Lilly USA, LLC. DOF-IX-US-0157.
Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71:599-611.
Data on file. Lilly USA, LLC. DOF-IX-US-0162.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Infections
Taltz may increase the risk of infection. In clinical trials of adult patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.

Hypersensitivity
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤ 0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.

Inflammatory Bowel Disease
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

Immunizations
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.

ADVERSE REACTIONS

Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis.

Please see Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 07MAY2020

Taltz is for Today and Tomorrow1-18