Dermatology Efficacy

Results at week 12



FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz is the first and only FDA-approved IL-17A antagonist that includes PASI 100 in the Prescribing Information1

Dermatology efficacy uncover-2 pasi

In UNCOVER-2, 83% of patients taking Taltz achieved sPGA 0,1 vs 2% who received placebo.


ADDITIONAL WEEK 12 RESULTS

In UNCOVER-1 (Taltz n=433; placebo n=431) and UNCOVER-3 (Taltz n=385; placebo n=193), Taltz patients achieved similar results: 89% and 87% of Taltz patients achieved PASI 75 vs 4% and 7% for placebo. Additionally, 71% and 68% of Taltz patients achieved PASI 90 vs 1% and 3% for placebo, and 35% and 38% of Taltz patients achieved PASI 100 vs 0% and 0% for placebo. Also, 82% and 81% of Taltz patients achieved sPGA 0,1 vs 3% and 7% for placebo.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
INFECTIONS
Taltz may increase the risk of infection. In clinical trials of 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 patients with psoriatic arthritis. 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.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz works early and effectively by week 122

Dermatology efficacy unover-2-12week


In UNCOVER-1, patients receiving Taltz achieved a mean PASI of 1.9 (an 88% improvement from the mean baseline score of 20.1) at week 12. Patients receiving placebo achieved a mean PASI of 18.9 (a 3% improvement from the mean baseline score of 20.3) at week 12.

In UNCOVER-3, patients receiving Taltz achieved a mean PASI of 1.6 (a 92% improvement from the mean baseline score of 20.7) at week 12. Patients receiving placebo achieved a mean PASI of 17.9 (a 14% improvement from the mean baseline score of 21.1) at week 12.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz provided high levels of efficacy compared to placebo at week 12 regardless of previous treatment with a biologic3

Dermatology efficacy uncover-1-2-3 bar


In these trials, 83% of biologic-naive and 80% of biologic-experienced patients receiving Taltz achieved sPGA 0,1 vs 5% and 2%, respectively, for patients receiving placebo.

In the placebo group, biologic-naive (n=535) and biologic-experienced (n=257) patients achieved PASI 75 rates of 5% and 3%, PASI 90 rates of 2% and 0%, and PASI 100 rates of 0% and 0%, respectively.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.

Efficacy you can see


FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

See the difference Taltz can make in 12 weeks4-7

Copying, downloading, or other use of patient photos is expressly prohibited.

Psoriasis can impact all areas of the body. The following images are of real adult patients with moderate to severe psoriasis who were treated with Taltz over a 12-week period. Photos at baseline and week 12 can be viewed below. Individual results may vary.

PASI 75

Dermatology efficacy before pasi 75

PATIENT AT BASELINE
(PASI SCORE=19.2)

Dermatology efficacy after pasi 75

PATIENT AT WEEK 12
(PASI SCORE=2.8)

Patients received a 160 mg starting dose of Taltz; then 80 mg of Taltz every 2 weeks.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

See the difference Taltz can make in 12 weeks4-7

Copying, downloading, or other use of patient photos is expressly prohibited.

Psoriasis can impact all areas of the body. The following images are of real adult patients with moderate to severe psoriasis who were treated with Taltz over a 12-week period. Photos at baseline and week 12 can be viewed below. Individual results may vary.

PASI 90

Dermatology efficacy before pasi 90

PATIENT AT BASELINE
(PASI SCORE=32.5)

Dermatology efficacy after pasi 90

PATIENT AT WEEK 12
(PASI SCORE=2.3)

Patients received a 160 mg starting dose of Taltz; then 80 mg of Taltz every 2 weeks.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

See the difference Taltz can make in 12 weeks4-7

Copying, downloading, or other use of patient photos is expressly prohibited.

Psoriasis can impact all areas of the body. The following images are of real adult patients with moderate to severe psoriasis who were treated with Taltz over a 12-week period. Photos at baseline and week 12 can be viewed below. Individual results may vary.

PASI 100

Dermatology efficacy before pasi 100

PATIENT AT BASELINE
(PASI SCORE=13)

Dermatology efficacy after pasi 100

PATIENT AT WEEK 12
(PASI SCORE=0)

Patients received a 160 mg starting dose of Taltz; then 80 mg of Taltz every 2 weeks.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

See the difference Taltz can make in 12 weeks4-7

Copying, downloading, or other use of patient photos is expressly prohibited.

Psoriasis can impact all areas of the body. The following images are of real adult patients with moderate to severe psoriasis who were treated with Taltz over a 12-week period. Photos at baseline and week 12 can be viewed below. Individual results may vary.

PASI SPGA 0,1

Dermatology efficacy before spga

PATIENT AT BASELINE
(PASI SCORE=4)

Dermatology efficacy after spga

PATIENT AT WEEK 12
(PASI SCORE=1)

Patients received a 160 mg starting dose of Taltz; then 80 mg of Taltz every 2 weeks.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.

Head-to-head results


Dermatology efficacy head-to-head

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz showed superiority in 2 head-to-head trials vs US-approved Enbrel1

Dermatology efficacy uncover-2-3-12w bar

Trial design


SELECT IMPORTANT SAFETY INFORMATION
ADVERSE EVENTS AND DISCONTINUATION RATES FOR TALTZ COMPARED TO US-APPROVED ETANERCEPT

The rate of serious adverse events during the controlled induction period (weeks 0-12) was 0.7% for US-approved etanercept and 2% for Taltz and the rate of discontinuation from adverse events was 0.7% for US-approved etanercept and 2% for Taltz. The incidence of infections was 18% for US-approved etanercept and 26% for Taltz. The rate of serious infections was 0.3% for both US-approved etanercept and Taltz.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz vs Stelara head-to-head trial results: PASI 90 and PASI 10011

Results at weeks, 12, 24, and 52

Dermatology efficacy ixora h2h

Trial design


SELECT IMPORTANT SAFETY INFORMATION
INFLAMMATORY BOWEL DISEASE

During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis.

Challenging body areas



FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Dermatology efficacy tough-to-treat

Subgroup analyses presented for nail, scalp, and palmoplantar psoriasis are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Data presented for nail and scalp are from the UNCOVER-3 open-label extension period.

Please see below tabs for full data.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Post hoc subgroup analyses of patients with scalp psoriasis12,13*

PSSI 100 response rates at weeks 12 and 60 (induction period and open-label extension)

Dermatology efficacy uncover-3 pasi


ADDITIONAL RESULTS

In UNCOVER-1 (Taltz n=210; placebo n=215) and UNCOVER-2 (Taltz n=144; placebo n=77), 68% and 71% of patients who received Taltz 80 mg every 2 weeks, respectively, achieved PSSI 100 at week 12 vs 3% and 3% for placebo.

Subgroup analyses presented are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Baseline severity was not specified in the inclusion criteria.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
INFLAMMATORY BOWEL DISEASE

During Taltz treatment, monitor patients for onset or exacerbation of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Post hoc subgroup analyses of patients with nail psoriasis14,15*

NAPSI 0 response rates at weeks 12 and 60 (induction period and open-label extension)

Dermatology efficacy uncover-3 napsi


ADDITIONAL RESULTS

In UNCOVER-1 (Taltz n=172; placebo n=168) and UNCOVER-2 (Taltz n=131; placebo n=72), 7% and 8%, respectively, of patients who received Taltz 80 mg every 2 weeks achieved NAPSI 0 at week 12 vs 0% and 4% for placebo.

Subgroup analyses presented are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Baseline severity was not specified in the inclusion criteria.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
IMMUNIZATIONS

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

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

More than half of patients achieved sPGA-G 0 by week 1216,17

At week 12, 73% of patients receiving Taltz achieved sPGA-G 0,1 vs 8% of patients receiving placebo.16,20

sPGA-G 0 was a prespecified, exploratory endpoint. It was not controlled for multiplicity; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.

sPGA-G 0,1=primary endpoint.

Dermatology efficacy ixora-q-spga-o-line

NRI of intent-to-treat population through week 12.17

sPGA-G=static Physician’s Global Assessment of Genitalia.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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 profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Post hoc subgroup analyses of patients* with palmoplantar psoriasis18,19

PPASI 100 response rate at week 12

Dermatology efficacy uncover-1-2-3-ppasi


ADDITIONAL RESULTS

In UNCOVER-1 (Taltz n=45; placebo n=47), UNCOVER-2 (Taltz n=31; placebo n=18), and UNCOVER-3 (Taltz n=38; placebo n=20), 53%, 52%, and 50%, respectively, of patients who received Taltz 80 mg every 2 weeks achieved PPASI 100 at week 12 vs 9%, 6%, and 10% for placebo.

Subgroup analyses presented are post hoc. The UNCOVER studies were not powered for these subgroup analyses, nor were analyses error-controlled. Therefore, treatment differences observed in these subgroups cannot be regarded as statistically significant. Baseline severity was not specified in the inclusion criteria.

Trial design


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.

Results at week 60



FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Reassure your patients that consistent results can be maintained with Taltz at week 601

Dermatology efficacy uncover-1-2-60w spga

Of the patients who completed 60 weeks of treatment without relapse (sPGA ≥3) or discontinuation (n=147), 92% maintained clear or almost clear skin (sPGA 0,1) at week 60 based on an observed analysis.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
INFECTIONS

Taltz may increase the risk of infection. In clinical trials of 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 patients with psoriatic arthritis. 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.

Results at week 204



FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Taltz maintained response through 204 weeks21

Induction period and open-label extension

Dermatology efficacy uncover-3-204w

In an mNRI analysis of patients receiving Taltz, PASI 75 results were 89% at week 60, 84% at week 108, 82% at week 156, and 83% at week 204. PASI 90 results were 78% at week 60, 71% at week 108, 69% at week 156, and 66% at week 204. PASI 100 results were 59% at week 60, 50% at week 108, 49% at week 156, and 48% at week 204.

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.

Trust Taltz to offer



FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Dermatology efficacy taltz header

Trial design


SELECT IMPORTANT SAFETY INFORMATION
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.


References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018. 2. Data on file. Lilly USA, LLC. TAL20160223C. 3. Data on file. Lilly, USA, LLC. TAL20160328C. 4. Data on File. Lilly USA, LLC. TAL20160222D. 5. Data on File. Lilly USA, LLC. TAL20160222A. 6. Data on File. Lilly USA, LLC. TAL20160222E. 7. Data on File. Lilly USA, LLC. TAL20160222B. 8. ClinicalTrials.gov Identifier: NCT03151551 9. ClinicalTrials.gov Identifier: NCT02561806. 10. ClinicalTrials.gov Identifier: NCT03573323. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0006. 12. Reich K, Leonardi C, Lebwohl M, et al. Sustained response with ixekizumab treatment of moderate-to-severe psoriasis with scalp involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2, UNCOVER-3). J Dermatolog Treat. 2017;28:282-287. 13. Data on file. Lilly USA, LLC. TAL20170829F. 14. Dennehy EB, Zhang L, Amato D, Goldblum O, Rich P. Ixekizumab is effective in subjects with moderate to severe plaque psoriasis with significant nail involvement: results from UNCOVER 3. J Drugs Dermatol. 2016;15:958-961. 15. Data on file. Lilly USA, LLC. TAL20170829B. 16. Ryan C, Menter A, Guenther L, et al; on behalf of IXORA-Q Study Group. Efficacy and safety of ixekizumab in a randomized, double-blinded, placebo-controlled phase 3b study of patients with moderate-to-severe genital psoriasis [published online ahead of print May 10, 2018]. Br J Dermatol. 2018. doi:10.1111/bjd.16736. 17. Data on file. Lilly USA, LLC. DOF-IX-US-0014. 18. Menter A, Warren RB, Langley RG, et al. Efficacy of ixekizumab compared to etanercept and placebo in patients with moderate-to-severe plaque psoriasis and non-pustular palmoplantar involvement: results from three phase 3 trials (UNCOVER-1, UNCOVER-2 and UNCOVER-3). J Eur Acad Dermatol Venereol. 2017;31:1686-1692. 19. Data on file. Lilly USA, LLC. TAL20170829D. 20. Data on file. Lilly USA, LLC. TAL20171219A. 21. Data on file. Lilly USA, LLC. DOF-IX-US-0010.

Indications and Important Safety Information
Indications

Taltz is indicated for your adult patients with active psoriatic arthritis (PsA).

Taltz is also indicated for your adult patients with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.

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 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 patients with psoriatic arthritis. 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
During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis.

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 profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.

Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.
IX HCP ISI 01DEC2017