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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 and ankylosing spondylitis. 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
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.

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
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 80 mg Q2W group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn’s disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn’s disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.

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
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

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
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 patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

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

Head-to-head results in 2 disease states

Plaque psoriasis

IXORA-R
(Results available 2019)

The primary outcome measure of this trial is the proportion of patients with moderate to severe plaque psoriasis achieving completely clear skin, as measured by PASI 100 at week 12.

IXORA-R is a 24-week, randomized, blinded, parallel-group study comparing the efficacy and safety of ixekizumab to guselkumab in patients with moderate to severe plaque psoriasis.

To learn more about this trial, visit ClinicalTrials.gov Identifier: NCT03573323.

IXORA-S
(Taltz showed superiority in the primary endpoint)

The primary outcome measure of this trial was the proportion of patients reaching PASI 90 at week 12. The proportion of patients achieving complete resolution of nail psoriasis (NAPSI 0) was also measured.

Click here for data

ClinicalTrials.gov Identifier: NCT02561806

UNCOVER-2 and -3
(Taltz showed superiority)

The co-primary outcome measures of these trials were the proportion of patients with sPGA 0, 1 with ≥2-point improvement from baseline, and proportion of patients achieving PASI 75 at week 12.

Click here for data

ClinicalTrials.gov Identifier: NCT01597245, NCT01646177

Psoriatic arthritis

Taltz has the first head-to-head study to test superiority vs Humira

SPIRIT-H2H
(Taltz showed superiority in the primary endpoint)

The primary outcome measure of this trial was the proportion of patients simultaneously achieving both ACR50 and PASI 100 at week 24.

SPIRIT-H2H was a 52-week, randomized, open-label, blinded-assessor study evaluating the efficacy and safety of Taltz vs Humira in patients with psoriatic arthritis who were biologic naive.

Click here for data

ClinicalTrials.gov Identifier: NCT03151551

*US - approved Enbrel.

Please refer to the Prescribing Information of each agent for indication, dosage, and administration.

The brands listed are registered trademarks of their respective owners.

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 was superior to Stelara in the percentage of patients who achieved PASI 90 and PASI 100 at week 1211

Results at weeks, 12, 24, and 52

Dermatology efficacy ixora h2h

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 and ankylosing spondylitis. 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 BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz was superior to Humira in the percentage of patients who simultaneously achieved both PASI 100 and ACR50 at week 2412

Primary Endpoint

SPIRIT-P1 and -P2: ACR response rates at week 241
In SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=107; placebo n=106) and SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=122; placebo n=118), 58% and 53% of Taltz patients, respectively, achieved ACR20 vs 30% and 20% for placebo. Additionally, 40% and 35% of patients receiving Taltz achieved ACR50 vs 15% and 5% for placebo.

Primary endpoint=ACR20 response at week 24.
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.
NRI of intent-to-treat population through week 24.

SPIRIT-P1 and -P2: PASI results at week 12
In SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=73; placebo n=67), among PsA patients with plaque psoriasis ≥3% BSA, 75% of patients receiving Taltz achieved PASI 75 at week 12 vs 8% of patients who received placebo. 32% of patients receiving Taltz achieved PASI 100 at week 12 vs 2% of patients who received placebo.13 In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=68; placebo n=67), among PsA patients with plaque psoriasis ≥3% BSA, 57% of patients receiving Taltz achieved PASI 75 at week 12 vs 10% for placebo. Additionally, 19% of patients receiving Taltz achieved PASI 100 at week 12 vs 6% for placebo.14
Among patients with sPGA ≥3 at baseline, in SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=52; placebo n=41), 75% of patients receiving Taltz achieved sPGA 0,1 at week 12 vs 7% for placebo.13 Additionally, in SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=60; placebo n=55), 63% of patients receiving Taltz achieved sPGA 0,1 vs 4% for placebo.14,15

NRI of intent-to-treat population through week 12.

PASI=Psoriasis Area Severity Index; ACR20/50=American College of Rheumatology 20%/50% response; NRI=nonresponder imputation; BSA=body surface area; sPGA=static Physician’s Global Assessment.

SPIRIT-H2H Trial Design

SPIRIT-P1 and -P2 Registration 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 BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz demonstrated superiority to Humira in the percentage of patients achieving PASI 100 at week 2416

Primary Endpoint

P=.001 vs Humira at week 24 for PASI 100.
Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.
All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, sPGA ≥3 followed the dosing regimen indicated for moderate to severe plaque psoriasis.

FOR BIOLOGIC-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS

Taltz provided comparable improvement in ACR50 to Humira at week 24, NRI12

In SPIRIT-H2H, 51% of patients receiving Taltz (n=283) achieved ACR50 at week 24 vs 47% for Humira (n=283)

Major secondary objective met: demonstrate noninferiority of Taltz vs Humira on ACR50 response at 24 weeks (50.5% vs 46.6%, respectively, 95% CI [-4.3% , 12.1%]) for noninferiority with -12.0% margin.

SPIRIT-H2H Trial Design

SPIRIT-P1 and -P2 Registration 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.

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 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 psoriasis17,18*

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 80 mg Q2W group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn’s disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn’s disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Post hoc subgroup analyses of patients with nail psoriasis19,20*

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 1221,22

At week 12, 73% of patients receiving Taltz achieved sPGA-G 0,1 vs 8% of patients receiving placebo.21,25

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 12.22

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 profiles observed in patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

FOR ADULTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Post hoc subgroup analyses of patients* with palmoplantar psoriasis23,24

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 and ankylosing spondylitis. 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 weeks26

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.

mNRI of intent-to-treat population through week 204. mNRI analysis imputes missing data due to study drug (eg, inadequate response, adverse event, or lack of efficacy) as nonresponsive; whereas missing data due to other reasons (eg, missed visits, lost to follow-up) is included as a predicated value based on statistical model of observed data.

mNRI=modified nonresponder imputation.

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
Dermatology efficacy trust taltz body

Click here for data

Dermatology efficacy trust taltz body-2

Click here for data

Dermatology efficacy trust taltz body-3

Click here for data

Dermatology efficacy trust taltz body-4

Click here for information

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; 2019. 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. Data on file. Lilly USA, LLC. DOF-IX-US-0121. 13. Mease PJ, van der Heijde 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. 14. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix. 15. Data on file. Lilly USA, LLC. TAL20171127A. 16. Data on file. Lilly USA, LLC. DOF-IX-US-0125. 17. 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 trials (UNCOVER-1, UNCOVER-2, UNCOVER-3). J Dermatolog Treat. 2017;28:282-287. 18. Data on file. Lilly USA, LLC. TAL20170829F. 19. 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. 20. Data on file. Lilly USA, LLC. TAL20170829B. 21. 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. 22. Data on file. Lilly USA, LLC. DOF-IX-US-0014. 23. 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. 24. Data on file. Lilly USA, LLC. TAL20170829D. 25. Data on file. Lilly USA, LLC. TAL20171219A. 26. 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) and active ankylosing spondylitis (AS).

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 and ankylosing spondylitis. 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 80 mg Q2W group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis and in the Taltz Q4W group in ankylosing spondylitis trials (Crohn’s disease 1.0% [2 patients], ulcerative colitis 0.5% [1 patient]) than in the placebo group (Crohn’s disease 0.5% [1 patient], ulcerative colitis 0%). In the ankylosing spondylitis trials, serious events occurred in 1 patient in the Taltz group and 1 patient in the placebo group.

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 patients with psoriatic arthritis and ankylosing spondylitis were consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis.

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SPIRIT-H2H: Trial design9

Taltz icon

SPIRIT-H2H (N=566) was a phase 4, randomized, open-label, blinded-assessor study evaluating the efficacy and safety of Taltz vs Humira in biologic-naive patients with active psoriatic arthritis and plaque psoriasis BSA ≥3.

Patients who met the trial design criteria for moderate to severe psoriasis (BSA ≥10%, PASI ≥12, and sPGA ≥3) in addition to psoriatic arthritis followed the psoriasis dosing regimen: Taltz patients (n=49) received an initial dose of 160 mg (two 80 mg injections), followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks thereafter. Humira patients (n=52) received an initial dose of 80 mg, then 40 mg every other week starting 1 week after the initial dose. For Taltz patients with psoriatic arthritis only (n=234), the initial dose (160 mg as 2 injections) was followed by 80 mg every 4 weeks. Humira patients (n=231) received 40 mg every other week and no initial dose.

SPIRIT-H2H: Trial design1

SPIRIT-H2H (N=566) was a phase 4, randomized, open-label, blinded-assessor study evaluating the efficacy and safety of Taltz vs Humira® (adalimumab) in biologic-naive patients with active psoriatic arthritis and plaque psoriasis BSA ≥3%. The primary efficacy endpoint was the proportion of patients simultaneously achieving ACR50 and PASI 100 at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints with an inadequate response to ≥1 cDMARD. Patients were randomized (1:1) to Taltz or Humira and allowed to continue a stable dose of concomitant cDMARD during the study. For Taltz patients with psoriatic arthritis only (n=234), the initial dose (160 mg as 2 injections) was followed by 80 mg every 4 weeks. Humira patients (n=231) received 40 mg every other week and no initial dose. Patients who met the trial design criteria for moderate to severe psoriasis (BSA ≥10%, PASI ≥12, and sPGA ≥3) in addition to psoriatic arthritis followed the psoriasis dosing regimen: Taltz patients (n=49) received an initial dose of 160 mg (two 80 mg injections), followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks thereafter. Humira patients (n=52) received an initial dose of 80 mg, then 40 mg every other week starting 1 week after the initial dose.

Reference:1. Data on file. Lilly USA, LLC. DOF-IX-US-0119.

BSA=body surface area; ACR50=American College of Rheumatology 50% response;
PASI=Psoriasis Area Severity Index; cDMARD=conventional disease-modifying antirheumatic drug; sPGA=static Physician's Global Assessment.

SPIRIT-P1 and -P2 Trial Design1-4

SPIRIT-P1 (N=417) and -P2 (N=363) were phase 3, randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz compared with placebo in patients with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic-naive. Patients in SPIRIT-P2 were tumor necrosis factor inhibitor (TNFi)-experienced, having had an inadequate response and/or intolerance to 1 or 2 prior TNFis. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints. Patients were randomized to placebo or Taltz 80 mg every 2 or 4 weeks following a 160 mg starting dose. In SPIRIT-P1, an active reference arm of Humira® (adalimumab) 40 mg every 2 weeks was included. Patients in all study arms were allowed to continue taking stable background medications during the trial. Inadequate responders (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, inadequate responders in the placebo and Humira arms were re-randomized to Taltz 80 mg every 2 or 4 weeks. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses during the double-blind treatment period.

Reference: 1. Taltz. Indianapolis, IN: Eli Lilly and Company; 2018. 2. Mease PJ, van der Heijde 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 3 trial SPIRIT-P1. Ann Rheum Dis. 2017;76(suppl):1-30. 3. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. 4. Nash P, Kirkham B, Okada M, et al; on behalf of SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.

ACR20=American College of Rheumatology 20% response.

SPIRIT-P1 and -P2: Trial design12-15

Registration Trials

SPIRIT-P1 (N=417) and SPIRIT-P2 (N=363) were phase 3, randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz compared with placebo in patients with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic-naive. Patients in SPIRIT-P2 were tumor necrosis factor inhibitor (TNFi)-experienced, having had an inadequate response and/or intolerance to 1 or 2 prior TNFis. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints. Patients were randomized to placebo or Taltz 80 mg every 2 or 4 weeks following a 160 mg starting dose. In SPIRIT-P1, an active reference arm of adalimumab 40 mg every 2 weeks was included. Patients in all study arms were allowed to continue taking stable background medications during the trial. Inadequate responders (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, inadequate responders in the placebo and adalimumab arms were re-randomized to Taltz 80 mg every 2 or 4 weeks. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses during the double-blind treatment period.