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Efficacy

A choice for patients with plaque PsO and for patients with PsA

Week 12 results

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

For adults with moderate to severe plaque psoriasis

Taltz can provide high levels of clearance—even complete resolution of plaques (PASI 100) is possible1

Trial 2 Week 12 Efficacy Trial 2 Week 12 Efficacy

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

Additional 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 respectively 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% achieved PASI 100 vs 0% and 0% for placebo. Also, 82% and 81% achieved sPGA 0,1 vs 3% and 7% for placebo.

In the 3 pivotal trials, examination of age, gender, race, body weight, and previous treatment with a biologic did not identify differences in response to Taltz among these subgroups at week 12.1

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.

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

In UNCOVER-2, the average change in PASI was 91% at week 122

Trial 2 Average % Change In PASI Trial 2 Average % Change In PASI

In UNCOVER-1, the mean percentage improvement in PASI at week 12 was 85% in the Taltz group compared to 0% in the placebo group. In UNCOVER-3, the mean percentage improvement in PASI at week 12 was 91% in the Taltz group compared to 14% in the placebo group.

The comparison of mean percent change in PASI using LOCF (last observation carried forward) at each study week between treatments is based on an analysis of covariance.

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PRE-TREATMENT EVALUATION FOR TUBERCULOSIS

Couple HoldingEvaluate 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.

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

Taltz showed superiority in 2 head-to-head trials vs US-approved etanercept1

Trial 2 and 3 Head-to-Head Results Trial 2 and 3 Head-to-Head Results

Results from US sites.

*US-approved etanercept.

In integrated UNCOVER-2 and -3, 73% of patients taking Taltz achieved clear or almost clear skin (sPGA 0,1) vs 27% who received etanercept.

Select Important Safety Information

adverse events and discontinuation rates for taltz compared to us-approved etanercept

Couple HoldingThe 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.

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

Taltz provided high levels of efficacy compared to placebo at week 12 regardless of previous treatment with a biologic1,3

TRIALS 1, 2, 3: WEEK 12 EFFICACY IN BIOLOGIC-NAIVE VS TNFi-EXPERIENCED* PATIENTS (NRI†) TRIALS 1, 2, 3: WEEK 12 EFFICACY IN BIOLOGIC-NAIVE VS TNFi-EXPERIENCED* PATIENTS (NRI†)

*Patients were classified as biologic-experienced if they had received prior treatment with at least 1 biologic agent.

NRI=nonresponder imputation.

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.

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HYPERSENSITIVITY

Couple HoldingSerious 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

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

See the difference Taltz can make in 12 weeks4-7

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. The photos at baseline and week 12 can be viewed below by dragging the slider right or left.

Taltz Patient PASI 75
Taltz Patient Baseline
Slider knob Slider knob

DRAG Drag To View TO VIEW
PATIENT AT BASELINE
(PASI SCORE=19.2)

DRAG Drag To View TO VIEW
PATIENT AT WEEK 12
(PASI SCORE=2.8)

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Zoom

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

Trial B was a phase 3b, double-arm, open-label study examining disease severity of Taltz-treated patients with moderate to severe plaque psoriasis through patient- and physician-reported clinical measures. The trial used sequential photographic images to support clinical measurements with visual representations of improvements in disease severity. All patients received a starting dose of 160 mg of Taltz, and then received 80 mg of Taltz every 2 weeks through week 12 (n=6).

Week 60 Results

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

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

Efficacy Week 60 Efficacy Week 60

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.

Patients who achieved clear or almost clear skin (sPGA 0,1) after initial treatment with Taltz 80 mg every 2 weeks were re-randomized at week 12 to receive either Taltz 80 mg every 4 weeks (n=181) or placebo (n=203).

*Patient responders at week 12.

NRI=Nonresponder imputation analysis.

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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.Couple Holding

Week 156 Results

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

PASI 75, PASI 90, and PASI 100 results at weeks 60, 108, and 1568*

Induction Period and Open-Label Extension

156 Week Data
156 Week Data

Patient and site personnel were blinded to study treatment until all patients completed week 12 or discontinued. The open label extension phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).

Analyses from UNCOVER-3, outcomes through week 156 mNRI and observed are post-hoc.

*A subset of moderate to severe plaque psoriasis patients from UNCOVER-3 who received a 160 mg starting dose of Taltz at week 0, followed by 80 mg every 2 weeks through week 12, followed by 80 mg every 4 weeks.

Nx=observed population at week 156.

mNRI=modified nonresponder imputation.

In an mNRI analysis of patients receiving Taltz at week 60, 89% of patients achieved PASI 75, 77% of patients achieved PASI 90, and 57% of patients achieved PASI 100. In an mNRI analysis of patients receiving Taltz at weeks 108 and 156, 84% and 81% of patients achieved PASI 75, 69% and 66% of patients achieved PASI 90, and 48% and 45% of patients achieved PASI 100. mNRI of intent-to-treat population through week 156. mNRI analysis imputes missing data due to study drug (eg, inadequate response, adverse event, or lack of efficacy) as nonresponse; whereas, missing data due to other reasons (eg, missed visits, lost to follow up) is included as a predicted value based on statistical modeling of observed data.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  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. Data on file. Lilly USA, LLC. TAL20171023A.

ACR at week 24

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz provided significant improvement in joint symptoms at week 24, as measured by ACR201,3

Primary endpoint=ACR20 response at week 24

Nonresponder imputation (NRI) of intent-to-treat population through week 52. After Week 24, patients knew they were taking active treatment, but remained blind to the dose until the last patient completed week 24. The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).

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.

In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=122; placebo n=118), 53% of patients receiving Taltz achieved ACR20 at week 24 vs 20% for placebo. Additionally, 35% and 22% of Taltz patients achieved ACR50 and ACR70, respectively, at week 24 vs 5% and 0%, for placebo.

ACR20/50/70=American College of Rheumatology 20%/50%/70% response rate.

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.

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR TNFi-EXPERIENCED PATIENTS WITH PSORIATIC ARTHRITIS

Taltz provided significant improvement in joint symptoms at week 24 in patients who had an intolerance to or had failed 1 or 2 TNF inhibitors1

Primary endpoint=ACR20 response at week 24

Nonresponder imputation (NRI) of intent-to-treat population through 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.1

In SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=107, placebo n=106), 58% of patients receiving Taltz achieved ACR20 at week 24 vs 30% for placebo. Additionally, 40% and 23% of patients receiving Taltz vs 15% and 6% of those receiving placebo achieved ACR50 and ACR70, respectively, at week 24.1

ACR20/50/70=American College of Rheumatology 20%/50%/70%; TNFi =tumor necrosis factor inhibitor; NRI=nonresponder imputation.

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.

Structure

In Clinical Trials of Patients with Active Psoriatic Arthritis

For BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz inhibited progression of structural joint damage in patients at week 16 vs placebo1,4

Primary endpoint=ACR20 response at week 24.

Inhibition of progression of structural damage was assessed radiographically and expressed as the mean change in mTSS and its components, the joint space narrowing score and bone erosion score, at week 16 vs baseline. The mTSS score was modified for psoriatic arthritis by addition of hand distal interphalangeal (DIP) joints.

mTSS=modified Total Sharp Score; MMRM=mixed-effect model of repeated measure.

SPIRIT-P2 (TNFi-experienced) did not include an assessment of radiographic progression.5

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  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 III trial SPIRIT-P1. Ann Rheum Dis. 2017;76:79-87.
  3. Désirée van der Heijde, Dafna Gladman, Mitsumasa Kishimoto, et al. Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase 3 Study (SPIRIT-P1). The Journal of Rheumatology, 2018.
  4. Data on file. Lilly USA, LLC. TAL20171026B.
  5. 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, placebocontrolled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389:2317-2327.
Indication and Important Safety Information

Psoriatic Arthritis:

Taltz is indicated for the treatment of adult patients with active psoriatic arthritis.

Plaque Psoriasis:

Taltz is indicated for the treatment of adult patients with moderate to severe plaque psoriasis 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