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TALTZ vs HUMIRA® (adalimumab)

FOR BIOLOGIC NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

The first and only IL-17A antagonist to demonstrate superiority in a head-to-head trial against Humira in PsA.1-5

As measured by the percentage of patients who simultaneously achieved both ACR50 and PASI 100 at week 24.1

PsA=psoriatic arthritis.

Humira® is a registered trademark of AbbVie Biotechnology Ltd.

Scroll down to see the data.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Superiority vs Humira at week 24: Simultaneous achievement of ACR50 and PASI 100 at week 24, with consistency at week 526

SPIRIT-H2H BIOLOGIC-NAIVE: PERCENTAGE OF PATIENTS SIMULTANEOUSLY ACHIEVING BOTH ACR50 AND PASI100 AT WEEK 24, NRI

*P<.05 vs Humira at week 24.

†P≤.001 vs Humira at week 52. Nominal P value: Week 52 measure of ACR50 + PASI 100 was not controlled for type-I error; therefore, no statistical comparisons can be made.

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 for moderate to severe PsO.7

See SPIRIT-H2H trial design

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.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

ACR50 responses that rivaled Humira at week 24 and were consistent at week 528,9

SPIRIT-H2H BIOLOGIC-NAIVE: ACR RESPONSE RATES AT WEEK 24, NRI

In an NRI analysis, 69% and 70% of patients taking Taltz vs 72% and 69% of patients taking Humira achieved ACR20 at weeks 24 and 52, respectively. Additionally, 32% and 35% of patients taking Taltz vs 26% and 34% of patients taking Humira achieved ACR70 at weeks 24 and 52, respectively.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.8

Major secondary objective met: demonstrated noninferiority of Taltz vs Humira in ACR50 response at 24 weeks (95% CI [−4.3%, 12.1%]) for noninferiority with −12.0% margin.8,9

ACR20 and ACR70 at week 24 and all responses at week 52 were prespecified but not type-I error-controlled; therefore, results cannot be regarded as statistically significant.8

See SPIRIT-H2H 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 PSORIATIC ARTHRITIS

Taltz vs Humira: Complete resolution of enthesitis at weeks 24 and 5210

SPIRIT-H2H BIOLOGIC-NAIVE: COMPLETE RESOLUTION OF ENTHESITIS (LEI=0) AT WEEKS 24 AND 52 AMONG PATIENTS WITH LEI>0 AT BASELINE, NRI

Enthesitis data were prespecified but not type-I error-controlled; therefore, results cannot be regarded as statistically significant.

A subset of patients from SPIRIT-H2H with enthesitis (LEI >0) at baseline.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.8

Mean baseline LEI scores were 2.5 for Taltz and 2.7 for Humira.8

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, and sPGA ≥3 followed the dosing regimen indicated for moderate to severe PsO.

See SPIRIT-H2H 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 BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz vs Humira: Complete resolution of dactylitis at weeks 24 and 5211

SPIRIT-H2H BIOLOGIC-NAIVE: COMPLETE RESOLUTION OF DACTYLITIS LDI-B=0) AT WEEKS 24 AND 52 AMONG PATIENTS WITH LDI-B>0 AT BASELINE, NRI

Dactylitis data were prespecified but not type-I error-controlled; therefore, results cannot be regarded as statistically significant.

A subset of patients from SPIRIT-H2H with dactylitis (LDI-B >0) at baseline.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.8

Mean baseline LDI-B scores were 40 for Taltz and 56 for Humira.8

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, and sPGA ≥3 followed the dosing regimen indicated for moderate to severe PsO.

See SPIRIT-H2H trial design

SELECT IMPORTANT SAFETY INFORMATION
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 exacerbation of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Superior PASI 100 response vs Humira at week 24, with consistency at week 5212

SPIRIT-H2H BIOLOGIC-NAIVE: PASI RESPONSE RATES AT WEEKS 24 AND 52, NRI

*P≤.001 vs Humira at week 24 for PASI 100.12

†P≤.001 vs Humira at week 52 for PASI 100.12 Nominal P value: Week 52 was not controlled for type-I error; therefore, no statistical comparisons can be made.

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.8

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, and sPGA ≥3 followed the dosing regimen indicated for moderate to severe psoriasis.8

See SPIRIT-H2H 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.

IN BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Safety profile of Taltz in SPIRIT-H2H is consistent with registration trials; no new safety signals were observed8,13,14

SPIRIT-H2H adverse events through weeks 24 and 52

The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity.14

Certain adverse events, such as MACE, malignancy, and cerebrocardiovascular events, require longer observation periods and larger patient exposure to ascertain risk. Lilly is conducting continued long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Taltz.

*Safety data show all results available at the time of the last patient reaching week 24, including results to week 52.

†Patients with uncontrolled ulcerative colitis (UC) or Crohn’s disease were excluded from the studies; however, patients with a personal or family history of UC/Crohn’s were allowed in the study.

‡Confirmed by adjudication.

§Event was reported as colitis and was adjudicated as probable Crohn’s disease.

See SPIRIT-H2H trial design

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

SPIRIT-H2H: Taltz vs Humira

TALTZ DEMONSTRATED POSITIVE RESULTS:

  • Superiority vs Humira in the percentage of patients who achieved both ACR50 and PASI 100 at week 24, with consistency at week 521,6
  • Complete resolution in key domains of PsA2-4,10-12 (Enthesitis, dactylitis, plaque psoriasis)
    Click here for data
  • Safety consistent with registration trials5,8,13,14
    Click here for data

See SPIRIT-H2H trial design

SPIRIT-P1 and P2 registration trial data

TALTZ HAS NO BOXED WARNING.14

Taltz icon

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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 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.

References: 1. Data on file. Lilly USA, LLC. DOF-IX-US-0121. 2. Data on file. Lilly USA, LLC. DOF-IX-US-0122. 3. Data on file. Lilly USA, LLC. DOF-IX-US-0123. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0124. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0125. 6. Data on file. Lilly USA, LLC. DOF-IX-US-0190. 7. Data on file. Lilly USA, LLC. DOF-IX-US-0119. 8. Mease PJ, Smolen JS, Behrens F, et al. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2020;79:123-131. 9. Data on file. Lilly USA, LLC. DOF-IX-US-0189. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0194. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0195. 12. Data on file. Lilly USA, LLC. DOF-IX-US-0191. 13. Data on file. Lilly USA, LLC. DOF-IX-US-0188. 14. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 15. 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. 16. 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. 17. 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.

INDICATIONS

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.

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

IX HCP ISI 07MAY2020