FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz vs Humira: Complete resolution of enthesitis at week 243

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

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

Mean baseline LEI score was 2.5 for Taltz and 2.7 for Humira.10

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

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

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.

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 week 244

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

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

Mean baseline LDI-B score was 40 for Taltz and 56 for Humira.10

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

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

Primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.

See SPIRIT-H2H Trial Design

SELECT IMPORTANT SAFETY INFORMATION
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.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz demonstrated superiority to Humira in the percentage of patients achieving PASI 100 at week 245

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

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 psoriasis.

The PASI 75 and PASI 90 data were prespecified but not type-I error-controlled; therefore, results cannot be regarded as statistically significant.

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

The safety profile of SPIRIT-H2H is consistent with registration trials; no new safety signals were observed11,12

*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.

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

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

Certain adverse events, such as malignancy, 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.

See SPIRIT-H2H Trial Design

Summary results from registration trials12,16

Taltz vs placebo

Taltz 80 mg every 4 weeks

Primary endpoint in SPIRIT-P1 and -P2=ACR20 response at week 24.12

The data presented from SPIRIT-P1 for dactylitis and enthesitis were not type-I error controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.

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.12

Nonresponder imputation (NRI) of intent-to-treat population through week 24.

SPIRIT-P1 and P2 Registration Trial Data

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.

Summary results from registration trials (cont’d)12,14,15

Taltz vs placebo

Taltz 80 mg every 4 weeks

Taltz icon

Primary endpoint in SPIRIT-P1 and -P2=ACR20 response at week 24.12

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.12

Nonresponder imputation (NRI) of intent-to-treat population through week 24.

SPIRIT-P1 and P2 Registration Trial 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.

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

SPIRIT-H2H:
Taltz vs Humira

TALTZ DEMONSTRATED:

  • Superiority vs Humira in the percentage of patients who simultaneously achieved both ACR50 and PASI 100 at week 241
    Click here for data
  • Complete resolution in key domains of PsA3-5
    (Enthesitis, dactylitis, plaque psoriasis)
    Click here for data
  • Safety consistent with registration trials11,12
    Click here for data

See SPIRIT-H2H Trial Design

SPIRIT-P1 and P2 Registration Trial Data

TALTZ HAS NO BOXED WARNING.12

Think Psoriatic Arthritis. Think Taltz.

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.


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. Schön MP. The plot thickens while the scope broadens: a holistic view on IL-17 in psoriasis and other inflammatory disorders. Exp Dermatol. 2014;23:804-806. 7. Raychaudhuri SK, Saxena A, Raychaudhuri SP. Role of IL-17 in the pathogenesis of psoriatic arthritis and axial spondyloarthritis. Clin Rheumatol. 2015;34:1019-1023. 8. Miossec P, Kolls JK. Targeting IL-17 and Th17 cells in chronic inflammation. Nat Rev Drug Discov. 2012;11:763-776. 9. Data on file. Lilly USA, LLC. DOF-IX-US-0119. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0120. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0126. 12. Taltz [package insert]. Indianapolis, IN: Eli Lilly and company; 2019. 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 3 trial SPIRIT-P1. Ann Rheum Dis. 2017;76(suppl):1-30. 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 SPIRITP2 phase 3 trial. Lancet. 2017;389:2317-2327. 15. 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. 16. 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.

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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IX HCP ISI 23AUG2019