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5 head-to-head clinical trials testing superiority in 2 disease states1-5

Adult Plaque Psoriasis

IXORA-R

The primary endpoint was the proportion of patients achieving PASI 100 at week 12.

IXORA-S

The primary endpoint was the proportion of patients achieving PASI 90 at week 12.

UNCOVER-2, -3

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.

Adult Psoriatic Arthritis

SPIRIT-H2H

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

*US-approved Enbrel.
Please refer to the Prescribing Information of each agent for indication, dosage, and administration.
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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.

PASI=Psoriasis Area Severity Index; PASI 75/90/100=75%/90%/100% improvement from baseline in PASI criteria; sPGA=static Physician’s Global Assessment; ACR50=American College of Rheumatology 50% response.

Taltz showed superiority in complete skin clearance (PASI 100) in head-to-head trials in 2 disease states6,7

PsO: TALTZ VS TREMFYA
PASI 100 response rates at
week 12, NRI

PsA: TALTZ VS HUMIRA (BIOLOGIC-NAIVE)
PASI 100 response rates at
week 24, NRI

*P<.001 vs Tremfya.
P=.001 vs Humira.

In the Taltz vs Humira study , primary endpoint=simultaneous achievement of ACR50 and PASI 100 at week 24.

All patients had BSA ≥3%; patients with BSA ≥10%, PASI ≥12, and sPGA ≥3 followed the dosing for moderate to severe psoriasis. All other patients followed PsA dosing.7

IXORA-R and SPIRIT-H2H trial designs.

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.

PASI=Psoriasis Area Severity Index; PASI 100=100% improvement from baseline in PASI criteria; PsO=psoriasis; NRI=nonresponder imputation; PsA=psoriatic arthritis; ACR50=American College of Rheumatology 50% response; BSA=body surface area; sPGA=static Physician’s Global Assessment.

References: 1. ClinicalTrials.gov Identifier: NCT03573323. 2. ClinicalTrials.gov Identifier: NCT02561806. 3. ClinicalTrials.gov Identifier: NCT01597245. 4. ClinicalTrials.gov Identifier: NCT01646177. 5. ClinicalTrials.gov Identifier: NCT03151551. 6. Blauvelt A, Papp K, Gottlieb A, et al; IXORA-R Study Group. A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 12-week efficacy, safety and speed of response from a randomized, double-blinded trial. Br J Dermatol. 2020;182:1348-1358. 7. Mease PJ, Smolen JS, Behrens F, et al; SPIRIT H2H Study Group. 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. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0167. 9. Paul C, Griffiths CEM, van der Kerkhof PCM, et al. Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: results from IXORA-S, a phase 3 study. J Am Acad Dermatol. 2019;80:70-79. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0006. 11. Taltz [package insert]. Indianapolis, IN: Lilly USA, LLC. 12. Data on file. Lilly USA, LLC. DOF-IX-US-0190. 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. 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. Data on file. Lilly USA, LLC. TAL20171127A. 17. Data on file. Lilly USA, LLC. DOF-IX-US-0191. 18. Data on file. Lilly USA, LLC. DOF-IX-US-0189.

INDICATIONS

Taltz is indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Taltz is also indicated for adult patients with active psoriatic arthritis (PsA), adult patients with active ankylosing spondylitis (AS), and adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

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.

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IX HCP ISI 07MAY2020