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Psoriatic Arthritis Efficacy

ACR results

Powerful joint symptom results in both biologic-naive and TNFi-experienced patients1-3

*P≤.001 vs placebo; P <.0001 vs 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. Nonresponders imputation (NRI) of intent-to-treat population through week 24.

Please click here for SPIRIT-P1 and SPIRIT-P2 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.

Radiographic response

Dactylitis

Enthesitis

Concomitant MTX use

ACR20 response vs placebo with or without concomitant methotrexate1,14-15

ADDITIONAL WEEK 24 RESULTS FROM SPIRIT-P2 TRIAL

In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=48; placebo n=40), 50% of Taltz patients achieved ACR20 with concomitant MTX at week 24 vs 18% for placebo. Additionally (Taltz n=74; placebo n=78), 55% of Taltz patients achieved ACR20 without MTX use at week 24 vs 21% for placebo. All patients in SPIRIT-P2 were previously treated with at least 1 cDMARD (methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine)

All patients were allowed to remain on stable background therapy.

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.

The data presented were from post hoc analyses and were not type-1 error-controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant.

No routine lab monitoring (including liver function tests) is required for treatment with Taltz as monotherapy.

During Taltz treatment, monitor patients for signs and symptoms of infection and for onset or exacerbation of inflammatory bowel disease. During and after treatment with Taltz, monitor patients for active tuberculosis (TB) infection.

MTX=methotrexate.

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.

Psoriatic Arthritis skin data

References: 1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020. 2. 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. 3. 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. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0013. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0015. 6. Genovese MC, Combe B, Kremer J, et al. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology. 2018. doi:10.1093/rheumatology/key182. 7. Data on file. Lilly USA, LLC. TAL20171026B. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0017. 9. van der Heijde D, Gladman DD, Kishimoto M, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase III study (SPIRIT-P1). J Rheumatol. 2018;45:367-377. 10. 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. 11. Data on file. Lilly USA, LLC. TAL04022018A. 12. Data on file. Lilly USA, LLC. TAL20171002A. 13. Data on file. Lilly USA, LLC. TAL04022018B. 14. Data on file. Lilly USA, LLC. TAL20170919A. 15. Data on file. Lilly USA, LLC. TAL20171026A. 16. Data on file. Lilly USA, LLC. TAL20171127A. 17. Data on file. Lilly USA, LLC. DOF-IX-US-0012.

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