The first ever IL-17A antagonist to demonstrate superiority in a head-to-head trial against Humira in PsA1-5
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.
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*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.8
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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, nonradiographic 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.
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
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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.
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.
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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.
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.
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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.
*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
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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.
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.
SPIRIT-P1 and P2 Registration Trial Data
TALTZ HAS NO BOXED WARNING.14
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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, nonradiographic 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.
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.
SPIRIT-H2H (N=566) was a phase 4, randomized, open-label, blinded-assessor study evaluating the efficacy and safety of Taltz vs Humira in biologic-naive patients with active psoriatic arthritis and plaque psoriasis BSA ≥3%.
Patients who met the trial design criteria for moderate to severe psoriasis (BSA ≥10%, PASI ≥12, and sPGA ≥3) in addition to psoriatic arthritis followed the psoriasis dosing regimen: Taltz patients (n=49) received an initial dose of 160 mg (two 80 mg injections), followed by 80 mg every 2 weeks through week 12, then 80 mg every 4 weeks thereafter. Humira patients (n=52) received an initial dose of 80 mg, then 40 mg every other week starting 1 week after the initial dose. For Taltz patients with psoriatic arthritis only (n=234), the initial dose (160 mg as 2 injections) was followed by 80 mg every 4 weeks. Humira patients (n=231) received 40 mg every other week and no initial dose.
