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  1. Medical Information Right
  2. Immunology Right
  3. Taltz (ixekizumab) injection Right
  4. What are the long-term safety results of Taltz® (ixekizumab) in the treatment of psoriatic arthritis?
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Taltz ® (ixekizumab) injection

80 mg/mL

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What are the long-term safety results of Taltz® (ixekizumab) in the treatment of psoriatic arthritis?

Exposure-adjusted incidence rate for treatment-emergent adverse events and serious adverse events remained stable or decreased over time in ixekizumab clinical trials.

US_cFAQ_IXE334_LONG_TERM_SAFETY_PsA
US_cFAQ_IXE334_LONG_TERM_SAFETY_PsAen-US

General Information

Appendix: Clinical Trial Brief Descriptions provides brief descriptions of the pivotal clinical trials for active psoriatic arthritis (PsA).

Data from multiple, different dosing regimens, including unapproved doses, are included in this response.

The long-term safety of ixekizumab was evaluated in 1401 patients with PsA who received ixekizumab up to 3 years (accounting for 2247.7 patient-years [PYs]). The safety profile is consistent with previous reports in patients who received ixekizumab for the treatment of psoriasis (PsO) or PsA and the rates of reported treatment-emergent adverse event (TEAEs) remained stable or decreased over time with continued ixekizumab exposure.1

Integrated Analysis of Ixekizumab Exposures

Across 4 ixekizumab PsA clinical trials, 1401 patients with active PsA received at least one dose of ixekizumab, representing 2247.7 PYs of exposure as of the data cutoff of March 19, 2020.1

Treatment-Emergent Adverse Events and Serious Adverse Events in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set Through March 2020 shows the number of TEAEs, serious adverse event (SAEs), deaths, and discontinuations due to an adverse event (AE) as of March 19, 2020. The most commonly reported TEAEs (exposure-adjusted incidence rate [IR] per 100 PYs) were

  • nasopharyngitis (9.0)
  • upper respiratory tract infection (8.3), and
  • injection site reactions (6.9).1
Treatment-Emergent Adverse Events and Serious Adverse Events in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set Through March 20201

Event, n (%) [IR]a

Pooled IXE
(N=1401; PY=2247.7)

Patients with ≥1 TEAEb

1131 (80.7) [50.3]c

Mild

461 (32.9) [20.5]

Moderate

556 (39.7) [24.7]

Severe

114 (8.1) [5.1]

Patients with ≥1 SAE

134 (9.6) [6.0]

Deaths

6 (0.4) [0.3]

Discontinuation due to AE

115 (8.2) [5.1]

Abbreviations: AE = adverse event; IR = exposure-adjusted incidence rate; IXE = ixekizumab; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event.
Note: Patients with multiple occurrences of the same event are categorized by the highest severity. Deaths are included among SAEs and among discontinuations due to AEs.

aIncidence rate per 100 PYs.

bPatients with multiple occurrences of the same event were counted under the highest severity.

cThe most commonly reported TEAEs (IR per 100 PYs) were nasopharyngitis (9.0), upper respiratory tract infection (8.3), and injection site reactions (6.9).

Adverse Events of Special Interest in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set Through March 2020 shows the number of AEs of special interest as of March 19, 2020.1

Adverse Events of Special Interest in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set Through March 20201,2

Event, n (%) [IR]a

Pooled IXE
(N=1401; PY=2247.7)

Infections

759 (54.2) [33.8]

Serious infections

28 (2.0) [1.2]

Candida infections

45 (3.2) [2.0]

Opportunistic infections

40 (2.9) [1.8]

Injection site reactionsb

260 (18.6) [11.6]

Hepatic reactionsc

112 (8.0) [5.0]

Allergic/hypersensitivity reactions 

102 (7.3) [4.5]

Cytopeniasd

56 (4.0) [2.5]

Inflammatory bowel disease (adjudicated)

3 (0.2) [0.1]e

MACE (adjudicated)

12 (0.9) [0.5]

Malignancies

15 (1.1) [0.7]

Depression

37 (2.6) [1.6]

Asthma

10 (0.7) [0.4]

Suicidal behaviour/self-injury

1 (0.1) [0]

Abbreviations: IR = exposure-adjusted incidence rate; IXE = ixekizumab; MACE = major adverse cerebrocardiovascular events; MedDRA = Medical Dictionary for Regulatory Activities; PY = patient-years; SMQ = standardized Medical Dictionary for Regulatory Activities query.

aIR per 100 PYs.

bMedDRA high-level term.

cThe most common hepatic reactions were alanine aminotransferase increased (n=37), aspartate aminotransferase increased (n=28), gamma-glutamyltransferase increased (n=21), and hepatic steatosis (n=21).

dBroad according to SMQ classification. The most common cytopenias were neutropenia (n=29), leukopenia (n=18), and neutrophil count decreased (n=9).

eThree patients had events of IBD confirmed by adjudication. One patient had more than 1 event. Crohn's disease, n=2; ulcerative colitis, n=1.

The rates of TEAEs decreased over time and the rates of SAEs and discontinuations due to AEs were low and remained stable over time with continued exposure to ixekizumab up to 3 years (Incidence Rates of Select Categories of Adverse Events at 1-Year Intervals Up to 3 Years of Treatment in Patients Exposed to Ixekizumab Across 4 Psoriatic Arthritis Trials).1,2

Incidence Rates of Select Categories of Adverse Events at 1-Year Intervals Up to 3 Years of Treatment in Patients Exposed to Ixekizumab Across 4 Psoriatic Arthritis Trials2

Figure 1 description: Across 4 psoriatic arthritis trials, the incidence rates for the treatment emergent adverse events decreased over time. The incidence rates for serious adverse events and discontinuations due to adverse events remained low and stable throughout the treatment period. Similarly, the incidence rates for serious infections were also low and stable over time. Incidence rates for injection-site reactions and allergic reactions/hypersensitivities decreased over the three-year treatment period with ixekizumab.

Abbreviations: AE = adverse event; IR = incidence rate; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event.
a Adjudicated cases. For IBD, 3 patients had IBD confirmed by adjudication. One patient had more than 1 event.

Enclosed Prescribing Information

TALTZ® (ixekizumab) injection, for subcutaneous administration, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Deodhar AA, Combe B, Accioly AP, et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022;81(7):944-950. https://doi.org/10.1136/annrheumdis-2021-222027

2Sesin C, Gallo G, Gellett AM, et al. Safety of ixekizumab in patients with psoriatic arthritis: an integrated analysis of 4 clinical trials. Ann Rheum Dis. 2021;80(suppl 1):789. European League Against Rheumatism Virtual Congress abstract POS1033. https://doi.org/10.1136/annrheumdis-2021-eular.567

3Mease PJ, van der Heijde D, Ritchlin CT, et al; 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(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709

4Nash P, Kirkham B, Okada M, et al; 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(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

5Coates LC, Pillai SG, Tahir H, et al; SPIRIT-P3 Study Group. Withdrawing ixekizumab in patients with psoriatic arthritis who achieved minimal disease activity: results from a randomized, double-blind withdrawal study. Arthritis Rheumatol. 2021;73(9):1663-1672. https://doi.org/10.1002/art.41716

6Mease 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(1):123-131. https://doi.org/10.1136/annrheumdis-2019-215386

Appendix: Clinical Trial Brief Descriptions

  • SPIRIT-P1 (N=417) was a phase 3, 24-week double-blind, placebo-controlled trial with an active reference arm, conducted in patients with active PsA who were naïve to disease-modifying antirheumatic drugs (bDMARDs) with an extension period of up to 3 years.3
  • SPIRIT-P2 (N=363) was a phase 3, 24-week double-blind, placebo-controlled trial, conducted in patients with active PsA and an inadequate response or intolerance to TNF inhibitors, with an extension period of up to 3 years.4
  • SPIRIT-P3 (N=394) consisted of a 36-week open-label period followed by a randomized double-blind withdrawal period from week 36 to week 104. This trial was conducted in patients who were naïve to bDMARDs.5
  • SPIRIT-H2H (N=566) was a phase 3, 52-week open-label, blinded-assessor trial that compared the efficacy and safety of ixekizumab and adalimumab, conducted in patients with active PsA who were naïve to bDMARDs.6

Date of Last Review: May 01, 2024

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