Taltz ® (ixekizumab) injection

80 mg/mL

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TALTZ® (ixekizumab): Long-Term Safety 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.

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General Information

Appendix: Clinical Trial Brief Descriptions provides  brief descriptions of the pivotal clinical trials for active 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 PYs). The safety profile is consistent with previous reports in patients who received ixekizumab for the treatment of PsO or PsA and the rates of reported 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 numbers of TEAEs, SAEs, deaths, and discontinuations due to an AE as of March 19, 2020. The most commonly reported TEAEs (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 = 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 20201

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]

Abbreviations: IR = 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.

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. 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 Trials1

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.

References

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

1Sesin C, Gallo G, Gellett AM, et al. Safety of ixekizumab in patients with psoriatic arthritis: an integrated analysis of 4 clinical trials. Poster presented at: European League Against Rheumatism Virtual Congress; June 2-5, 2021.

2Mease 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

3Nash 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

4A long-term efficacy and safety study of ixekizumab (LY2439821) in participants with active psoriatic arthritis (SPIRIT P3). ClinicalTrials.gov identifier: NCT02584855. Updated November 15, 2019. Accessed May 25, 2021. https://www.clinicaltrials.gov/ct2/show/NCT02584855

5Mease PJ, Smolen JS, Behrens F, et al; The 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

Glossary

AE = adverse event

bDMARD = biologic disease-modifying antirheumatic drug

IR = incidence rate

PsA = psoriatic arthritis

PsO = psoriasis

PY = patient-years

SAE = serious adverse event

TEAE = treatment-emergent adverse event

TNF = tumor necrosis factor

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 bDMARDs with an extension period of up to 3 years.2
  • 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.3
  • SPIRIT-P3 (N=570) 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.4
  • 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.5

Date of Last Review: May 13, 2021


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