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Taltz ® (ixekizumab) injection
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.
Has lymphoma been reported with Taltz® (ixekizumab)?
The incidence rate of lymphoma across 17 ixekizumab trials conducted in adult patients with plaque psoriasis was .03 per 100 patient-years as of March 2021.
Treatment-Emergent Malignancies Including Lymphoma in Psoriasis Clinical Trials
Across 17 pooled psoriasis trials in adult patients (N=6892), accounting for 18,025.7 patient-years (PYs) of total ixekizumab exposure as of the March 19, 2021 database lock, the treatment-emergent lymphomas reported based on Medical Dictionary for Regulatory Activities (MedDRA) preferred terms included
- B-cell lymphoma (n=2, 0.0%)
- diffuse large B-cell lymphoma (n=1, 0.0%)
- Hodgkin's disease (n=1, 0.0%)
- Hodgkin's disease mixed cellularity stage unspecified (n=1, 0.0%), and
- Non-Hodgkin's lymphoma (n=1, 0.0%).1
In the safety data set described previously, the incidence rate (IR) of overall malignancies was 0.8 per 100 PYs of exposure.2
Treatment-Emergent Malignancies Including Lymphoma in Psoriatic Arthritis Clinical Trials
Four pooled psoriatic arthritis trials (N=1401, accounting for 2247.7 PYs of total ixekizumab exposure as of the March 19, 2021 database lock), reported no treatment-emergent lymphomas based on MedDRA-preferred terms.1
In the safety data set described previously, the IR of overall malignancies was 0.7 per 100 PYs of exposure.3
Treatment-Emergent Malignancies Including Lymphoma in Axial Spondyloarthritis Trials
Four axial spondyloarthritis trials that include patients with ankylosing spondylitis/radiographic axial spondyloarthritis and nonradiographic axial spondyloarthritis (N=932, accounting for 2096.2 PYs of total ixekizumab exposure as of the March 19, 2021 database lock), reported no treatment-emergent lymphomas reported based on MedDRA-preferred terms.1
In the safety data set described previously, the IR of overall malignancies was 0.4 per 100 PYs of exposure.3
Enclosed Prescribing Information
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Griffiths C, Blauvelt A, Reich K, et al. Long-term safety of ixekizumab in patients with moderate-to-severe psoriasis: results from more than 17,000 patient-years of exposure. Poster presented at: 6th Congress of the Skin Inflammation & Psoriasis International Network; April 25-27, 2019; Paris, France.
3Schwartzman S, Deodhar A, Combe B, et al. Safety profile of ixekizumab for the treatment of psoriatic arthritis and axial spondyloarthritis up to 3 years: an updated integrated safety analysis. Poster presented at: Annual Meeting of the America College of Rheumatology (ACR Convergence Virtual); November 1-10, 2021.
Date of Last Review: April 18, 2022