Taltz® ▼ (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Taltz Summary of Product Characteristics (SmPC)

Taltz▼ (ixekizumab): Treatment-Emergent Lymphoma in Psoriasis and Psoriatic Arthritis Clinical Trials

Treatment-emergent lymphoma was not reported in patients treated with ixekizumab or placebo, up to week 12, in the phase 3 placebo-controlled clinical trials

Malignancy-Related Ixekizumab Clinical Trial Criteria

  • Ixekizumab product labeling does not contain a contraindication for use in patients with a malignancy or history of malignancy.1 However, the use of ixekizumab in this population has not been studied.

  • Clinical Trial Exclusion Criteria:2-4

    • Active, or a history of malignant disease was an exclusion criterion in the pivotal psoriasis UNCOVER clinical trials (history of malignant disease within 5 years prior to baseline for SPIRIT-P2 and later trials, including IXORA psoriasis studies and SPIRIT-H2H in PsA).

    • Patients were excluded if they had current or a history of lymphoproliferative disease, or signs or symptoms of lymphoproliferative disease (limited to within 5 years of baseline for later trials).

    • Patients with successfully treated basal-cell carcinoma (no more than 3), squamous-cell carcinoma of the skin, or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline were allowed to participate in the pivotal psoriasis studies.

    • Note: This is not an all-inclusive list of exclusion criteria, but rather a list of those exclusion criteria related to malignancy.

  • Clinical Trial Discontinuation Criteria:2,4

    • The clinical trial protocols required patients who developed a malignancy to discontinue the studies.

    • Patients were allowed to continue if they developed no more than 2 NMSC over any 12-month period during the studies.

    • Note: This is not an all-inclusive list of discontinuation criteria, but rather discontinuation criteria related to malignancy.

Treatment-Emergent Lymphoma in Psoriasis Clinical Trials

  • Across 13 pooled psoriasis trials (N=5898, accounting for 17,003.4 PYs of total ixekizumab exposure as of September 2018 database lock), the IR of malignancies was 0.8 per 100 PYs of exposure.5

  • Treatment-emergent lymphomas reported in the 13 integrated psoriasis trial data cut described above based on MedDRA preferred terms were

    • 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%).4

Treatment-Emergent Lymphoma in Psoriatic Arthritis Clinical Trials

  • Across 3 pooled PsA trials (N=1118, accounting for 1937.7 PYs of total ixekizumab exposure as of September 2018 database lock), the IR of malignancies was 0.8 per 100 PYs of exposure.4

  • No treatment-emergent lymphomas were reported in the 3 integrated PsA trial data cut described above based on MedDRA preferred terms.4

Therapeutic Indications

Ixekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.1

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.1

References

1. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Gordon KB, Blauvelt A, Papp KA, et al. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

3. Langley RG, Papp K, Gooderham M, et al. Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P). Br J Dermatol. 2018;178(6):1315-1323. http://dx.doi.org/10.1111/bjd.16426

4. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

5. Griffiths 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.

Glossary

IR = incidence rate

MedDRA = Medical Dictionary for Regulatory Activities

NMSC = nonmelanoma skin cancer

PsA = psoriatic arthritis

PY = patient-years

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: May 16, 2019

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