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Updated: Jul 25, 2025
The Goeckerman Regimen for the Treatment of Moderate to Severe Psoriasis
Published on: July 11, 2013
Integrated Safety Analysis on Skin Cancers among Patients with Psoriasis Receiving Ixekizumab in Clinical Trials
Saxon D Smith1, Alexandros Stratigos2, Matthias Augustin3
1ANU Medical School, ANU College of Health and Medicine, The Australian National University, Canberra, Australian Capital Territory, Australia. dr.saxon.smith@gmail.com.
Introduction:
Limited data exist on skin cancer risk in patients with psoriasis using biologics. Here, we report treatment-emergent adverse events (TEAEs) of skin cancer in patients treated with ixekizumab from psoriasis clinical trials.
Methods:
Integrated safety databases from 17 clinical trials of adults with moderate-to-severe psoriasis treated with ≥ 1 dose of ixekizumab for ≤ 5 years were used to analyze exposure-adjusted incidence rates (IRs) per 100 patient-years of exposure (PYE) and clinically characterize dermatologist-adjudicated skin cancer TEAEs.
Results:
Of 6892 patients, 58 presented with ≥ 1 skin cancer TEAE (IR 0.3) with IRs remaining stable with longer ixekizumab exposure. Non-melanoma skin cancer (NMSC) was the most common event (IR 0.3) affecting 55 patients; of those, 44 had basal cell carcinoma (IR 0.2) and 16 had squamous cell carcinoma (IR 0.1). Two treatment-emergent melanoma events were identified; neither were classified as serious AEs.
Conclusions:
Incidence of skin neoplasms in patients with psoriasis treated with ixekizumab for ≤ 5 years was low, and among those events, NMSC was most common. Limitations included that longer exposure may be required to confirm risk of skin cancer and that the study exclusion criteria of several studies, which excluded patients with skin cancer events within 5 years prior to baseline, might limit interpretation of skin cancer risk in this cohort. These findings support the safety profile of ixekizumab for patients requiring long-term psoriasis control.
Insights
Skin cancer risk appears low in patients with psoriasis treated with ixekizumab (a biologic). Non-melanoma skin cancers were most common, with stable incidence rates over time, supporting ixekizumab
Area of Science:
- Dermatology
- Oncology
- Pharmacology
Background:
- Limited data exist on skin cancer risk associated with biologic therapies for psoriasis.
- Psoriasis patients treated with biologics require careful monitoring for potential adverse events, including skin neoplasms.
- Understanding the safety profile of ixekizumab regarding skin cancer is crucial for long-term patient management.
Purpose of the Study:
- To evaluate the incidence and characteristics of treatment-emergent adverse events (TEAEs) of skin cancer in patients with psoriasis receiving ixekizumab.
- To analyze skin cancer risk associated with ixekizumab exposure over a period of up to five years.
- To assess the safety profile of ixekizumab in the context of long-term psoriasis treatment.
Main Methods:
- Integrated safety data from 17 clinical trials involving adults with moderate-to-severe psoriasis treated with ixekizumab were analyzed.
- Exposure-adjusted incidence rates (IRs) per 100 patient-years of exposure (PYE) were calculated for skin cancer TEAEs.
- Dermatologist-adjudicated skin cancer TEAEs were clinically characterized.
Main Results:
- A total of 58 out of 6892 patients experienced at least one skin cancer TEAE, with an overall IR of 0.3 per 100 PYE.
- Non-melanoma skin cancer (NMSC) was the most frequent type, accounting for 55 cases (IR 0.3), including basal cell carcinoma (IR 0.2) and squamous cell carcinoma (IR 0.1).
- Two treatment-emergent melanoma events were reported, neither classified as serious adverse events, and IRs remained stable with longer ixekizumab exposure.
Conclusions:
- The incidence of skin neoplasms in psoriasis patients treated with ixekizumab for up to five years was low.
- Non-melanoma skin cancer was the predominant type of skin neoplasm observed.
- Findings support the safety profile of ixekizumab for long-term psoriasis management, though longer exposure data may refine risk assessment.
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