Does Stelara Increase Skin Cancer Risk?
Stelara (ustekinumab), a biologic for psoriasis, Crohn's disease, and ulcerative colitis, carries warnings for skin cancer in its prescribing information. The label notes cases of basal cell carcinoma and squamous cell carcinoma, including in patients without prior immunosuppression.[1] Post-marketing reports include cutaneous T-cell lymphoma and melanoma. The FDA requires monitoring for non-melanoma skin cancers, especially in patients with many years of prior phototherapy, PUVA, or methotrexate use.
What Clinical Trials Show
In psoriasis trials, non-melanoma skin cancers occurred at rates of 0.3-1.1% in Stelara groups versus 0.7-1.6% in placebo or active comparators like etanercept. Melanoma cases were rare (0.1% or less). Crohn's and ulcerative colitis trials reported similar low rates, with no clear excess risk over comparators. Long-term extensions (up to 5 years) showed cumulative incidence around 2-4% for non-melanoma skin cancers in psoriasis patients, often in those with risk factors like fair skin or heavy sun exposure.[1][2]
Why Might It Happen?
Stelara blocks IL-12 and IL-23, cytokines involved in immune regulation. This dampens T-cell responses, potentially impairing skin cancer surveillance. Patients with psoriasis already have higher baseline skin cancer risk from chronic inflammation, UV treatments, and smoking. Immunosuppression amplifies this, though Stelara's targeted mechanism may pose less risk than broad immunosuppressants.[3]
Patient Risk Factors to Watch
Risk rises with:
- History of skin cancer or precancers (e.g., actinic keratosis).
- Prior phototherapy (especially PUVA >250 sessions).
- Fair skin, extensive sun exposure, or older age.
- Concurrent immunosuppressants.
Guidelines recommend annual dermatology exams for high-risk patients on biologics like Stelara.[1][4]
Compared to Other Biologics
| Drug | Non-Melanoma Skin Cancer Rate (Psoriasis Trials) | Melanoma Notes |
|------|--------------------------------------------------|---------------|
| Stelara | 0.3-1.1% | Rare |
| Humira (adalimumab) | 0.8-2.0% | Slightly higher reports |
| Cosentyx (secukinumab) | 0.2-0.7% | Similar low risk |
| Tremfya (guselkumab) | 0.4-1.2% | Comparable to Stelara |
Stelara's profile aligns with IL-23 inhibitors but shows marginally higher non-melanoma rates than some IL-17 blockers in head-to-head data.[2][5]
What Doctors Advise
Perform skin exams before starting and regularly during treatment. Use sun protection, avoid tanning beds, and report new lesions immediately. Discontinue if invasive squamous cell carcinoma develops. No routine skin cancer screening mandate exists, but psoriasis societies urge vigilance.[1][4]
[1]: Stelara Prescribing Information (FDA)
[2]: Pivotal Psoriasis Trials (NEJM)
[3]: IL-23 Inhibition Mechanism (Nature Reviews)
[4]: AAD Psoriasis Guidelines
[5]: Biologic Safety Meta-Analysis (Lancet)