Heal House Vitiligo Research 45 · Original Article
Do long-term use of Protopic and ELIDEL with phototherapy for vitiligo increase cancer risk?
The long-term risk of lymphoma and skin cancer did not increase after topical calcineurin inhibitor use and phototherapy in a cohort of 25,694 patients with vitiligo.
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In short
A total of 25,694 vitiligo patients were followed for a long time. Even with long-term use of Protopic ointment and ELIDEL cream along with long-term phototherapy, there was no increase in lymphoma or skin cancer.
"Is it really safe to use this ointment for a long time?" This is a question we often hear in the clinic. The package inserts for Protopic ointment and ELIDEL cream, which are commonly used for vitiligo, contain warnings about lymphoma and skin cancer. Many patients ask about this with concern after reading those warnings. Phototherapy, which uses ultraviolet light, has also always raised concerns about whether it might increase skin cancer risk. Therefore, in this multi-center study in which I participated as a co-investigator, we followed 25,694 vitiligo patients over a long period to determine whether these concerns are actually supported by evidence.
Q1 What did we check and how?
We gathered 25,694 patients who had used Protopic ointment or ELIDEL cream for at least 6 weeks, or who had received phototherapy for at least 6 weeks. Data from multiple hospitals were collected and followed from 2001 to 2019. We did not simply look at whether cancer occurred. We also examined how much ointment was used and how many phototherapy sessions were received. This was to determine whether greater use was associated with an increase in cancer. Cases where cancer actually occurred were confirmed one by one through medical records and biopsy results. Thanks to this, we were able to assess safety based on actual data rather than vague anxiety.
Q2 What Were the Results?
To summarize the conclusion, neither treatment increased the risk of lymphoma or skin cancer even with long-term use. Over a follow-up period of 95,203 person-years, there were 13 cases of lymphoma. Skin cancer cases, when combined, were also few. Most importantly, using more ointment or receiving more phototherapy sessions did not increase the risk. Even when both treatments were used together, there was no signal of added risk. The table below summarizes the number of cases actually confirmed during this long follow-up.
Results from following 25,694 vitiligo patients for 95,203 person-years
| Item | Content |
|---|---|
| Lymphoma | 13 cases |
| Actinic keratosis | 22 cases |
| Non-melanoma skin cancer | 15 cases |
| Melanoma | 5 cases |
| Key conclusion | No increase in risk even with greater ointment use or more phototherapy sessions |
Closing remarks
Now, for patients who worry, "If I use it for a long time, will I get cancer?", we can say, based on large-scale data, "You do not need to be overly concerned." Of course, it remains important not to use any treatment more than necessary and to regularly check the skin. However, we hope that effective treatments are not abandoned prematurely due to vague fears.
