More on Melanoma with Transdifferentiation

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Abstract
Mullen et al. (Feb. 7 issue)1 report on two cases of melanoma in patients with multiple sclerosis who received natalizumab. Their letter shows the limited interpretability of individual case reports in establishing cause-and-effect relationships. In response to this letter, we performed a meta-analysis of safety data from clinical trials of natalizumab. The incidence of melanoma was similar among patients who received natalizumab (3 of 4250 [0.07%]) as compared with those who received placebo (2 of 2059 [0.10%]). Rates of melanoma followed a similar pattern: 0.419 per 1000 patient-years among persons who received natalizumab versus 0.823 per 1000 patient-years among persons who received placebo. In addition, postmarketing surveillance data as of December 2007 do not indicate an increased risk of melanoma among more than 21,000 patients who received natalizumab (unpublished data).