Vitamin D supplementation significantly increases vitamin D levels and reduces vitamin D deficiency, which is prevalent in adults with erythropoietic protoporphyria (EPP), whether or not they are treated with Senesse (amelanotide). This has been reported in recent studies.
However, treatment with Scenesse did not significantly affect vitamin D levels in these patients, except in patients older than 50 years or after long-term treatment (2.5 to 5 years).
“Based on these findings, we recommend that future guidelines include the following:” [vitamin D] Prescription of supplements and regular monitoring of vitamin D levels, including in patients with EPP. [Scenesse]” the researchers wrote.
the study, “Effects of cholecalciferol and afamelanotide on vitamin D levels in erythropoietic protoporphyria.Multicenter cohort study” was published. British Society of Dermatology Journal.
EPP is a type of porphyria characterized by skin sensitivity to sunlight and certain types of artificial light, leading to vitamin D deficiency and decreased bone density, or osteoporosis, in a significant proportion of patients.
Scenesse is a skin implant for increasing light exposure without pain.
Scenesse, developed by Clinuvel, is a skin implant approved in the US and Europe to painlessly increase light exposure and prevent phototoxic reactions, which refers to damage to the skin caused by exposure to sunlight. is. Each implant contains 16 mg of afamelanotide and is placed under the skin once every two months from spring to summer.
However, “studies on vitamin D levels during EPP have only looked at patients who did not receive vitamin D treatment.” [Scenesse]”
To investigate the prevalence of vitamin D deficiency in EPP patients receiving afamelanotide and/or vitamin D (cholecalciferol) supplementation, researchers conducted a follow-up study at two medical centers in the Netherlands and Germany. We conducted an observational study of adult patients with EPP who underwent treatment.
A total of 230 patients (138 from the Netherlands, 92 from Germany) were mostly male (53%), with a mean age of 39.1 years and a median follow-up of 8 months.
Overall, the researchers conducted 1,774 vitamin D measurements. This corresponds to an average of 7.7 cases per patient over a median interval of 2 months.
Vitamin D measurements were performed in four patient groups. A total of 135 measurements were taken in patients receiving no treatment, 331 in patients receiving Senesse, 104 in patients receiving vitamin D supplementation, and 1,104 in patients receiving both treatments. Measurements were taken.
79% of EPP patients are vitamin D deficient
The prevalence of vitamin D deficiency (vitamin D level ≤50 nmol/L) in patients with EPP was 79%, and more than half of the patients (55%) had severe deficiency (vitamin D level ≤30 nmol/L). L).
Vitamin D supplementation significantly increased median vitamin D levels to 60 nmol/L when administered alone and to 62 nmol/L when combined with Senes, increasing the prevalence of vitamin D deficiency to 46%. , the prevalence of severe vitamin D deficiency decreased to 46%. 19%.
Treatment with Senese alone did not significantly increase median vitamin D levels or reduce the prevalence of vitamin D deficiency (71%).
After adjusting data for gender, age, season, and treatment group, the researchers found that both vitamin D supplementation and combination treatment significantly increased vitamin D levels over time. These effects were observed immediately after starting treatment.
When Senesse was administered alone, vitamin D levels significantly increased only after 2.5 to 5 years of treatment. Significant increases in vitamin D levels were also observed in patients over 50 years of age taking Senesse.
Subgroup analysis also revealed that women with EPP had higher vitamin D levels than men, and that women generally had better treatment outcomes. Vitamin D supplementation was more effective during winter, and all treatments generally had a more pronounced effect in older patients.
“Our study highlights the continued importance of cholecalciferol as part of supportive care for patients with EPP. [Scenesse]” the researchers wrote, adding, “Future studies should focus on EPP patients receiving afamelanotide for a long period of time to assess the effect of afamelanotide on vitamin D levels.” Ta.
