Intravenous sodium thiosulfate does not improve skin lesions or reduce the risk of dying from calciphylaxis, a rare but life-threatening condition, in patients with chronic kidney disease (CKD), investigators report.
Sodium thiosulfate has been used off-label to improve pain and wound healing in patients with calciphylaxis since 2004, but there has been no data available from a clinical trial to inform its efficacy and safety, Wen Wen, MD, MMSc, of Beijing Tsinghua Changgung Hospital in China, and colleagues noted.
The investigators conducted a meta-analysis of 19 retrospective cohort studies published from 2006 to 2019 involving 422 patients with CKD and calciphylaxis. Skin lesion improvement and death risk did not differ significantly among patients receiving vs not receiving intravenous sodium thiosulfate, Dr Wen’s team reported in JAMA Network Open. Oral, intraperitoneal, intralesional, and other administrations of sodium thiosulfate were excluded.
Among the 422 patients, 347 were on dialysis. Calciphylaxis affects 1 in every 600 people on dialysis annually, according to the National Kidney Foundation. Among this subgroup, outcomes were no better for those receiving vs not receiving intravenous sodium thiosulfate.
The investigators found a negative correlation between skin lesion improvement and publication year indicating a temporal publication bias. According to Dr Wen’s team, studies including nonresponders have more recently been published. They acknowledged that their meta-analysis of cohort studies could not account for between-group differences and potential biases. Whether certain patient characteristics are more amenable to treatment with sodium thiosulfate warrants prospective research.
“Identification of such factors will allow judicious application of STS to patients with calciphylaxis and will guide the patient selection criteria of future clinical trials,” the investigators wrote. The BEAT-CALCI trial (NCT05018221) is currently comparing sodium thiosulphate, magnesium, and vitamin K treatments for patients with calciphylaxis.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Wen W, Portales-Castillo I, Seethapathy R, et al. Intravenous sodium thiosulphate for calciphylaxis of chronic kidney disease: A systematic review and meta-analysis. JAMA Netw Open. Published online April 26, 2023. doi:10.1001/jamanetworkopen.2023.10068