Efficacy of iguratimod on mineral and bone disorders after kidney transplantation: a preliminary study

Abstract

Background

Iguratimod has been shown to promote bone formation and inhibit bone resorption in rheumatoid arthritis patients. We aimed to explore its effect on bone metabolism and vascular calcification (VC) in kidney transplant recipients (KTRs).

Methods

A post hoc analysis was conducted among the subjects in our previous randomized clinical trial (NCT02839941). Forty-three KTRs completing bone metabolism 52 weeks after enrollment were selected for this analysis, among whom 27 patients received VC examinations. In the iguratimod group, iguratimod (25 mg twice daily) was added adjuvant to the traditional triple regimen. At the 52-week follow-up, the following parameters were assessed: serum calcium, phosphorus, 25-hydroxyvitamin D, intact parathyroid hormone (iPTH), bone alkaline phosphatase (BALP), osteocalcin, type I collagen N-terminal peptide (NTx), type I collagen C-terminal peptide (CTx), bone mineral density (BMD) of the femoral neck and lumbar spine, coronary artery calcification (CAC) and thoracic aortic calcification (TAC). Bone metabolic and VC indices were compared between the two groups using the independent samples t test and Wilcoxon nonparametric test.

Results

At 52 weeks after enrollment, the iguratimod group had lower osteocalcin (p = 0.010), BALP (p = 0.015), NTx (p = 0.007), CTx (p = 0.012), CAC (p = 0.080) and TAC scores (p = 0.036) than the control group. There was no significant difference in serum calcium, phosphorus, 25-hydroxyvitamin D, iPTH and BMD between the groups. Iguratimod could reduce bone turnover markers (BTMs) at both high and low iPTH levels. The adverse effect of iguratimod was mild and tolerable.

Conclusion

Iguratimod is safe, can reduce BTMs and may could attenuate VC in the first year after KT.

Keywords:

• Kidney transplantation
• iguratimod
• chronic kidney disease
• mineral and bone disorders
• vascular calcification

Disclosure statement

The authors report no conflict of interest.

Statement of Ethics

This study was approved by the Ethics Committee of the First Affiliated Hospital of Nanjing Medical University (2016-SR-029) and has been registered at www.clinicaltrials.gov (NCT02839941). Written informed consent was obtained from all KTRs.

Data availability

Reasonable requests for data will be accommodated by contacting the corresponding author.

Additional information

Funding

This work was supported by the National Natural Science Foundation of China [grant numbers 82170769, 81870512, 82070769, 81770751, 81900684] and Jiangsu Province Capability Improvement Project through Science, Technology and Education ZDXK202219.