Association between roxadustat use and suppression of thyroid function: a systematic review and meta-analysis

Table 1 Summary of included studies

Author/Year	Country	Study design	Roxadustat dose	Comparator dose	The number of patients (hypothyroidism or suppression of thyroid function) with roxadustat vs. comparator	Population	Follow-up period
Comparator: Placebo
Besarab et al. (2015) [21]	United States	RCT (Single-blind)	0.7–2.0 mg/kg/day	Placebo	88 (1) vs. 28 (0)	NDD-CKD	4 weeks
Coyne et al. (2020) [22]	United States	RCT (Double-blind)	70 mg/day (45–70 kg) or 100 mg/day (≥ 70 kg)^a TIW	Placebo	616 (0) vs. 306 (1)	NDD-CKD	1.4 years
Comparator: ESA
Charytan et al. (2021) [23]	United States	RCT (Open-label)	70–200 mg/day TIW^a	Epoetin alfa 6000–16000 IU/week^a	370 (1) vs. 370 (0)	DD-CKD	1–3 years
Fishbane et al. (2022) [24]	United States	RCT (Open-label)	70 mg (45–70 kg) or 100 mg (> 70–160 kg) TIW^a	Epoetin alfa 50 IU/kg TIW^a	1048 (1) vs. 1053 (0)	DD-CKD	1.8 years
Zheng et al. (2023) [25]	China	Observational study	Standard doses^b	rHuEPO standard doses^c	50 (36) vs 60 (21)	NDD- or DD-CKD	1 year
Cheng et al. (2023) [26]	China	Observational study	Standard doses^b	rHuEPO standard doses^c	76 (37) vs 75 (7)	NDD- or DD-CKD	0.25–1.25 year

Hypothyroidism in RCTs was identified from the results sections and supplementary materials of the included studies [21,22,23,24]. For observational studies, suppression of thyroid function was identified based on a decrease in TSH, FT3, or FT4 [25], or a ≥ 50% decrease in TSH [26]
DD-CKD, dialysis-dependent (hemodialysis or peritoneal dialysis) chronic kidney disease; ESA, erythropoiesis-stimulating agent; NDD-CKD, non-dialysis-dependent chronic kidney disease; RCT, randomized controlled trial; rHuEPO, recombinant human erythropoietin; TIW, thrice weekly
^aIt was equal to or equivalent to the pretrial dose and the dose was subsequently adjusted according to an algorithm
^bStandard doses in China are 100 mg (45–60 kg) or 120 mg (≥ 60 kg) for DD-CKD and 70 mg (45–60 kg) or 100 mg (≥ 60 kg) for NDD-CKD, three times a week. Moreover, the maximum dose is 2.5 mg/kg/dose
^cThe standard dose of rHuEPO in China is 100–150 IU/kg/week in DD-CKD and 75–100 IU/kg/week in NDD-CKD. The dose can be increased to 30 IU/kg/week for epoetin alfa and 60–240 IU/kg/week for epoetin beta

ISSN: 2055-0294