Risk of Hypocalcemia with Denosumab in Patients with Rheumatoid Arthritis Based on Data From MID-NET® in Japan
- VernacularTitle:Risk of Hypocalcemia with Denosumab in Patients with Rheumatoid Arthritis Based on Data From MID-NET® in Japan
- Author:
Kei SAGAWA
1
;
Atsushi TAKITA
2
;
Takuyuki MATSUMOTO
1
;
Hirokazu TANABE
1
Author Information
- Keywords: denosumab; hypocalcemia; Japanese; rheumatoid arthritis; MID-NET®
- From:Japanese Journal of Pharmacoepidemiology 2024;29(2):31-42
- CountryJapan
- Language:English
- Abstract: Objective: To evaluate the real-world risk of hypocalcemia in Japanese patients with rheumatoid arthritis (RA) receiving disease-modifying antirheumatic drugs (DMARDs) newly initiated on denosumab (PRALIA®) versus those receiving DMARDs alone.Design: Observational cohort study utilizing data obtained from the Medical Information Database Network (MID-NET®) in Japan.Methods: Patients were eligible if they had a prescription record for any DMARD during the study period (July 2016-December 2020), with their RA diagnosis ＜30 days before the date of DMARD prescription. Primary and secondary outcomes included the incidence of hypocalcemia (serum calcium level ＜8.50 mg/dL), and severe hypocalcemia (serum calcium level ＜7.00 mg/dL), respectively. Data was classified according to denosumab-exposure versus non-exposure, with outcomes assessed during the follow-up period. Results: Overall, 4,222 patients (denosumab-exposed patients: N＝293; non-exposed patients: N＝3,929) met the study criteria. Hypocalcemia occurred in 4.8％（95％CI: 2.6-7.9) of denosumab-exposed patients and 1.0％（95％CI: 0.7-1.4) of non-exposed patients, for an adjusted risk ratio (RR) of 1.67（95％CI: 0.90-3.10).Conclusion: The incidence of hypocalcemia was increased in denosumab-exposed patients compared with non-exposed patients with RA in this observational study utilizing data from MID-NET®. As the adjusted RR of hypocalcemia with denosumab was modest, current risk management strategies outlined in the package insert are appropriate.
