1.Risk of Hypocalcemia with Denosumab in Patients with Rheumatoid Arthritis Based on Data From MID-NET® in Japan
Kei SAGAWA ; Atsushi TAKITA ; Takuyuki MATSUMOTO ; Hirokazu TANABE
Japanese Journal of Pharmacoepidemiology 2024;():29.e3-
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.
2.Risk of Hypocalcemia with Denosumab in Patients with Rheumatoid Arthritis Based on Data From MID-NET® in Japan
Kei SAGAWA ; Atsushi TAKITA ; Takuyuki MATSUMOTO ; Hirokazu TANABE
Japanese Journal of Pharmacoepidemiology 2024;29(2):31-42
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.