TARPEYO: established safety profile1
The majority of adverse reactions were mild or moderate1
Adverse reactions occurring in ≥5% of patients treated with TARPEYO + RASi and ≥2% higher than patients treated with RASi alone1*
- Incidence of TESAEs with TARPEYO + RASi vs RASi alone was (9% vs 5%)2*
- 4 patients (2%) in both treatment groups had TESAEs considered treatment-related2*
- <10% of patients treated with TARPEYO + RASi discontinued due to TEAEs (9% vs 2%)2*
- High rate of study completion: 87% of patients treated with TARPEYO + RASi completed 9 months of treatment similar to 91% of patients on RASi alone3†
- Low rate of severe infections requiring hospitalization2,3
- 3 (1.5%) in TARPEYO + RASi treatment group vs 1 (0.5%) in RASi-alone group2*
- Most adverse reactions occurring at a greater incidence in the TARPEYO + RASi group were consistent with hypercortisolism and resolved within 3 months after discontinuation1
- Incidence of infections was comparable between treatment groups: TARPEYO + RASi (37.4%); RASi alone (33.5%)2
*Safety updated based on NefIgArd Safety Analysis Set, which included data from all patients who received ≥1 dose of study drug. In the global study, an additional 29 patients were enrolled in China for regulatory requirements after global recruitment had ended. ADRs or ARs were reported in the placebo-controlled 9-month treatment period until 14 days after completion of the tapering period.2 †Data based on FAS of 364 patients.1
ADR=adverse drug reaction; AR=adverse reaction; RASi=renin-angiotensin system inhibitor; TEAE=treatment-emergent adverse event; TESAE=treatment-emergent serious adverse event.
No clinically relevant differences between treatment groups in blood pressure, body weight, HbA1c, or creatinine excretion observed3
BLOOD PRESSURE2*
Median changes in systolic and diastolic blood pressure were small and resolved to baseline levels within 3 months after the end of treatment
WEIGHT2*
Median change in body weight from baseline did not exceed 2.2 lbs and returned to baseline within 3 months after the end of treatment
HbA1c2,3†
Generally unchanged throughout treatment. Increases in HbA1c observed during treatment generally resolved after the end of treatment
SKELETAL2‡
No new osteonecrosis events observed
NO REMS1
TARPEYO is not subject to an FDA-required REMS program. No FDA-mandated drug monitoring beyond usual care
*Small increases from baseline in median systolic and diastolic blood pressure observed with TARPEYO compared with placebo were not clinically relevant, and resolved to levels similar to baseline within 3 months of the end of treatment. Similarly, small increases in median body weight were seen during TARPEYO treatment that were not clinically relevant and returned to baseline within 3 months of the end of treatment.2 †A small numerical increase in median HbA1c levels was observed during TARPEYO treatment, with some outliers evident. Increases occurred in a few TARPEYO-treated patients with a diabetes diagnosis pre-enrollment or with baseline values indicative of pre-diabetes per ADA-defined thresholds (HbA1c 5.7% or FBG 100 mg/dL).2 ‡During the 15-month observational follow-up, there were 3 confirmed fractures in the TARPEYO group and 2 confirmed fractures in the RASi-alone group that were considered not treatment related.2
FBG=fasting blood glucose; HbA1c=hemoglobin A1c; REMS=Risk Evaluation and Mitigation Strategy.
REFERENCES: 1. TARPEYO. Prescribing Information. Calliditas Therapeutics AB; June 2024. 2. Data on file. Part B. Calliditas Therapeutics AB. 3. Lafayette R, Kristensen J, Stone A, et al. Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomized phase 3 trial. Lancet. 2023;402(10405):825-936. http://doi.org/10.1016/S0140-6736(23)01554-4