What is the clinical evidence from this study?

Study design: Observational. Population: Olaparib-related anemia (n=7993). Intervention: Daily olaparib dose per body weight ≥ 12 mg/kg vs. Daily olaparib dose per body weight < 12 mg/kg. Primary outcome: Occurrence of olaparib-related anemia (aROR 4.483, 95% CI 3.009-6.680, p=<0.001).

October 11, 2022Open Access

Analysis of clinical factors in olaparib-related anemia using adverse drug event reporting databases

Q: What are the key findings of this study?

A daily olaparib dose per body weight of ≥12 mg/kg was significantly associated with an increased risk of anemia occurrence in the FAERS database (aROR 4.483).

Resultado clave

A daily olaparib dose per body weight of ≥12 mg/kg was significantly associated with an increased risk of anemia occurrence in the FAERS database (aROR 4.483).

Diseño del estudio

Tipo

Observational (n=7,993)

PICO estructurado

What are the clinical risk factors for olaparib-related anemia in real-world settings?

Población

7,993 adverse event reports of patients receiving olaparib from the FAERS and JADER databases between 2018 and 2021, analyzed to identify risk factors for olaparib-related anemia.

Exposición

Olaparib (evaluating risk factors such as daily dose per body weight ≥12 mg/kg, concomitant drugs, and previous platinum treatment)

Comparador

Reports of other adverse events (no anemia) during olaparib administration

Resultado

Occurrence of olaparib-related anemiasafety

High daily olaparib dose per body weight, concomitant use of drugs suppressing vitamin B12, and previous platinum treatment history significantly increase the risk of olaparib-related anemia.

Resultado numérico

Odds Ratio: 4.483 (95% CI 3.009–6.68)

valor p: p=<0.001

Limitaciones

Spontaneous adverse event reports could not be collected systematically.
Causality between events and medications is uncertain.
Incomplete laboratory data.
Information regarding the concomitant use of drugs that potentially interact with olaparib was lacking.
Could not evaluate renal and liver functions as risk factors due to lack of clinical laboratory data.
The severity of anemia events was not evaluated.

Resumen

Abstract Purpose: Anemia is one of the dose-limiting toxicities of olaparib. The global phase Ⅲ trial confirmed that anemia occurrence in Japanese was relatively high. The factors related to anemia in different nationalities remain unknown. Therefore, this study investigated the factors of olaparib-related anemia in real-world settings using an adverse event reporting system database. Methods: We used data from FDA Adverse Events Reporting System (FAERS) and Japanese Adverse Drug Event Report database (JADER) between 2018 and 2021. FAERS reports from Japan were collected to conduct subgroup analyses, which was defined as FAERS-Japan. The endpoint was the occurrence of olaparib-related anemia. Disproportionality analysis was conducted to calculate reporting odds ratio (ROR), with a confidence interval of 95%. Adjusted ROR (aROR) was calculated to control for gender differences. Results: In FAERS and JADER, the daily olaparib dose per body weight (DPBW) ≥12 mg/kg was detected to be a positive signal for anemia occurrence (aROR; FAERS, 4.483 3.009–6.680, p<0.001, FAERS-Japan, 1.834 1.091–3.063, p=0.009, and JADER, 1.628 1.039–2.551, p=0.034). Furthermore, FAERS reports confirmed that females with body weight <50kg, reports from Japan, concomitant use of drugs suppressing vitamin B 12 , and previous platinum treatment history were positive signals of olaparib-related anemia. FAERS-Japan also showed that body weight <50kg and previous platinum treatment history were positive signals for the anemia occurrence. Conclusion: High DPBW poses a significant risk of anemia. The co-administration of drugs suppressing vitamin B 12 and previous platinum treatment history are also important information to evaluate the risk of olaparib-related anemia.

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