Abstract

Immune check inhibitors (iri) are currently one of the main drug treatment for lung cancer. However, it has been reported that immune-related adverse events unique to iri often occur. The purpose of this study was to investigate the number of irAE cases and the distribution of days of irAE onset in lung cancer based on Claims Data in Japan. We used data from 12346 patients(M:9500,F:2846) who received iri were used from Medical Data Vision data, mainly at DPC(Diagnosis Procedure Combination) hospitals. Using the three digits of the ICD10 code, the disease that first appeared after iri administration was extracted. The diseases targeted were relatively high incidence, interstitial lung disease(J84), thyroid dysfunction(E03, 05, 06, 07), and tuberculosis(A16), pituitary disorders(E22, E23) and type 1 diabetes(E10) that were added to the package insert after release. The number of patients expressing the disease and the average value and median of the number of days until expression of disease were calculated. The results of the major irAEs are as follows: Interstitial pneumonia(J84:1049 cases(8.4% occurrence rate), average onset day 161.19 days(median onset day 91 days)), thyroid dysfunction(E03:1335(10.81%), 96.56(45), E05:321(2.6), 96.56(45), E06:219(1.77), 101.05(63), E07:242(1.96), 113.88(51)). Diseases that have been added to the package insert as serious side effects are as follows: Tuberculosis (A16:54(0.44), 215.81(129)), type 1 diabetes(E10:46(0.37), 190.2(137)), pituitary abnormality(E22:47(0.38), 209.17(139), E23:176(1.43), 185.9(144.5)). Approximately 10% of cases of interstitial pneumonia and hypothyroidism were observed as in previous reports. In particular, thyroid dysfunction was observed relatively earlier from the median date of onset, suggesting that it is necessary to watch closely immediately after iri administration. With regard to tuberculosis, type 1 diabetes, and pituitary abnormalities, the incidence rate was 1% or less, and the timing of occurrence was various.

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