Intest Res.  2023 Jan;21(1):88-99. 10.5217/ir.2021.00154.

Incidence rates for hospitalized infections, herpes zoster, and malignancies in patients with ulcerative colitis in Japan: an administrative health claims database analysis

• Matsuoka K
• Togo K
• Yoshii N
• Hoshi M
• Arai S

• KMID: 2539008
• DOI: http://doi.org/10.5217/ir.2021.00154

Abstract

Background/Aims
Patients with ulcerative colitis (UC) are at an increased risk of certain infections and malignancies compared with the general population. Incidence rates (IRs) of hospitalized infections, herpes zoster (HZ), and malignancies in patients with UC, stratified by treatment, in Japan were estimated.
Methods
This retrospective study identified patients with UC treated with corticosteroids, immunosuppressants, or tumor necrosis factor inhibitors (TNFi) from 2 administrative databases (Japan Medical Data Center [JMDC] and Medical Data Vision [MDV]). IRs (unique patients with events per 100 patient‐years) were estimated for hospitalized infections, HZ, and malignancies, between June 2010 and May 2018.
Results
Among 6,033 MDV patients with UC receiving corticosteroids, immunosuppressants, or TNFi, IRs (95% confidence intervals) were: hospitalized infections, 1.73 (1.52–1.93); HZ, 1.00 (0.85–1.16), and malignancies, 1.48 (1.29–1.66). Among 958 JMDC patients with UC receiving corticosteroids, immunosuppressants, or TNFi, IRs (95% confidence intervals) were: HZ, 1.82 (1.27–2.37) and malignancies, 1.35 (0.87–1.82). In both cohorts, IRs of malignancies were generally similar among patients receiving immunosuppressants, TNFi, or combination therapy (immunosuppressants and TNFi); this was also true for IRs of hospitalized infections and HZ in the MDV cohort. IRs of hospitalized infections, HZ, and malignancies were higher in patients receiving calcineurin inhibitors compared with immunosuppressants or TNFi, in both cohorts.
Conclusions
IRs of hospitalized infections, HZ, and malignancies among patients with UC were generally similar regardless of UC treatment, except for calcineurin inhibitors.

Keyword

Colitis, ulcerative; Safety; Infections; Neoplasms

Figure

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  Fig. 1. Selection of patients with ulcerative colitis in the JMDC and MDV databases. CS included prednisolone, prednisolone sodium succinate, prednisolone sodium phosphate, budesonide, triamcinolone acetonide, betamethasone, betamethasone sodium phosphate, methylprednisolone, or methylprednisolone acetate. IM included TAC monohydrate, 6-MP, AZA, or CyA. TNFi included infliximab, adalimumab, or golimumab. Concomitant 5-aminosalicylates were permitted in all groups. Patients could be included in more than 1 group. JMDC, Japan Medical Data Center; MDV, Medical Data Vision; ICD-10, International Classification of Diseases, 10th Revision; CS, corticosteroid; IM, immunosuppressant; TNFi, tumor necrosis factor inhibitor; TAC, tacrolimus; CyA, cyclosporine; 6-MP, 6-mercaptopurine; AZA, azathioprine.

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  Fig. 2. Incidence rates (unique patients with events per 100 patient-years) for hospitalized infections in the MDV database. (A) Hospitalized infection 1 (defined as an infection which results in hospitalization). (B) Hospitalized infection 2 (defined as an infection which results in the most charged medical resource during hospitalization). MDV, Medical Data Vision; CS, corticosteroid; IM, immunosuppressant; TNFi, tumor necrosis factor inhibitor; TAC, tacrolimus; CyA, cyclosporine; 6-MP, 6-mercaptopurine; AZA, azathioprine; n, number of events; PY, patient-years; IR, incidence rate (unique patients with events per 100 PY); CI, confidence interval.

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  Fig. 3. Incidence rates (unique patients with events per 100 patient-years) for herpes zoster in the (A) JMDC database and the (B) MDV database. JMDC, Japan Medical Data Center; MDV, Medical Data Vision; CS, corticosteroid; IM, immunosuppressant; TNFi, tumor necrosis factor inhibitor; TAC, tacrolimus; CyA, cyclosporine; 6-MP, 6-mercaptopurine; AZA, azathioprine; n, number of events; PY, patient-years; IR, incidence rate (unique patients with events per 100 PY); CI, confidence interval.

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  Fig. 4. Incidence rates (unique patients with events per 100 patient-years) for malignancies in the (A) JMDC database and the (B) MDV database. aMalignancy 1 was defined as an ICD-10 code of malignancy (C00–C97 malignant neoplasm or D00–D09 in situ neoplasms) along with a cancer management code (B-001-00-03, B-001-00-18, B-001-00-22, B-001-00-23, B-001-00-24, B-005-06, H-007-02) within the same claim month; bMalignancy 2 was defined as confirmed diagnosis within 2 consecutive claims months. JMDC, Japan Medical Data Center; MDV, Medical Data Vision; ICD-10, International Classification of Diseases, 10th Revision; CS, corticosteroid; IM, immunosuppressant; TNFi, tumor necrosis factor inhibitor; TAC, tacrolimus; CyA, cyclosporine; 6-MP, 6-mercaptopurine; AZA, azathioprine; n, number of events; PY, patient-years; IR, incidence rate (unique patients with events per 100 PY); CI, confidence interval.

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