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Abstract Number: 98

How to Assess Risks for Pulmonary Infection in Patients Receiving Immunosuppressive Treatment for Rheumatic Diseases? A Report From a Large-Scale Prospective Cohort Study

Hayato Yamazaki1, Ryoko Sakai1, Ryuji Koike2, Yasunari Miyazaki3, Michi Tanaka1, Toshihiro Nanki1, Kaori Watanabe1, Shinsuke Yasuda4, Takashi Kurita5, Yuko Kaneko6, Yoshiya Tanaka7, Yasuhiko Nishioka8, Yoshinari Takasaki9, Kenji Nagasaka10, Koichi Amano11, Shigeto Tohma12, Makoto Dohi13, Takahiko Sugihara14, Haruhito Sugiyama15, Yasushi Kawaguchi16, Naohiko Inase17, Sae Ochi18, Hiroyuki Hagiyama19, Nobuyuki Miyasaka20 and Masayoshi Harigai21, 1Department of Pharmacovigilance, Tokyo Medical and Dental University, Tokyo, Japan, 2Clinical Research Center, Tokyo Medical and Dental University, Tokyo, Japan, 3Department of Integrated Pulmonology, Tokyo Medical and Dental University, Tokyo, Japan, 4Division of Rheumatology, Endocrinology and Nephrology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, 5Department of Medicine II, Hokkaido University, Sapporo, Japan, 6Dept of Internal Medicine, Keio Univ School of Medicine, Tokyo, Japan, 7The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, 8Department of Respiratory Medicine & Rheumotology, The Univeristy of Tokushima Graduate School, Tokushima, Japan, 9Internal Medicine and Rheumatology, Juntendo University School of Medicine, Tokyo, Japan, 10Department of Rheumatology, Ome Municipal General Hospital, Ome, Japan, 11Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan, 12Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital, Sagamihara, Japan, 13Department of Allergy and Rheumatology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan, 14Department of Medicine and Rheumatology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan, 15Division of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan, 16Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, 17Dept of Integrated Pulmonology, Tokyo Medical and Dental University, Tokyo, Japan, 18Department of Rheumatology, Tokyo Metropolitan Bokutoh Hospital, Tokyo, Japan, 19Department of Rheumatology, Yokohama-city Bay Red Cross Hospital, Yokohama, Japan, 20Department of Medicine and Rheumatology and Global Center of Excellence Program, Tokyo Medical and Dental University, Tokyo, Japan, 21Dept of Pharmacovigilance, Tokyo Medical and Dental University, Tokyo, Japan

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: corticosteroids, immune response, Infection, pulmonary complications and risk assessment

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Session Information

Title: Epidemiology and Health Services Research: Epidemiology and Outcomes of Rheumatic Disease I

Session Type: Abstract Submissions (ACR)

Background/Purpose: Patients with rheumatic diseases given immunosuppressive therapy are susceptible to various types of infections, especially pulmonary infections that affect their vital prognosis. The aim of this large-scale, multi-center, prospective cohort study was to identify risk factors for development of pulmonary infection in patients receiving immunosuppressive treatment for rheumatic diseases (PREVENT study).

Methods: We enrolled those patients who were admitted to participating hospitals for treatment of rheumatic diseases and started immunosuppressive therapy with corticosteroids, conventional immunosuppressants, or biologics. Observation was stopped either 12 months after enrollment, or the day a patient developed predefined pulmonary infection or was lost-to- follow up, whichever came first. The validity of the diagnosis for pulmonary infection was assessed by an event-monitoring committee. We collected demographic data and clinical data for rheumatic diseases at baseline, data for candidate risk factors for pulmonary infection at baseline and month 6, and usage of drugs throughout the observation period. Risk factors for pulmonary infection were investigated by univariate and multivariate analyses.

Results: Of 766 patients enrolled, 668 patients (87.2%) were observed for 12 months, 32 patients (4.2%) died, and 66 (8.6%) patients were lost-to-follow up by month 12. Sixty-one patients (8.0%) developed pulmonary infection: bacterial pneumonia, 25; Pneumocystis jirovecii pneumonia, 20; fungal pneumonia, 5; cytomegalovirus pneumonia, 3; tuberculosis, 3; others, 5. Kaplan-Meier curves showed a significantly lower cumulative survival rate in patients with pulmonary infection compared to those without pulmonary infection (p<0.01, log-rank test). Because treatment for RA patients without active extra-articular manifestation (articular RA patients, n=145) was significantly different from that for the rest of the patients, we performed multivariate analyses using COX hazard regression models in all patients (n=766) and in these patients excluding articular RA patients (n=621) (Table 1). Older age (≥65 years-old), higher Brinkman index (≥400), higher serum creatinine (sCr) level, and higher maximum prednisolone dose (mg/kg/day) during the first two weeks of treatment were significantly associated with development of pulmonary infection in all patients. Older age, higher Brinkman index, higher sCr level, and disturbed performance status were significantly associated with development of pulmonary infection in patients excluding articular RA patients.

Conclusion: This is the first large-scale, prospective study identifying risk factors for pulmonary infection in patients with rheumatic diseases in the literature. Prophylactic measures should be taken accordingly for better benefit-risk balance of treatment.

 


Disclosure:

H. Yamazaki,
None;

R. Sakai,
None;

R. Koike,
None;

Y. Miyazaki,
None;

M. Tanaka,
None;

T. Nanki,
None;

K. Watanabe,
None;

S. Yasuda,
None;

T. Kurita,
None;

Y. Kaneko,
None;

Y. Tanaka,

Bristol-Myers Squibb KK,

2,

MSD KK,

2,

Chugai Pharmaceutical ,

2,

Mitsubishi Tanabe Pharma,

2,

Astellas Pharma ,

2,

Abbot Japan ,

2,

Eisai,

2,

Janssen Pharmaceutical KK,

2,

Mitsubishi Tanabe Pharma ,

8,

Abbot Japan ,

8,

Chugai Pharmaceutical ,

8,

Janssen Pharmaceutica KK,

8,

Santen Pharmaceutical ,

8,

Pfizer Japan ,

8,

Astellas Pharma ,

8,

Daiichi Sankyo ,

8;

Y. Nishioka,

Chugai Pharmaceutical,

2,

Pfizer Japan,

2,

Abbott Japan,

2,

Baistol-Myers Squibb KK,

2;

Y. Takasaki,
None;

K. Nagasaka,
None;

K. Amano,

Chugai Pharmaceutical ,

2,

Abbott Japan ,

2,

Astellas Pharmaceutical ,

2;

S. Tohma,

Pfizer Japan,

2,

Eisai,

2,

Chugai Pharmaceutical,

2;

M. Dohi,
None;

T. Sugihara,
None;

H. Sugiyama,
None;

Y. Kawaguchi,
None;

N. Inase,
None;

S. Ochi,
None;

H. Hagiyama,
None;

N. Miyasaka,

Abbot Japan,

2,

Astellas Pharma,

2,

Chugai Pharmaceutical,

2,

Daiichi Sankyo,

2,

Eisai,

2,

Janssen Pharmaceutical KK,

2,

Mitsubishi Tanabe Pharma,

2,

Taketa Pharmaceutical ,

2,

Teijin Pharma,

2,

Bristol-Myers Squibb KK,

2;

M. Harigai,

Abbott Japan,

2,

Astellas Pharma,

2,

Bristol Myers Squibb KK,

2,

Chugai Pharmaceutical,

2,

Eisai,

2,

Janssen Pharmaceutical KK,

2,

Micsubishi Tanabe Pharma,

2,

Santen Pharmaceutical,

2,

Takeda Pharmaceutical,

2,

Pfizer Japan,

2.

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