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Research article
Yuichi Ishikawa
University of Occupational and Environmental Health, Japan
Corresponding Author
ORCiD: https://orcid.org/0000-0001-7406-2309
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Background: Infection is a major cause of mortality in patients with systemic lupus erythematosus (SLE). Therefore, minimizing the risk of infection is an important clinical goal to improve the long-term prognosis of SLE patients. Treatment with ≥7.5 mg prednisolone (PSL) or equivalent has been reported to increase the risk of infections. However, it remains unclear whether <7.5 mg PSL or equivalent dose affects the risk of infection in SLE patients. This study evaluated the association between the occurrence of infection in patients with SLE and low-dose glucocorticoids (GC) usage, especially <7.5 mg PSL or equivalent, to explore the GC dose that could reduce infection occurrence.
Methods: This prospective cohort study included patients from the Japanese multicenter registry of patients with SLE (defined as ≥4 American College of Rheumatology 1997 revised criteria) over 20 years of age. The PSL dose was categorized as PSL 0‒2.5, 2.6‒5.0, 5.1‒7.5, and 7.6‒15.0 mg. The primary outcome was infection requiring hospitalization. We conducted a multivariable analysis using time-dependent Cox regression analysis to assess the hazard ratio of infection occurrence compared with a dose of 0‒2.5 mg PSL or equivalent in the other three PSL dose groups. Based on previous reports and clinical importance, the covariates selected were age, sex, and concurrent use of immunosuppressants with GC. In addition, two sensitivity analyses were conducted.
Results: The mean age of the 509 SLE patients was 46.7 years; 89.0% were female, and 77.2% used multiple immunosuppressants concomitantly. During the 1-year observation period, infection requiring hospitalization occurred in 52 patients. The incidence of infection with a PSL dose of 5.0‒7.5 mg was significantly higher than that in the PSL 0–2.5 mg group (adjusted hazard ratio: 6.80, 95% confidence interval: 2.17‒21.27). The results of the two sensitivity analyses were similar.
Conclusions: Our results suggested that the use of 5.0‒7.5 mg PSL or equivalent could pose an infection risk in SLE patients. This finding indicated that PSL dose should be reduced to as low as possible in SLE patients to avoid infection.
Keywords
glucocorticoids, infection, prospective cohort study, systemic lupus erythematosus
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This preprint is under consideration at Arthritis Research & Therapy. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Yuichi Ishikawa
University of Occupational and Environmental Health, Japan
Corresponding Author
ORCiD: https://orcid.org/0000-0001-7406-2309
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 28 Oct, 2021
No community comments so far
Reviews received
Received 22 Nov, 2021
Reviewers invited
Invitations sent on 11 Nov, 2021
Editor assigned
On 25 Oct, 2021
Submission checks complete
On 24 Oct, 2021
Editor invited
On 24 Oct, 2021
First submitted
On 22 Oct, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Infection is a major cause of mortality in patients with systemic lupus erythematosus (SLE). Therefore, minimizing the risk of infection is an important clinical goal to improve the long-term prognosis of SLE patients. Treatment with ≥7.5 mg prednisolone (PSL) or equivalent has been reported to increase the risk of infections. However, it remains unclear whether <7.5 mg PSL or equivalent dose affects the risk of infection in SLE patients. This study evaluated the association between the occurrence of infection in patients with SLE and low-dose glucocorticoids (GC) usage, especially <7.5 mg PSL or equivalent, to explore the GC dose that could reduce infection occurrence.
Methods: This prospective cohort study included patients from the Japanese multicenter registry of patients with SLE (defined as ≥4 American College of Rheumatology 1997 revised criteria) over 20 years of age. The PSL dose was categorized as PSL 0‒2.5, 2.6‒5.0, 5.1‒7.5, and 7.6‒15.0 mg. The primary outcome was infection requiring hospitalization. We conducted a multivariable analysis using time-dependent Cox regression analysis to assess the hazard ratio of infection occurrence compared with a dose of 0‒2.5 mg PSL or equivalent in the other three PSL dose groups. Based on previous reports and clinical importance, the covariates selected were age, sex, and concurrent use of immunosuppressants with GC. In addition, two sensitivity analyses were conducted.
Results: The mean age of the 509 SLE patients was 46.7 years; 89.0% were female, and 77.2% used multiple immunosuppressants concomitantly. During the 1-year observation period, infection requiring hospitalization occurred in 52 patients. The incidence of infection with a PSL dose of 5.0‒7.5 mg was significantly higher than that in the PSL 0–2.5 mg group (adjusted hazard ratio: 6.80, 95% confidence interval: 2.17‒21.27). The results of the two sensitivity analyses were similar.
Conclusions: Our results suggested that the use of 5.0‒7.5 mg PSL or equivalent could pose an infection risk in SLE patients. This finding indicated that PSL dose should be reduced to as low as possible in SLE patients to avoid infection.
Figure 1
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