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Comparative risk of infection in patients with SLE treated with belimumab versus oral immunosuppressants

Aug 21, 2023

Learning objective: After reading this article, learners will be able to cite the comparative risk of infection associated with the initiation of belimumab versus oral immunosuppressants in patients with SLE


Test your knowledge! Take our quick quiz before and after you read this article to find out if you improved your knowledge. Results help us to improve content and continually provide open-access education.

Question 1 of 1

When comparing belimumab with oral immunosuppressants, a retrospective study of 21,481 patient records found that the adjusted cumulative incidence of serious infection in one year with belimumab was:

A

B

C

D

As previously reported on the Lupus Hub, patients with systemic lupus erythematosus (SLE) are at increased risk of serious infection, which is a leading cause of mortality and morbidity for these patients. The risk of infection is primarily attributed to the disease state of SLE, characterized by reduced complement cascade factors and cell surface receptor expression, and poor clearance of immune complexes. Treatment of these patients with immunosuppressants, such as steroid-sparing agents and glucocorticoids, increases the risk of serious infection and hospitalization.

Prior studies have demonstrated an increased risk of infection and hospitalization associated with oral immunosuppressants such as methotrexate, azathioprine, or mycophenolate when compared with hydroxychloroquine. However, the comparative risk of infection with biologic immunosuppressant belimumab versus oral immunosuppressants in patients with SLE is still unknown.

To bridge this knowledge gap, Materne et al.1 recently published an article in Arthritis & Rheumatology comparing the risk of infection with belimumab versus either azathioprine, methotrexate, or mycophenolate in patients with non-renal SLE. Patients were identified from TriNetX, a United States multicenter electronic health record database which includes >90,000 patient records for patients with SLE.

The baseline patient characteristics are presented in Table 1. A total of 21,481 patients with non-renal SLE were included. All covariates were balanced in each comparison after propensity score overlap weighting. The mean age was 45 years and 94% of the patients were female.

Table 1. Baseline patient characteristics*

CKD, chronic kidney disease; ER, emergency room; IQR, interquartile range; SD, standard deviation; SLE, systemic lupus erythematosus.
*Adapted from Materne, et al.1

Characteristic, %
(unless otherwise stated)

Belimumab

(n = 3,955)

Azathioprine

(n = 6,957)

Methotrexate

(n = 8,917)

Mycophenolate

(n = 8,617)

Mean age (SD), years

44.2 (13.2)

44.7 (15.5)

47.5 (14.7)

43.9 (16.1)

Female

95.0

92.0

93.0

88.6

Race/ethnicity

               Asian

2.1

2.3

1.6

3.0

               Black

25.1

32.8

26.3

37.1

               Hispanic

7.5

10.4

8.7

11.7

               Other

7.9

8.0

8.8

8.3

               White

57.4

46.5

54.6

39.8

CKD stage ≥3

12.8

15.6

11.5

23.5

Mean Charlson Comorbidity Index (SD)

0.91 (0.85)

0.98 (1.03)

0.86 (0.98)

1.14 (1.22)

SLE Severity Index

               Mild 

53.7

51.9

65.0

46.5

               Moderate 

32.4

31.9

24.1

34.4

               Severe 

13.9

16.2

10.9

19.1

Medication Use

               Glucocorticoids

61.5

54.9

50.7

54.0

               Hydroxychloroquine

54.2

45.1

45.9

40.5

               Azathioprine

14.8

5.9

11.3

               Belimumab

3.3

2.6

3.4

               Methotrexate

20.3

10.7

8.3

               Mycophenolate

16.3

9.1

5.0

            Other oral             immunosuppressant

9.7

5.7

6.0

3.4

               Rituximab

2.4

1.7

1.2

1.9

               Cyclophosphamide

0.6

1.0

0.5

1.8

Healthcare Utilization

               Median outpatient visits     (IQR)

3 (6)

3 (7)

2 (6)

3 (7)

               ER/Inpatient visits

19.4

25.7

20.9

30.9

Prior hospitalized infection

1.3

3.0

2.2

4.3

We are pleased to present below a visual abstract summarizing the key results.


Visual Abstract

To download this visual abstract, click below.

References

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