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Comparative risk of infection in patients with SLE treated with belimumab versus oral immunosuppressants
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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*
|
Characteristic, % |
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 |
|
CKD, chronic kidney disease; ER, emergency room; IQR, interquartile range; SD, standard deviation; SLE, systemic lupus erythematosus. |
||||
We are pleased to present below a visual abstract summarizing the key results.
- Materne E, Choi H, Zhou B, et al. Comparative risks of infection with belimumab versus oral immunosuppressants in patients with non-renal systemic lupus erythematosus. Arthritis Rheumatol. 2023. Online ahead of print. DOI: 1002/art.42620
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