Session Information
Date: Monday, November 9, 2015
Session Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment Poster Session II
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose:
SLE is associated with a significantly increased risk of infection. Both disease activity and the medications required to control disease are contributory factors. Rituximab is used in the treatment of SLE patients refractory to standard immunosuppressive therapy. The objective of this analysis is to describe the frequency and pattern of infections associated with Rituximab use in this cohort of SLE patients.
Methods:
Patients with SLE (≥ 4 ACR 1997 criteria) on Rituximab enrolled in the BILAG-BR, a UK, multicentre, prospective study of safety and efficacy of biologics in SLE were analysed. Infection related events were coded using Medra software. Serious infections (SI) were defined as any infection resulting in treatment with iv antibiotics, hospitalisation, disability or death. For the purposes of the study, infections occurring within 9 months of Rituximab were deemed to be therapy related.
Results:
In the period May 2010-March 2015, 208 Rituximab treated patients were followed for a median (IQR) of 1 (0.5-2) yrs. There were 204 infectious episodes observed in 77 (37%) patients, 173 (85%) of which occurred within the 9 month period of interest. 50 patients suffered multiple infections. There were 25 (14%) serious infections in 20 (10%) patients within the 9 month window. The overall and serious infection rates/100 patient years follow up were 57.9 and 8.3 respectively.
The frequency of all infections and SI’s are described in Table 1.The most frequent opportunistic infections reported were Candida (n=8 in 7 patients) and Herpes zoster (shingles) (n=6 in 6 patients).
The highest rate of infections occurred in the first 3 months following treatment with Rituximab: 102 (59%) which declined over time, with 57 (33%) infections occurring between 3 – 6 months and 14 (8%) between 6 – 9 months. A similar trend was noted for SI’s with 14 (56%) occurring within 3 months, 8 (32%) at 3-6 months and 3 (12%) at 6-9 months.
There was a higher number and proportion of non-respiratory infections within the first 3 months post-rituximab (non-respiratory infections: < 3 months = 55/102 (54%) vs 3–9 months = 27/71 (38%), OR 1.9 (95% C.I. 1.03-3.5, p = 0.04). There were no significant differences in individual SI’s across the time points, although the proportion of non-respiratory SIs was also higher in the first 3 months post-rituximab [8/14 (58%) vs 4/11 (36%)].
No infection related deaths were reported.
Conclusion:
An increased number of infections were observed in the first 3 months post-rituximab therapy with a higher proportion of these early infections being non-respiratory in nature. This could be explained by the period of maximum B cell depletion, the effect of concomitant glucocorticoids or the effect of disease activity before maximum efficacy of rituximab. Physicians and patients should have increased vigilance for infection, particularly in the early months following rituximab therapy.
Table 1. Infection rates in Rituximab treated patients.
|
|
|
|
|
|
All infections (% all infections) |
Serious Infections (% total SI) |
|
Total |
173 |
25 |
|
Respiratory |
91 (53) |
14 (52) |
|
Urinary |
30 (17) |
3 (11) |
|
Opportunistic |
15 (9) |
1 (4) |
|
Skin |
10 (6) |
0 (0) |
|
GI |
7 (4) |
4 (15) |
|
Other |
20 (12) |
3 (19) |
To cite this abstract in AMA style:
McCarthy EM, Sutton E, Isenberg DA, Rahman A, Rhodes B, Hewins P, McHugh NJ, Parker B, Griffiths B, Lanyon P, Vital EM, Teh LS, Akil M, Youssef H, D'Cruz DP, Khamashta M, Erb N, Jayne D, Edwards CJ, Prabu A, Batley M, Gendi N, Dasgupta B, Stratton RJ, Yee CS, Zoma A, Gordon C, Chan A, Young Min S, Dubey S, King J, De Lord D, O'Riordan E, Jeffery R, Hassan W, Regan M, Bruce IN. Infections Observed in Rituximab Treated Patients with Refractory Systemic Lupus Erythematosus (SLE): Results from a National Multicentre Register [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/infections-observed-in-rituximab-treated-patients-with-refractory-systemic-lupus-erythematosus-sle-results-from-a-national-multicentre-register/. Accessed February 28, 2021.« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/infections-observed-in-rituximab-treated-patients-with-refractory-systemic-lupus-erythematosus-sle-results-from-a-national-multicentre-register/