Session Information
Session Title: Systemic Lupus Erythematosus - Clinical Aspects and Treatment: Treatment and Management Studies
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Published efficacy data for rituximab in SLE are complex with positive single-centre case series and negative randomised controlled trials. This may be due to heterogeneity of SLE or the populations, design and endpoints of trials. The BILAG Biologic Registry (BILAG BR) is a national, multicentre, prospective study of safety and efficacy of biologics in SLE patients refractory to standard immunosuppressive therapy. The objective of the present analysis was to describe clinical response to rituximab at three and six-months post therapy.
Methods:
Patients with SLE (≥ 4 ACR 1997 criteria), ≥ 5 years old, refractory to conventional therapy and newly starting treatment with rituximab, from centres across the UK, were recruited into the BILAG BR. A comprehensive questionnaire collected information on concomitant medications, risk factors for infection, co-morbidities and SLE disease duration. Disease activity was measured using the BILAG 2004 Index and the SLEDAI2K at treatment initiation, 3 and 6 months post therapy.
Results:
Baseline, 3 and 6 month disease activity were collected for 80 patients (92.5% women) starting therapy with rituximab. The cohort included 44 (60.3%) white British patients. The median (interquartile range [IQR]) age and disease duration at baseline were 39.5 years (IQR 30.0, 47.3) and 5.7 years (IQR 2.5, 11.6) respectively. The most commonly involved BILAG 2004 index systems were mucocutaneous (33 [41.25%]), renal (28 [35.0%]) and musculoskeletal (25 [31.0%]). The baseline SLEDAI2K was 8 (IQR 4, 13.5). At 3 months follow-up, 47 (58.75%) patients showed an improvement in their overall BILAG 2004 index, 16 (20.0%) had persisting active disease and 12 (15.0%) had deteriorating disease. The majority of patients (11/12 [91.7%]) who deteriorated, did so in one system only. In the same follow-up period, 56 (70.0%) had an improved SLEDAI2K, 15 (18.75%) had no change and 9 (11.25%) worsened. Data at 6 months showed 39 (48.75%) with improvement, 18 (22.5%) with persistent disease and 16 (20.0%) deteriorating. In addition, there was a trend towards steroid dose being reduced over the 6 month period (Table 1).
Conclusion:
There was variability in the degree of response to rituximab with respect to both the magnitude and duration of response, in this cohort of SLE patients refractory to standard immunosuppression. Although nearly half of the cohort demonstrated significant reduction in disease activity across all systems at 6 months, there was a sub-group that worsened in either the original system involved, or developed activity in a new system. This may be explained some patients who initially responded to rituximab at 3 months, beginning to flare by 6 months post therapy. Further analysis will attempt to identify predictors of response in this cohort.
Table 1:
|
N = 80 unless otherwise stated |
N (%) |
|
|
Baseline Characteristics |
|
|
|
Female |
74 (92.5) |
|
|
Ethnicity (n = 73) |
|
|
|
White British / other white |
44 (60.3) |
|
|
Indian / Pakistani / Bangladeshi |
10 (13.7) |
|
|
African Ancestry |
10 (13.7) |
|
|
Mixed (white/Caribbean) / other mixed |
9 (12.3) |
|
|
BILAG 2004 Index score at baseline (n = 80) |
|
|
|
≥1 A score and/or ≥2 B score |
55 (68.8) |
|
|
|
median (IQR) |
|
|
Age at diagnosis (years) |
30.0 (18.4, 40.2) |
|
|
Age at baseline (years) |
39.5 (30.0, 47.3) |
|
|
Disease duration at baseline (years) |
5.7 (2.5, 11.6) |
|
|
Prednisolone dose at baseline (mg/day) (n = 70) |
10 (8.0, 22.5) |
|
|
Number of previous immunosuppressant therapies at baseline (n = 78) |
2 (1, 3) |
|
|
Baseline SLEDAI 2K score |
8 (4, 13.5) |
|
|
Baseline SLICC / ACR Damage Index (n=64) |
0 (0, 1) |
|
|
Patient Follow-up |
|
|
|
BILAG 2004 Index |
3M: N (%) |
6M: N (%) |
|
Improvement [All As to B/C/D; all Bs to C/D (allowing for 1≤B persisting)] |
47 (58.75) |
39 (48.75) |
|
Persistent active disease [Any system still A or 2Bs as per previous time point] |
16 (20.0) |
18 (22.5) |
|
Deterioration [Any system to A from B/C/D or to B from C/D] |
12 (15.0) |
16 (20.0) |
|
No Change / Inactive [Stable C/D/E with no new A or B] |
5 (6.25) |
7 (8.75) |
|
SLEDAI2K (n=80) |
3M |
6M |
|
Score at follow-up [median (IQR)] |
4 (2, 6.5) |
4 (2, 7) |
|
Improve: N (%) |
56 (70.0) |
56 (70.0) |
|
Persist: N (%) |
15 (18.75) |
13 (16.25) |
|
Worsen: N (%) |
9 (11.25) |
11 (13.75) |
|
|
|
|
|
Prednisolone dose at follow-up (mg/day) [median (IQR)] |
10 (5, 13.75) |
8.5 (5, 12.5) |
Disclosure:
E. Sutton,
Roche Pharmaceuticals,
2,
GlaxoSmithKline,
2;
K. D. Watson,
None;
D. A. Isenberg,
Merck Serono,
5,
Eli Lilly and Company,
5,
UCB,
5;
A. Rahman,
None;
D. Jayne,
Roche/Genentech,
5,
Roche/Genentech,
2;
C. Gordon,
Merck Serono, UCB Pharma, Bristol-Myers Squibb, GlaxoSmithKline, MedImmune,
5,
Amgen, Roche,
9;
B. Parker,
None;
D. P. D’Cruz,
GlaxoSmithKline, Roche and Lilly,
5;
M. A. Khamashta,
None;
P. Lutalo,
None;
P. Lanyon,
Eli Lilly and Company,
9;
B. Rhodes,
None;
B. Griffiths,
None;
E. M. Vital,
Roche Pharmaceuticals,
8,
GSK,
8,
NIHR clinician scientist fellowship,
2;
C. S. Yee,
None;
C. Edwards,
Celgene Corporation, Pfizer Inc, Roche, and Samsung,
2,
Celgene Corporation, Pfizer Inc, Roche, and Samsung,
5,
Abbott, Glaxo-SmithKline, Pfizer Inc, and Roche,
8;
M. Akil,
None;
N. Erb,
None;
A. Prabu,
None;
A. A. Zoma,
None;
N. McHugh,
None;
H. Youssef,
None;
L. S. Teh,
None;
M. W. Beresford,
None;
I. N. Bruce,
None.
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