Session Information
Session Type: Abstract Submissions (ACR)
Prolonged improvement of systemic lupus erythematosus following systematic administration of rituximab and cyclophosphamide.
Background/Purpose: We report sustained improvement in 15 patients with corticosteroid dependent SLE who received a systematic regimen of rituximab and cyclophosphamide administered at months 0, 6, and 18. All patients had active SLE despite prior therapy. Five patients were male and 10 were female. Seven patients had biopsy proven DPGN. Three patients were Hispanic, 5 were Asian, 1 African American, and 6 Caucasian. All experienced a marked and sustained reduction in their corticosteroid dose with improvement in C3, C4, Hb, ESR, Cr, serum albumin and SLEDAI which persisted at 60 months following initiation of therapy (42 months following the last dose of these medications).
Methods: All patients received rituximab 750 mg/m2 (max 1 gram) on day 1 and cyclophosphamide 750 mg/m2 on day 2. This regimen was repeated on days 15 and 16. All patients received a further two doses of rituximab and cyclophosphamide at month 6 and two doses at month18. Patients with active DPGN received additional doses of cyclophosphamide (750 mg/ m2) at 6, 10, 14, and 18 weeks. The prednisone dosage was gradually decreased at the discretion of the treating physician. Because the data were nonparametric Wilcoxon signed rank tests were used for all statistical comparisons.
Results: Significant improvement occurred in prednisone dose, C3, C4, Hb, ESR, Cr, serum albumin and SLEDAI which persisted (see chart). No patient experienced a disease flare requiring hospitalization. The mean SLEDAI score decreased from 8.929 to 1.917 after the first six months of therapy and remained low thereafter. Four patients are known to be ANA negative at month 36 following the initiation of treatment.
|
|
N = 15 |
N = 15 |
N = 15 |
N = 13 |
N = 9 |
|
|
Month 0 |
Month 12 |
Month 24 |
Month 36 |
Month 60 |
|
Prednisone dose (mg daily) |
29.10 + 21.88 |
14.74*** + 7.35 |
10.43*** + 3.518 |
8.409** + 2.567 |
8.5** + 4.802 |
|
C3 (mg/dl) |
60.78 + 26.55 |
105.8*** + 32.74 |
108.3*** + 30.50 |
117.2** + 23.50 |
105.6** + 16.56 |
|
C4 (mg/dl) |
10.61 + 5.807 |
21.57*** + 9.832 |
22.85*** + 9.584 |
24.86*** + 10.80 |
24.40* + 8.876 |
|
HGB (g/dl) |
11.43 + 1.958 |
12.44*** + 1.588 |
12.76*** + 1.372 |
12.68** + 1.696 |
13.24** + 1.459 |
|
ESR (mm/hr) |
39.40 + 25.87 |
19.60*** + 21.73 |
16.67*** + 18.00 |
11.08** + 13.10 |
15* + 16.07 |
|
Cr (mg/dl) |
0.8067 + 0.2120 |
0.8143*** + 0.1994 |
0.7933*** + 0.1672 |
0.7683** + 0.1938 |
0.7100** + 0.1115 |
|
Alb (mg/dl) |
3.336 + 0.8545 |
4.107*** + 0.4148 |
4.080*** + 0.5784 |
4.254** + 0.4294 |
4.289** + 0.4197 |
|
WBC (/nl) |
9.049 + 7.149 |
7.558*** + 3.237 |
8.101*** + 2.801 |
7.402*** + 1.877 |
6.550** + 1.907 |
* 0.01 < p ≤ 0.05
** 0.001< p ≤ 0.01
*** p≤ 0.001
Conclusion: A specific 18 month regimen of systematically administered cyclophosphamide and rituximab led to sustained improvement in prednisone dosage, C3, C4, Hb, ESR, Cr, serum albumin and SLEDAI which persisted at 60 months following initiation of therapy which was maintained 42 months following the completion of therapy.
Disclosure:
T. J. A. Lehman,
Genentech and Biogen IDEC Inc.,
5;
E. Baird,
None;
A. Ramanathan,
None;
R. Alperin,
None;
E. J. MacDermott,
None;
A. B. Adams,
None;
L. V. Barinstein,
None;
L. N. Moorthy,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/prolonged-improvement-of-systemic-lupus-erythematosus-following-systematic-administration-of-rituximab-and-cyclophosphamide/