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Abstract Number: 621

Prolonged Improvement of Systemic Lupus Erythematosus Following Systematic Administration of Rituximab and Cyclophosphamide

Thomas J. A. Lehman1, Emily Baird2, Anusha Ramanathan3, Risa Alperin3, Emma J. MacDermott3, Alexa B. Adams3, Laura V. Barinstein3 and Lakshmi N. Moorthy4, 1Chief Div Ped Rheum PTD, Hosp for Special Surgery, New York, NY, 2Hospital for Special Surgery, NY, 3Pediatric Rheumatology, Hospital for Special Surgery, New York, NY, 4Pediatric Rheumatology, Robert Wood Johnson Medical School-Rutgers University, New Brunswick, NJ

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: B cells, remission, rituximab and systemic lupus erythematosus (SLE)

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Session Information

Title: Systemic Lupus Erythematosus: Clinical Aspects

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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