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Abstract Number: 596

Extended Follow-Up Of a Investigator-Initiated  trial Comparing Two Sequential Induction and Maintenance Treatment Regimens For Proliferative Lupus Nephritis Based Either On Cyclophosphamide Or Cyclosporine A

Jakub Zavada1, Satu Pesickova2, Romana Rysava3, Pavel Horak4, Zbynek Hrncir5, Jozef Rovensky6, Jozef Lukac7, Jirina Vitova8, Jana Böhmova9, Marta Olejarova10, Dana Tegzova11 and Vladimir Tesar12, 1Charles University, Prague, Czech Republic, 2Nephrology, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic, 3General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic, 43rd Department of Internal Medicine, 3rd Department of Internal Medicine University Hospital Olomouc, Olomouc, Czech Republic, 52nd Department of Medicine, Faculty of Medicine and University Hospital, Hradec Kralove, Czech Republic, 6PRINTO, Genoa, Italy, 7National Institute of Rheumatology, Piestany, Slovakia, 8Hospital, Ceske Budejovice, Czech Republic, 9Faculty Hospital St. Anna, Brno, Czech Republic, 10Institute of Rheumatology, Prague, Prague, Czech Republic, 11Institute of Rheumatology, Prague, Czech Republic, 12Department of Nephrology, General University Hospital and First Faculty of Medicine, Charles University, Prague, Czech Republic

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: cyclophosphamide, cyclosporine and lupus nephritis

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Session Information

Title: Systemic Lupus Erythematosus - Clinical Aspects I - Renal, Malignancy, Cardiovascular Disease

Session Type: Abstract Submissions (ACR)

Background/Purpose:

In the investigator-initiated CYLOFA-LUNE trial we tested the hypothesis that immunosuppressive regimen based on Cyclosporine A (CYA) may have similar efficacy but greater safety than that based on cyclophosphamide (CPH). 

CYCLOFA-LUNE TRIAL
a multicenter, randomized, open-label, controlled trial
conducted from January 2002 through December 2006 in 7 centers in Czech Republic and one center in Slovakia
Eligibility criteria:
•The diagnosis of systemic lupus erythematosus (by meeting 4 criteria of the American College of Rheumatology)
•Renal biopsy documenting proliferative glomerulonephritis class III  or IV according to WHO/ISN-RPS
•Clinical activity as defined by presence of at least two of the following: abnormal proteinuria (> 500mg /24-hours), active urinary sediment, and/or C3 hypocomplementemia
 
Treatment:
The duration of the controlled study protocol was 18 months
Cyclophosphamide (CPH) arm: 8 boluses of intravenous cyclophosphamide (10mg/kg) given within 9 months in subsequently prolonged intervals (2x3weeks, 4×4 weeks, 2×6 weeks) followed by 4-5 oral cyclophosphamide boluses (10mg/d in 6-8 week intervals).
Cyclosporine arm: oral cyclosporine A (CyA) 4-5mg/kg/day (given in two divided doses) for 9 months followed by gradually decreasing dose of cyclosporine (3.75-1.25 mg/kg/day) within the next 9 months
Glucocorticoids: prescribed according to a unified protocol

The main purpose of the current analysis was to ascertain the long-term renal outcome of patients randomised in the CYCLOFA-LUNE trial.

Methods:

Data for kidney function, and adverse events (death, cardiovascular event, tumor, premature menopause) were collected by a cross-sectional suvey for 38 of 40 patients initially randomised in the CYCLOFA-LUNE trial
Results:

The median follow-up time was 7.7 years (range 5.0-10.3). Rates of renal impairment and end-stage renal disease, adverse events (death, cardiovascular event, tumor, premature menopause) did not differ between the CPH and CyA group, nor did mean serum creatinine, 24 h proteinuria and SLICC damage score at last follow-up. Most patients in both groups were still treated with glucocorticoids, other immunosuppressant agents, and blood pressure lowering drugs.

 
All (n=38)
CPH (n=19)
CyA (n=19)
Age (years), mean (SD)
39 (10)
37 (5)
38 (8)
Female, n
27 (71)
13 (68)
14 (74)
Follow-up (years), median (range)
7.7 (5.0-10.3)
7.4 (5.0-9.7)
8.3 (5.3-10.3)
50% increase in creatinine concentration
5 (13)
3 (16)
2 (11)
Non-sustained doubling of the creatinine concentration
2 (5)
1 (5)
1 (5)
Sustained doubling of serum creatinine
2 (5)
1 (5)
1 (5)
End-stage renal disease
2 (5)
1 (5)
1 (5)
Current serum creatinine (μmol/l)
67 (19)
71 (23)
63 (15)
Current 24 h proteinuria (g)
0.4 (0.6)
0.5 (0.5)
0.4 (0.7)
Additional IS drugs ever received
1 (1)
1 (2)
1 (1)
Deaths
0 (0)
0 (0)
0 (0)
Malignancy
2 (5)
0 (0)
2 (11)
Cumulative cardiovascular events
1 (3)
1 (5)
0 (0)
Premature menopause*
1 (4)
1 (8)
0 (0)
Pregnant*
9 (33)
6 (46)
3 (21)
Current SLICC DI (median, IQR)
0.0 (1.0)
0.0 (1.0)
0.5  (1.0)
2 patients included in the ESRD group are counted within the other groups with less severe renal impairment), Figures are numbers (%) of patients, or median (IQR) * since the end of the CYCLOFA-LUNE protocol treatment. 

Conclusion:

Both regimens based either on CPH or CyA achieved good and similar clinical results in the very long term
Acknowledgements: Supported by the project (Ministry of Health, Czech Republic) MZO 00023728.


Disclosure:

J. Zavada,
None;

S. Pesickova,
None;

R. Rysava,
None;

P. Horak,
None;

Z. Hrncir,
None;

J. Rovensky,
None;

J. Lukac,
None;

J. Vitova,
None;

J. Böhmova,
None;

M. Olejarova,
None;

D. Tegzova,
None;

V. Tesar,
None.

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