Author/Authors :
Mitwalli, Ahmed H. King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Al Wakeel, Jamal S. King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Hurraib, Sameer King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Abu Aisha King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Al Suwaida, Abdulkaraem King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Alam, Awatif King Saud University - King Khalid University Hospital - Department of Family and Community Medicine, Saudi Arabia , Hammad, Durdana King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Sulimani, Fathia King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Memon, Nawaz A. King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Askar, Akram King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia , Al Tuwaijri, Ali King Saud University - King Khalid University Hospital - Department of Physiology, Saudi Arabia , Qudsi, Abdo King Saud University - King Khalid University Hospital - Department of Medicine, Saudi Arabia
Abstract :
To evaluate the outcome of low doses of cyclophosphamide (Cyclo) therapy in lupus nephritis (LN) patients,we studied 117 biopsy-proven,de novo LN WHO class IV patients double-blinded and randomized in December 1997 to receive Cyclo in different doses; Group I (n=73) received Cyclo 10 mg/kg monthly for six months then every two months for 12 months. Group II (n=44) received Cyclo 5 mg/kg monthly for six months then every two months for 36 months. The patients were followed-up till January 2007. Six months post-induction values for creatinine clearance were significantly higher in Group I (67.7 ± 28.6 mL/min) compared with Group II (55.1 ± 30.1 mL/min),P = 0.026. Serum C4 and ANA were not significantly different between the groups (P 0.05). At the mean follow-up of 6.77 ± 3.3 years,the mean creatinine clearance was 44.74 ± 31.7 mL/min in Group I vs. 49.3 ± 38.8 in Group II. Urinary protein was 1.65 ± 1.8 g/dL in Group I vs. 1.02 ± 1.01 in Group II (P = 0.03). The survival curve showed that kidney survival overtime was comparable in both groups (P = 0.2). Complete remission was observed in 25 (34.2%) patients in Group I vs. 11 (25%) in Group II (P = 0.288),while partial remission was similar in both groups; 43 (58.9%) patients in Group I vs. 26 (59%) patients in Group II. End-stage renal disease was observed in 10 (13.7%) patients in Group I vs. 9 (20.4%) patients in Group II (P = 0.359). Side-effects were more frequent in Group I patients than in Group II patients; gonadal toxicity and malignancy were lower in Group II patients (P = 0.0000). Moreover,different infections occurred in 23 (31.3%) patients vs. six (13.6%),digital infarcts occurred in 1.35% vs. 0%,diabetes in 4.1% vs. 2.27%,and vasculitis in 4.1% vs. 2.27% in Group I vs. Group II,respectively. Sustained amenorrhea without pregnancy was observed in both groups; however,significantly more in Group I patients,P ≤ 0.05. We conclude that low-dose Cyclo therapy is sufficiently effective for WHO class IV LN patients with lower side-effects compared with standard dose.
