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Management of Systemic Lupus Erythematosus

           corticosteroids  alone  in  patients  with  moderate  non-renal  SLE  at  12
           months. The second RCT demonstrated that ciclosporin also reduced
           the  mean  dose  of  corticosteroids  by  >50%  compared  with  baseline
           (p<0.001) in patients with severe non-renal SLE at 12 months. The first
           RCT had a score of 1 while the second had a score of 3 based on Jadad
           scale. 68, level I
           The reported AEs in the review included hypertension, respiratory tract
           infection and anaemia. 68, level I  Additionally, other common AEs include
           hypertrichosis,  gum  hypertrophy,  paraesthesia,  tremor,  GI  symptoms
           and  impaired  renal  function,  especially  at  higher  doses  (>3  mg/kg/
           day). 21
           •   Tacrolimus
           In  a  systematic  review,  a  cohort  study  demonstrated  that  tacrolimus
           1 - 3 mg/day significantly reduced mean SLEDAI scores and dose of
           prednisolone  in  SLE  patients  without  active  nephritis  after  one  year.
           Non-serious AEs were observed in 40% of the cohort. However, quality
           assessment of the study was not reported. 68, level I

           iv)  Cyclophosphamide
           Cyclophosphamide  (CYC)  is  a  non-specific  alkylating  agent  that
           prevents cell division by forming cross-linkages in DNA, which leads to
           inhibition of T and B lymphocytes proliferation.

           A  small,  low  quality  RCT  in  a  Cochrane  systematic  review  studied
           neuropsychiatric  SLE  (NPSLE).  The  patients  had  IV  induction  of
           methylprednisolone  and  tapering  oral  prednisolone.  Comparison
           between  CYC  and  continuation  of  methylprednisolone  showed  the
           former was more effective in achieving 20% improvement in clinical,
           serological  and  specific  neurological  measures,  improvement  of
           SLEDAI score and reduction of prednisolone requirements. There was
           no significant differences in AEs and deaths. 70, level I

           Another  systematic  review  that  included  two  small  RCTs  on  NPSLE
           showed that CYC in combination with corticosteroids was more effective
           than corticosteroids alone in the following outcomes: 68, level I
             •  clinical improvement at six months (p=0.005)
             •  reduction of relapses at three months (p=0.005)
             •  electroencephalogram improvement (p=0.003)
             •  ≥20%  improvement  in  clinical,  serological  and  neurological
               measures at two years (p<0.03)
           There was no difference in AE in one of the RCTs. Both RCTs scored
           1 - 3 on Jadad scale.

           The use of CYC in renal SLE is mentioned in Subchapter 7.1.


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