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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.

21