Background Immunosuppressants such as mycophenolate are widely used in people with systemic lupus erythematosus (SLE), but not all are specifically licensed by FDA, EMA (1) and in the case of Colombia the Regulatory Agency for Food and Drugs (INVIMA) has not approved it for this indication, only for the prevention of the rejection of some transplants. Mycophenolate mofetil was found to be associated with a lower risk of toxic adverse events such as ovarian failure, alopecia and leucopenia, compared with cyclophosphamide (1).
Objectives To describe the population of patients with SLE receiving mycophenolate during a five year period.
Methods We conducted a retrospective observational study, extracting information from a database in our rheumatic diseases center; we reviewed the clinical record of each patient with diagnosis of SLE and receiving mycophenolate. Descriptive epidemiology was performed for each variable presented.
Results 1989 patients were diagnosed with Systemic Lupus Erythematosus (SLE) during 2011 and 2016 and 287 were receiving mycophenolate. Regarding demographic characteristics 94% were woman and 6% men, mean age was 49 years ± 15. 41% of patients were employed, 40% were housekeepers, 11% students and 8% retired. The indication for mycophenolate was mainly for lupus nephritis 62%, SLE in overlapping with systemic sclerosis 30% and only for SLE in 8% of cases. 36% of patients received a daily dose of 2000 mg, 30% 1500 mg, 20% 1000 mg, 8% 3000 mg, 3.5% 4000 mg and 1.5% 6000 mg and 1% 500mg. The mean value for 24 hour urine protein was 792 mg/dl ± 140 and for creatinine was 0.84 mg/dl ± 0.36. In our population patients were taking mycophenolate during a median of 24 months with a minimum of 6 and a maximum of 132. In combination with mycophenolate 28% of the patients were taking corticoids, 21% hydroxichloroquine, 20% chloroquine, 17% antihypertensive drugs, 7% other medications and only 4% were taking the mycophenolate alone.
Conclusions Despite of the absence of a license for mycophenolate for the management of Systemic Lupus Erythematosus, the use off-label of this drug continues to be frequently as an alternative and effective treatment in patients with lupus nephritis and other conditions associated to SLE.
National Institute for Health Care Excellence. NICE. Systemic lupus erythematosus: oral mycophenolate. England: NICE 2014.
Disclosure of Interest None declared