title: Mycophenolate mofetil in systemic lupus erythematosus: results from a retrospective study in a large monocentric cohort and review of the literature.
abstract: In the present study, we performed a retrospective study on the indication, efficacy and causes of withdrawal of mycophenolate mofetil (MMF) in patients with systemic lupus erythematosus (SLE). Moreover, a review of the literature concerning the use of MMF in the real life was performed. We recorded data about indications, mean dosage, duration of treatment and reasons for drug withdrawal. The efficacy was evaluated according to changes in SLE Disease Activity Index 2000 (SLEDAI-2K), renal SLEDAI-2K and daily proteinuria, after 4 and 12 months of treatment. Six hundred and nine SLE patients were evaluated; among them, 109 patients (17.9 %) were treated with MMF (mean treatment duration 33.9 ± 31.2 months, mean dosage 28.1 ± 10.6 mg/kg). The most frequent indications for using MMF were lupus nephritis (55.9 %) and musculoskeletal manifestations (33.0 %). After 4 and 12 months, a significant reduction of mean SLEDAI-2K, renal SLEDAI and daily proteinuria, compared with baseline, was demonstrated. Thirty-one patients (28.4 %) discontinued MMF therapy (mean treatment duration at the time of discontinuation 17.5 ± 21.2 months). The incidence risks of MMF discontinuation due to inefficacy and side effects were 0.09 and 0.1, respectively. Patients with disease duration longer than 36 months (70.6 %) had a significant increased risk of MMF withdrawal (RR 0.4, P = 0.03). The results of the present study demonstrated that MMF should be considered a treatment option for SLE manifestation other than renal involvement in daily clinical practice.
authors.affiliation: Lupus Clinic, Reumatologia, Dipartimento di Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Viale del Policlinico 155, 00161, Rome, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Conti
authors.forename: Fulvia
authors.initials: F
authors.lastname: Ceccarelli
authors.forename: Carlo
authors.initials: C
authors.lastname: Perricone
authors.forename: Laura
authors.initials: L
authors.lastname: Massaro
authors.forename: Enrica
authors.initials: E
authors.lastname: Cipriano
authors.forename: Viviana Antonella
authors.initials: VA
authors.lastname: Pacucci
authors.forename: Simona
authors.initials: S
authors.lastname: Truglia
authors.forename: Francesca
authors.initials: F
authors.lastname: Miranda
authors.forename: Francesca
authors.initials: F
authors.lastname: Morello
authors.forename: Cristiano
authors.initials: C
authors.lastname: Alessandri
authors.forename: Francesca Romana
authors.initials: FR
authors.lastname: Spinelli
authors.forename: Guido
authors.initials: G
authors.lastname: Valesini
mesh_terms: D000293:Adolescent; D000328:Adult; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004791:Enzyme Inhibitors; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid