Safety and Effectiveness of Mycophenolate in Systemic Sclerosis. A Systematic Review
Open Access
- 1 May 2015
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLOS ONE
- Vol. 10 (5), e0124205
- https://doi.org/10.1371/journal.pone.0124205
Abstract
Mycophenolate is increasingly being used in the rheumatic diseases. Its main adverse effects are gastrointestinal, myelosuppression, and infection. These may limit use in systemic sclerosis (SSc) since gastrointestinal involvement is common. The objective of this study is to evaluate gastrointestinal adverse events of mycophenolate in SSc. Secondarily we evaluated other adverse events, and the effectiveness of mycophenolate in skin and lung disease. A literature search of Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL (inception-2013) was performed. Studies reporting use of mycophenolate in SSc patients, adverse events, modified Rodnan skin score (MRSS), forced vital capacity (FVC), or diffusing capacity of carbon monoxide (DLCO) were included. The primary outcome was gastrointestinal events occurring after the initiation of mycophenolate. Secondary safety outcomes included myelosuppression, infection, malignancy, and death after the initiation of mycophenolate. 617 citations were identified and 21 studies were included. 487 patients were exposed to mycophenolate. The mean disease duration ranged between 0.8-14.1 years. There were 18 deaths and 90 non-lethal adverse events. The non-lethal adverse events included 43 (47.7%) gastrointestinal events, 34 (26%) infections, 6 (5%) cytopenias and 2 (2%) malignancies. The most common gastrointestinal events included diarrhea (n=18 (14%)), nausea (n=12 (9%)), and abdominal pain (n=3 (2%)). The rate of discontinuation ranged between 8%-40%. Seven observational studies reported improvement or stabilization in FVC, and 5 studies report stabilization or improvement in MRSS. Mycophenolate-associated gastrointestinal adverse events are common in SSc, but not severe enough to preclude its use. Observational data suggests mycophenolate may be effective in improving or stabilizing interstitial lung disease, and skin involvement.Keywords
This publication has 53 references indexed in Scilit:
- Effect and Safety of Mycophenolate Mofetil or Sodium in Systemic Sclerosis-Associated Interstitial Lung Disease: A Meta-AnalysisPulmonary Medicine, 2012
- American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritisArthritis Care & Research, 2012
- Prevalence, correlates and clinical usefulness of antibodies to RNA polymerase III in systemic sclerosis: a cross-sectional analysis of data from an Australian cohortArthritis Research & Therapy, 2011
- Azathioprine versus mycophenolate mofetil for long-term immunosuppression in lupus nephritis: results from the MAINTAIN Nephritis TrialAnnals Of The Rheumatic Diseases, 2010
- Mycophenolic Acid May Delay Allograft Fibrosis by Inhibiting Transforming Growth Factor-β1-Induced Activation of Nox-2 Through the Nuclear Factor-κB PathwayTransplantation, 2010
- Assessment of tissue fibrosis in skin biopsies from patients with systemic sclerosis employing confocal laser scanning microscopy: an objective outcome measure for clinical trials?Rheumatology, 2010
- Reliability and validity of the university of california, los angeles scleroderma clinical trial consortium gastrointestinal tract instrumentArthritis Care & Research, 2009
- Molecular ablation of transforming growth factor β signaling pathways by tyrosine kinase inhibition: The coming of a promising new era in the treatment of tissue fibrosisArthritis & Rheumatism, 2008
- Enteric-Coated Mycophenolate SodiumDrugs, 2008
- Clinical Pharmacokinetics and Pharmacodynamics of Mycophenolate in Solid Organ Transplant RecipientsClinical Pharmacokinetics, 2007