Session Information
Title: Systemic Sclerosis, Fibrosing Syndromes, and Raynaud’s - Clinical Aspects and Therapeutics II
Session Type: Abstract Submissions (ACR)
Background/Purpose:
Mycophenolate reduces chronic allograft nephropathy and interstitial fibrosis by inhibiting TGF-β, which is an important molecule in the pathogenesis of systemic sclerosis (SSc). The main side effects observed are gastrointestinal disturbance, myelosuppression, and increased risk of infection. This maybe a limitation of its use in SSc patients since gastrointestinal involvement is very common. The objective of this study is to evaluate the safety, in particular gastrointestinal adverse events, of mycophenolate in SSc. Secondarily we evaluated the effectiveness of mycophenolate in SSc skin and lung disease.
Methods: A literature search of Medline, Embase, Cochrane Central Register of Controlled Trials, and CINAHL (inception – September 2012) was performed. Titles and abstracts were screened to identify studies that described the use of mycophenolate in SSc patients. Inclusion criteria included exposure to mycophenolate, and reporting of modified Rodnan skin score (MRSS), forced vital capacity (FVC), diffusing capacity of carbon monoxide (DLCO); or adverse events. The primary outcome was gastrointestinal events occurring after the initiation of mycophenolate. Secondary safety outcomes included myelosuppression, infection, malignancy, and death occurring after the initiation of mycophenolate.
Results:
616 citations were identified and 20 were included in the analysis. 477 patients have been exposed to mycophenolate. The mean disease duration ranged between 0.8-14.1 years. There were 89 non-lethal adverse events, of which 43 (48%) were gastrointestinal and 46 (52%) were non-gastrointestinal adverse events. The most commonly reported gastrointestinal events included diarrhea (n=18 (20%)), nausea (n=12 (13%)), and abdominal pain (n=3 (3%)). The most commonly reported non-gastrointestinal adverse events were infections (n=33 (37%), and 6 cytopenias (n=6, (7%)). The reported rate of discontinuation ranged between 8-40%. Seven observational studies report mycophenolate is effective improvement or stabilization in FVC, and 5 observational studies report stabilization or improvement in MRSS.
Conclusion: Observational studies report mycophenolate is effective in improving or stabilizing interstitial lung disease, and may be effective for skin involvement. However, gastrointestinal adverse events are common in SSc patients.
Disclosure:
M. Omair,
None;
A. Alahmadi,
None;
S. R. Johnson,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-effectiveness-of-mycophenolate-in-systemic-sclerosis-a-systemic-review/