Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement
Identifieur interne : 001188 ( Main/Exploration ); précédent : 001187; suivant : 001189Open label randomized controlled trial assessing the efficacy of mycophenolate sodium against other conventional immunosuppressive agents in active systemic lupus erythematosus patients without renal involvement
Auteurs : Fariz Yahya [Malaisie] ; Raja Jasmin [Malaisie] ; Chin Teck Ng [Malaisie] ; Tien Eang Cheah [Malaisie] ; Sargunan Sockalingam [Malaisie]Source :
- International Journal of Rheumatic Diseases [ 1756-1841 ] ; 2013-12.
English descriptors
- Teeft :
- Adverse events, Aiha, Azathioprine, Baseline, Control group, Disease activity index, Erythematosus, Glucocorticoid, Immunological parameters, International journal, Lupus, Mycophenolate, Mycophenolate group, Mycophenolate mofetil, Mycophenolate sodium, Positive trend, Prednisolone, Renal, Renal involvement, Rheumatic diseases, Side effects, Sledai, Sledai score, Sledai scores, Statistical difference, Steroid dose reduction, Study subjects, Systemic lupus erythematosus, Treatment groups.
Abstract
Aim: Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (SLE) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra‐renal SLE involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra‐renal SLE. Methods: A total of 14 SLE patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included SLE Disease Activity Index (SLEDAI) score, other organ‐specific parameters and immunological parameters, including anti‐double stranded DNA and C3. Steroid‐sparing effect of mycophenolate sodium was also evaluated. Results: Mycophenolate sodium produced a significant reduction in SLEDAI scores (P < 0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ‐specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. No major adverse events were reported in this study. Conclusion: Mycophenolate sodium is a safe alternative therapy in SLE patients with extra‐renal involvement. The reduction in SLEDAI scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non‐renal SLE is warranted.
Url:
DOI: 10.1111/1756-185X.12179
Affiliations:
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groups</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract">Aim: Mycophenolate is an immunosuppressive agent which has been used in systemic lupus erythematosus (SLE) patients who have failed conventional therapy. However, the use of mycophenolate sodium in extra‐renal SLE involvement has yet to be established. This study aimed to assess the efficacy of mycophenolate sodium in extra‐renal SLE. Methods: A total of 14 SLE patients without renal involvement were randomized either to receive mycophenolate sodium or other immunosuppressive agents. Patients were assessed monthly from baseline until week 16. Assessment parameters included SLE Disease Activity Index (SLEDAI) score, other organ‐specific parameters and immunological parameters, including anti‐double stranded DNA and C3. Steroid‐sparing effect of mycophenolate sodium was also evaluated. Results: Mycophenolate sodium produced a significant reduction in SLEDAI scores (P < 0.05) after 16 weeks of treatment. Mixed responses were detected in terms of organ‐specific clinical changes. A positive trend was observed in improvement of immunological parameters and steroid dose reduction. No major adverse events were reported in this study. Conclusion: Mycophenolate sodium is a safe alternative therapy in SLE patients with extra‐renal involvement. The reduction in SLEDAI scores and the observation of no major safety concerns suggest that a larger prospective study of mycophenolate sodium in non‐renal SLE is warranted.</div></front></TEI><affiliations><list><country><li>Malaisie</li></country></list><tree><country name="Malaisie"><noRegion><name sortKey="Yahya, Fariz" sort="Yahya, Fariz" uniqKey="Yahya F" first="Fariz" last="Yahya">Fariz Yahya</name></noRegion><name sortKey="Cheah, Tien Eang" sort="Cheah, Tien Eang" uniqKey="Cheah T" first="Tien Eang" last="Cheah">Tien Eang Cheah</name><name sortKey="Jasmin, Raja" sort="Jasmin, Raja" uniqKey="Jasmin R" first="Raja" last="Jasmin">Raja Jasmin</name><name sortKey="Ng, Chin Teck" sort="Ng, Chin Teck" uniqKey="Ng C" first="Chin Teck" last="Ng">Chin Teck Ng</name><name sortKey="Sockalingam, Sargunan" sort="Sockalingam, Sargunan" uniqKey="Sockalingam S" first="Sargunan" last="Sockalingam">Sargunan Sockalingam</name><name sortKey="Sockalingam, Sargunan" sort="Sockalingam, Sargunan" uniqKey="Sockalingam S" first="Sargunan" last="Sockalingam">Sargunan Sockalingam</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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