Immunosuppressant MMF More Effective in Cases With Kidney Issues
Mycophenolate mofetil (MMF), an immunosuppressant, may sustain remission more efficiently than other therapies in ANCA-associated vasculitis (AAV) patients who have kidney symptoms, a review of clinical trials found.
The findings showed that, in clinical trials enrolling only patients with kidney involvement, more than 90% were estimated to maintain their remission status with MMF.
Overall, and consistent with previous findings, MMF was as effective as cyclophosphamide at inducing remission, and may be considered as an option for inducing remission regardless of kidney involvement, according to researchers.
“These findings might influence clinical practice,” the team wrote.
The study, “Induction and maintenance of remission with mycophenolate mofetil in ANCA-associated vasculitis: A systematic review and meta-analysis,” was published in Nephrology Dialysis Transplantation.
MMF, sold as CellCept and other brand names, is known to suppress immune responses — namely from B- and T-cells — and reduce the production of antibodies.
While it appears to provide a safe and effective alternative to the standard induction therapy cyclophosphamide (sold as Cytoxan and Neosar), there is still debate around its use for maintaining remission in AAV.
To shed more light on MMF’s efficacy at sustaining remission, an international team of researchers conducted a meta-analysis of published clinical trials that had examined MMF either as an induction regimen or as a remission-maintenance treatment.
The analysis included 10 clinical trials — five Phase 2 and five Phase 3 — involving a total of 532 patients with granulomatosis with polyangiitis or microscopic polyangiitis.
Four of the clinical trials assessed remission induction while three assessed remission maintenance. The other three assessed both remission induction and maintenance. Time to the primary endpoint varied from six to 12 months for remission induction, and from 12 to 18 months for remission maintenance, with the exception of one clinical trial, which had a longer follow-up of 39 months (just over three years).
In most patients, MMF was used at a dose of 2,000 milligrams per day, and all trials used it in combination with glucocorticoids. Five of the clinical trials lacked a control group and the other five used either cyclophosphamide or azathioprine for comparison purposes.
First, the researchers looked at the likelihood of remission induction in patients treated with MMF versus those on cyclophosphamide. They found no significant differences, regardless of whether they included trials involving only patients with kidney manifestations or a mixed population with and without kidney problems.
“In the induction of remission, MMF could be considered as an alternative option regardless of kidney involvement,” the researchers wrote.
However, MMF performed better as a maintenance-induction regimen in clinical trials enrolling only patients with kidney involvement. Indeed, 92% of patients were estimated to maintain their remission status, compared with 56% in clinical trials enrolling patients with and without kidney involvement.
Serious side effects to MMF were reported in almost one-third (31.8%) of the patients who received MMF. In general, the most common side effects were severe infections (28.7%), gastrointestinal symptoms (21.6%), and lower-than-normal numbers of white blood cells (9.2%), but the rates of these events were similar in MMF and control groups.
“In AAV, MMF use is significantly associated with higher sustained remission rates in trials enrolling only patients with kidney involvement,” the researchers wrote. Therefore, MMF might be considered as an option for remission maintenance in patients with AAV affecting the kidneys.
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