Tacrolimus maintenance therapy may be safe and effective in patients with lupus nephritis, according to a Japanese study published by Takeuchi et al in The Journal of Rheumatology. In an open-label, noncomparative, observational, prospective, postmarketing surveillance study, researchers examined treatment continuation, cumulative incidence of adverse drug reactions, relapse, and progression to renal failure or dialysis among 1,355 patients with lupus nephritis from Japan who received tacrolimus as maintenance therapy. After a follow-up of 10 years, the patients had a 49.3% continuation rate and reduced their corticosteroid doses from 16.0 mg/day to 7.2 mg/day. Further, 4.45%, 12.20%, and 4.50% of the patients experienced relapse, renal failure, and dialysis, respectively. The researchers reported that the most common adverse drug reactions were infections (n = 131) and that there were no increases in the incidence of renal impairment, malignancies, or cardiac dysfunction with the agent. The researchers concluded that tacrolimus maintenance therapy was effective and well tolerated in this patient population.


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