Tacrolimus Offers Better Response Rates, Infection Risks in Lupus Nephritis

SAN FRANCISCO, CA—Tacrolimus outperforms cyclophosphamide (CYC) and mycophenolate mofetil (MMF) as an induction therapy for lupus nephritis, achieving superior overall response rates and reducing the risk of serious infections, according to a meta-analysis of data from nine studies, reported at the 2015 ACR/ARHP Annual Meeting.

“Tacrolimus was the most efficacious induction treatment for patients with lupus nephritis, and had the highest probability of decreasing the risk of serious infections,” reported study authors Young Ho Lee, MD, and Gwan Gyu Song, MD, of the Division of Rheumatology, Korea University Medical Center in Seoul, South Korea, in a poster presentation.

“Higher remission rates combined with a more favorable safety profile suggest that MMF is superior to CYC as induction treatment in these patients,” they reported.

CYC regimens “have long been considered the gold standard for inducing renal remission and preventing renal flares in [WHO class III and IV] proliferative glomerulonephritis,” they noted. But CYC regimens' benefits are “outweighed by the significant drug-related adverse effects,” including elevated risks of serious infections and ovarian toxicity.

Randomized controlled clinical efficacy and safety trials for other immunosuppressive induction drugs are needed for treating lupus nephritis but relatively few such studies have been undertaken–and they have been largely inconclusive, thanks to small sample sizes. By pooling data for analysis from multiple studies of induction therapy with tacrolimus, MMF, and CYC for lupus nephritis, the study authors sought to clarify the relative safety and efficacy of these alternative induction regimens.

Nine randomized clinical trials met inclusion criteria, representing 972 patients.

“Tacrolimus showed a significantly higher overall response rate (complete remission plus partial remission) than CYC (OR [odds ratio] 2.35, 95% credible interval [CrI] 1.03–5.45), and was more efficacious than MMF (OR 1.60, 95% CrI 0.70–3.57),” Drs. Lee and Song reported. “MMF was superior to CYC in terms of overall response (OR 1.45, 95% CrI 0.96–2.42). “

Tacrolimus “had the highest probability of being the best treatment for achieving the overall response, followed by MMF, and CYC,” they concluded. “In terms of safety, tacrolimus showed the highest probability of decreasing the risk of serious infections, followed by MMF, and CYC.”

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