Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis.

Autor:	Gomez Mendez LM; Department of Pediatric Nephrology, University of California San Francisco, San Francisco, California, USA., Cascino MD; Product Development Clinical Science, Genentech Inc, South San Francisco, California, USA., Katsumoto TR; Product Development Clinical Science, Genentech Inc, South San Francisco, California, USA.; Early Development, Genentech Inc, South San Francisco, CA, United States., Brakeman P; Department of Pediatric Nephrology, University of California San Francisco, San Francisco, California, USA., Brunetta P; Product Development Clinical Science, Genentech Inc, South San Francisco, California, USA., Jayne D; Department of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, UK., Dall'Era M; Department of Rheumatology, University of California San Francisco, San Francisco, CA, United States., Rovin B; Department of Internal Medicine/Nephrology, Ohio State University Wexner Medical Center, Columbus, Ohio, USA., Garg J; Product Development Clinical Science, Genentech Inc, South San Francisco, California, USA.
Jazyk:	angličtina
Zdroj:	Lupus science & medicine [Lupus Sci Med] 2019 Feb 04; Vol. 6 (1), pp. e000308. Date of Electronic Publication: 2019 Feb 04 (Print Publication: 2019).
DOI:	10.1136/lupus-2018-000308
Abstrakt:	Objective: The outcome of participants with nephrotic syndrome in clinical trials of lupus nephritis has not been studied in detail. Methods: Collated data from two randomised controlled trials in lupus nephritis, Lupus Nephritis Assessment of Rituximab (LUNAR) and A Study to Evaluate Ocrelizumab in Patients With Nephritis due to Systemic Lupus Erythematosus (BELONG) were analysed. Nephrotic syndrome was defined as albumin <3 g/dL and urine protein/creatinine ratio ≥3.5 g/g at start of trial. Renal response was defined as a first morning urine protein/creatinine ratio ≤0.5 g/g in addition to ≤25% increase in creatinine from trial entry assessed at week 48. Logistic regression was used to evaluate the association of nephrotic syndrome with renal response while adjusting for treatment received and ACE inhibitor or angiotensin receptor blocker use. Results: 28 (26%) participants with nephrotic syndrome achieved renal response as compared with 130 (52.5%) of those without (p<0.001). Having nephrotic syndrome at baseline significantly lowered the likelihood of achieving renal response (OR 0.32, 95 % CI 0.19 to 0.54, p<0.001). 125 (80%) participants achieved resolution of their nephrotic syndrome in a median time of 16 weeks. Conclusions: Nephrotic syndrome at baseline decreases the likelihood of renal response at 1 year. Longer clinical trials or better short-term predictors of long-term outcomes may better assess the effect of novel therapeutic approaches on subjects with nephrotic syndrome. Competing Interests: Competing interests: MDC, JG, TRK and PB are employees of Roche/Genentech. LMGM, PB, MD’E, DJ and BR have no disclosures.
Databáze:	MEDLINE
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