Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis
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 Pa...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2019-12-01
|
| Series: | Lupus Science and Medicine |
| Online Access: | https://lupus.bmj.com/content/6/1/e000308.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850118759574929408 |
|---|---|
| author | Brad Rovin Maria Dall’Era Paul Brunetta Liliana Michelle Gomez Mendez Matthew D Cascino Tamiko R Katsumoto Paul Brakeman Jay Garg |
| author_facet | Brad Rovin Maria Dall’Era Paul Brunetta Liliana Michelle Gomez Mendez Matthew D Cascino Tamiko R Katsumoto Paul Brakeman Jay Garg |
| author_sort | Brad Rovin |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b0ab78e5c0544bc8b7e0ad36a6960fcc |
| institution | OA Journals |
| issn | 2053-8790 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Lupus Science and Medicine |
| spelling | doaj-art-b0ab78e5c0544bc8b7e0ad36a6960fcc2025-08-20T02:35:47ZengBMJ Publishing GroupLupus Science and Medicine2053-87902019-12-016110.1136/lupus-2018-000308Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritisBrad Rovin0Maria Dall’Era1Paul Brunetta2Liliana Michelle Gomez Mendez3Matthew D Cascino4Tamiko R Katsumoto5Paul Brakeman6Jay Garg73 Medicine, Ohio State University, Columbus, Ohio, USA14Ohio State University, Columbus OH, United States of AmericaGenentech Inc, South San Francisco, California, USA1 Department of Pediatric Nephrology, University of California San Francisco, San Francisco, California, USAGenentech Inc, South San Francisco, California, USA2 Product Development Clinical Science, Genentech Inc, South San Francisco, California, USA1 Department of Pediatric Nephrology, University of California San Francisco, San Francisco, California, USA2 Product Development Clinical Science, Genentech Inc, South San Francisco, California, USAObjective 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.https://lupus.bmj.com/content/6/1/e000308.full |
| spellingShingle | Brad Rovin Maria Dall’Era Paul Brunetta Liliana Michelle Gomez Mendez Matthew D Cascino Tamiko R Katsumoto Paul Brakeman Jay Garg Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis Lupus Science and Medicine |
| title | Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis |
| title_full | Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis |
| title_fullStr | Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis |
| title_full_unstemmed | Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis |
| title_short | Outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis |
| title_sort | outcome of participants with nephrotic syndrome in combined clinical trials of lupus nephritis |
| url | https://lupus.bmj.com/content/6/1/e000308.full |
| work_keys_str_mv | AT bradrovin outcomeofparticipantswithnephroticsyndromeincombinedclinicaltrialsoflupusnephritis AT mariadallera outcomeofparticipantswithnephroticsyndromeincombinedclinicaltrialsoflupusnephritis AT paulbrunetta outcomeofparticipantswithnephroticsyndromeincombinedclinicaltrialsoflupusnephritis AT lilianamichellegomezmendez outcomeofparticipantswithnephroticsyndromeincombinedclinicaltrialsoflupusnephritis AT matthewdcascino outcomeofparticipantswithnephroticsyndromeincombinedclinicaltrialsoflupusnephritis AT tamikorkatsumoto outcomeofparticipantswithnephroticsyndromeincombinedclinicaltrialsoflupusnephritis AT paulbrakeman outcomeofparticipantswithnephroticsyndromeincombinedclinicaltrialsoflupusnephritis AT jaygarg outcomeofparticipantswithnephroticsyndromeincombinedclinicaltrialsoflupusnephritis |