according to findings in the real-world U.K. Juvenile Systemic Lupus Erythematosus Cohort Study.
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The study involved 34 patients who received mycophenolate mofetil and 17 who received IV cyclophosphamide as induction therapy for proliferative lupus nephritis in juvenile-onset systemic lupus erythematosus (JSLE). Along with her coinvestigators, first author Eve M.D. Smith, MD, PhD, of the University of Liverpool (England) and Alder Hey Children’s NHS Foundation Trust, described it as the largest study to date investigating induction treatments for proliferative lupus nephritis in JSLE.
The patients were aged 16 years or younger at diagnosis and monitored during 2006-2018 as part of the U.K. JSLE Cohort Study. They met four or more American College of Rheumatology SLE classification criteria and had a renal biopsy result demonstrating proliferative lupus nephritis, defined as class III or IV lupus nephritis by the International Society of Nephrology/Renal Pathology Society. Within the mycophenolate group, half received oral prednisolone only and half received both IV methylprednisolone and oral prednisolone, whereas 2 in the cyclophosphamide group received oral prednisolone only and 15 received both IV methylprednisolone and oral prednisolone.
All the patient demographic factors at baseline – including gender, ethnicity, age at diagnosis, and age at lupus nephritis onset – were similar in both treatment groups.
The investigators detected no significant differences between the two treatment groups at 4-8 and 10-14 months post renal biopsy and last follow-up in renal pediatric British Isles Lupus Assessment Grade scores, urine albumin/creatinine ratio, serum creatinine, erythrocyte sedimentation rate, anti-double stranded DNA antibody, Complement 3 levels, and patient/physician global scores. JSLE-related damage on the Systemic Lupus International Collaborating Clinics Standardized Damage Index also was no different between the groups after a median 13 months following renal biopsy. Lupus nephritis became inactive in 82%-85% of each group, taking a median of 262 days with mycophenolate and 151 days with IV cyclophosphamide, while flares occurred in 69% treated with mycophenolate at a median of 451 days and in 50% with cyclophosphamide at a median of 343 days.
“Results from the presented study highlight the need for prospective comparison of mycophenolate mofetil versus IV cyclophosphamide induction treatment to better inform lupus nephritis treatment protocols for children, especially given IV cyclophosphamide’s poor safety profile,” the investigators wrote.
SOURCE: Smith EMD et al. Lupus. 2019 Mar 14. doi: 10.1177/0961203319836712.