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Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids.
Ann Rheum Dis 2013; 72(8):1280-6AR

Abstract

OBJECTIVES

Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE). All current treatment regimens include oral steroids, which are associated with severe adverse events and long-term damage. We have piloted a steroid-avoiding protocol (rituxilup) for the treatment of biopsy-proven active International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III, IV, or class V LN.

METHODS

We report the findings from the first 50 consecutive patients, treated with 2 doses of rituximab (1 g) and methyl prednisolone (500 mg) on days 1 and 15, and maintenance treatment of mycophenolate mofetil. Patients on maintenance steroids or with life-threatening SLE or requiring dialysis were excluded. Renal remission was defined as serum creatinine no greater than 15% above baseline; complete biochemical remission (CR) was defined as urine protein : creatinine ratio (PCR)<50 mg/mmol or partial remission (PR) if PCR>50 mg/mmol but non-nephrotic and >50% reduction.

RESULTS

A total of 45 (90%) patients achieved CR or PR by a median time of 37 weeks (range 4-200). Overall, 72% (n=36) achieved CR (median time 36 weeks (11-58)) and a further 18% (n=9) achieved persistent PR (median time 32 weeks (19-58)). By 52 weeks, CR and PR had been achieved in 52% (n=26) and 34% (n=17) respectively. In all, 12 relapses occurred in 11 patients, at a median time of 65.1 weeks (20-112) from remission. A total of 6/50 patients had systemic flares. Of the 45 responders, only 2 required >2 weeks of oral steroids. Adverse events were infrequent; 18% were admitted, 10% for an infective episode.

CONCLUSIONS

The rituxilup cohort demonstrates that oral steroids can be safely avoided in the treatment of LN. If findings are confirmed, it could mark a step change in the approach to the treatment of LN.

Authors+Show Affiliations

Imperial College NHS Healthcare Trust Lupus Centre, Hammersmith Hospital, London, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23740227

Citation

Condon, Marie B., et al. "Prospective Observational Single-centre Cohort Study to Evaluate the Effectiveness of Treating Lupus Nephritis With Rituximab and Mycophenolate Mofetil but No Oral Steroids." Annals of the Rheumatic Diseases, vol. 72, no. 8, 2013, pp. 1280-6.
Condon MB, Ashby D, Pepper RJ, et al. Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids. Ann Rheum Dis. 2013;72(8):1280-6.
Condon, M. B., Ashby, D., Pepper, R. J., Cook, H. T., Levy, J. B., Griffith, M., ... Lightstone, L. (2013). Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids. Annals of the Rheumatic Diseases, 72(8), pp. 1280-6. doi:10.1136/annrheumdis-2012-202844.
Condon MB, et al. Prospective Observational Single-centre Cohort Study to Evaluate the Effectiveness of Treating Lupus Nephritis With Rituximab and Mycophenolate Mofetil but No Oral Steroids. Ann Rheum Dis. 2013;72(8):1280-6. PubMed PMID: 23740227.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids. AU - Condon,Marie B, AU - Ashby,Damien, AU - Pepper,Ruth J, AU - Cook,H Terence, AU - Levy,Jeremy B, AU - Griffith,Megan, AU - Cairns,Tom D, AU - Lightstone,Liz, Y1 - 2013/06/05/ PY - 2013/6/7/entrez PY - 2013/6/7/pubmed PY - 2013/9/21/medline KW - B cells KW - Corticosteroids KW - Lupus Nephritis KW - Treatment SP - 1280 EP - 6 JF - Annals of the rheumatic diseases JO - Ann. Rheum. Dis. VL - 72 IS - 8 N2 - OBJECTIVES: Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE). All current treatment regimens include oral steroids, which are associated with severe adverse events and long-term damage. We have piloted a steroid-avoiding protocol (rituxilup) for the treatment of biopsy-proven active International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III, IV, or class V LN. METHODS: We report the findings from the first 50 consecutive patients, treated with 2 doses of rituximab (1 g) and methyl prednisolone (500 mg) on days 1 and 15, and maintenance treatment of mycophenolate mofetil. Patients on maintenance steroids or with life-threatening SLE or requiring dialysis were excluded. Renal remission was defined as serum creatinine no greater than 15% above baseline; complete biochemical remission (CR) was defined as urine protein : creatinine ratio (PCR)<50 mg/mmol or partial remission (PR) if PCR>50 mg/mmol but non-nephrotic and >50% reduction. RESULTS: A total of 45 (90%) patients achieved CR or PR by a median time of 37 weeks (range 4-200). Overall, 72% (n=36) achieved CR (median time 36 weeks (11-58)) and a further 18% (n=9) achieved persistent PR (median time 32 weeks (19-58)). By 52 weeks, CR and PR had been achieved in 52% (n=26) and 34% (n=17) respectively. In all, 12 relapses occurred in 11 patients, at a median time of 65.1 weeks (20-112) from remission. A total of 6/50 patients had systemic flares. Of the 45 responders, only 2 required >2 weeks of oral steroids. Adverse events were infrequent; 18% were admitted, 10% for an infective episode. CONCLUSIONS: The rituxilup cohort demonstrates that oral steroids can be safely avoided in the treatment of LN. If findings are confirmed, it could mark a step change in the approach to the treatment of LN. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/23740227/Prospective_observational_single_centre_cohort_study_to_evaluate_the_effectiveness_of_treating_lupus_nephritis_with_rituximab_and_mycophenolate_mofetil_but_no_oral_steroids_ L2 - http://ard.bmj.com/cgi/pmidlookup?view=long&amp;pmid=23740227 DB - PRIME DP - Unbound Medicine ER -