Nathalie E Chalhoub1, Scott E Wenderfer2, Deborah M Levy3, Kelly Rouster-Stevens4, Amita Aggarwal5, Sonia I Savani6, Natasha M Ruth6, Thaschawee Arkachaisri7, Tingting Qiu8, Angela Merritt8, Karen Onel9, Beatrice Goilav10, Raju P Khubchandani11, Jianghong Deng12, Adriana R Fonseca13, Stacy P Ardoin14, Coziana Ciurtin15, Ozgur Kasapcopur16, Marija Jelusic17, Adam M Huber18, Seza Ozen19, Marisa S Klein-Gitelman20, Simone Appenzeller21, André Cavalcanti22, Lampros Fotis23, Sern Chin Lim24, Rodrigo M Silva13, Julia Ramírez- Miramontes25, Natalie L Rosenwasser26, Claudia Saad-Magalhaes27, Dieneke Schonenberg-Meinema28, Christiaan Scott29, Clovis A Silva30, Sandra Enciso31, Maria T Terreri32, Alfonso-Ragnar Torres-Jimenez33, Maria Trachana34, Sulaiman M Al-Mayouf35, Prasad Devarajan36, Bin Huang36, Hermine I Brunner36. 1. University of Cincinnati College of Medicine, Cincinnati, Ohio. 2. Baylor College of Medicine, Houston, Texas. 3. The Hospital for Sick Children and The University of Toronto, Toronto, Ontario, Canada. 4. Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia. 5. Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. 6. Medical University of South Carolina, Charleston. 7. KK Women's and Children's Hospital, Singapore. 8. Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio. 9. Hospital for Special Surgery, New York, New York. 10. Albert Einstein College of Medicine, New York, New York. 11. SRCC Children's Hospital, Mumbai, India. 12. Capital Medical University and National Center for Children's Health, Beijing, China. 13. Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil. 14. Nationwide Children's Hospital, Columbus, Ohio. 15. University College London, London, UK. 16. Cerrahpasa Medical School, Istanbul University-Cerrahpasa, Istanbul, Turkey. 17. University of Zagreb School of Medicine, Zagreb, Croatia. 18. IWK Health Centre and Dalhousie University, Halifax, Nova Scotia, Canada. 19. Hacettepe University, Ankara, Turkey. 20. Northwestern University Feinberg School of Medicine and Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois. 21. University of Campinas, Campinas, Brazil. 22. Hospital das Clínicas da Universidade Federal de Pernambuco, Recife, Brazil. 23. National and Kapodistian University of Athens, Athens, Greece. 24. University Teknologi MARA, Sungaig Buloh, Malaysia. 25. Instituto Mexicano del Seguro Social, Monterrey, Mexico. 26. University of Washington and Seattle Children's Hospital, Seattle, Washington. 27. São Paulo State University, Botucatu, Brazil. 28. Amsterdam University Medical Center, Amsterdam, The Netherlands. 29. Red Cross War Memorial Children's Hospital and University of Cape Town, Cape Town, South Africa. 30. Universidade de São Paulo, Sao Paulo, Brazil. 31. Hospital de la Beneficencia Española, Mexico City, Mexico. 32. Universidade Federal de São Paulo, Sao Paulo, Brazil. 33. National Medical Center La Raza, Mexico City, Mexico. 34. Aristotle University of Thessaloniki, Thessaloniki, Greece. 35. King Faisal Specialist Hospital and Research Center and Alfaisal University, Riyadh, Saudi Arabia. 36. University of Cincinnati College of Medicine and Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Abstract
OBJECTIVE: To develop a standardized steroid dosing regimen (SSR) for physicians treating childhood-onset systemic lupus erythematosus (SLE) complicated by lupus nephritis (LN), using consensus formation methodology. METHODS: Parameters influencing corticosteroid (CS) dosing were identified (step 1). Data from children with proliferative LN were used to generate patient profiles (step 2). Physicians rated changes in renal and extrarenal childhood-onset SLE activity between 2 consecutive visits and proposed CS dosing (step 3). The SSR was developed using patient profile ratings (step 4), with refinements achieved in a physician focus group (step 5). A second type of patient profile describing the course of childhood-onset SLE for ≥4 months since kidney biopsy was rated to validate the SSR-recommended oral and intravenous (IV) CS dosages (step 6). Patient profile adjudication was based on majority ratings for both renal and extrarenal disease courses, and consensus level was set at 80%. RESULTS: Degree of proteinuria, estimated glomerular filtration rate, changes in renal and extrarenal disease activity, and time since kidney biopsy influenced CS dosing (steps 1 and 2). Considering these parameters in 5,056 patient profile ratings from 103 raters, and renal and extrarenal course definitions, CS dosing rules of the SSR were developed (steps 3-5). Validation of the SSR for up to 6 months post-kidney biopsy was achieved with 1,838 patient profile ratings from 60 raters who achieved consensus for oral and IV CS dosage in accordance with the SSR (step 6). CONCLUSION: The SSR represents an international consensus on CS dosing for use in patients with childhood-onset SLE and proliferative LN. The SSR is anticipated to be used for clinical care and to standardize CS dosage during clinical trials.
OBJECTIVE: To develop a standardized steroid dosing regimen (SSR) for physicians treating childhood-onset systemic lupus erythematosus (SLE) complicated by lupus nephritis (LN), using consensus formation methodology. METHODS: Parameters influencing corticosteroid (CS) dosing were identified (step 1). Data from children with proliferative LN were used to generate patient profiles (step 2). Physicians rated changes in renal and extrarenal childhood-onset SLE activity between 2 consecutive visits and proposed CS dosing (step 3). The SSR was developed using patient profile ratings (step 4), with refinements achieved in a physician focus group (step 5). A second type of patient profile describing the course of childhood-onset SLE for ≥4 months since kidney biopsy was rated to validate the SSR-recommended oral and intravenous (IV) CS dosages (step 6). Patient profile adjudication was based on majority ratings for both renal and extrarenal disease courses, and consensus level was set at 80%. RESULTS: Degree of proteinuria, estimated glomerular filtration rate, changes in renal and extrarenal disease activity, and time since kidney biopsy influenced CS dosing (steps 1 and 2). Considering these parameters in 5,056 patient profile ratings from 103 raters, and renal and extrarenal course definitions, CS dosing rules of the SSR were developed (steps 3-5). Validation of the SSR for up to 6 months post-kidney biopsy was achieved with 1,838 patient profile ratings from 60 raters who achieved consensus for oral and IV CS dosage in accordance with the SSR (step 6). CONCLUSION: The SSR represents an international consensus on CS dosing for use in patients with childhood-onset SLE and proliferative LN. The SSR is anticipated to be used for clinical care and to standardize CS dosage during clinical trials.
Authors: Hermine I Brunner; Michael Holland; Michael W Beresford; Stacy P Ardoin; Simone Appenzeller; Clovis A Silva; Francisco Flores; Beatrice Goilav; Scott E Wenderfer; Deborah M Levy; Angelo Ravelli; Raju Khunchandani; Tadej Avcin; Marisa S Klein-Gitelman; Brian M Feldman; Nicolino Ruperto; Jun Ying Journal: Arthritis Care Res (Hoboken) Date: 2018-04-25 Impact factor: 4.794