Indices to assess patients with systemic lupus erythematosus in clinical trials, long-term observational studies, and clinical care

Clinical and Experimental Rheumatology

Volumn 32, Issue , 2014, Pages S85-S95

  Castrejón, Isabel ^a   Tani, Chiara ^b   Jolly, Meenakshi ^a   Huang, Annie ^a   Mosca, Marta ^b  

^a RUSH UNIVERSITY MEDICAL CENTER   (United States)

^b UNIVERSITY OF PISA   (Italy)

Author keywords

Assessment; Damage index; Disease activity index; Quality of life; Response index; Systemic lupus erythematosus

Indexed keywords

ARTICLE; BRIEF INDEX OF LUPUS DAMAGE; BRITISH ISLES LUPUS ASSESSMENT GROUP INDEX; EUROPEAN CONSENSUS LUPUS ACTIVITY MEASUREMENT; HUMAN; LUPUS ACTIVITY INDEX; LUPUS DAMAGE INDEX QUESTIONNAIRE; LUPUS PATIENT REPORTED OUTCOME; PATIENT MONITORING; PRIORITY JOURNAL; QUALITY OF LIFE; RELIABILITY; RESPONDER INDEX FOR LUPUS ERYTHEMATOSUS; ROUTINE ASSESSMENT OF PATIENT INDEX DATA 3; SENSITIVITY AND SPECIFICITY; SHORT FORM 36; SLEDAI; SYSTEMIC LUPUS ACTIVITY MEASURE; SYSTEMIC LUPUS ERYTHEMATOSUS; SYSTEMIC LUPUS ERYTHEMATOSUS ACTIVITY QUESTIONNAIRE; TREATMENT RESPONSE; VALIDATION PROCESS; VALIDITY; CLINICAL PATHWAY; CLINICAL TRIAL (TOPIC); DISABILITY; LUPUS ERYTHEMATOSUS, SYSTEMIC; OBSERVATIONAL STUDY; PAIN MEASUREMENT; PREDICTIVE VALUE; PROCEDURES; QUESTIONNAIRE; RHEUMATOLOGY; SEVERITY OF ILLNESS INDEX; TIME; TREATMENT OUTCOME;

CLINICAL TRIALS AS TOPIC; CRITICAL PATHWAYS; DISABILITY EVALUATION; HUMANS; LUPUS ERYTHEMATOSUS, SYSTEMIC; OBSERVATIONAL STUDY AS TOPIC; PAIN MEASUREMENT; PREDICTIVE VALUE OF TESTS; QUESTIONNAIRES; RHEUMATOLOGY; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84922393224     PISSN: 0392856X     EISSN: 1593098X     Source Type: Journal    
DOI: None     Document Type: Article

References (61)

1. GOLDSMITH CH, SMYTHE HA, HELEWA A: Interpretation and power of a pooled index. J Rheumatol 1993; 20: 575-8.
2. WOLLASTON SJ, FAREWELL VT, ISENBERG DA et al.: Defining response in systemic lupus erythematosus: a study by the Systemic Lupus International Collaborating Clinics group. J Rheumatol 2004; 31: 2390-4.
3. NOSSENT J, KISS E, ROZMAN B et al.: Disease activity and damage accrual during the early disease course in a multinational inception cohort of patients with systemic lupus erythematosus. Lupus 2010; 19: 949-56.
4. ROMERO-DIAZ J, ISENBERG D, RAMSEYGOLDMAN R: Measures of adult systemic lupus erythematosus: updated version of British Isles Lupus Assessment Group (BILAG 2004), European Consensus Lupus Activity Measurements (ECLAM), Systemic Lupus Activity Measure, Revised (SLAMR), Systemic Lupus Activity Questionnaire for Population Studies (SLAQ), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Arthritis Care Res (Hoboken) 2011; 63 (Suppl. 11): S37-46.
5. CASTREJON I, RUA-FIGUEROA I, ROSARIO MP, CARMONA L: Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Reumatol Clin 2014; 10: 309-20.
6. SYMMONS DP, COPPOCK JS, BACON PA et al.: Development and assessment of a computerized index of clinical disease activity in systemic lupus erythematosus. Members of the British Isles Lupus Assessment Group (BILAG). Q J Med 1988; 69: 927-37.
7. ISENBERG DA, RAHMAN A, ALLEN E et al.: BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford) 2005; 44: 902-6.
8. RAMSEY-GOLDMAN R, ISENBERG DA: Systemic lupus erythematosus measures: British Isles Lupus Assessment Group (BILAG), European Consensus Lupus Activity Measurement (ECLAM), Systemic Lupus Activity Measure (SLAM), Systemic Lupus Erythematosus Disease Activity Measure (SLEDAI), and Systemic Lupus International Collaborating Clinics/American College of Rheumatology-Damage Index (SLICC/ ACR-DI; SDI). Arthritis Care & Research 2003; 49: S225-S33.
9. STOLL T, STUCKI G, MALIK J, PYKE S, ISENBERG DA: Further validation of the BILAG disease activity index in patients with systemic lupus erythematosus. Ann Rheum Dis 1996; 55: 756-60.
10. GORDON C, SUTCLIFFE N, SKAN J, STOLL T, ISENBERG DA: Definition and treatment of lupus flares measured by the BILAG index. Rheumatology (Oxford) 2003; 42: 1372-9.
11. ISENBERG DA, GORDON C: From BILAG to BLIPS-disease activity assessment in lupus past, present and future. Lupus 2000; 9: 651-4.
12. VITALI C, BENCIVELLI W, ISENBERG DA et al.: Disease activity in systemic lupus erythematosus: report of the Consensus Study Group of the European Workshop for Rheumatology Research. II. Identification of the variables indicative of disease activity and their use in the development of an activity score. The European Consensus Study Group for Disease Activity in SLE. Clin Exp Rheumatol 1992; 10: 541-7.
13. BENCIVELLI W, VITALI C, ISENBERG DA et al.: Disease activity in systemic lupus erythematosus: report of the Consensus Study Group of the European Workshop for Rheumatology Research. III. Development of a computerised clinical chart and its application to the comparison of different indices of disease activity. The European Consensus Study Group for Disease Activity in SLE. Clin Exp Rheumatol 1992; 10: 549-54.
14. MOSCA M, BENCIVELLI W, VITALI C, CARRAI P, NERI R, BOMBARDIERI S: The validity of the ECLAM index for the retrospective evaluation of disease activity in systemic lupus erythematosus. Lupus 2000; 9: 445-50.
15. VITALI C, BENCIVELLI W, MOSCA M, CARRAI P, SERENI M, BOMBARDIERI S: Development of a clinical chart to compute different disease activity indices for systemic lupus erythematosus. J Rheumatol 1999; 26: 498-501.
16. LIANG MH, SOCHER SA, LARSON MG, SCHUR PH: Reliability and validity of six systems for the clinical assessment of disease activity in systemic lupus erythematosus. Arthritis Rheum 1989; 32: 1107-18.
17. BAE SC, KOH HK, CHANG DK, KIM MH, PARK JK, KIM SY: Reliability and validity of systemic lupus activity measure-revised (SLAM-R) for measuring clinical disease activity in systemic lupus erythematosus. Lupus 2001; 10: 405-9.
18. ISENBERG DA, ALLEN E, FAREWELL V et al.: An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. Ann Rheum Dis 2011; 70: 54-9.
19. BOMBARDIER C, GLADMAN DD, UROWITZ MB, CARON D, CHANG CH: Derivation of the SLEDAI. A disease activity index for lupus patients. The Committee on Prognosis Studies in SLE. Arthritis Rheum 1992; 35: 630-40.
20. PETRI M, BUYON J, SKOVRON ML, KIM M: Disease activity and health status (SF-36) in postmenopausal systemic lupus erythematosus: the SELENA trial. Arthritis Rheum 1987; 40.
21. GLADMAN DD, IBANEZ D, UROWITZ MB: Systemic lupus erythematosus disease activity index 2000. J Rheumatol 2002; 29: 288-91.
22. GUZMAN J, CARDIEL MH, ARCE-SALINAS A, SANCHEZ-GUERRERO J, ALARCON-SEGOVIA D: Measurement of disease activity in systemic lupus erythematosus. Prospective validation of 3 clinical indices. J Rheumatol 1992; 19: 1551-8.
23. GLADMAN DD, GOLDSMITH CH, UROWITZ MB et al.: Sensitivity to change of 3 Systemic Lupus Erythematosus Disease Activity Indices: international validation. J Rheumatol 1994; 21: 1468-71.
24. CHANG E, ABRAHAMOWICZ M, FERLAND D, FORTIN PR: Comparison of the responsiveness of lupus disease activity measures to changes in systemic lupus erythematosus activity relevant to patients and physicians. J Clin Epidemiol 2002; 55: 488-97.
25. TOUMA Z, UROWITZ MB, GLADMAN DD: SLEDAI-2K for a 30-day window. Lupus 2010; 19: 49-51.
26. TOUMA Z, UROWITZ MB, IBANEZ D, GLADMAN DD: SLEDAI-2K 10 days versus SLEDAI-2K 30 days in a longitudinal evaluation. Lupus 2011; 20: 67-70.
27. TOUMA Z, UROWITZ MB, FORTIN PR et al.: Systemic lupus erythematosus disease activity index 2000 responder index-50: a reliable index for measuring improvement in disease activity. J Rheumatol 2011; 38: 868-73.
28. ABRAHAMOWICZ M, FORTIN PR, du BERGER R, NAYAK V, NEVILLE C, LIANG MH: The relationship between disease activity and expert physician's decision to start major treatment in active systemic lupus erythematosus: a decision aid for development of entry criteria for clinical trials. J Rheumatol 1998; 25: 277-84.
29. RATAIN JS, PETRI M, HOCHBERG MC, HELLMANN DB: Accuracy of creatinine clearance in measuring glomerular filtration rate in patients with systemic lupus erythematosus without clinical evidence of renal disease. Arthritis Rheum 1990; 33: 277-80.
30. PETRI M, BOCKENSTEDT L, COLMAN J et al.: Serial assessment of glomerular filtration rate in lupus nephropathy. Kidney international 1988; 34: 832-9.
31. HELLMANN DB, PETRI M, WHITINGO'KEEFE Q: Fatal infections in systemic lupus erythematosus: the role of opportunistic organisms. Medicine 1987; 66: 341-8.
32. PETRI M, HELLMANN D, HOCHBERG M: Validity and reliability of lupus activity measures in the routine clinic setting. J Rheumatol 1992; 19: 53-9.
33. KARLSON EW, DALTROY LH, RIVEST C et al.: Validation of a Systemic Lupus Activity Questionnaire (SLAQ) for population studies. Lupus 2003; 12: 280-6.
34. YAZDANY J, YELIN EH, PANOPALIS P, TRUPIN L, JULIAN L, KATZ PP: Validation of the systemic lupus erythematosus activity questionnaire in a large observational cohort. Arthritis Rheum 2008; 59: 136-43.
35. PETRI M, BARR SG, BUYON J, DAVIS A, GINZLER E, KALUNIAN K: RIFLE: Responder Index for Lupus Erythematosus [abstract]. Arthritis Rheum 2000; 43: S244.
36. FURIE RA, PETRI MA, WALLACE DJ et al.: Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum 2009; 61: 1143-51.
37. WALLACE DJ, KALUNIAN K, PETRI MA et al.: Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, doubleblind, placebo-controlled, multicentre study. Ann Rheum Dis 2014; 73: 183-90.
38. AMERICAN COLLEGE OF RHEUMATOLOGY AD HOC COMMITTEE ON SYSTEMIC LUPUS ERYTHEMATOSUS RESPONSE CRITERIA: The American College of Rheumatology response criteria for systemic lupus erythematosus clinical trials: measures of overall disease activity. Arthritis Rheum 2004; 50: 3418-26.
39. PETRI M, KASITANON N, SINGH S et al.: Systemic lupus international collaborating clinics renal activity/response exercise: comparison of agreement in rating renal response. Arthritis Rheum 2008; 58: 1789-95.
40. FURIE R, PETRI M, ZAMANI O et al.: A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum 2011; 63: 3918-30.
41. WALLACE DJ, STOHL W, FURIE RA et al.: A phase II, randomized, double-blind, placebo-controlled, dose-ranging study of belimumab in patients with active systemic lupus erythematosus. Arthritis Rheum 2009; 61: 1168-78.
42. FORTIN PR, ABRAHAMOWICZ M, CLARKE AE et al.: Do lupus disease activity measures detect clinically important change? J Rheumatol 2000; 27: 1421-8.
43. WARD MM, MARX AS, BARRY NN: Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. J Rheumatol 2000; 27: 664-70.
44. GLADMAN D, GINZLER E, GOLDSMITH C et al.: The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum 1996; 39: 363-9.
45. THUMBOO J, LEE HY, FONG KY et al.: Accuracy of medical record scoring of the SLICC/ACR damage index for systemic lupus erythematosus. Lupus 2000; 9: 358-62.
46. GLADMAN DD, GOLDSMITH CH, UROWITZ MB et al.: The Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index for Systemic Lupus Erythematosus International Comparison. J Rheumatol 2000; 27: 373-6.
47. RAHMAN P, GLADMAN DD, UROWITZ MB, HALLETT D, TAM LS: Early damage as measured by the SLICC/ACR damage index is a predictor of mortality in systemic lupus erythematosus. Lupus 2001; 10: 93-6.
48. COSTENBADER KH, KHAMASHTA M, RUIZGARCIA S et al.: Development and initial validation of a self-assessed lupus organ damage instrument. Arthritis Care Res (Hoboken) 2010; 62: 559-68.
49. PONS-ESTEL BA, SANCHEZ-GUERRERO J, ROMERO-DIAZ J et al.: Validation of the Spanish, Portuguese and French versions of the Lupus Damage Index questionnaire: data from North and South America, Spain and Portugal. Lupus 2009; 18: 1033-52.
50. YAZDANY J, TRUPIN L, GANSKY SA et al.: Brief index of lupus damage: a patient-reported measure of damage in systemic lupus erythematosus. Arthritis Care Res (Hoboken) 2011; 63: 1170-7.
51. FEI Y, SHI X, GAN F et al.: Death causes and pathogens analysis of systemic lupus erythematosus during the past 26 years. Clinical rheumatology 2014; 33: 57-63.
52. MORONI G, LONGHI S, GIGLIO E, MESSA P, PONTICELLI C: What happens after complete withdrawal of therapy in patients with lupus nephritis. Clin Exp Rheumatol 2013; 31: S75-81.
53. MOSCA M, TANI C, ARINGER M et al.: European League Against Rheumatism recommendations for monitoring patients with systemic lupus erythematosus in clinical practice and in observational studies. Ann Rheum Dis 2010; 69: 1269-74.
54. CASTREJON I, McCOLLUM L, TANRIOVER MD, PINCUS T: Importance of patient history and physical examination in rheumatoid arthritis compared to other chronic diseases: Results of a physician survey. Arthritis Care Res (Hoboken) 2012; 64: 1250-5.
55. WARE JE, Jr., SHERBOURNE CD: The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Medical care 1992; 30: 473-83.
56. PINCUS T, SWEARINGEN CJ, BERGMAN MJ et al.: RAPID3 (Routine Assessment of Patient Index Data) on an MDHAQ (Multidimensional Health Assessment Questionnaire): agreement with DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) activity categories, scored in five versus more than ninety seconds. Arthritis Care Res (Hoboken) 2010; 62: 181-9.
57. JOLLY M, PICKARD AS, BLOCK JA et al.: Disease-Specific Patient Reported Outcome Tools for Systemic Lupus Erythematosus. Semin Arthritis Rheum 2012; 42: 56-65.
58. JOLLY M: How does quality of life of patients with systemic lupus erythematosus compare with that of other common chronic illnesses? J Rheumatol 2005; 32: 1706-8.
59. ASKANASE AD, CASTREJON I, PINCUS T: Quantitative data for care of patients with systemic lupus erythematosus in usual clinical settings: a patient Multidimensional Health Assessment Questionnaire and physician estimate of noninflammatory symptoms. J Rheumatol 2011; 38: 1309-16.
60. CASTREJON I, BERGMAN MJ, PINCUS T: MDHAQ/RAPID3 to recognize improvement over 2 months in usual care of patients with osteoarthritis, systemic lupus erythematosus, spondyloarthropathy, and gout, as well as rheumatoid arthritis. J Clin Rheumatol 2013; 19: 169-74.
61. JOLLY M, KOSINSKI M, TOLOZA S et al.: Equivalence of Various Language Versions of Lupus Specific Patient Reported Outcomes Measure (LupusPRO). Arthritis Rheum 2012; 64: S607.