Table 1.

Suggested correlation of SLEDAI-2000 and BILAG 2004 clinical parameters for SLE clinical trials^a

SLEDAI-2000 termb	BILAG 2004 parameterc	Comment
Seizure	30. Seizure disorders
	31. Status epilepticus
Psychosis	24. Psychosis
(3) Organic brain syndrome	23. Acute confusional state
(4) Visual disturbance (limited to retinal changes of SLE)	69, 70. Posterior uveitis/retinal vasculitis—mild and severe	SLEDAI-2000 definition includes only retinal lesions; original SLEDAI and SELENA-SLEDAI included all areas of the eye
	74. Retinal/choroidal vaso-occlusive disease
	75. Isolated cotton-wool spots/cytoid bodies
	76. Optic neuritis
	77. Anterior ischemic optic neuropathy
(5) Cranial nerve disorder	27. Cranial neuropathy
(6) Lupus headache	37. Lupus headache—severe unremitting	Intended to be associated with active cerebral inflammation
	38. Headache from IC hypertension
(7) CVA	32. Cerebrovascular disease
(8) Vasculitis	13. Major cutaneous vasculitis/thrombosis	Confirm splinter hemorrhages are due to serious vasculitis
	18. Splinter hemorrhages
	20. Cerebral vasculitis
	51. Pulmonary hemorrhage/vasculitis
	55. Coronary vasculitis
	58. Lupus enteritis or colitis if vasculitis confirmed or other condition in which vasculitis is documented by imaging or biopsy
(9) Arthritis	41. Arthritis (severe)	Note that SLEDAI-2000 requires ≥2 joints involved, while original SLEDAI and SELENA-SLEDAI required >2 joints (at least 3)
	42. Arthritis (moderate) if at least 2 joints involved
(10) Myositis	39. Myositis—severe
	40. Myositis—mild
(11) Urinary casts	88. Active urinary sediment and supporting laboratory value	Rarely detected in central laboratory urine specimens due to transport requirement; fresh urine sample in clinic required to detect
(12) Hematuria	88. Active urinary sediment and supporting laboratory value
(13) Proteinuria >0.5 g/24 h, new or recent onset	81. Urine dipstick protein ≥3
	83. UPCR ≥50 mg/mmol
	85. Nephrotic syndrome
(14) Pyuria >5 WBC/hpf, excluding infection	88. Active urinary sediment and supporting laboratory value
(15) (New) rash	5. Skin eruption—severe
	6. Skin eruption—mild
	7. Angioedema—severe
	8. Angioedema—mild
	17. Periungual erythema/chilblains
(16) Alopecia	15. Alopecia—severe
	16. Alopecia—mild
(17) Mucosal ulcers	9. Mucosal ulceration—severe
	10. Mucosal ulceration—mild
(18) Pleurisy	48. Pleurisy/pericarditis
	50. Pleural effusion with dyspnea
(19) Pericarditis	49. Cardiac tamponade
	48. Pleurisy/pericarditis
(20) Low complement	Not applicable to BILAG-2004	Not applicable to BILAG-2004
(21) Increased DNA binding	Central laboratory value	Not applicable to BILAG-2004
(22) Fever	1. Pyrexia, any 1–4	Note difference in glossary definitions
(23) Thrombocytopenia	Central laboratory value
(24) Leukopenia	Central laboratory value

^aThis is a guidance only. Depending on the clinical presentation, other BILAG-2004 terms may match with SLEDAI-2004 terms

^bSee Gladman et al. [16]

^cSee [20–22]