Table 1. Subset of clinical and... | American Society of Hematology

Table 1.

Subset of clinical and laboratory features considered in determining diagnostic criteria

	Systematic literature review cases (N = 128)¹¹				Siltuximab trial cases (N = 79)²³				Submitted cases (N = 37)
Clinical features	Reported positive finding	Reported positive or negative finding	% of patients, minimum*	% of patients, maximum†	Reported positive finding	Reported positive or negative finding	% of patients, minimum*	% of patients, maximum†	Reported positive finding	Reported positive or negative finding	% of patients, maximum*
Multicentric lymphadenopathy	128	128	100	100					37	37	100
Constitutional symptoms
Fatigue					68	79	86	86	3	3	100
Night sweats	13	21	10	62	41	79	52	52	1	1	100
Weight loss	21	29	16	72	24	79	30	30
Fever	33	64	26	52	13	79	17	17	25	37	68
Enlarged liver ± spleen (per CT)	52	67	41	78					10	14	71
Palpable liver					10	79	13	13	1	2	50
Palpable spleen or splenomegaly					9	79	11	11	11	24	46
Edema, ascites, ± anasarca‡	29	37	23	78	34	79	43	43	23	37	62
Laboratory features
Low hemoglobin§	79	91	62	87	32	59	41	54	28	37	76
Thrombocytopenia‖	28	63	22	44	5	59	6	8	13	15	87
Thrombocytosis¶	16	63	13	25	15	59	19	25	1	15	7
Elevated ESR#	44	48	34	92	35	52	44	67
Elevated CRP**	65	79	51	82	41	79	49	52	31	37	84
Elevated sIL-2R††	20	21	16	95					6	12	50
Elevated VEGF‡‡	16	20	13	80					7	9	78
Elevated IL-6a	57	63	45	90	13	75	17	17	12	12	100
Elevated IgG levelsb	63	82	49	77	36	79	46	46	19	37	51
Elevated IgA levelsc					32	79	41	41
Hypoalbuminemiad	57	63	45	90	24	57	30	42	25	37	68
Renal dysfunctione	12	17	9	71	5	57	6	9	9	15	60

	Systematic literature review cases (N = 128)¹¹				Siltuximab trial cases (N = 79)²³				Submitted cases (N = 37)
Clinical features	Reported positive finding	Reported positive or negative finding	% of patients, minimum*	% of patients, maximum†	Reported positive finding	Reported positive or negative finding	% of patients, minimum*	% of patients, maximum†	Reported positive finding	Reported positive or negative finding	% of patients, maximum*
Multicentric lymphadenopathy	128	128	100	100					37	37	100
Constitutional symptoms
Fatigue					68	79	86	86	3	3	100
Night sweats	13	21	10	62	41	79	52	52	1	1	100
Weight loss	21	29	16	72	24	79	30	30
Fever	33	64	26	52	13	79	17	17	25	37	68
Enlarged liver ± spleen (per CT)	52	67	41	78					10	14	71
Palpable liver					10	79	13	13	1	2	50
Palpable spleen or splenomegaly					9	79	11	11	11	24	46
Edema, ascites, ± anasarca‡	29	37	23	78	34	79	43	43	23	37	62
Laboratory features
Low hemoglobin§	79	91	62	87	32	59	41	54	28	37	76
Thrombocytopenia‖	28	63	22	44	5	59	6	8	13	15	87
Thrombocytosis¶	16	63	13	25	15	59	19	25	1	15	7
Elevated ESR#	44	48	34	92	35	52	44	67
Elevated CRP**	65	79	51	82	41	79	49	52	31	37	84
Elevated sIL-2R††	20	21	16	95					6	12	50
Elevated VEGF‡‡	16	20	13	80					7	9	78
Elevated IL-6a	57	63	45	90	13	75	17	17	12	12	100
Elevated IgG levelsb	63	82	49	77	36	79	46	46	19	37	51
Elevated IgA levelsc					32	79	41	41
Hypoalbuminemiad	57	63	45	90	24	57	30	42	25	37	68
Renal dysfunctione	12	17	9	71	5	57	6	9	9	15	60

BUN, blood urea nitrogen; CRP, C-reactive protein; CT, computed tomography; ESR, erythrocyte sedimentation rate; IL-6, interleukin-6; sIL-2R, soluble interleukin-2 receptor; VEGF, vascular endothelial growth factor.

Positive cases divided by the number of total cases.

†

Positive cases divided by reported positive and negative findings.

‡

For siltuximab trial patients, definition of “fluid retention” was used.

For systematic review patients: hemoglobin <115 g/L or stated “anemic”; for siltuximab trial patients, hemoglobin less than stated reference range; and for submitted cases patients, hemoglobin <125 g/L.

‖

For systematic review patients, platelet count <150 × 10⁹/L or stated “thrombocytopenia”; for siltuximab trial patients, platelet count less than stated reference range; and for submitted cases patients, platelet count <150 × 10⁹/L.

For systematic review patients, platelet count >500 × 10⁹/L or stated “thrombocytosis”; for siltuximab trial patients, platelet count greater than stated reference range; and for submitted cases patients, platelet count >500 × 10⁹/L.

For systematic review patients, ESR >30 mm/h or stated “elevated ESR”; and for siltuximab trial patients, ESR greater than stated reference range.

For systematic review patients, CRP >10 mg/L or CRP >95.24 nmol/L; for siltuximab trial patients, CRP greater than stated reference range; and for submitted cases patients, CRP >10 mg/L.

††

For systematic review patients, sIL-2R greater than stated reference range; and for submitted cases patients, sIL-2R greater than stated reference range.

‡‡

For systematic review patients, VEGF >100 pg/mL or VEGF greater than stated reference range; and for submitted cases patients, VEGF greater than stated reference range.

For systematic review patients, IL-6 >6 pg/mL or IL-6 greater than stated reference range; for siltuximab trial patients, IL-6 greater than stated reference range; and for submitted cases patients, IL-6 greater than stated reference range.

For systematic review patients, IgG >1700 mg/dL or stated “hypergammaglobulinemia”; for siltuximab trial patients, IgG greater than stated reference range; and for submitted cases patients, IgG >17 000 g/L.

For siltuximab trial patients, IgA greater than stated reference range.

For systematic review patients, albumin <3.5 g/dL; for siltuximab trial patients, albumin less than stated reference range; and for submitted cases patients, albumin <35 g/L.

For systematic review patients, creatinine >106 μmol/L or BUN >7.14 mmol/L; for siltuximab trial patients, creatinine greater than stated reference range; and for submitted cases patients, creatinine >106 μmol/L or greater than stated reference range, or BUN >7.14 mmol/L.

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