Table 4 Estimates of the risk of... | American Society of Hematology

Table 4

Estimates of the risk of inhibitors development in previously treated hemophilia patients

Year	Author/reference	Study design	Sample	Follow-up, mo	Inhibitors	Rate, × 1000 patient/years	Age, y
1988	McMillan et al⁵⁴*	Prospective	1306	48	31	0.0080
1995	Colvin et al⁵⁵†	Cross-sectional	2160	48	32	0.0015
2004	Darby et al⁵‡	Registry	6078	24	133	0.0020	≥ 15
					42	0.0029	5-14
2006	Kempton et al⁵⁶§	Prospective	838	48	7	0.0021
2011	Hay et al⁷‖	Registry	2258	144	106	0.0053	10-49
					11	0.0052	50-59

Year	Author/reference	Study design	Sample	Follow-up, mo	Inhibitors	Rate, × 1000 patient/years	Age, y
1988	McMillan et al⁵⁴*	Prospective	1306	48	31	0.0080
1995	Colvin et al⁵⁵†	Cross-sectional	2160	48	32	0.0015
2004	Darby et al⁵‡	Registry	6078	24	133	0.0020	≥ 15
					42	0.0029	5-14
2006	Kempton et al⁵⁶§	Prospective	838	48	7	0.0021
2011	Hay et al⁷‖	Registry	2258	144	106	0.0053	10-49
					11	0.0052	50-59

Patient of all severities. A total of 14 inhibitors were in patients > 75 ED; 11 of 14 were low titer, and 6 of 14 were transient. Total patients with > 75 ED not reported but rate likely estimated at .0023.

†

Only patients with factor VIII < 0.03 U/mL were studied. A total of 13 inhibitors were in patients > 10 years of age. Total patients > 10 years not reported, but the rate was definitely < 0.002.

‡

Patients of all severities. 95% confidence interval for ≥ 15 was 0.0017-0.0023. Rate was 0.0052 in severe patients 5-14 years of age and 0.0038 in those ≥ 15 years of age.

Patients of all severities with negative titer before and at enrollment in UDC. All had > 50 ED. Two additional transient inhibitor were reported; 6 of 7 inhibitors were low titer.

‖

Severe patients only. Of the 106 inhibitors in patients 10-49 years of age, 54 were high and 28 were low titer. Of the 11 in patients 50-59 years of age, 9 were high and 9 were low titer.

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