Association of brand of rFVIII with the risk of inhibitor development
| . | . | All inhibitor development . | High-titer inhibitor development . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| . | n . | Events n (%) [95% CI] . | Unadjusted HR (95% CI) . | P . | Adjusted HR (95% CI) . | P . | Events n (%) . | Unadjusted HR (95% CI) . | P . | Adjusted HR (95% CI) . | P . |
| All patients (n = 407) | |||||||||||
| Advate | 172 | 42 (24.4) [18.6-31.4] | 1.00 | Ref | 1.00 | Ref | 19 (11.1) [7.2-16.6] | 1.00 | Ref | 1.00 | NA |
| Kogenate Bayer/Helixate NexGen | 128 | 45 (35.2) [27.4-43.8] | 1.63 (1.07-2.48) | .02 | 1.75 (1.11-2.76) | .02 | 25 (19.5) [13.6-27.2] | 1.97 (1.09-3.59) | .03 | 2.14 (1.12-4.10) | .02 |
| Refacto | 52 | 12 (23.1) [13.7-36.1] | 0.93 (0.49-1.77) | .83 | 0.79 (0.36-1.73) | .55 | 10 (19.2) [10.8-31.9] | 1.70 (0.79-3.65) | .18 | 1.52 (0.57-4.04) | .40 |
| Refacto AF | 44 | 15 (34.1) [21.9-48.9] | 1.95 (1.08-3.52) | .03 | 2.63 (1.26-5.47) | .01 | 3 (6.8) [2.3-18.2] | 0.87 (0.26-2.94) | .82 | 1.28 (0.33-5.00) | .72 |
| Recombinate | 11 | 4 (36.4) [15.2-64.6] | 2.19 (0.78-6.11) | .14 | 1.95 (0.62-6.20) | .26 | 3 (27.3) [9.7-56.6] | 3.54 (1.05-12.00) | .04 | 3.68 (0.88-15.35) | .07 |
| Patients not included in RODIN | |||||||||||
| Advate | 124 | 29 (23.4) [16.8-31.6] | 1.00 | Ref | 1.00 | Ref | 14 (11.3) [6.8-18.1] | 1.00 | Ref | 1.00 | Ref |
| Kogenate Bayer/Helixate NexGen | 107 | 35 (32.7) [24.6-42.1] | 1.60 (0.98-2.62) | .06 | 1.64 (0.94-2.87) | .08 | 19 (17.8) [11.7-26.1] | 1.77 (0.89-3.54) | .11 | 2.00 (0.93-4.34) | .08 |
| Patients included in RODIN | |||||||||||
| Advate | 48 | 13 (27.1) [16.6-41.0] | 1.00 | Ref | 1.00 | Ref | 5 (10.4) [4.5-22.2] | 1.00 | Ref | 1.00 | Ref |
| Kogenate Bayer/Helixate NexGen | 21 | 10 (47.6) [28.3-67.6] | 2.01 (0.88-4.59) | .10 | 3.58 (1.25-10.27) | .02 | 6 (28.6) [13.8-50.0] | 3.17 (0.97-10.40) | .06 | 2.90 (0.49-17.13) | .24 |
| . | . | All inhibitor development . | High-titer inhibitor development . | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| . | n . | Events n (%) [95% CI] . | Unadjusted HR (95% CI) . | P . | Adjusted HR (95% CI) . | P . | Events n (%) . | Unadjusted HR (95% CI) . | P . | Adjusted HR (95% CI) . | P . |
| All patients (n = 407) | |||||||||||
| Advate | 172 | 42 (24.4) [18.6-31.4] | 1.00 | Ref | 1.00 | Ref | 19 (11.1) [7.2-16.6] | 1.00 | Ref | 1.00 | NA |
| Kogenate Bayer/Helixate NexGen | 128 | 45 (35.2) [27.4-43.8] | 1.63 (1.07-2.48) | .02 | 1.75 (1.11-2.76) | .02 | 25 (19.5) [13.6-27.2] | 1.97 (1.09-3.59) | .03 | 2.14 (1.12-4.10) | .02 |
| Refacto | 52 | 12 (23.1) [13.7-36.1] | 0.93 (0.49-1.77) | .83 | 0.79 (0.36-1.73) | .55 | 10 (19.2) [10.8-31.9] | 1.70 (0.79-3.65) | .18 | 1.52 (0.57-4.04) | .40 |
| Refacto AF | 44 | 15 (34.1) [21.9-48.9] | 1.95 (1.08-3.52) | .03 | 2.63 (1.26-5.47) | .01 | 3 (6.8) [2.3-18.2] | 0.87 (0.26-2.94) | .82 | 1.28 (0.33-5.00) | .72 |
| Recombinate | 11 | 4 (36.4) [15.2-64.6] | 2.19 (0.78-6.11) | .14 | 1.95 (0.62-6.20) | .26 | 3 (27.3) [9.7-56.6] | 3.54 (1.05-12.00) | .04 | 3.68 (0.88-15.35) | .07 |
| Patients not included in RODIN | |||||||||||
| Advate | 124 | 29 (23.4) [16.8-31.6] | 1.00 | Ref | 1.00 | Ref | 14 (11.3) [6.8-18.1] | 1.00 | Ref | 1.00 | Ref |
| Kogenate Bayer/Helixate NexGen | 107 | 35 (32.7) [24.6-42.1] | 1.60 (0.98-2.62) | .06 | 1.64 (0.94-2.87) | .08 | 19 (17.8) [11.7-26.1] | 1.77 (0.89-3.54) | .11 | 2.00 (0.93-4.34) | .08 |
| Patients included in RODIN | |||||||||||
| Advate | 48 | 13 (27.1) [16.6-41.0] | 1.00 | Ref | 1.00 | Ref | 5 (10.4) [4.5-22.2] | 1.00 | Ref | 1.00 | Ref |
| Kogenate Bayer/Helixate NexGen | 21 | 10 (47.6) [28.3-67.6] | 2.01 (0.88-4.59) | .10 | 3.58 (1.25-10.27) | .02 | 6 (28.6) [13.8-50.0] | 3.17 (0.97-10.40) | .06 | 2.90 (0.49-17.13) | .24 |
Data are adjusted for ethnic group, age at first exposure to factor VIII, year of first factor VIII exposure, center of first treatment, FH of hemophilia, FH of inhibitors, intensive treatment at first treatment, and FVIII genotype (adjusted for high/low risk as defined in “Methods”). Missing data have been imputed by multiple logistic regression models. Where subjects have been subdivided into RODIN and non-RODIN groups, only Advate and Kogenate Bayer/Helixate NexGen have been reported because of limited numbers.
Ref, reference group.