Indication | Total | RA | AS | PsA | PSO | CD | UC |
---|---|---|---|---|---|---|---|
Baseline characteristics | |||||||
n | 1632 (100) | 654 (40.1) | 286 (17.5) | 89 (5.5) | 153 (9.4) | 307 (18.8) | 109 (6.7) |
Age, mean, yrs | 48.2 | 54.9 | 45.5 | 49.0 | 48.3 | 39.5 | 41.7 |
Female | 910 (55.8) | 474 (72.5) | 75 (26.2) | 41 (46.1) | 67 (43.8) | 181 (59.0) | 53 (48.6) |
Baseline weight, kg, mean | 78.8 | 77.3 | 80.4 | 86.6 | 93.6 | 72.5 | 76 |
Remicade-naive | 1069 (65.5) | 468 (71.6) | 228 (79.7) | 62 (69.7) | 89 (58.2) | 136 (44.3) | 63 (57.8) |
No. infusions | 24,852 (100) | 11,090 (45) | 4706 (19) | 1236 (5) | 1971 (8) | 3966 (16) | 1294 (5) |
Infusion dose, mg, mean | 355.2 | 300.4 | 371.1 | 372.3 | 432.1 | 395.8 | 407.6 |
No. infusions/subject, mean | 15.3 | 17.0 | 16.5 | 13.9 | 13.0 | 13.0 | 11.9 |
Total exposure, patient-yrs, n | 3427.2 | 1569.6 | 657.8 | 169.1 | 290.7 | 552.6 | 174.4 |
Exposure, patient-yrs, mean | 2.1 | 2.4 | 2.3 | 1.9 | 1.9 | 1.8 | 1.6 |
Concomitant medication | |||||||
Any IS | 975 (59.7) | 497 (76.0) | 114 (39.9) | 60 (67.4) | 73 (47.7) | 154 (50.2) | 57 (52.3) |
MTX | 663 (40.6) | 437 (66.8) | 80 (28.0) | 52 (58.4) | 38 (24.8) | 33 (10.7) | 9 (8.3) |
AZA/6-MP | 198 (12.1) | 11 (1.7) | 14 (4.9) | 1 (1.1) | 1 (0.7) | 118 (38.4) | 50 (45.9) |
Corticosteroids | 521 (31.9) | 271 (41.4) | 81 (28.3) | 14 (15.7) | 8 (5.2) | 73 (23.8) | 62 (56.9) |
Medication administered prior to infusion, no. infusions | |||||||
None | 12,993 (52.3) | 6435 (58.0) | 2709 (57.6) | 718 (58.1) | 918 (46.6) | 1324 (33.4) | 520 (40.2) |
Acetaminophen | 8424 (33.9) | 3528 (31.8) | 1681 (35.7) | 444 (35.9) | 808 (41.0) | 1347 (34.0) | 492 (38.0) |
Antihistamines | 5672 (22.8) | 2378 (21.5) | 865 (18.4) | 135 (10.9) | 557 (28.3) | 1283 (32.3) | 342 (26.4) |
Steroids | 5587 (22.5) | 1582 (14.3) | 783 (16.6) | 65 (5.3) | 273 (13.9) | 2161 (54.5) | 660 (51.0) |
Infusion reactions | |||||||
No. infusion reactions | 322 (1.3) | 182 (1.6) | 47 (1.0) | 6 (0.5) | 27 (1.4) | 40 (1.0) | 12 (0.9) |
No. subjects with at least 1 infusion reaction | 201 (12.3) | 112 (17.1) | 25 (8.8) | 6 (6.7) | 20 (13.2) | 25 (8.2) | 7 (6.4) |
RA: rheumatoid arthritis; AS: ankylosing spondylitis; PsA: psoriatic arthritis; PSO: psoriasis; CD: Crohn disease; UC: ulcerative colitis; IS: immunosuppressant; MTX: methotrexate; AZA: azathioprine; 6-MP: 6-mercaptopurine.