Findings
Introduction
Methods
Study design and patient population
Outcomes and analysis
Results
Patient disposition and baseline characteristics
Participated n = 29 | Did not participate n = 17 | Total cohort 2a n = 46 | |
---|---|---|---|
Age at enrolment, years | 4.2 (0.9) | 3.8 (1.2) | 4.1 (1.0) |
Female, n (%) | 16 (55.2) | 12 (70.6) | 28 (60.9) |
Weight, kg | 18.4 (3.6) | 18.0 (3.5) | 18.2 (3.5) |
Weight categories, kg, n (%) | |||
< 25 | 27 (93.1) | 16 (94.1) | 43 (93.5) |
25–50 | 2 (6.9) | 1 (5.9) | 3 (6.5) |
≥ 50 | 0 | 0 | 0 |
Race, n (%) | |||
White | 29 (100.0) | 15 (88.2) | 44 (95.7) |
Black/African American | 0 | 1 (5.9) | 1 (2.2) |
Other | 0 | 1 (5.9) | 1 (2.2) |
Geographic region, n (%) | |||
South America | 4 (13.8) | 4 (23.5) | 8 (17.4) |
Europe | 25 (86.2) | 11 (64.7) | 36 (78.3) |
Rest of world | 0 | 2 (11.8) | 2 (4.3) |
Duration of JIA, years | 0.8 (1.0) | 0.8 (1.0) | 0.8 (1.0) |
JIA disease onset categories, n (%) | |||
Polyarthritis RF− | 18 (62.1) | 12 (70.6) | 29 (63.0) |
Polyarthritis RF+ | 0 | 2 (11.8) | 3 (6.5) |
Extended oligoarthritis | 8 (27.6) | 2 (11.8) | 10 (21.7) |
Psoriatic arthritis | 3 (10.3) | 1 (5.9) | 4 (8.7) |
No. of active joints | 10.0 (6.4) | 8.1 (5.2) | 9.3 (6.0) |
No. of joints with limitation of motion | 9.6 (5.9) | 7.1 (4.8) | 8.7 (5.6) |
CHAQ-DI score | 1.0 (0.7) | 1.2 (0.6) | 1.1 (0.7) |
Parent global assessment score | 37.0 (22.9) | 41.4 (26.0) | 38.6 (23.9) |
Physicians global assessment score | 50.2 (16.1) | 41.9 (20.4) | 47.1 (18.0) |
CRP, mg/dL | 0.8 (1.4) | 2.3 (3.4) | 1.3 (2.4) |
MTX dose ay Day 1, mg/m2/week | n = 22 13.5 (4.5) | n = 14 12.0 (2.3) | n = 37 12.9 (3.8) |
Prednisone dose at Day 1, mg/kg/day | n = 3 0.2 (0.0) | n = 5 0.3 (0.2) | n = 8 0.2 (0.1) |
Protective antibody assessment
Patient number | Age, sex (years; female or male) | Abatacept dose (mg); duration of exposurea (months) | Number of vaccine injections | Duration between last vaccination and abatacept initiation (months) | Duration between last vaccination and antibody sample collection (months) | Blood antibody level to diphtheriab (IU/mL) | Blood antibody level to tetanusb (IU/mL) | Concomitant MTX dosec (mg/m2/week; oral or SC) | Concomitant prednisone dosec (mg/kg/day) |
---|---|---|---|---|---|---|---|---|---|
1 | 5, F | 50; 27 | N/A | N/A | N/A | 0.6 | 5.4 | – | – |
2 | 3, F | 50; 19 | 4 | 30 | 49 | 0.8 | 0.4 | 7.9, O | – |
3 | 3, M | 50; 4 | 4 | 27 | 30 | 0.2 | 0.8 | 16.6, O | – |
4 | 5, F | 50; 24 | 4 | −3 | 21d | 0.8 | 2.2 | 15.5, O | – |
5 | 5, F | 50; 22 | 5 | N/A | N/A | 0.5 | 4.9 | 3.4, O | – |
6 | 5, F | 50; 22 | 4 | 52 | 73 | 0.9 | 1.0 | 9.9, O | – |
7 | 4, M | 87.5e; 19 | 4 | 47 | 66 | 0.5 | 5.9 | – | – |
8 | 4, M | 50; 19 | 5 | 43 | 62 | 0.7 | 8.2 | 13.1, SC | – |
9 | 4, F | 50; 16 | 3 | 52 | 67 | 0.5 | 0.6 | 16.2, SCf | – |
10 | 5, M | 50; 19 | 5 | 54 | 72 | 0.7 | 8.3 | 16.0, SC | – |
11 | 3, F | 50; 19 | 4 | 36 | 54 | 0.5 | 0.4 | – | – |
12 | 4, M | 87.5; 4 | 4 | 35 | 39 | 0.4 | 2.3 | 14.0, O | – |
13 | 3, F | 50; 4 | 4 | 30 | 34 | 0.6 | 2.0 | 11.7, SC | – |
14 | 4, F | 50; 2 | 4 | 46 | 48 | 0.5 | 1.8 | 10.4, SC | – |
15 | 2, F | 50; 2 | 3 | 24 | 26 | 0.6 | 3.1 | 14.3, SC | – |
16 | 5, M | 50; 3 | 4 | 57 | 60 | 0.4 | 0.6 | – | – |
17 | 5, M | 87.5; 3 | 4 | 57 | 60 | 0.3 | 1.1 | – | – |
18 | 2, F | 50; 3 | 4 | 21 | 24 | 0.1 | 0.2 | – | – |
19 | 4, F | 50; 3 | 4 | 46 | 49 | 0.5 | 1.4 | 11.5, SC | – |
20 | 5, M | 50; 30 | 4 | 49 | 79 | 0.1 | 0.3 | – | – |
21 | 5, M | 50; 24 | 5 | 54 | 78 | 1.1 | 5.7 | 10.0, SC | – |
22 | 4, F | 87.5e; 24 | 4 | 45 | 69 | 1.5 | 23.2 | – | – |
23 | 5, M | 50; 16 | 4 | 31 | 47 | 0.2 | 3.2 | – | – |
24 | 4, M | 87.5e; 16 | 4 | 35 | 51 | 0.1 | 1.8 | 11.7, O | – |
25 | 5, F | 50; 19 | N/A | N/A | N/A | 0.5 | 0.8 | 22.9, O | 0.1 |
26 | 5, F | 87.5e; 19 | N/A | N/A | N/A | 3.8 | 3.8 | 11.5, O | – |
27 | 5, M | 50; 19 | N/A | N/A | N/A | 0.6 | 3.3 | 20.1, O | 0.1 |
28 | 4, M | 87.5g; 21 | N/A | N/A | N/A | 0.5 | 0.5 | 14.8, O | – |
29 | 5, F | 87.5e; 10 | N/A | N/A | N/A | 8.0 | 12.5 | 12.2, O | – |
Safety
Event | Participated n = 29 | Did not participate n = 17 | Total cohort 2a n = 46 |
---|---|---|---|
Deaths | 0 | 0 | 0 |
SAEs | 4 (13.8)b | 1 (5.9) | 5 (10.9) |
Related SAEsc | 2 (6.9) | 0 | 2 (4.3) |
Discontinued due to SAEs | 0 | 0 | 0 |
AEs | 29 (100.0) | 15 (88.2) | 44 (95.7) |
Related AEs | 23 (79.3) | 7 (41.2) | 30 (65.2) |
Discontinued due to AEs | 0 | 1 (5.9) | 1 (2.2) |