Table. Study and Patient Characteristics.
Source | Country | No. of Patients (Primary) [Secondary]a | Treatment Setting | Outcome Assessment by Week | HLA-C*06:02-Positive Patients, No. (%) | Age, Mean (SD), y | Male, No. (%) | Biological Naivety, No. (%) | Baseline PASI, Mean (SD) | Body Mass Index, Mean (SD)b |
---|---|---|---|---|---|---|---|---|---|---|
Anzengruber et al,20 2018 | Switzerland | 30 (28) | Daily practice | 16, 28c | 13 (43) | 50 (12) | 22 (73) | 20 (67) | 10 (5) | NA |
Chiu et al,10 2014 | Taiwan | 66 | Daily practice | 16, 28 | 8 (12) | 45 (12) | 55 (83) | 28 (42) | 18 (10) | 26 (4) |
Galluzzo et al,11 2016 | Italy | 64 (63) | Daily practice | 12, 28 | 35 (55) | 46 (12) | 46 (72) | 30 (47) | 17 (8) | NA |
Li et al,18 2016 | United States | 332 (254) | Randomized clinical triald | 12, 24, 28 | 139 (42) | 47 (11) | 195 (59) | 226 (68) | 19 (7) | 31 (7) |
Raposo et al,19 2017 | Portugal | 116 | Daily practice | 12, 24 | 47 (41) | 48 (14) | 66 (57) | 93 (80) | 13 (5) | NA |
Talamonti et al,7 2013 | Italy | 51 (49) | Daily practice | 12, 28 | 28 (55) | 46 (12) | 37 (73) | 10 (20) | 16 (7) | NA |
Talamonti et al,8 2016 | Italy | 134 (123) [129] | Daily practice | 12, 28 | 73 (54) | 44 (13), 50 (12)e | 83 (62) | 56 (42) | 16 (7), 17 (9)f | 26 (4), 27 (5)g |
Talamonti et al,16 2017 | Belgium, Italy, and the Netherlands | 255 (238) [239] | Daily practice | 12, 28 | 127 (50) | 51 (12) | 168 (66) | 51 (20) | 17 (7) | 29 (6) |
Abbreviations: NA, not applicable; PASI, Psoriasis Area and Severity Index.
Total number of patients originally included in the study (n = 1048); for the primary outcome of risk difference at 6 months (n = 942); and for the secondary outcome of risk difference at 3 months (n = 1027).
Calculated as weight in kilograms divided by height in meters squared.
Week 28 data provided by the authors.
In the randomized clinical trials used for this study, patients were randomized to ustekinumab vs placebo (PHOENIX-1 and PHOENIX-2) or to ustekinumab vs etanercept (ACCEPT). Patients were not stratified according to genotype before randomization. Of those patients randomized to receive ustekinumab, a subset of patients was later included for pharmacogenetic study of HLA-C*06:02.
HLA-C*06:02–positive patients: 44 (13); HLA-C*06:02–negative patients: 50 (12).
HLA-C*06:02–positive patients: 16 (7); HLA-C*06:02–negative patients: 17 (9).
HLA-C*06:02–positive patients: 26 (4); HLA-C*06:02–negative patients: 27 (5).