Table 3.
The number of tuberculosis, hepatitis, and herpes zoster in both treatment groups and placebo groups in the included RCTs.
| Source | Trial Name/ClinicalTrials.gov identifier | Treatment (dose) | Treatment Group | Placebo Group | ||
|---|---|---|---|---|---|---|
| Number of patients | Number of events | Number of patients | Number of events | |||
| Tuberculosis | ||||||
| Mease et al., 2014 (20) | NCT01516957 | Brodalumab (140 mg, at weeks 0, 1, then Q2W) Brodalumab (280 mg, at weeks 0, 1, then Q2W) |
56 56 |
0 0 |
55 | 0 |
| Mease et al., 2017 (24) | SPIRIT-P1/NCT01695239 | Ixekizumab (160 mg at week 0, then 80 mg Q2W) Ixekizumab (160 mg at week 0, then 80 mg Q4W) |
102 107 |
0 0 |
106 | 0 |
| Nash et al., 2017 (25) | SPIRIT-P2/NCT02349295 | Ixekizumab (160 mg at week 0, then 80 mg Q2W) Ixekizumab (160 mg at week 0, then 80 mg Q4W) |
123 122 |
0 0 |
118 | 0 |
| Mease et al., 2015 (29) | FUTURE1/NCT01392326 | Secukinumab (10 mg per kilogram at weeks 0, 2, and 4, then 75 mg Q4W) Secukinumab (10 mg per kilogram at weeks 0, 2, and 4, then 150 mg Q4W) |
202 202 |
0 0 |
202 | 0 |
| McInnes et al., 2015 (30) | FUTURE2/NCT01752634 | Secukinumab (75 mg, QW for 4 weeks, then Q4W) Secukinumab (150 mg, QW for 4 weeks, then Q4W) Secukinumab (300 mg, QW for 4 weeks, then Q4W) |
99 100 100 |
0 0 0 |
98 | 0 |
| Mease et al., 2018 (32) | FUTURE5/NCT02404350 | Secukinumab (150 mg with loading dose, QW for 4 weeks, then Q4W) Secukinumab (150 mg without loading dose, QW for 4 weeks, then Q4W) Secukinumab (300 mg, QW for 4 weeks, then Q4W) |
822 | 0 | 332 | 0 |
| Nguyen et al., 2022 (38) | CHOICE/ NCT02798211 |
Secukinumab (150 mg, QW for 4 weeks, then Q4W) Secukinumab (300 mg, QW for 4 weeks, then Q4W) |
103 103 |
0 0 |
52 | 0 |
| Gordon et al., 2021 (41) | BE READY/ NCT03410992 |
Bimekizumab (320 mg Q4W) | 349 | 0 | 86 | 0 |
| McInne et al., 2023 (42) | BE OPTIMAL/NCT03895203 | Bimekizumab (160 mg Q4W) | 431 | 0 | 281 | 0 |
| Merola et al., 2023 (43) | BE COMPLETE/ NCT03896581 |
Bimekizumab (160 mg Q4W) | 267 | 0 | 132 | 0 |
| Reich et al., 2021 (44) | BE VIVID/ NCT03370133 |
Bimekizumab (320 mg Q4W) | 321 | 0 | 83 | 0 |
| Ritchlin et al., 2020 (45) | BE ACTIVE/NCT02969525 | Bimekizumab (160 mg Q4W) Bimekizumab (160 mg Q4W) Bimekizumab (160 mg Q4W, loading dose) Bimekizumab (320 mg Q4W) |
39 43 41 41 |
0 0 0 0 |
42 | 0 |
| Reich et al., 2017 (47) | VOYAGE 2/NCT02207244 | Guselkumab (100 mg, at weeks 0 and 4, then Q8W) | 494 | 0 | 248 | 0 |
| Deodhar et al., 2020 (49) | DISCOVER-1/ NCT03162796 |
Guselkumab (100 mg, Q4W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
128 127 |
0 0 |
126 | 0 |
| Mease et al., 2020 (50) | DISCOVER-2/ NCT03158285 |
Guselkumab (100 mg, Q4W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
245 248 |
0 0 |
246 | 0 |
| Ohtsuki et al., 2018 (51) | NCT02325219 | Guselkumab (50 mg, at weeks 0 and 4, then Q8W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
65 63 |
0 0 |
64 | 0 |
| Deodhar et al., 2018 (52) | NCT02319759 | Guselkumab (100 mg, at weeks 0 and 4, then Q8W) | 100 | 0 | 49 | 0 |
| Gordon et al., 2015 (53) | NCT01483599 | Guselkumab (5 mg, at weeks 0 and 4, then Q12W8) Guselkumab (15 mg Q8W) Guselkumab (50 mg, at weeks 0 and 4, then Q12W) Guselkumab (100 mg Q8W) Guselkumab (200 mg, at weeks 0 and 4, then Q12W) |
41 41 42 42 41 |
0 0 0 0 0 |
42 | 0 |
| Gordon et al., 2018 (54) | UltIMMa-1/ NCT02684370 |
Risankizumab (150 mg, at weeks 0, 4, and 16) | 304 | 0 | 102 | 0 |
| Gordon et al., 2018 (54) | UltIMMa-2/ NCT02684357 |
Risankizumab (150 mg, at weeks 0, 4, and 16) | 294 | 0 | 98 | 0 |
| Kristensen et al., 2022 (55) | KEEPsAKE 1/ NCT03675308 |
Risankizumab (150 mg, at weeks 0, 4, and 16) | 483 | 0 | 481 | 0 |
| Östör et al., 2022 (56) | KEEPsAKE 2/ NCT03671148 |
Risankizumab (150 mg, at weeks 0, 4, and 16) | 224 | 0 | 219 | 0 |
| Blauvelt et al., 2020 (57) | NCT02672852 | Risankizumab (150 mg, at weeks 0, 4, and 16) | 407 | 0 | 100 | 0 |
| Reich et al., 2017 (58) | reSURFACE 1/ NCT01722331 |
Tildrakizumab (100 mg, at weeks 0, 4, and 16) Tildrakizumab (200 mg, at weeks 0, 4, and 16) |
309 308 |
0 0 |
154 | 0 |
| Reich et al., 2017 (58) | reSURFACE 2/ NCT01729754 |
Tildrakizumab (100 mg, at weeks 0, 4, and 16) Tildrakizumab (200 mg, at weeks 0, 4, and 16) |
307 314 |
0 0 |
156 | 0 |
| Papp et al., 2015 (59) | NCT01225731 | Tildrakizumab (5 mg, at weeks 0, 4, and 16) Tildrakizumab (25 mg, at weeks 0, 4, and 16) Tildrakizumab (100 mg, at weeks 0, 4, and 16) Tildrakizumab (200 mg, at weeks 0, 4, and 16) |
42 91 89 86 |
0 0 0 0 |
45 | 0 |
| Hepatitis | ||||||
| Langley et al., 2014 (28) | FIXTURE/NCT01358578 | Secukinumab (150 mg, QW for 5 weeks, then Q4W) Secukinumab (300 mg, QW for 5 weeks, then Q4W) |
327 326 |
0 0 |
327 | 1 |
| McInnes et al., 2015 (30) | FUTURE2/NCT01752634 | Secukinumab (75 mg, QW for 4 weeks, then Q4W) Secukinumab (150 mg, QW for 4 weeks, then Q4W) Secukinumab (300 mg, QW for 4 weeks, then Q4W) |
99 100 100 |
0 0 1 |
98 | 0 |
| Mease et al., 2020 (50) | DISCOVER-2/ NCT03158285 |
Guselkumab (100 mg, Q4W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
245 248 |
1 0 |
246 | 0 |
| Ohtsuki et al., 2018 (51) | NCT02325219 | Guselkumab (50 mg, at weeks 0 and 4, then Q8W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
65 63 |
0 0 |
64 | 0 |
| Herpes zoster | ||||||
| Mease et al., 2021 (18) | AMVISION-1/NCT02029495; AMVISION-2/NCT02024646 |
Brodalumab (140 mg, at weeks 0, 1, then Q2W) Brodalumab (210 mg, at weeks 0, 1, then Q2W) |
318 321 |
0 0 |
320 | 3 |
| Mease et al., 2014 (20) | NCT01516957 | Brodalumab (140 mg, at weeks 0, 1, then Q2W) Brodalumab (280 mg, at weeks 0, 1, then Q2W) |
56 56 |
0 0 |
55 | 0 |
| Papp et al., 2012 (21) | NCT00975637 | Brodalumab (70 mg, at weeks 0, 1, then Q2W) Brodalumab (140 mg, at weeks 0, 1, then Q2W) Brodalumab (210 mg, at weeks 0, 1, then Q2W) Brodalumab (280 mg, monthly) |
39 39 40 41 |
0 1 0 0 |
38 | 0 |
| Gordon et al., 2016 (23) | UNCOVER-1/NCT01474512; UNCOVER-2/NCT01597245; UNCOVER-3/ NCT01646177 |
Ixekizumab (160 mg at week 0, then 80 mg Q2W) Ixekizumab (160 mg at week 0, then 80 mg Q4W) |
1167 1161 |
0 0 |
791 | 0 |
| Mease et al., 2017 (24) | SPIRIT-P1/NCT01695239 | Ixekizumab (160 mg at week 0, then 80 mg Q2W) Ixekizumab (160 mg at week 0, then 80 mg Q4W) |
102 107 |
1 0 |
106 | 0 |
| Mease et al., 2020 (50) | DISCOVER-2/ NCT03158285 |
Guselkumab (100 mg, Q4W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
245 248 |
0 0 |
246 | 0 |
| Ohtsuki et al., 2018 (51) | NCT02325219 | Guselkumab (50 mg, at weeks 0 and 4, then Q8W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
65 63 |
0 0 |
64 | 0 |
| Gordon et al., 2018 (54) | UltIMMa-2/ NCT02684357 |
Risankizumab (150 mg, at weeks 0, 4, and 16) | 294 | 1 | 98 | 0 |
| Kristensen et al., 2022 (55) | KEEPsAKE 1/ NCT03675308 |
Risankizumab (150 mg, at weeks 0, 4, and 16) | 483 | 2 | 481 | 1 |
| Östör et al., 2022 (56) | KEEPsAKE 2/ NCT03671148 |
Risankizumab (150 mg, at weeks 0, 4, and 16) | 224 | 0 | 219 | 1 |
| Blauvelt et al., 2020 (57) | NCT02672852 | Risankizumab (150 mg, at weeks 0, 4, and 16) | 407 | 0 | 100 | 0 |
| Reich et al., 2017 (58) | reSURFACE 2/ NCT01729754 |
Tildrakizumab (100 mg, at weeks 0, 4, and 16) Tildrakizumab (200 mg, at weeks 0, 4, and 16) |
307 314 |
0 1 |
156 | 0 |