Table 4.
Cases of tuberculosis, hepatitis, and herpes zoster reported in the OLE studies.
| Source | Trial Name/ClinicalTrials.gov identifier | Treatment (dose) | Duration of Open-label Extension Period | Case of Tuberculosis | Case of Hepatitis | Case of Herpes zoster |
|---|---|---|---|---|---|---|
| Lebwohl et al., 2015 (17) | AMAGINE-2/NCT01708603 | Brodalumab (140mg or 210 mg, Q2W) | 52 weeks | NA | 1 | 1 |
| Lebwohl et al., 2019 (62) | NCT01101100 | Brodalumab (210 mg, Q2W) | 6 years | 1 | 1 | NA |
| van der Heijde et al., 2018 (64) | SPIRIT-P1/NCT01695239 | Ixekizumab (160 mg at week 0, then 80 mg Q2W) Ixekizumab (160 mg at week 0, then 80 mg Q4W) |
52 weeks | 0 0 |
0 1 |
1 0 |
| Chandran et al., 2020 (65) | SPIRIT-P1/NCT01695239 | Ixekizumab (160 mg at week 0, then 80 mg Q2W) Ixekizumab (160 mg at week 0, then 80 mg Q4W) |
3 years | 1 0 |
NA NA |
1 0 |
| Genovese et al., 2018 (66) | SPIRIT-P2/NCT02349295 | Ixekizumab (160 mg at week 0, then 80 mg Q2W) Ixekizumab (160 mg at week 0, then 80 mg Q4W) |
52 weeks | 0 1 |
0 0 |
2 0 |
| Gordon et al., 2014 (67) | NCT01107457 | Ixekizumab (6 doses at 0, 2, 4, 8, 12, and 16 weeks, then 120 mg Q4W) | 52 weeks | 0 | NA | NA |
| Blauvelt et al., 2017 (69) | CLEAR/ NCT02074982 |
Secukinumab (300 mg, QW for 4 weeks, then Q4W) | 52 weeks | 0 | NA | NA |
| McInnes et al., 2017 (70) | FUTURE2/NCT01752634 | Secukinumab (75, 150 or 300 mg, QW for 4 weeks, then Q4W) | 104 weeks | 0 | NA | NA |
| van der Heijde et al., 2020 (71) | FUTURE5/NCT02404350 | Secukinumab (150 mg, QW for 4 weeks, then Q4W) Secukinumab (300 mg, QW for 4 weeks, then Q4W) |
52 weeks | 0 0 |
NA NA |
NA NA |
| Bissonnette et al., 2018 (73) | SCULPTURE/NCT01640951 | Secukinumab (300mg, QW for 4 weeks, then Q4W, fixed interval) | 1 year 2 years 3 years 4 years 5 years |
0 0 0 0 0 |
0 0 0 0 0 |
0 0 0 0 0 |
| Coates et al., 2022 (75) | BE ACTIVE/NCT03347110 | Bimekizumab (160 mg Q4W); Bimekizumab (320 mg Q4W) | 152 weeks | 0 | NA | 0 |
| Strober et al., 2023 (76) | BE RADIANT/ NCT03536884 |
Bimekizumab (320 mg Q4W) | 1 year 2 years |
0 0 |
NA NA |
NA NA |
| McInnes et al., 2021 (79) | DISCOVER-2/ NCT03158285 |
Guselkumab (100 mg, Q4W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
52 weeks | 0 0 |
1 0 |
0 0 |
| McInnes et al., 2022 (80) | DISCOVER-2/ NCT03158285 |
Guselkumab (100 mg, Q4W) Guselkumab (100 mg, at weeks 0 and 4, then Q8W) |
112 weeks | 0 0 |
1 0 |
0 1 |
| Gooderham et al., 2022 (81) | UltIMMa-1/NCT02684370; UltIMMa-2/NCT02684357 |
Risankizumab (150 mg, at weeks 0 and 4, then Q12W) | 52 weeks | 0 | NA | NA |
| Gooderham et al., 2022 (81) | LIMMitless/NCT03047395 | Risankizumab (150 mg, at weeks 0 and 4, then Q12W) | 172 weeks | 0 | NA | NA |
| Papp et al., 2021 (82) | LIMMitless/NCT03047395 | Risankizumab (150 mg, at weeks 0 and 4, then Q12W) | 208 weeks | 0 | NA | NA |
| Reich et al., 2020 (83) | reSURFACE 1/ NCT01722331; reSURFACE 2/ NCT01729754 |
Tildrakizumab (100 mg, at weeks 0 and 4, then Q12W) Tildrakizumab (200 mg, at weeks 0 and 4, then Q12W) |
148 weeks | 0 0 |
NA NA |
0 1 |
| Thaci et al., 2021 (84) | reSURFACE 1/ NCT01722331; reSURFACE 2/ NCT01729754 |
Tildrakizumab (100 mg, at weeks 0 and 4, then Q12W) Tildrakizumab (200 mg, at weeks 0 and 4, then Q12W) |
256 weeks | 0 0 |
NA NA |
0 1 |