Reference | Study type | Patients n | Disease | Treatment | Results |
39 | Phase 2 | 130 | CD | BRO |
|
35 | Phase 2 | 59 | CD | SEC |
|
11 | Phase 3 | 226 | AS | SEC | No case of CD or UC |
12 | Phase 3 | 290 | AS | SEC | EIAR for CD: 0.4, for UC 0.5 |
13 | Phase 3 | 200 | AS | SEC | Incidence: 0.8 per 100 PY |
14 | Phase 3 | 274 | AS | SEC | EAIR for CD: 0.6, for UC: 0.2 |
15 | Phase 3 | 219 | AS | SEC | EIAR for CD : 0.7 |
17 | Phase 3 | 219 | AS | SEC | EIAR for CD: 0.6, for UC: 0.6 |
19 | Review of phase 3 studies | 4209 | PsO | IXE |
|
67 | Systematic review and meta-analysis | 16 690 | PsO PsA AS | IXE SEC BRO |
|
68 | Systematic review | 8742 | PsO | IXE SEC BRO |
|
69 | Retrospective evaluation of pooled studies | 7355 | PsO PsA AS | SEC |
|
70 | Phase 3 | 590 | AS | SEC | Pooled exposure-adjusted incidence rates from grade 3 and 4 for CD: 0.7/100 PY |
71 | Phase 3 | 341 | AS | IXE | One case of probable CD in the group with IXE every 2 weeks |
AS, ankylosing spondylitis; BRO, brodalumab; CD, Crohn’s disease; CDAI, Crohn’s Disease Activity Index; CRP, C reactive protein; EAIRs, exposure-adjusted incidence rates (per 100 patients years); FC, faecal calprotectin; IBD, inflammatory bowel disease; IC, indeterminate colitis; IL-17, interleukin-17; IXE, ixekizumab; PsA, psoriatic arthritis; PsO, psoriasis; PY, patient years; SEC, secukinumab; UC, ulcerative colitis.