Summary of outcome measures used in trials of giant cell arteritis (GCA) by study type†(6–12,33–51). Values are expressed as number (%) of studies reporting the listed outcome variable.
| Outcome | Clinical Trials, n = 9 (%) | Treatment Series or Metaanalysis, n = 11 (%) | Biomarker Studies, n = 6 (%) | Overall, n = 26 (%) |
|---|---|---|---|---|
| GCA-related outcomes | ||||
| GCA disease activity scale | 1 (11) | 0 (0) | 2 (33) | 3 (11) |
| GCA complications | 5 (56) | 8 (73) | 2 (33) | 15 (58) |
| Flare | 2 (22) | 2 (18) | 3 (50) | 7 (27) |
| Remission | 3 (33) | 4 (36) | 0 (0) | 7 (27) |
| Relapse | 5 (56) | 6 (55) | 3 (50) | 14 (54) |
| Symptoms and/or physical examination | 9 (100) | 8 (77) | 6 (100) | 23 (89) |
| Other GCA-related outcomes* | 2 (22) | 2 (18) | 0 (0) | 4 (15) |
| Laboratory testing outcomes | ||||
| Erythrocyte sedimentation rate | 9 (100) | 5 (46) | 5 (83) | 19 (73) |
| C-reactive protein | 6 (67) | 2 (18) | 5 (83) | 13 (50) |
| Complete blood count | 7 (78) | 3 (27) | 2 (33) | 12 (46) |
| Glucocorticoid-related outcomes | ||||
| Duration of GC treatment | 2 (22) | 3 (27) | 0 (0) | 5 (19) |
| Cumulative GC dose | 7 (78) | 5 (45) | 0 (0) | 12 (46) |
| Percentage on GC at end of study | 2 (22) | 0 (0) | 1 (17) | 3 (12) |
| GC dose at end of study | 3 (33) | 0 (0) | 0 (0) | 3 (12) |
| GC-related adverse events | 6 (67) | 5 (46) | 0 (0) | 11 (42) |
| Other GC-related outcomes** | 5 (56) | 3 (27) | 1 (17) | 9 (35) |
| Other outcomes | ||||
| Mortality | 1 (11) | 1 (9) | 0 (0) | 2 (8) |
| Study drug-related adverse event (non-GC) | 5 (56) | 2 (18) | NA | 5 (25) |
| Imaging | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Patient-reported assessments | 1 (11) | 0 (0) | 1 (17) | 2 (8) |