Table 1.
Characteristics of included studies.
| Source | Trial Name (Study Phase) |
Inclusion Criteria | Follow-Up, Weeks | Treatment Arms: Patient Numbers |
Age, Mean (SD) |
Gender, Female (%) |
|---|---|---|---|---|---|---|
| Kimball et al., 2016 [21] | PIONEER I (Phase 3) |
≥2 distinct anatomical areas, AN count of ≥3, IR to antibiotics |
12 | Adalimumab: 153 Placebo: 154 |
36.2 (10.8) 37.8 (11.3) |
59.5 68.2 |
| Kimball et al., 2016 [21] | PIONEER II (Phase 3) |
≥2 distinct anatomical areas, AN count of ≥3, IR to antibiotics |
12 | Adalimumab: 163 Placebo: 163 |
34.9 (10.0) 36.1 (12.2) |
66.3 69.3 |
| Kimball et al., 2012 [22,23] | Nil (Phase 2) |
Stable, moderate to severe HS |
12 | Adalimumab: 44 Placebo: 43 |
36.6 (10.7) 37.7 (12.0) |
67.4 70.5 |
| Bechara et al., 2021 [24] | SHARPS (Phase 4) |
≥3 distinct anatomical areas, Draining fistula count of ≤20, AN count of ≥3 |
12 | Adalimumab: 103 Placebo: 103 |
38.5 (11.7) 36.8 (10.8) |
50 53 |
| Kimball et al., 2022 [25] | SUNSHINE (Phase 3) |
≥2 distinct anatomical areas, Draining fistula count of ≤20, AN count of ≥5 |
16 | Secukinumab q4w: 180 Secukinumab q2w: 181 Placebo: 180 |
32.8 (7.9) 32.6 (7.9) 32.0 (7.1) |
55.6 56.4 56.7 |
| Kimball et al., 2022 [25] | SUNRISE (Phase 3) |
≥2 distinct anatomical areas, Draining fistula count of ≤20, AN count of ≥5 |
16 | Secukinumab q4w: 180 Secukinumab q2w: 180 Placebo: 183 |
32.0 (7.5) 31.9 (7.8) 31.4 (7.4) |
57.2 54.4 57.4 |
| Glatt et al., 2021 [26] | Nil (Phase 2) |
Draining fistula count of ≤20, AN count of ≥3, IR to antibiotics |
12 | Bimekizumab: 44 Adalimumab: 20 Placebo: 20 |
36.7 (11.9) 31.1 (9.4) 40.7 (12.8) |
65 81 67 |
|
NCT03926169 [27] |
DETERMINED 1 (Phase 2) |
≥2 distinct anatomical areas, Draining fistula count of ≤20, AN count of ≥5, IR to antibiotics |
16 | Risankizumab 180 mg: 80 Risankizumab 360 mg: 81 Placebo: 82 |
38.9 (11.5) 38.2 (12.0) 37.2 (12.0) |
66.3 63.0 58.5 |
|
NCT03628924 [28] |
NOVA (Phase 2) |
≥2 distinct anatomical areas, Draining fistula count of ≤20, AN count of ≥3, IR to antibiotics |
16 | Guselkumab 200 mg sc: 59 Guselkumab 1200 mg IV, then 200 mg sc: 60 Placebo: 62 |
39.0 (12.4) 37.2 (10.9) 38.2 (11.6) |
54.2 75.0 61.3 |
|
NCT03487276 [29] |
SHINE (Phase 2) |
≥ 2 distinct anatomical areas, AN count of ≥3, IR to antibiotics |
16 | IFX-1 800 mg Q4w: 35 Placebo: 36 |
35.0 (NA) 34.5 (NA) |
51.4 58.3 |
| Kirby et al., 2021 [30] | Aurora (Phase 2) |
≥2 distinct anatomical areas, Draining fistula count of ≤20, AN count of ≥5, IR to antibiotics |
12 | Avacopan 30 mg bid: 134 Placebo: 130 |
NA | NA |
| Kimball et al., 2022 [31] | Nil (Phase 2) |
≥2 distinct anatomical areas, Draining fistula count of ≤25, AN count of ≥4, BW 50 kg–150 kg |
16 | CJM 112: 33 Placebo: 33 |
36.0 (9.8) 39.0 (10.9) |
66.7 66.7 |