Table 1.
Study and baseline characteristics.
| Study name, year and NCT | Phase | Intervention | Total population | Age (years) | Sex (M/F) | Duration since AD diagnosis | IGA score of 4 | EASI score | POEM | DLQI | BSA affected | SCORAD | Itch NRS | Skin Pain NRS | Outcomes | Follow up |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean (SD) | N | Mean (SD) | N | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | Mean (SD) | ||||||
| Simpson EL et al. (AD5) 2021 NCT03435081 | Phase III | Placebo | 147 | 39 (17) | 80/67 | 23 (17) | 61 | 27.0 (11) | – | 15 (7) | 41.5 (23) | – | 7.0 (2.4) | 6.5 (2.7) | EASI 50, EASI 75, EASI 90, IGA score of 0 or 1, Change in DLQI, SCORAD 90, SCORAD 75, Itch NRS, TEAEs, Skin infection requiring antibiotic treatment, Skin Pain NRS, BSA affected, and POEM. | 16 weeks |
| Baricitinib 1 mg |
147 | 40 (17) | 75/72 | 24 (17) | 62 | 27.7 (12) | – | 15 (7) | 41.4 (23) | – | 7.2 (2.0) | 6.5 (2.6) | ||||
| Baricitinib 2 mg |
146 | 40 (15) | 69/77 | 24 (16) | 61 | 26.6 (11) | – | 15 (8) | 39.7 (22) | – | 7.3 (2.1) | 6.7 (2.6) | ||||
| Reich K et al. (AD7) 2020 NCT03733301 | Phase III | Placebo | 109 | 33.7 (13.2) | 71/38 | 22.0 (12.2) | 48 | 28.5 (12.3) | 20.9 (6.7) | 15.0 (7.9) | 48.1 (24.4) | 66.6 (13.8) | 7.4 (1.7) | 6.8 (2.3) | EASI 50, EASI 75, EASI 90, IGA score of 0 or 1, Change in DLQI, SCORAD 90, SCORAD 75, Itch NRS, TEAEs, Skin infection requiring antibiotic treatment, Skin Pain NRS, BSA affected, and POEM. | 16 weeks |
| Baricitinib 2 mg |
109 | 33.8 (12.8) | 70/39 | 24.6 (14.8) | 50 | 29.3 (11.9) | 21.0 (6.3) | 15.0 (7.7) | 50.6 (21.6) | 66.8 (14.0) | 7.0 (2.1) | 6.3 (2.5) | ||||
| Baricitinib 4 mg |
111 | 33.9 (11.4) | 75/36 | 25.5 (13.2) | 50 | 30.9 (12.6) | 21.4 (6.0) | 14.7 (7.9) | 52.1 (23.3) | 68.3 (13.2) | 7.0 (2.0) | 6.0 (2.5) | ||||
| Guttman-Yassky E 2018 NCT02576938 | Phase II | Placebo | 49 | 37 (14.81) | 24/25 | 18.16 (16.44) | – | 21.8 (9.4) | 20 (4.44) | 14.6 (6.66) | – | 54.56 (14) | 7 (1.5) | – | EASI 50, EASI 75, EASI 90, IGA score of 0 or 1, Change in DLQI, and TEAEs. | 16 weeks |
| Baricitinib 2 mg |
37 | 40 (19.25) | 22/15 | 28.4 (16.44) | – | 23.7 (11.5) | 18 (9.6) | 11.3 (7.4) | – | 54.76 (8.29) | 6.33 (2.22) | – | ||||
| Baricitinib 4 mg |
38 | 35.5 (16.29) | 22/16 | 19.7 (18) | – | 19.7 (9) | 19 (11.1) | 11.66 (6.66) | – | 57.33 (11.4) | 6.16 (2.96) | – | ||||
| Simpson EL et al. (AD1) NCT03334396 | Phase III | Placebo | 249 | 35 (12.6) | 148/101 | 26 (15.5) | 105 | 32 (13.0) | 21 (5.6) | 14 (7.4) | 53 (23.1) | 68 (14.0) | 6.7 (2.0) | 61 (25) | EASI 50, EASI 75, EASI 90, IGA score of 0 or 1, Change in DLQI, SCORAD 90, SCORAD 75, Itch NRS, TEAEs, Skin infection requiring antibiotic treatment, Skin Pain NRS, BSA affected, and POEM. | 16 weeks |
| Baricitinib 1 mg |
127 | 36 (12.4) | 78/49 | 27 (14.9) | 53 | 29 (11.8) | 20 (5.6) | 13 (6.8) | 47 (21.2) | 66 (14.4) | 6.1 (2.1) | 5.5 (2.4) | ||||
| Baricitinib 2 mg |
123 | 35 (13.7) | 82/41 | 25 (14.6) | 52 | 31 (11.7) | 21 (5.6) | 13 (7.7) | 50 (22.1) | 68 (13.0) | 6.4 (2.2 | 5.7 (2.6) | ||||
| Baricitinib 4 mg |
125 | 37 (12.9) | 83/42 | 25 (14.9) | 51 | 32 (12.7) | 21 (5.6) | 14 (7.1) | 52 (21.8) | 68 (12.9) | 6.5 (2.0) | 5.7 (2.4) | ||||
| Simpson EL et al. (AD2) NCT03334422 | Phase III | Placebo | 244 | 35 (13.0) | 154/90 | 25 (13.9) | 121 | 33 (12.8) | 21 (6.3) | 15 (8.1) | 52 (21.7) | 68 (12.7) | 6.8 (2.2) | 6.2 (2.5) | EASI 50, EASI 75, EASI 90, IGA score of 0 or 1, Change in DLQI, SCORAD 90, SCORAD 75, Itch NRS, TEAEs, Skin infection requiring antibiotic treatment, Skin Pain NRS, BSA affected, and POEM. | 16 weeks |
| Baricitinib 1 mg |
125 | 33 (10.0) | 80/45 | 24 (12.7) | 63 | 33 (12.7) | 20 (6.5) | 15 (8.1) | 55 (21.9) | 67 (12.9) | 6.4 (2.2) | 5.7 (2.7) | ||||
| Baricitinib 2 mg |
123 | 36 (13.2) | 65/58 | 24 (13.8) | 62 | 35 (16.0) | 21 (6.0) | 14 (7.7) | 55 (26.1) | 69 (13.3) | 6.6 (2.2) | 6.2 (2.5) | ||||
| Baricitinib 4 mg |
123 | 34 (14.1) | 82/41 | 23 (14.8) | 63 | 33 (12.7) | 20 (6.3) | 14 (8.4) | 54 (21.5) | 68 (13.6) | 6.6 (2.2) | 6.0 (2.6) | ||||
| NCT03428100 (AD4) | Phase III | placebo | 93 | 38.7 (13.6) | 49/44 | – | – | – | – | – | – | – | – | – | EASI 50, EASI 75, EASI 90, IGA score of 0 or 1, Change in DLQI, SCORAD 90, SCORAD 75, Itch NRS, TEAEs, Skin infection requiring antibiotic treatment, Skin Pain NRS, BSA affected, and POEM. | 16 weeks |
| Baricitinib 1 mg |
93 | 38.9 (14.0) | 58/35 | – | – | – | – | – | – | – | – | – | ||||
| Baricitinib 2 mg |
185 | 37.3 (13.6) | 133/52 | – | – | – | – | – | – | – | – | – | ||||
| Baricitinib 4 mg |
92 | 38.7 (13.3) | 57/35 | – | – | – | – | – | – | – | – | – |