Table 2.
Summary of adverse events in phase 3 clinical trials of FDA-approved JAK Inhibitors in dermatology
| Author/clinical trial | Dermatologic condition | Study duration | Study intervention (N) | Adjudicated adverse cardiovascular events (n, %) | Adjudicated venous thromboembolism (n, %) | Serious infection (n, %) | Malignancy, NMSC (n, %) | Malignancy, non-NMSC (n, %) | Death (n, %) |
|---|---|---|---|---|---|---|---|---|---|
| 2020/Simpson et al. JADE MONO-1 [28] | Atopic dermatitis | 12 weeks | Abrocitinib 100 mg (n = 156) | 0 | 0 | Not reported | 0 | 0 | 0 |
| Abrocitinib 200 mg (n = 154) | 0 | 0 | 0 | 0 | 0 | ||||
| Placebo (n = 77) | 0 | 0 | 0 | 0 | 0 | ||||
| 2020/Silverberg et al. JADE MONO-2 [48] | Atopic dermatitis | 12 weeks | Abrocitinib 100 mg (n = 155) | 1 (0.6) | 0 | 3 (1.9) | 0 | 0 | 1 (0.6) |
| Abrocitinib 200 mg (n = 158) | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Placebo (n = 78) | 0 | 0 | 1 (1.3) | 0 | 0 | 0 | |||
| 2021/Blauvelt et al. JADE REGIMEN [56] | Atopic dermatitis | 40 weeks | Abrocitinib 100 mg (n = 200) | Not reported | 1 (0.5) | 2 (0.8) | Not reported | Not reported | Not reported |
| Abrocitinib 200 mg (n = 200) | 0 | 5 (1.9) | |||||||
| Placebo (n = 200) | 0 | 2 (0.7) | |||||||
| 2020/Guttman-Yassky et al. [49] | Atopic dermatitis | 16 weeks | Upadacitinib 7.5 mg (n = 42) | 0 | 0 | 2 (4.8) | 0 | 0 | 0 |
| Upadacitinib 15 mg (n = 42) | 0 | 0 | 1 (2.4) | 0 | 0 | 0 | |||
| Upadacitinib 30 mg (n = 42) | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Placebo (n = 41) | 0 | 0 | 0 | 0 | 0 | 0 | |||
| 2021/Guttman-Yassky et al. (MEASURE UP-1) [50] | Atopic dermatitis | 16 weeks | Upadacitinib 15 mg (n = 281) | 1(0.4) | 0 | 2 (0.7) | 1 (0.4) | 0 | 0 |
| Upadacitinib 30 mg (n = 285) | 0 | 0 | 2 (0.7) | 0 | 2 (0.7) | 0 | |||
| Placebo (n = 281) | 0 | 0 | 0 | 0 | 0 | 0 | |||
| 2021/Guttman-Yassky et al. (MEASURE UP-2) [50] | Atopic dermatitis | 16 weeks | Upadacitinib 15 mg (n = 276) | 0 | 0 | 1 (0.4) | 2 (0.7) | 0 | 0 |
| Upadacitinib 30 mg (n = 282) | 0 | 0 | 2 (0.7) | 1 (0.4) | 1 (0.4) | 0 | |||
| Placebo (N = 278) | 0 | 0 | 2 (0.7) | 0 | 0 | 0 | |||
| 2021/Reich et al. (AD Up) [64] | Atopic dermatitis | 16 weeks | Upadacitinib 15 mg + corticosteroids (n = 300) | 0 | 0 | 3 (1.0) | 0 | 0 | 0 |
| Upadacitinib 30 mg + corticosteroids (n = 297) | 0 | 0 | 0 | 1 (0.3) | 1 (0.3) | 0 | |||
| Placebo + corticosteroids (n = 304) | 0 | 0 | 3 (1.0) | 0 | 0 | 0 | |||
| 2022/Simpson et al. [27] | Atopic dermatitis | 52 weeks | Upadacitinib 15 mg (n = 797) | 1 (0.1) | 1 (0.1) | 21 (2.6) | 4 (0.5) | 2 (0.3) | 0 |
| Upadacitinib 30 mg (n = 811) | 0 | 1 (0.1) | 35 (4.3) | 4 (0.5) | 5 (0.6) | 1 (0.1) | |||
| 2022/King et al. (BRAAVE-1) [52] | Alopecia areata | 36 weeks | Baricitinib 2 mg (n = 183) | 1(0.5) 0 0 | 0 | 0 | 0 | 0 | 0 |
| Baricitinib 4 mg (n = 270) | 0 | 0 | 0 | 0 | 0 | 0 | |||
| Placebo (n = 189) | 0 | 0 | 0 | 0 | 0 | 0 | |||
| 2022/King et al. (BRAAVE-2) [52] | Alopecia areata | 36 weeks | Baricitinib 2 mg (n = 155) | 0 | 0 | 2 (1.3) | 0 | 1 (0.6) | 0 |
| Baricitinib 4 mg (n = 233) | 0 | 0 | 1 (0.4) | 0 | 0 | 0 | |||
| Placebo (n = 154) | 0 | 0 | 0 | 0 | 1 (0.6) | 0 | |||
| 2022/Armstrong et al. POETYK PSO-1 [54] | Psoriasis | 52 weeks | Deucravacitinib 6 mg (n = 531) | 1 (0.2) | 1 (0.2) | 6 (1.1) | 2 (0.4) | 2 (0.4) | 0 |
| Apremilast 30 mg (n = 168) | 2 (1.2) | 0 | 3 (1.8) | 0 | 0 | 0 | |||
| Placebo (n = 165) | 2 (1.2) | 0 | 1 (0.6) | 0 | 0 | 1 (0.6) | |||
| 2022/Strober et al. POETYK PSO-2 [55] | Psoriasis | 52 weeks | Deucravacitinib 6 mg (n = 833) | 2 (0.4) | 1 (0.1) | 11 (2.0) | 5 (0.9) | 1 (0.2) | 0 |
| Apremilast 30 mg (n = 254) | 1 (0.9) | 0 | 1 (0.9) | 1 (0.9) | 1 (0.9) | 0 | |||
| Placebo (n = 501) | 1 (0.5) | 0 | 1 (0.5) | 0 | 0 | 0 |