Table 2.
Selected studies and registered clinical trials on currently available JAK inhibitors for the treatment of atopic dermatitis.
| Study Identifier | Phase | Study Group | Intervention | Primary Endpoint(s) |
|---|---|---|---|---|
| Delgocitinib (topical pan-JAK inhibitor) | ||||
| JapicCTI-173553 [9] | II | 2–15 | Delgocitinib (oint), vehicle |
mEASI change at week 4:
- 0.25% oint: −54.2% - 0.5% oint: −61.8% |
| JapicCTI-152887 [10] | II | 16–65 | Delgocitinib (oint), tacrolimus, vehicle |
mEASI change at week 4:
- 0.25% oint: −41.7% - 0.5% oint: −57.1% - 1% oint: 54.9% - 3% oint: 72.9% - vehicle: −12.2% |
| JapicCTI-173554 [11] | III | ≥16 | Delgocitinib (oint), vehicle |
mEASI change at week 4 (part 1):
- 0.5% oint: −44.3% - vehicle: −1.7% mEASI improvement maintained through the 24-week open-label extension period (part 2) |
| JapicCTI-184064 [12] | III | 2–15 | Delgocitinib (oint), vehicle |
mEASI change at week 4 (part 1):
- 0.25% oint: −39.3% - vehicle: −10.9% mEASI improvement maintained through the 56-week open-label extension period (part 2) |
| Tofacitinib (topical pan-JAK inhibitor) | ||||
| NCT02001181 [13] | II | 18–60 | Tofacitinib (oint), vehicle |
EASI change at week 4:
- 2% oint: −81.7% - vehicle: −29.9% |
| Ruxolitinib (topical selective JAK1/2 inhibitor) | ||||
| NCT03745638 (TRuE AD1) [14] | III | ≥12 | Ruxolitinib (cream), vehicle |
Patients with IGA 1/0 at week 8:
- 0.75% cream: 50% - 1.5% cream: 53.8% - vehicle: 15.1% |
|
NCT03745651 (TRuE AD2) [14] |
III | ≥12 | Ruxolitinib (cream), vehicle |
Patients with IGA 1/0 at week 8:
- 0.75% cream: 39% - 1.5% cream: 51.3% - vehicle: 7.6% |
| Baricitinib (systemic selective JAK1/2 inhibitor) | ||||
| NCT02576938 [15] | II | ≥18 years | Baricitinib, placebo, TCS |
Patients with EASI-50 at week 16:
- 2 mg: 57% - 4 mg: 61% - placebo: 37% |
| NCT03334396 (BREEZE-AD1) [16] | III | ≥18 years | Baricitinib, placebo |
Patients with IGA 0/1 at week 16:
- 1 mg: 11.8% - 2 mg: 11.4% - 4 mg: 16.8% - placebo: 4.8% |
| NCT03334422 (BREEZE-AD2) [16] | III | ≥18 years | Baricitinib, placebo |
Patients with IGA 0/1 at week 16:
- 1 mg: 8.8% - 2 mg: 10.6% - 4 mg: 13.8% - placebo: 4.5% |
| NCT03334435 (BREEZE-AD3) [17] | III | ≥18 years | Baricitinib (long-term extension of BREEZE-AD1 and BREEZE-AD2) |
Patients with IGA 0/1 at week 68:
- 2 mg: 59.3% - 4 mg: 47.1% |
| NCT03428100 (BREEZE-AD4) [18] | III | ≥18 years | Baricitinib, placebo, TCS |
Patients with EASI-75 at week 16:
- 2 mg: 28% - 4 mg: 32% - placebo: 17% |
| NCT03435081 (BREEZE-AD5) [19] | III | ≥18 years | Baricitinib, placebo |
Patients with EASI-75 at week 16:
- 1 mg: 13% - 2 mg: 30% - placebo: 8% |
| NCT03559270 (BREEZE-AD6) * | III | ≥18 years | Baricitinib | Active, not recruiting |
| NCT03733301 (BREEZE-AD7) [20] | III | ≥18 years | Baricitinib, placebo, TCS |
Patients with IGA 0/1 at week 16:
- 2 mg: 24% - 4 mg: 31% - placebo: 15% |
| NCT03952559 (BREEZE-AD Peds) * | III | 2–17 years | Baricitinib, placebo, TCS | Recruiting |
| Upadacitinib (systemic selective JAK 1 inhibitor) | ||||
| NCT02925117 [21] | II | 18–75 years | Upadacitinib, placebo |
EASI improvement at week 16:
- 7.5 mg: 39% - 15 mg: 62% - 30 mg: 74% - placebo: 23% |
| NCT03569293 (Measure Up-1) [22,23] | III | 12–75 years | Upadacitinib, placebo |
Patients with EASI-75 at week 16:
- 15 mg: 70% - 30 mg: 80% - placebo: 16% |
| NCT03607422 (Measure Up-2) [22,23] | III | 12–75 years | Upadacitinib, placebo |
Patients with EASI-75 at week 16:
- 15 mg: 60% - 30 mg: 73% - placebo: 13% |
| NCT03568318 (AD Up) [24,25] | III | 12–75 years | Upadacitinib, placebo, TCS |
Patients with EASI-75 at week 16:
- 15 mg: 65% - 30 mg: 77% - placebo: 23% Patients with IGA 0/1 at week 16:- 15 mg: 40% - 30 mg: 59% - placebo: 11% |
| NCT03738397 (Heads Up) [26] | III | 12–75 years | Upadacitinib, dupilumab |
Patients with EASI-75 at week 16:
- Upadacitinib 30 mg: 71% - Dupilumab: 61.1% |
| NCT03661138 (Rising Up) [27] | III | 12–75 years | Upadacitinib, placebo, TCS | n/a (safety analysis) |
| NCT04195698 * | III | 18–75 years | Upadacitinib | Active, not recruiting |
| Abrocitinib (systemic JAK 1 inhibitor) | ||||
| NCT02780167 [28] | II | 18–75 years | Abrocitinib, placebo |
Patients with IGA 0/1 at week 12:
- 10 mg: 40% (10.9%) - 30 mg: 59% (8.9%) - 100 mg: 29.6% - 200 mg: 43.8% - placebo: 5.8% |
| NCT04345367 * | III | ≥18 years | Abrocitinib, dupilumab | not yet available |
| NCT03349060 (JADE MONO-1) [29] | III | ≥12 years | Abrocitinib, placebo |
Patients with IGA 0/1 at week 12:
- 100 mg: 44% - 200 mg: 24% - placebo: 8% |
| NCT03575871 (JADE MONO-2) [30] | III | ≥12 years | Abrocitinib, placebo |
Patients with IGA 0/1 at week 12:
- 100 mg: 44% - 200 mg: 24% - placebo: 8% |
|
NCT03796676 (JADE TEEN) [31] |
III | 12–17 years | Abrocitinib, placebo |
Patients with EASI-75 at week 12:
- 100 mg: 44.5% - 200 mg: 61% - placebo: 10.4% Patients with IGA 0/1 at week 12:- 100 mg: 38.1% - 200 mg: 28.4% - placebo: 9.1% |
| NCT03627767 (JADE REGIMEN) [32] | III | ≥12 years | Abrocitinib, placebo | n/a (assessment of treatment modification on AD symptoms/flares) |
| NCT03720470 (JADE COMPARE) [33] | III | ≥18 years | Abrocitinib, dupilumab, placebo |
Patients with EASI-75 at week 12:
- 100 mg: 58.7% - 200 mg: 70.3% - dupilumab: 58.1% - placebo: 27.1% Patients with IGA 0/1 at week 12:- 100 mg: 36.6% - 200 mg: 48.4% - dupilumab: 36.5% - placebo: 14% |
| NCT03422822 (JADE EXTEND) [34] | III | ≥12 years | Abrocitinib (extension study after switching from dupilumab) |
Patients (Dupilumab-responders) with EASI-75 at week 12:
- 100 mg: 90.2% - 200 mg: 93.5% Patients (Dupilumab-non-responders) with EASI-75 at week 12:- 100 mg: 67.7% - 200 mg: 80% |
| NCT05375929 * | III | ≥12 years | Abrocitinib | Not yet recruiting |
| SHR0302 (systemic selective JAK 1 inhibitor) | ||||
| NCT04717310 (MARBLE-23) * | II/III | ≥12 | SHR0302 (oint), vehicle | Recruiting |
| NCT04162899 [35] | II | 18–75 | SHR0302 |
Patients with IGA 0/1 at week 12:
- 4 mg: 25.7% - 8 mg: 54.3% - placebo: 5.7% |
| NCT04875169 * | III | ≥12 | SHR0302, placebo | Active, not recruiting |
EASI: Eczema Area and Severity Index; IGA: Investigator’s Global Assessment; mEASI: modified Eczema Area and Severity Index; n/a: not applicable; TCS: topical corticosteroids; * Additional, unpublished RCTs listed on https://www.clinicaltrials.gov, accessed on 10 June 2022.