Table 2.
JAK Inhibitors for Atopic Dermatitis (Currently Approved or Completed Phase 3 Clinical Trials)
| Biologic | Study Type | Trial Identifier | Subject Number | Duration (weeks) | Dose (%) | Age (years) | Primary Endpoints Achieved | Key Secondary Endpoints Achieved | Notable Adverse Events |
|---|---|---|---|---|---|---|---|---|---|
| Abrocitinib(JAK1) | Phase 3 (monotherapy) | JADE MONO-1, NCT 03349060 | 387 | 12 wks | 200mg, 100mg | 12+ | IGA 0/1, EASI-75 | PP-NRS4, %PSAAD | Nausea, vomiting, elevated CPK, headache, herpes simplex, folliculitis, nasopharyngitis transient thrombocytopenia |
| Phase 3 (monotherapy) | JADE MONO-2, NCT 03575871 | 391 | 12 wks | 200mg, 100mg | 12+ | IGA 0/1, EASI-75 | PP-NRS4, %PSAAD | ||
| Phase 3 (monotherapy) | JADE-REGIMEN, NCT 03627767 | 1,233 | 52 wks | 200mg, 100mg | 12+ | Flare, loss of EASI-50, IGA | IGA 0/1 | ||
| Phase 3 (+TCS) | JADE-TEEN,NCT 03796676 | 285 | 12 wks | 200mg, 100mg | 12–17 | IGA 0/1, EASI-75 | PP_NRS4, %PSAAD | ||
| Phase 3 (+TCS) | JADE EXTEND, NCT 03422822 | 3154 | Variable | 200mg, 100mg | 12 | Safety multiple | IGA, EASI-50,75,90, iNRS, Pt-GA, BSA, DLQI, POEM | ||
| Phase 3 (+TCS vs DUPI 300 q2wks) | JADECOMPARE, NCT 03720470 | 838 | 16 wks | 200mg, 100mg | >18 | IGA 0/1 wk 12, EASI-75 wk 12 | PP-NRS4 vs placebo, DUPI, IGA 0/1 vs placebo, DUPI, EASI-75 vs placebo, DUPI* | ||
| Baricitinib | Phase 3 (monotherapy) | BREEZE-AD1,NCT03334396 | 624 | 16 wks | 4mg, 2mg, 1mg | >18 | vIGA-AD 0/1 | vIGA-AD 0/1, %EASI, EASI-75, 90, SCORAD-75, i-NRS, %skin pain-NRS, Item 2-ADSS | Headache, herpes simplex, increased CPK |
| Phase 3 (monotherapy) | BREEZE-AD2,NCT03334422 | 615 | 16 wks | 4mg, 2mg, 1mg | >18 | vIGA-AD 0/1 | vIGA-AD 0/1, %EASI, EASI-75, 90, SCORAD-75, i-NRS, %skin pain-NRS, Item 2-ADSS | Headache, increased CPK | |
| Phase 3 (+TCS) | BREEZE-AD3, NCT03334435 | 1645 | 52 wks | 4mg, 2mg | >18 | VIGA-AD 0/1 (wks 16, 32,52) | IGA- 0/1/2, IGA 0/1 (non-responders), EASI-75, i-NRS, Skin-pain NRS4, Item2-ADSS1.5 | No change from Breeze, 1, 2 | |
| Phase 3 (+TCS) | BREEZE-AD4, NCT03428100 | 463 | 16 wks | 4mg, 2mg, 1mg | >18 | EASI-75 | %EASI, EASI-90, vIGA 0/1, SCORAD-75, iNRS, %skinpain-NRS, Item2-ADSS | Headache, influenza, nasopharyngitis | |
| Phase 3 (monotherapy) | BREEZE-AD5, NCT03435081 | 440 | 16 wks | 2mg, 1mg | >18 | EASI-75 | EASI-90, vIGA, i-NRS, % skin-pain-NRS, % item2-ADSS, SCORAD 75 | Herpes simplex, diarrhea, nasopharyngitis, upper respiratory infection, nausea | |
| Phase 3 (monotherapy) | BREEZE-AD6, NCT03559270 | 374 | 16 wks | 4mg, 2mg | >18 | EASI-75 | IGA- 0/1, BSA<3%, Itch-NRS4 | Headache, herpes simplex, upper respiratory infection | |
| Phase 3 (+TCS) | BREEZE-AD7, NCT03733301 | 329 | 16 wks | 4mg, 2mg | >18 | vIGA-AD 0/1 | EASI-75,90, SCORAD-75, i-NRS, %skin pain-NRS, %item 2-ADSS | ||
| Upadacitinib | Phase 3 (monotherapy) | Measure UP 1, NCT03569293 | 847 | 16 wks | 30mg, 15mg | 12–75 | EASI-75, vIGA 0/1 | EASI 90/100, worst itch-NRS4, POEM4, DLQI4, DLQI 0/1 | Acne, headache, nasopharyngitis, herpes zoster, increased CPK, upper respiratory infection |
| Phase 3 (monotherapy) | Measure Up 2, NCT03607422 | 836 | 16 wks | 30mg, 15mg | 12–75 | EASI-75, vIGA 0/1 | EASI 90/100, worst itch-NRS4, POEM4, DLQI4, DLQI 0/1 | Acne, headache, nasopharyngitis, herpes zoster, increased CPK, upper respiratory infection | |
| Phase 3 (+TCS) | AD Up, NCT03568318 | 300 | 16 wks | 30mg, 15mg | 12–75 | EASI-75, vIGA 0/1 | EASI90/100, worst itch-NRS4 | Acne, headache, nasopharyngitis, herpes zoster, increased CPK, upper respiratory infection, eczema herpeticum | |
| Phase 3 (monotherapy vs.DUPI 300 q2 wks) | Heads Up, NCT 03738397 | 692 | 16 wks | 30mg | 18–75 | EASI-75 | EASI 90/100, worst itch-NRS4, % worst itch-NRS 30 mg dose superior to DUPI | Rates of acne, serious infection, eczema herpeticum, herpes zoster, and laboratory-related adverse events were higher for upadacitinib Rates of conjunctivitis and injection-site reactions were higher for DUPI |
*
200mg (not 100mg) of ABRO was superior to DUPI for itch scores only (not IGA or EASI-75).