In addition, upadacinitib compared to placebo increases the proportion of patients achieving EASI90, with improvement in peak score on numerical rating scale (NRS) for pruritus and improves quality of life. The evidence is based on 3 RCTs, applicability of the evidence is high.
Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
---|---|---|---|---|---|
RCT=randomized controlled trial; EASI=Eczema Area and Severity Index, IGA=Investigator Global Assessment, NRS=Numeric Rating Scale, SCORAD=SCORing Atopic Dermatitis, BSA=Body Surface Area, POEM=Patient-Oriented Eczema Measure, AE=Adverse Event, DLQI=Dermatology Life Quality Index, vIGA-AD=validated Investigator's Global Assessment for Atopic Dermatitis, ADerm-IS=Atopic Dermatitis Impact Scale; ADerm-SS=the Atopic Dermatitis Symptom Scale, HADS-A=Hospital Anxiety and Depression Scale, anxiety; HADS-D=Hospital Anxiety and Depression Scale, depression. | |||||
«Guttman-Yassky E, Teixeira HD, Simpson EL ym. Once...»1 | 2 RCTs | Patients 12-75 years of age with moderate to severe atopic dermatitis (EASI ≥
16 and an IGA score of ≥ 3), an inadequate response to topical treatments or
using systemic treatment. Multicenter study n1=847 n2=836 |
Upadacitinib 15mg or upadacitinib 30mg vs. placebo |
Primary: EASI-75 and vIGA-AD Secondary: NRS, EASI-90, ADerm-IS, ADerm-SS, EASI-100, POEM, DLQI, HADS-A, HADS-D |
Low |
«Reich K, Teixeira HD, de Bruin-Weller M ym. Safety...»2 | RCT | Patients 12-75 years of age with moderate to severe atopic dermatitis (EASI ≥
16 and an IGA score of ≥ 3, onset ≥ 3yrs before baseline) Multicenter study N=901 |
Upadacitinib 15mg with topical treatment or upadacitinib 30mg with topical treatment vs. Placebo with topical treatment Choice of topical treatment aligned with potency was at the investigator's discretion. |
Primary outcome: EASI-75, vIGA-AD Secondary outcomes: WP-NRS, EASI-90, EASI-100, EASI. |
Low |
Reference | Comments |
---|---|
«Guttman-Yassky E, Teixeira HD, Simpson EL ym. Once...»1 |
|
«Reich K, Teixeira HD, de Bruin-Weller M ym. Safety...»2 |
|
Results
Results are shown for upadacitinib 15 and 30 mg.
Reference | Number of studies and number of patients (I/C) | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | ARR (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval; ARR=Absolute risk reduction; TCS=topical corticosteroids; UPA=upadacitinib | |||||
«Guttman-Yassky E, Teixeira HD, Simpson EL ym. Once...»1 | RCT 1, UPA 15 mg, no concomitant TCS allowed (281 /281) |
16 | 196 (69.6) | 46 (16.3) | 53.3 (46.4-60.2) |
RCT 1, UPA 30 mg, no concomitant TCS allowed (285 /281) |
16 | 227 (79.7) | 46 (16.3) | 63.4 (57.1-69.8) | |
RCT 2, UPA 15 mg, no concomitant TCS allowed (276/278) |
16 | 166 (60.1) | 37 (13.3) | 46.9 (39.9- 53.9) | |
RCT 2, UPA 30 mg, no concomitant TCS allowed (282/278) |
16 | 206 (72.9) | 37 (13.3) | 59.6 (53.1-66.2) | |
«Reich K, Teixeira HD, de Bruin-Weller M ym. Safety...»2 | UPA 15 mg, concomitant TCS allowed (300 / 304) |
16 | 194 (64.6) | 80 (26.4) | 38.1 (30.8 - 45.4) |
UPA 30 mg, concomitant TCS allowed (297/304) |
16 | 229 (77.1) | 80 (26.4) | 50.6 (43.8-57.4) | |
Level of evidence: High |
Reference | Number of studies and number of patients (I/C) | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | ARR (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval; ARR=Absolute risk reduction; TCS=topical corticosteroids; UPA=upadacitinib | |||||
«Guttman-Yassky E, Teixeira HD, Simpson EL ym. Once...»1 | RCT 1, UPA 15 mg, no concomitant TCS allowed (281 /281) |
16 | 149 (53.1) | 23 (8.1) | 45.1 (38.6-51.7) |
RCT 1, UPA 30 mg, no concomitant TCS allowed (285 /281) |
16 | 187 (65.8) | 23 (8.1) | 57.8 (51.5-64.1) | |
RCT 2, UPA 15 mg, no concomitant TCS allowed (276/278) |
16 | 117 (42.4) | 15 (5.4) | 36.9 (30.6-43.3) | |
RCT 2, UPA 30 mg, no concomitant TCS allowed (282/278) |
16 | 165 (58.5) | 15 (5.4) | 53.1 (46.7-59.4) | |
«Reich K, Teixeira HD, de Bruin-Weller M ym. Safety...»2 | UPA 15 mg, concomitant TCS allowed (300 / 304) |
16 | 128 (42.8) | 40 (13.2) | 29.5 (22.8-36.3) |
UPA 30 mg, concomitant TCS allowed (297/304) |
16 | 187 (63.1) | 40 (13.2) | 49.9 (43.3-56.4) | |
Level of evidence: High |
Reference | Number of studies and number of patients (I/C) | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | ARR (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval; ARR=Absolute risk reduction; TCS=topical corticosteroids; UPA=upadacitinib | |||||
«Guttman-Yassky E, Teixeira HD, Simpson EL ym. Once...»1 | RCT 1, UPA 15 mg, no concomitant TCS allowed (281 /281) |
16 | 135 (48.1) | 24 (8.4) | 39.8 (33.2-46.4) |
RCT 1, UPA 30 mg, no concomitant TCS allowed (285 /281) |
16 | 177 (62.0) | 24 (8.4) | 53.6 (47.2-60.0) | |
RCT 2, UPA 15 mg, no concomitant TCS allowed (276/278) |
16 | 107 (38.8) | 13 (4.7) | 34.0 (27.8-40.2) | |
RCT 2, UPA 30 mg, no concomitant TCS allowed (282/278) |
16 | 147 (52.0) | 13 (4.7) | 47.4 (41.9-53.7) | |
«Reich K, Teixeira HD, de Bruin-Weller M ym. Safety...»2 | UPA 15 mg, concomitant TCS allowed (300 / 304) |
16 | 119 (64.6) | 33 (10.9) | 28.5 (22.1-34.9) |
UPA 30 mg, concomitant TCS allowed (297/304) |
16 | 174 (58.6) | 33 (10.9) | 47.6 (41.1-54.0) | |
Level of evidence: High |
Reference | Number of studies and number of patients (I/C) | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval; ARR=Absolute risk reduction; TCS=topical corticosteroids; UPA=upadacitinib | |||||
«Guttman-Yassky E, Teixeira HD, Simpson EL ym. Once...»1 | RCT 1, UPA 15 mg, no concomitant TCS allowed (281 /281) |
16 | 143/274 (52.2) | 32/272 (11.8) |
40.5 (33.5-47.5) |
RCT 1, UPA 30 mg, no concomitant TCS allowed (285 /281) |
16 | 168/280 (60.0) | 32/272 (11.8) | 48.2 (41.3-55.0) | |
RCT 2, UPA 15 mg, no concomitant TCS allowed (276/278) |
16 | 113/270 (41.9) | 25/274 (9.1) | 32.6 (25.8-39.4) | |
RCT 2, UPA 30 mg, no concomitant TCS allowed (282/278) |
16 | 167/280 (59.6) | 25/274 (9.1) | 50.4 (43.8-57.1) | |
«Reich K, Teixeira HD, de Bruin-Weller M ym. Safety...»2 | UPA 15 mg, concomitant TCS allowed (300 / 304) |
16 | 149/288 (51.7) | 44/294 (15.0) | 36.8 (29.7-43.8) |
UPA 30 mg, concomitant TCS allowed (297/304) |
16 | 186/291 (63.9) | 44/294 (15.0) | 48.8 (41.9-55.7) | |
Level of evidence: high |
Reference | Number of studies and number of patients (I/C) | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval; ARR=Absolute risk reduction; TCS=topical corticosteroids; UPA=upadacitinib | |||||
«Guttman-Yassky E, Teixeira HD, Simpson EL ym. Once...»1 | RCT 1, UPA 15 mg, no concomitant TCS allowed (281 /281) |
16 | 192/254 (75.4) | 73/250 (29.0) | 46.7 (39.0-54.4) |
RCT 1, UPA 30 mg, no concomitant TCS allowed (285 /281) |
16 | 210/256 (82.0) | 73/250 (29.0) | 53.2% (45.9-60.5) | |
RCT 2, UPA 15 mg, no concomitant TCS allowed (276/278) |
16 | 180/251 (71.7) | 71/250 (28.4) | 42.8 (35.0-50.6) | |
RCT 2, UPA 30 mg, no concomitant TCS allowed (282/278) |
16 | 195/251 (77.6) | 71/250 (28.4) | 49.0 (41.4-56.5) | |
Level of evidence: high |
Reference | Number of studies and number of patients (I/C) | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | Absolute difference (95% CI) |
---|---|---|---|---|---|
I=intervention; C=comparison; CI=confidence interval; ARR=Absolute risk reduction; TCS=topical corticosteroids; UPA=upadacitinib | |||||
«Guttman-Yassky E, Teixeira HD, Simpson EL ym. Once...»1 | RCT 1, UPA 15 mg, no concomitant TCS allowed (281 /281) |
16 | 209/278 (75.0) | 63/276 (22.8) | 52.3 (45.2-59.4) |
RCT 1, UPA 30 mg, no concomitant TCS allowed (285 /281) |
16 | 228/280 (81.4) | 63/276 (22.8) | 58.6 (51.9-65.3) | |
RCT 2, UPA 15 mg, no concomitant TCS allowed (276/278) |
16 | 190/268 (70.9) | 77/268 (28.7) | 42.1 (34.5-49.8) | |
RCT 2, UPA 30 mg, no concomitant TCS allowed (282/278) |
16 | 225/269 (83.5) | 77/268 (28.7) | 54.7 (47.7-61.7) | |
Level of evidence: high |