In addition, there is evidence that compared to placebo dupilumab may increase proportion of patients with IGA 0 or 1 and reduce pruritus. The evidence is based on 1 RCT with low risk of bias.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; BSA= body surface area, IGA=Investigator's Global Assessment); EASI=Eczema Area and Severity Index; NRS=weekly averaged baseline worst itch score, Peak Pruritus Numerical Rating Scale; TCS= topical corticosteroids; q2w=every 2 weeks; q4w= every 4 weeks | |||||
| «Paller AS, Siegfried EC, Thaçi D ym. Efficacy and ...»1 | RCT | Children age 6-11 years with atopic dermatitis (American Academy of Dermatology consensus criteria 20) diagnosed ≥ 1 year before screening; IGA score of 4, EASI score ≥ 21, affected BSA ≥ 15%, NRS ≥ 4; weight ≥ 15 kg; and documented history of inadequate response to topical medication within 6 months of baseline. N=367 |
Q2w: dupilumab + TCS every 2 weeks; q4w: dupilumab + TCS every 4 weeks; matching placebo + TCS |
Primary: proportion of patients with an IGA score of 0 or 1; >75% improvement in EASI (EASI-75). Secondary: percent change in EASI and weekly average of peak pruritus NRS. Follow-up time 16 weeks. |
low |
| Reference | Comments |
|---|---|
| EASI=Eczema Area and Severity Index; TCS= topical corticosteroids; q2w= every 2 weeks; q4w= every 4 weeks | |
| «Paller AS, Siegfried EC, Thaçi D ym. Efficacy and ...»1 | Patients had severe atopic dermatitis (EASI ≥ 21) and they had high rates of
atopic comorbidities like asthma, allergic rhinitis, and food allergies. Approximately
one third of the patients had a prior systemic treatment for atopic dermatitis. Dupilumab dosing: q2w + TCS; weight-tiered: baseline weight 15 to<30 kg, 100 mg q2w + TCS, 200 mg loading dose; baseline weight ≥30 kg, 200 mg q2w + TCS, 400 mg loading dose. 300 mg q4w + TCS; 600 mg loading dose regardless of weight All patients received concomitant once-daily medium-potency TCS starting 2 weeks before baseline. Rescue treatment with high-potency TCS or systemic therapy was permitted. Of the study patients 362 (98.2%) received at least one dose of study treatment. 351 patients (95.6%) completed the study treatment. |
Results
| Reference | Number of patients | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | Risk Ratio (95% CI) NNT (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval; RR=risk ratio, NNT=number needed to treat; q2w=dosing every two weeks; q4w=dosing every four weeks; TCS=topical corticosteroids | |||||
| «Paller AS, Siegfried EC, Thaçi D ym. Efficacy and ...»1 | Q2w+TCS n=122 placebo n=123 |
16 | 82 (67.2) | 33 (26.8) | RR 2.51 (1.87-3.44) NNT 2.5 (1.9-3.4) |
| Q4w+TCS n=122 placebo n=123 |
16 | 85 (69.7) | 33 (26.8) | RR 2.6 (1.9-3.6), NNT 2.3 (1.85-3.2) | |
| Level of evidence: moderate | |||||
| Reference | Number of patients | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (RR)* (95% CI), NNT* |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval, RR=risk ratio, NNT=number needed to treat; *not reported, self-calculated; q2w=dosing every two weeks; q4w=dosing every four weeks; TCS=topical corticosteroids | |||||
| «Paller AS, Siegfried EC, Thaçi D ym. Efficacy and ...»1 | Q2w+TCS n=122 placebo n=123 |
16 | 36 (29.5) | 14 (11.4) | RR 2.59 (1.47-4.56) NNT 5.5 (3.6-12.1) |
| Q4w+TCS n=122 placebo n=123 |
16 | 40 (32.8) | 14 (11.4) | RR 2.88 (1.65-5.02) NNT 4.7 (3.2-8.8) |
|
| Level of evidence: moderate | |||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time (weeks) | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval; NA=not available; q2w=dosing every two weeks; q4w=dosing every four weeks; TCS=topical corticosteroids | |||||
| «Paller AS, Siegfried EC, Thaçi D ym. Efficacy and ...»1 | Q2w+TCS n=122 placebo n=123 |
16 | 82 (67.2) | 33 (26.8) | NA |
| Q4w+TCS n=122 placebo n=123 |
16 | 85 (69.7) | 33 (26.8) | NA | |
| Level of evidence: low The level of evidence is downgraded due to imprecision. |
|||||