Tralokinumab has been compared to placebo. The evidence is based on 3 RCTs, but the quality of evidence varies among outcomes, applicability of the evidence is high.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; IGA=Investigator's Global Assessment score; EASI=Eczema Area and Severity Index, POEM50= 50% improvement in POEM (Patient-Oriented Eczema Measure) score; SAE=serious adverse effects; TCS=topical corticosteroids; q2w=every 2 weeks | |||||
| «Wollenberg A, Blauvelt A, Guttman-Yassky E ym. Tra...»1 | 2 RCTs | Patients ≥ 18 years with moderate to severe atopic dermatitis (EASI ≥
12 at screening and ≥ 16 at baseline, IGA score of ≥ 3) for ≥
1 year, an inadequate response to topical treatments n1=802 n2=794 |
Subcutaneous tralokinumab 300 mg, after a 600 mg loading dose on day 0, or placebo every other week. |
Primary: IGA score of 0 (clear skin) or 1 (almost clear skin) and EASI-75 at week 16. |
Low |
| «Silverberg JI, Toth D, Bieber T ym. Tralokinumab p...»2 | RCT | Patients ≥ 18 years with moderate-to-severe atopic dermatitis (EASI score ≥
12 at screening and ≥ 16 at baseline, IGA score of ≥ 3) for ≥
1 year and an inadequate response to topical medications or documented systemic treatment in the past year. N=380. |
Subcutaneous tralokinumab 300 mg or placebo every 2 weeks (Q2W) with TCS as needed
after day 0. Loading dose of 600 mg tralokinumab or placebo. |
Primary: IGA score of 0 or 1 and EASI-75 at week 16. | Low |
| Reference | Comments |
|---|---|
| «Wollenberg A, Blauvelt A, Guttman-Yassky E ym. Tra...»1 | Two identical 52-week, multinational, randomized, double-blind, placebo-controlled
trials. Patients were randomized to treatment and placebo groups 3 : 1. Rescue treatment for AD could be provided at the discretion of the investigator. For the purpose of efficacy analysis, patients who received rescue treatment during the initial treatment period were considered nonresponders in the primary analysis but were permitted to continue their assigned study treatment if rescue consisted of topical medications. After a 16-week initial treatment period, tralokinumab-treated patients who achieved the prespecified criteria for clinical response of IGA score of 0 or 1, or ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) were rerandomized 2:2:1 to tralokinumab 300 mg every 2 weeks (Q2W) or every 4 weeks (Q4W), or placebo for a 36-week maintenance treatment period. The study was sponsored by pharma. |
| «Silverberg JI, Toth D, Bieber T ym. Tralokinumab p...»2 | A double-blind, randomized, placebo-controlled 32-week trial conducted across 63 sites
in Europe and North America. Supplied topical corticosteroids were advised to be used as needed, once daily to areas with active lesions [mometasone furoate 0.1% cream; Europe class 3 (potent)]. The study was sponsored by pharma. |
Results
| 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 | |||||
| «Wollenberg A, Blauvelt A, Guttman-Yassky E ym. Tra...»1 | RCT 1 no concomitant TCS allowed N= 798 (601/197) |
16 | 150 (25.0%) |
25 (12.7%) |
12.1 (6.5 - 17.7) |
| RCT 2 no concomitant TCS allowed N=792 (591/201) |
16 | 196 (33.2%) | 23 (11.4%) | 21.6 (15.8 - 27.3) |
|
| «Silverberg JI, Toth D, Bieber T ym. Tralokinumab p...»2 | RCT concomitant TCS allowed N= 380 (253/127) |
16 | 141 (56.0%) | 45 (35.7%) | 20.2 (9.8–30.6) |
| 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 | |||||
| «Wollenberg A, Blauvelt A, Guttman-Yassky E ym. Tra...»1 | RCT 1 no concomitant TCS allowed N= 798 (601/197) |
16 | 87 (14.5%) | 8 (4.1%) | 10.3 (6.4 - 14.1) |
| RCT 2 no concomitant TCS allowed N=792 (591/201) |
16 | 108 (18.3%) | 11 (5.5%) | 12.7 (8.3-17.0) | |
| «Silverberg JI, Toth D, Bieber T ym. Tralokinumab p...»2 | RCT concomitant TCS allowed N= 380 (253/127) |
16 | 83 (32.9%) | 27 (21.4%) | 11.4 (2.1–20.7) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision (wide confidence intervals and possible lack of clinically meaningful difference). |
|||||
| 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) |
|---|---|---|---|---|---|
| «Wollenberg A, Blauvelt A, Guttman-Yassky E ym. Tra...»1 | RCT 1 no concomitant TCS allowed N= 798 (601/197) |
16 | 95 (15.8%) |
14 (7.1%) | 8.6% (4.1–13.1) |
| RCT 2 no concomitant TCSallowed N=792 (591/201) |
16 | 131(22.2%) | 22(10.9%) | 11.1% (5.8–16.4) | |
| «Silverberg JI, Toth D, Bieber T ym. Tralokinumab p...»2 | RCT concomitant TCS allowed N= 380 (253/127) |
16 | 98 (38.9%) | 33 (26.2%) | 12.4% (2.9–21.9) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision. |
|||||
| I=intervention; C=comparison; CI=confidence interval; ARR=Absolute risk reduction; TCS=topical corticosteroids | |||||
| 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 | |||||
| «Wollenberg A, Blauvelt A, Guttman-Yassky E ym. Tra...»1 | RCT 1 no concomitant TCS allowed N= 798 (601/197) |
16 | 119 (20.0%) | 20 (10.3%) | 9.7 (4.4 - 15.0) |
| RCT 2 no concomitant TCS allowed N=792 (591/201) |
16 | 144 (25.0%) | 19 (9.5%) | 15.6 (10.3 - 20.9) | |
| «Silverberg JI, Toth D, Bieber T ym. Tralokinumab p...»2 | RCT concomitant TCS allowed N= 380 (253/127) |
16 | 113 (45.4%) | 43 (34.1%) | 11.3 (0.9–21.6) |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision. |
|||||
| 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 | |||||
| «Wollenberg A, Blauvelt A, Guttman-Yassky E ym. Tra...»1 | RCT 1 no concomitant TCS allowed N= 798 (601/197) |
16 | 258 (44.6%) |
60 (31.6%) | 13.0 (5.4 - 20.5) |
| RCT 2 no concomitant TCS allowed N=792 (591/201) |
16 | 325 (56.3%) | 54 (27.3%) | 28.9 (21.4 - 36.3) | |
| «Silverberg JI, Toth D, Bieber T ym. Tralokinumab p...»2 | RCT concomitant TCS allowed N= 380 (253/127) |
16 | 207 (83.5%) | 81 (65.9%) | 17.6 (8.0–27.1) |
| Level of evidence: moderate The quality of evidence is downgraded due to inconsistency. |
|||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time, weeks | Mean change (SE) I | Mean change (SE) C | Difference (95% CI) |
|---|---|---|---|---|---|
| I=intervention; C=comparison; CI=confidence interval; SE=standard error; TCS=topical corticosteroids; POEM maximum score 28 points. | |||||
| «Wollenberg A, Blauvelt A, Guttman-Yassky E ym. Tra...»1 | RCT 1 no concomitant TCS allowed N= 798 (601/197) |
16 | -7.6 (0.35) | -3.0 (0.66) | -4.6 (-6.0- -3.1) |
| RCT 2 no concomitant TCS allowed N=792 (591/201) |
16 | -8.8 (0.33) | -3.7 (0.66) | -5.1 (-6.5 - -3.6) | |
| «Silverberg JI, Toth D, Bieber T ym. Tralokinumab p...»2 | RCT concomitant TCS allowed N= 380 (253/127) |
16 | -11.8 (0.46) | -7.8 (0.66) | -4.0 (-5.6- -2.4) |
| Level of evidence: high | |||||