Risankizumab in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo
Näytönastekatsaukset
15.6.2020
Level of evidence: B
Risankizumab treatment when compared to placebo, increases the proportion of patients moderate to severe plaque psoriasis to achieve a clinically meaningful improvement at 16 weeks of treatment. The safety profile of risankizumab seems to be equal to placebo after 16 weeks treatment.
The evidence is based on 3 phase 3 RCT’s.
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias «Risankizumab in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo»1 |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; PASI=Psoriasis area severity index, PGA=Physician's Global Assessment | |||||
| «Gordon KB, Strober B, Lebwohl M ym. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled »1 | Pooled analysis of 2 RCTs | Moderate to severe chronic plaque psoriasis, patients from 15 countries.N=997 | Risankizumab 150 mg at weeks 0, 4, 16, 28, 40 Placebo at weeks 0, 4 | PASI90 and PGA score | low |
| «Ohtsuki M, Fujita H, Watanabe M ym. Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial. J Dermatol 2019;46:686»2 | RCT | Adults (>20 years) with moderate to severe chronic plaque psoriasis. N=123 | Risankizumab 150 mg at weeks 0, 4, and then every 12 weeks Placebo at weeks 0, 4 | Primary: PASI90 Secondary: PASi75, PASi100, PGA score | low |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval; NA not available | |||||
| «Gordon KB, Strober B, Lebwohl M ym. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled »1 | 1 RCT (UltIMMa-1)n= 304/ 102 | 16 | 229 (75.3) | 5 (4.9) | NA |
| 1 RCT (UltIMMa-2)n=294/98 | 16 | 220 (74.8) | 2 (2.0) | NA | |
| «Ohtsuki M, Fujita H, Watanabe M ym. Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial. J Dermatol 2019;46:686»2 | RCT n=55/58 | 16 | 41 (74.5) | 1 (1.7) | NA |
| Level of evidence: high | |||||
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative effect (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval | |||||
| «Gordon KB, Strober B, Lebwohl M ym. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled »1 | 1 RCT (UltIMMa-1)n= 304/ 102 | 16 | 267 (87.8) | 8 (7.8) | NA |
| 1 RCT (UltIMMa-2)n=294/98 | 16 | 246 (83.7) | 5 (5.1) | NA | |
| «Ohtsuki M, Fujita H, Watanabe M ym. Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial. J Dermatol 2019;46:686»2 | RCT n=55/58 | 16 | 51 (92.7) | 6 (10.3) | NA |
| Level of evidence: high | |||||
| Reference | Number of studies and number of patients (E/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Relative risk (95% CI) |
|---|---|---|---|---|---|
| I= intervention; C=comparison; CI=confidence interval | |||||
| «Gordon KB, Strober B, Lebwohl M ym. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled »1 | 1 RCT (UltIMMa-1)n= 304/ 102 | 16 | Any adverse event:151 (49.7) Serious adverse event 6 (2.0) | Any adverse event:52 (51.0) Serious adverse event: Placebo 3 (2.9) | NA |
| 1 RCT (UltIMMa-2)n=294/98 | 16 | Any adverse event:134 (45.6)Serious adverse event 6 (2.0) | Any adverse event:45 (45.9) Serious adverse event:1 (1.0) | NA | |
| «Ohtsuki M, Fujita H, Watanabe M ym. Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial. J Dermatol 2019;46:686»2 | RCT n=55/58 | 16 | Any adverse event:
31 (56%)
Serious adverse event: 2 (4%) | Any adverse event:
33 (57%)
Serious adverse event: 1 (2%) | NA |
| Level of evidence: moderate The quality of evidence is downgraded due to imprecision. | |||||
References
- Gordon KB, Strober B, Lebwohl M ym. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet 2018;392:650-661 «PMID: 30097359»PubMed
- Ohtsuki M, Fujita H, Watanabe M ym. Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: Results from the SustaIMM phase 2/3 trial. J Dermatol 2019;46:686-694 «PMID: 31237727»PubMed