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Risankizumab in treatment of moderate to severe plaque psoriasis: effectiveness compared to placebo

Näytönastekatsaukset
Raija Sipilä
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.

Table 1. Description of the included studies
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 s...»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 s...»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

Table 2. Patients reaching PASI90
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 s...»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 s...»2 RCT n=55/58 16 41 (74.5) 1 (1.7) NA
Level of evidence: high
Table 3. PGA score 0-1
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 s...»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 s...»2 RCT n=55/58 16 51 (92.7) 6 (10.3) NA
Level of evidence: high
Table 4. Adverse events
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 s...»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 s...»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

  1. 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
  2. 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