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

Näytönastekatsaus | Julkaistu: 15.06.2020 Tulosta

Raija Sipilä

Näytönastekatsaukset

Raija Sipilä

15.6.2020

Level of evidence: B

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.

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

Article ID: nak09504 (050.062)

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