Takaisin

Ixekizumab treatment in patients with active skin psoriasis: effectiveness compared to placebo

Näytönastekatsaukset
Jorma Komulainen
15.6.2020

Level of evidence: A

Ixekizumab treatment at the dose of 80 mg, when compared to placebo, increases the proportion of patients with active skin psoriasis to achieve a clinically meaningful improvement at 12 weeks of treatment.

There seems to be no clinically relevant differences in efficacy between 2-weeks and 4-weeks interval dosing regimens. However, treatment seems to have more adverse events than placebo at 12 weeks of treatment.

Table 1. Description of the included studies
RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis
Reference Study type Population Intervention and comparison Outcomes Risk of bias «Ixekizumab treatment in patients with active skin psoriasis: effectiveness compared to placebo»1
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 SR/MA Adult (at least 18 years) patients with moderate to severe plaque psoriasis.RCTs reporting outcomes at 12-16 weeks. Ixekizumab 80mg every 4 weeks (4WR); Ixekizumab 80mg every 2 weeks (2WR); placebo Primary: PASI-75 orPGA/IGA 0/1 by 12-16 weeks;Secondary: PASI-90 by 12-16 weeks,Adverse events, including withdrawals due to toxicity Low

Results

Table 2. PASI-75
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
4WR = Ixekizumab 80mg every 4 weeks
2WR = Ixekizumab 80mg every 2 weeks
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 3 RCTs with 3126 participants (2334/792) 12 weeks 4WR: 951 (81.6)
2WR: 1037 (88.7)
PLAC: 35 (4.4) 4WR: RR 18.2 (10.6-31.2);
2WR: RR 19.8 (11.1-35.5)
Level of evidence: high
Table 3. 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)
4WR = Ixekizumab 80mg every 4 weeks
2WR = Ixekizumab 80mg every 2 weeks
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 3 RCTs with 3126 participants (2334/792) 12 weeks 4WR: NA
2WR: NA
PLAC: NA 4WR: RR 53.6 (14.0-204.7);
2WR: RR 63.8 (15.2-267.5)
Level of evidence: moderate
Assess the risk of bias and delete irrelevant sources of bias:
The quality of evidence is downgraded due to, imprecision.
Table 4. PGA/IGA 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
4WR = Ixekizumab 80mg every 4 weeks
2WR = Ixekizumab 80mg every 2 weeks
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 3 RCTs with 3126 participants (2334/792) 12 weeks 4WR: 874 (79.4)
2WR: 956 (81.8)
31 (3.9) 4WR: RR 18.8 (10.4-34.2);
2WR: RR 20.4 (11.0-37.8)
Level of evidence: high
Table 5. Withrawals due to toxicity
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)
4WR = Ixekizumab 80mg every 4 weeks
2WR = Ixekizumab 80mg every 2 weeks
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 3 RCTs with 3126 participants (2334/792) 12 weeks 4WR: 33 (2.8)
2WR: 33 (2.8)
11 (1.4) RR 2.4 (1.2-4.6) (4WR) and 2.4 (1.2-4.7) (2WR).
Level of evidence: low
Assess the risk of bias and delete irrelevant sources of bias:
The quality of evidence is downgraded due to study limitations, imprecision.

References

  1. Bilal J, Berlinberg A, Bhattacharjee S ym. A systematic review and meta-analysis of the efficacy and safety of the interleukin (IL)-12/23 and IL-17 inhibitors ustekinumab, secukinumab, ixekizumab, brodalumab, guselkumab and tildrakizumab for the treatment of moderate to severe plaque psoriasis. J Dermatolog Treat 2018;29:569-578 «PMID: 29532693»PubMed