Takaisin

Tildrakizumab in treatment of moderate to severe plaque psoriasis: effectiveness and safety compared to placebo

Näytönastekatsaukset
Raija Sipilä
15.6.2020

Level of evidence: B

Tildrakizumab, compared to placebo, seems to increase the proportion of patients with moderate to severe plaque psoriasis who reach PGA0-1 at 12-16 weeks of treatment. It may be effective in terms of PASI90 and the safety profile may be comparable to placebo at 16 weeks of treatment. The most common treatment-emergent adverse event is nasopharyngitis.

The evidence is based on 3 placebo controlled RCTs with short follow-up (12-16 weeks).

Table 1. Description of the included studies
Reference Study type Population Intervention and comparison Outcomes Risk of bias «Tildrakizumab in treatment of moderate to severe plaque psoriasis: effectiveness and safety compared to placebo»1
RCT=randomized controlled trial; MA=meta-analysis
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 MA RCTs, adults (> 18 years) with moderate to severe plaque psoriasis treated with biologic agents.
n=1768
Tildrakizumab 200 mg or 100 mg at baseline, week 4 and every 12 weeks vs. placebo Primary: PASI-75, PGA 0-1 at 12-16 weeks Secondary: PASI-90, safety low
«Blauvelt A, Reich K, Papp KA ym. Safety of tildrak...»2 Pooled analysis 3 RCTs Adults (> 18 years) with moderate to severe plaque psoriasis treated with biologic agents.
n=1768
Tildrakizumab 200 mg or 100 mg at baseline, week 4 and every 12 weeksvs. placebo Treatment-emergent adverse events, serious AE. low

Results

Table 2. 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
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 3 RCTs
100 mg (705/355)
200 mg (708/355)
12 weeks 402 (57.0)
432 (61.0)
18 (5.1) RR 10.03 (6.45-15.59)
RR 10.97 (6.44-18.69)
Level of evidence: moderate
The quality of evidence is downgraded due to imprecision.
Table 3. PASI-90
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
«Bilal J, Berlinberg A, Bhattacharjee S ym. A syste...»1 3 RCTs100 mg (705/355)200 mg (708/355) 12 weeks 280 (39,7)283 (40,0) 7 (2,0)7 (2,0) RR 17.27 (8.24-36.19)RR 17.97 (8.58-37.64)
Level of evidence: low
The quality of evidence is downgraded due to indirectness(secondary outcome) and imprecision.
Table 4. Adverse events (AE)
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, TEAEs=treatment-emergent adverse events
«Blauvelt A, Reich K, Papp KA ym. Safety of tildrak...»2 3 RCTs100 mg (705/355)200 mg (708/355) 16 weeks TEAEs100 mg 340 (48.2)200mg 339 (47.9)Serious AEs100 mg 10 (1.4)200 mg 16 (2.3) 191 (53.8)6 (1.7) NA
Level of evidence: low
The quality of evidence is downgraded due to 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
  2. Blauvelt A, Reich K, Papp KA ym. Safety of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials. Br J Dermatol 2018;179:615-622 «PMID: 29742274»PubMed