2021
DOI: 10.1016/j.jaad.2020.09.047
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Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: Long-term results from 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2)

Abstract: Background: Data for the effect of metabolic syndrome (MetS) on the efficacy and safety of biologic agents for psoriasis treatment are limited.Objective: To evaluate long-term tildrakizumab efficacy, drug survival, and safety in patients with psoriasis by baseline MetS status.Methods: Post hoc analyses of up to 3 years of efficacy data and 5 years of safety data from the phase 3, double-blind, randomized controlled reSURFACE 1 and 2 trial (NCT01722331 and NCT01729754) base and extension studies were conducted … Show more

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Cited by 20 publications
(24 citation statements)
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“…Percentages of patients with PASI 75, 90 and 100 improvements at weeks 12, 52, and 148 were similar in patients with and without metabolic syndrome for both tildrakizumab doses and median absolute PASI values decreased to comparable low levels over 148 weeks (Figure 3). The safety profile in patients with and without metabolic syndrome was confirmed over 5 years [39,40].…”
Section: Metabolic Syndromementioning
confidence: 86%
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“…Percentages of patients with PASI 75, 90 and 100 improvements at weeks 12, 52, and 148 were similar in patients with and without metabolic syndrome for both tildrakizumab doses and median absolute PASI values decreased to comparable low levels over 148 weeks (Figure 3). The safety profile in patients with and without metabolic syndrome was confirmed over 5 years [39,40].…”
Section: Metabolic Syndromementioning
confidence: 86%
“…The efficacy in PASI 75 responders at week 28 was preserved, with >90% median PASI increases in all weight categories at week 52. Moreover, neither the efficacy nor safety of tildrakizumab were altered by the presence of metabolic syndrome in a post hoc analysis of reSURFACE 1 and 2 through 52 weeks [38] and confirmed at 148 weeks [39]. Percentages of patients with PASI 75, 90 and 100 improvements at weeks 12, 52, and 148 were similar in patients with and without metabolic syndrome for both tildrakizumab doses and median absolute PASI values decreased to comparable low levels over 148 weeks (Figure 3).…”
Section: Metabolic Syndromementioning
confidence: 89%
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“…The proportion of patients who achieved PASI 75 at week 52 was comparable in patients with MetS and patients without MetS (tildrakizumab 100 mg, 85% and 86% vs 86% and 94% for reSURFACE 1/2, respectively; tildrakizumab 200 mg, 76% and 87% vs 76% and 87% for reSURFACE 1/2, respectively). 5 Tildrakizumab also demonstrated efficacy and safety for up to 5 years in 2 other phase 3 RCTs with no dose-related differences in frequency of injections and malignancies. Tildrakizumab 100 mg is the recommended dose.…”
Section: Il-23 Inhibitors Updatementioning
confidence: 95%
“…A post hoc analysis of 2 phase 2 RCTs (reSURFACE 1/2) involving adults (N=338 and N=307) with moderate to severe plaque psoriasis assessed long-term efficacy (3 years), drug survival, and safety for 5 years of continuous tildrakizumab 100 mg and 200 mg in adults with comorbid MetS. 5 Although no difference in efficacy was concluded, greater body mass index of the MetS population was shown to be associated with lower biologic efficacy compared to the general population. The proportion of patients who achieved PASI 75 at week 52 was comparable in patients with MetS and patients without MetS (tildrakizumab 100 mg, 85% and 86% vs 86% and 94% for reSURFACE 1/2, respectively; tildrakizumab 200 mg, 76% and 87% vs 76% and 87% for reSURFACE 1/2, respectively).…”
Section: Il-23 Inhibitors Updatementioning
confidence: 99%