BACKGROUND: The phase 3 reSURFACE 1 and reSURFACE 2 (NCT01722331/NCT01729754) trials of the anti-interleukin-23p19 monoclonal antibody tildrakizumab for psoriasis treatment are complete.OBJECTIVES: We present 5-year pooled data from reSURFACE 1 and reSURFACE 2.METHODS: reSURFACE 1 and reSURFACE 2 were double-blind, randomised, controlled studies with optional long-term extensions. Adults with moderate-to-severe chronic plaque psoriasis were randomised 2:2:1 to tildrakizumab 100 (TIL100) or 200 mg (TIL200) or placebo at weeks 0 and 4, and every 12 weeks thereafter (reSURFACE 2 included an etanercept arm). Efficacy outcomes included proportions of patients achieving absolute and relative improvement from baseline Psoriasis Area and Severity Index (PASI) score through week 244 in tildrakizumab responders (≥75% improvement from baseline PASI; PASI 75 response) continuously receiving the same dose and etanercept partial responders and nonresponders (PASI <75 response) switched to TIL200 at week 28. Safety was assessed from adverse events (AEs) in all patients as-treated.RESULTS: Efficacy analyses included 329 and 227 week 28 responders to TIL100 and TIL200, respectively, and 121 etanercept partial responders/nonresponders switched to TIL200 at week 28. Of TIL100 or TIL200 responders and etanercept partial responders/nonresponders entering the extensions, 235/302, 176/213, and 85/107, respectively, were evaluated at week 244, and 88·7%, 92·5%, and 81·3%, respectively, achieved PASI 75 response. Exposure-adjusted rates of serious AEs were 6·3 and 6·0 patients with events/100 patient-years of TIL100 and TIL200, respectively.CONCLUSIONS: Tildrakizumab treatment provided sustained disease control over 5 years in week 28 tildrakizumab responders and etanercept partial responders/nonresponders, with a reassuring safety profile.
Five-year efficacy and safety of tildrakizumab in patients with moderate to severe psoriasis who respond at week 28: pooled analyses of two randomised phase 3 clinical trials (reSURFACE 1 and reSURFACE 2)
Piaserico, S;
2021
Abstract
BACKGROUND: The phase 3 reSURFACE 1 and reSURFACE 2 (NCT01722331/NCT01729754) trials of the anti-interleukin-23p19 monoclonal antibody tildrakizumab for psoriasis treatment are complete.OBJECTIVES: We present 5-year pooled data from reSURFACE 1 and reSURFACE 2.METHODS: reSURFACE 1 and reSURFACE 2 were double-blind, randomised, controlled studies with optional long-term extensions. Adults with moderate-to-severe chronic plaque psoriasis were randomised 2:2:1 to tildrakizumab 100 (TIL100) or 200 mg (TIL200) or placebo at weeks 0 and 4, and every 12 weeks thereafter (reSURFACE 2 included an etanercept arm). Efficacy outcomes included proportions of patients achieving absolute and relative improvement from baseline Psoriasis Area and Severity Index (PASI) score through week 244 in tildrakizumab responders (≥75% improvement from baseline PASI; PASI 75 response) continuously receiving the same dose and etanercept partial responders and nonresponders (PASI <75 response) switched to TIL200 at week 28. Safety was assessed from adverse events (AEs) in all patients as-treated.RESULTS: Efficacy analyses included 329 and 227 week 28 responders to TIL100 and TIL200, respectively, and 121 etanercept partial responders/nonresponders switched to TIL200 at week 28. Of TIL100 or TIL200 responders and etanercept partial responders/nonresponders entering the extensions, 235/302, 176/213, and 85/107, respectively, were evaluated at week 244, and 88·7%, 92·5%, and 81·3%, respectively, achieved PASI 75 response. Exposure-adjusted rates of serious AEs were 6·3 and 6·0 patients with events/100 patient-years of TIL100 and TIL200, respectively.CONCLUSIONS: Tildrakizumab treatment provided sustained disease control over 5 years in week 28 tildrakizumab responders and etanercept partial responders/nonresponders, with a reassuring safety profile.Pubblicazioni consigliate
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