INTRODUCTION
Plaque psoriasis, the most common type of psoriasis, is a chronic, inflammatory skin disorder that requires life-long management.1-3 This multisystem disease is associated with a range of medical and psychological comorbidities, including cardiovascular disease, obesity, type 2 diabetes, psoriatic arthritis, inflammatory bowel disease, and depression.1,3 Moderate-to-severe plaque psoriasis typically requires systemic treatment, although topical treatments and phototherapy are also available.3
Tildrakizumab is a humanized anti-interleukin-23 p19 monoclonal antibody therapy approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic or phototherapy.4-6 The safety and efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis were established in two Phase 3 randomized, double-blind clinical trials (reSURFACE 1 [NCT01722331] and reSURFACE 2 [NCT01729754]).7-9 Patients receiving tildrakizumab who completed the 64-week reSURFACE 1 or 52-week reSURFACE 2 study with at least a greater than or equal to 50% improvement from baseline Psoriasis Area and Severity Index (PASI) score could enroll in optional extension studies continuing the same dose for an additional 4 years.10,11 Pooled analysis of data from reSURFACE 1 and reSURFACE 2 and corresponding extension studies demonstrated sustained disease control and a favorable safety profile for up to 5 years of treatment in patients who achieved a greater than or equal to 75% improvement from baseline PASI score (PASI 75 response) at week 28.11
The long-term efficacy and safety of tildrakizumab are well established in randomized, blinded clinical trial settings, but real-world evidence is limited.3 To address this gap, we performed a Phase 4 study to assess the effect of tildrakizumab treatment on health-related quality of life in patients with moderate-to-severe plaque psoriasis over 64 weeks of treatment under real-world conditions.12,13 Effectiveness and safety were also assessed as secondary endpoints, and interim analysis results demonstrated sustained clinical improvement through week 28, with no new reported safety concerns.14 Here, we report the effectiveness and safety results through week 64 of the Phase 4 study.
Tildrakizumab is a humanized anti-interleukin-23 p19 monoclonal antibody therapy approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic or phototherapy.4-6 The safety and efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis were established in two Phase 3 randomized, double-blind clinical trials (reSURFACE 1 [NCT01722331] and reSURFACE 2 [NCT01729754]).7-9 Patients receiving tildrakizumab who completed the 64-week reSURFACE 1 or 52-week reSURFACE 2 study with at least a greater than or equal to 50% improvement from baseline Psoriasis Area and Severity Index (PASI) score could enroll in optional extension studies continuing the same dose for an additional 4 years.10,11 Pooled analysis of data from reSURFACE 1 and reSURFACE 2 and corresponding extension studies demonstrated sustained disease control and a favorable safety profile for up to 5 years of treatment in patients who achieved a greater than or equal to 75% improvement from baseline PASI score (PASI 75 response) at week 28.11
The long-term efficacy and safety of tildrakizumab are well established in randomized, blinded clinical trial settings, but real-world evidence is limited.3 To address this gap, we performed a Phase 4 study to assess the effect of tildrakizumab treatment on health-related quality of life in patients with moderate-to-severe plaque psoriasis over 64 weeks of treatment under real-world conditions.12,13 Effectiveness and safety were also assessed as secondary endpoints, and interim analysis results demonstrated sustained clinical improvement through week 28, with no new reported safety concerns.14 Here, we report the effectiveness and safety results through week 64 of the Phase 4 study.
