Guselkumab for the Treatment of Moderate-to-Severe Plaque Psoriasis During Induction Phase: A Systematic Review and Network Meta-Analysis

2018 ◽  
Vol 4 (2) ◽  
pp. 81-92 ◽  
Author(s):  
C. Cameron ◽  
C. Druchok ◽  
B. Hutton ◽  
S. McElligott ◽  
S. Nair ◽  
...  
Keyword(s):  
Systematic Review ◽  
Plaque Psoriasis ◽  
Baseline Risk ◽  
Comparable Efficacy ◽  
Control Group ◽  
Induction Phase ◽  
Efficacy And Safety ◽  
Severe Plaque Psoriasis ◽  
Group Response ◽  
Study Characteristics

Background: Guselkumab is an interleukin-23 inhibitor indicated for treatment of moderate-to-severe plaque psoriasis. Objective: The objective was to determine the relative efficacy and safety of guselkumab compared to other biologics. Methods: A systematic review was performed to identify randomized controlled trials (RCTs). Bayesian network meta-analyses (NMAs) were conducted using meta-regression analyses that adjusted for cross-trial differences and risk differences. The primary outcome was Psoriasis Area and Severity Index (PASI) 90 response. Other efficacy and safety outcomes were considered. Several meta-regressions were performed to account for variations in patient and study characteristics: baseline risk adjustment (ie, control group response), prior biologic use, duration of psoriasis, weight, age, race, and baseline PASI/dermatology life quality index scores. The best-fitting model using predefined criteria was selected. Results: Forty-five RCTs were identified. Patient and study characteristics differed between RCTs as reflected in variations in control group response. Both the baseline risk-adjusted NMA and the risk-difference NMA fit the data best and suggested guselkumab has one of the highest PASI 90 responses. Pairwise comparisons from the baseline risk-adjusted PASI 90 NMA suggested guselkumab has comparable efficacy with ixekizumab (relative risk [RR]: 0.999, 95% credible intervals [CrIs]: 0.89-1.13) and brodalumab (RR: 1.04, 95% CrIs: 0.91-1.17) and superior efficacy versus all other treatments in the network (RR range, 1.20 to 43.22). Guselkumab was superior or comparable to other therapies for other efficacy outcomes and had a more favorable safety profile than most. Conclusions: Guselkumab has one of the highest PASI 90 responses among psoriasis treatments; similar findings were observed for other efficacy outcomes. Guselkumab has a favorable benefit–risk balance compared to moderate-to-severe psoriasis therapies.

scholarly journals Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients

Dermatology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Katharina A. Drerup ◽  
Claudia Seemann ◽  
Sascha Gerdes ◽  
Ulrich Mrowietz
Keyword(s):  
Cohort Study ◽  
Real World ◽  
Plaque Psoriasis ◽  
Prospective Cohort ◽  
Registry Data ◽  
Comparable Efficacy ◽  
Routine Practice ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Severe Plaque Psoriasis

<b><i>Background:</i></b> After registration of drugs, evidence about efficacy and safety is solely based on data of phase 2/3 clinical trial programs. A major drawback is the selection of patients following inclusion/exclusion criteria. There is a considerable time and knowledge gap between study and registry data that evaluate real-world evidence (RWE). To close this gap, prospective cohort data are helpful. <b><i>Objectives:</i></b> Soon after tildrakizumab, an interleukin 23p19-inhibitor, was registered for moderate-to-severe plaque psoriasis, a prospective single-center cohort study was established to evaluate efficacy and safety of tildrakizumab in daily practice. <b><i>Methods:</i></b> Following approval of tildrakizumab, patients with moderate-to-severe plaque psoriasis eligible for systemic treatment were included into the Kiel Tildra Cohort (KTC) and followed using routine assessments of efficacy, psoriasis area and severity index (PASI), body surface area (BSA), dermatology life quality index (DLQI), itch (visual analog scale), and safety. Data of the KTC were compared to the respective phase 3 clinical trials. <b><i>Results:</i></b> The KTC included 150 patients differing substantially from those in the trial program. There was a high rate of previous systemic (87.3%) and biologic (31.8%) therapy and of comorbidity in the KTC as compared to the phase 3 studies. Due to the best practice approach, baseline PASI was lower in the KTC, but DLQI was similar in both groups. At the time of this analysis, 126 patients completed week 28, 92 patients week 52, and 58 patients week 76, respectively. There was a constant improvement in PASI, BSA, DLQI, and itch from baseline until week 76. There was no clinically meaningful laboratory abnormality. <b><i>Conclusions:</i></b> Patients treated in routine practice with tildrakizumab differed substantially from the phase 3 studies. Despite systemic pre-treatment and increased comorbidity, tildrakizumab showed comparable efficacy and safety in the KTC. Prospective cohort studies are a suitable tool to generate RWE before registry data become available.

Pharmacoeconomic analysis of using genetically engineered biologic drugs for treating adult patients with moderate to severe plaque psoriasis in the Russian Federation

2020 ◽  
pp. 57-65
Author(s):  
Maksim Frolov ◽  
Vladimir Rogov ◽  
Alla Salasyuk
Keyword(s):  
Plaque Psoriasis ◽  
Impact Analysis ◽  
Pharmacoeconomic Analysis ◽  
Certolizumab Pegol ◽  
Genetically Engineered ◽  
Adult Patients ◽  
Comparable Efficacy ◽  
Biologic Drugs ◽  
Severe Plaque Psoriasis ◽  
Cost Minimisation Analysis

The aim of the study was to assess clinical and economic effectiveness of netakimab compared to other genetically engineered biologic drugs (infliximab, adalimumab, etanercept, ustekinumab, secukinumab, ixekizumab, certolizumab pegol) for the treatment of adult patients with moderate to severe plaque psoriasis. We have conducted cost-benefit analysis, cost-minimisation analysis, and budget impact analysis. We have considered only direct medical costs. The results of the study show that netakimab has higher or comparable efficacy and significantly lower costs compared to other biologic drugs, that makes it the most preferable treatment option for patients with moderate to severe plaque psoriasis. Use of netakimab in clinical practice will significantly reduce budget expenditures and increase patient access to biologic therapy.

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