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.
Aim: The importance of adjusting for cross-study heterogeneity when conducting network meta-analyses (NMAs) was demonstrated using a case study of biologic therapies for moderate-to-severe plaque psoriasis. Methods: Bayesian NMAs were conducted for Psoriasis Area and Severity Index 90 response. Several covariates were considered to account for cross-trial differences: baseline risk (i.e., placebo response), prior biologic use, body weight, psoriasis duration, age, race and baseline Psoriasis Area and Severity Index score. Model fit was evaluated. Results: The baseline risk-adjusted NMA, which adjusts for multiple observed and unobserved effect modifiers, was associated with the best model fit. Lack of adjustment for cross-trial differences led to different clinical interpretations of findings. Conclusion: Failure to adjust for cross-trial differences in NMA can have important implications for clinical interpretations when studying the comparative efficacy of healthcare interventions.
Background: The fully human monoclonal antibody guselkumab is an effective treatment option for patients with moderate to severe psoriasis. Objective: The objective of this study was to examine the cost per responder of guselkumab compared with other targeted therapies for the treatment of moderate to severe plaque psoriasis in Germany. Methods: A one-year cost per responder model was developed based on efficacy and safety data from a published network meta-analysis. Drug, treatment administration, resource use, and adverse event costs were included in the analysis. The primary analysis assessed the cost per Psoriasis Area and Severity Index (PASI) 90 responder at week 16. Additional analyses were conducted at year 1. In the year 1 analyses, treatment response was assessed at the end of the induction period (week 16) to determine which patients continued onto maintenance therapy (responders) and which patients moved onto a subsequent adalimumab or secukinumab therapy (non-responders). Results: At week 16, the cost per PASI 90 responder was lower for guselkumab than all comparators except adalimumab and brodalumab. Similarly, in the year 1 analyses, guselkumab had a lower cost per PASI 90 responder than all comparators except brodalumab. Conclusions: Guselkumab is a cost-effective therapy option in Germany.
Objectives: Psoriasis represents a significant public health challenge, affecting approximately 125 million people globally. It may occur at any age with 75% of patients being diagnosed before the age of 40. In many European countries it is estimated that 1-3% of the population are affected, of whom 30% have moderate to severe disease. The objective of the study is to determine the annual economic burden of plaque psoriasis in Greece from a societal perspective. Methods: This was a national, 6-month, multi-centre, prospective, epidemiological study across different geographical locations in Greece assessing adult patients who had stable plaque psoriasis for the past 6 months. In order to calculate the annual societal burden of psoriasis, data were obtained on direct (medication and self-care products, laboratory and diagnostic procedures, outpatient visits, hospitalization and transportation) and indirect (i.e. productivity loss) costs. Work productivity burden was also calculated using the psoriasis specific Work Productivity and Activity Impairment (WPAI:PSO) questionnaire. Results: The mean (95% CI) annual economic burden of psoriasis was calculated at V4,683 (V4,311-V5,119) per patient. The annual societal burden was found to be significantly lower among patients with mild psoriasis compared to those patients with moderate to severe psoriasis. The mean (95%) annual direct cost was V4,544 (V4,199-V5,000), while the annual indirect cost was V139 (V99-V194). The main driver for both was treatment specific costs, followed by outpatient visit costs. 56.4% of 668 patients reported that they had missed work during the past six months due to their disease with median time lost being four hours. Conclusions: The study provides evidence that psoriasis represents a substantial direct cost burden in Greece. The economic burden of psoriasis is significant, with a majority of it coming from direct costs.
The slope of change for each method by fitting a straight line using the linear least-squares method, and correlation between the slopes was calculated using Pearson's correlation coefficient. Results: Measures of bone area change and cartilage thickness showed broadly similar responsiveness to change (Table 1), and both measures were considerably more responsive than minJSW. The 3D bone femur vector measurement was the most responsive. The 2-year slopes for all bone measures and cartilage thickness correlate very weakly (typical r2 of w0.25), as does the correlation of bone change with minJSW. Slopes of cartilage change correlate more strongly with minJSW (w0.4). Conclusions: Changes in bone area and shape markers provide a sensitive measure of change, which shows comparable sensitivity to the measurement of cartilage thickness. The femur vector provides improved sensitivity. Both measures are superior to the radiographic measurement of minJSW. The poor correlation of the slopes suggests that the measures address different constructs, and that change of these constructs proceeds at a different rate within the population over this time period. Further work will address whether different individuals are progressing differently for each measure.
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