scholarly journals Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study

2020 ◽  
Vol 21 (1) ◽  
pp. 87-96
Author(s):  
Alan Menter ◽  
Petr Arenberger ◽  
Sigrid Balser ◽  
Stefan Beissert ◽  
Ashley Cauthen ◽  
...  
Keyword(s):  
Plaque Psoriasis ◽  
Reference Product ◽  
Similar Efficacy ◽  
Phase Iii ◽  
Chronic Plaque Psoriasis

Tu1862 BI 695501 DEMONSTRATES SIMILAR EFFICACY AND COMPARABLE SAFETY TO ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH ACTIVE CROHN'S DISEASE: FINAL ANALYSIS OF THE PHASE III VOLTAIRE-CD STUDY

2020 ◽  
Vol 158 (6) ◽  
pp. S-1192-S-1193
Author(s):  
Stephen B. Hanauer ◽  
Stefan Schreiber ◽  
Sigrid E. Balser ◽  
Ekkehard Brockstedt ◽  
Viktoria Moschetti ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Reference Product ◽  
Final Analysis ◽  
Similar Efficacy ◽  
Phase Iii

Network Meta-analysis of Treatments for Chronic Plaque Psoriasis in Canada

2014 ◽  
Vol 18 (6) ◽  
pp. 371-378 ◽  
Author(s):  
Aditya K. Gupta ◽  
Deanne Daigle ◽  
Danika C.A. Lyons
Keyword(s):  
Clinical Trials ◽  
Plaque Psoriasis ◽  
Meta Analysis ◽  
Severity Index ◽  
Phase Iii ◽  
Chronic Plaque Psoriasis ◽  
Phase Iii Clinical Trials ◽  
Statistical Framework ◽  
Consistency Model ◽  
Systemic Treatments

Background: Psoriasis affects approximately 500,000 Canadians. Eight treatments are currently licensed for chronic plaque psoriasis in Canada. Objective: To compare the efficacy of systemic treatments for chronic plaque psoriasis for the outcome > 75% reduction in the Psoriasis Area and Severity Index (PASI) using network meta-analysis. Methods: PubMed and clinicaltrials.gov databases were searched up until October 15, 2013, for phase III clinical trials. A consistency model based on a random-effects bayesian statistical framework was used to compare the rates of > 75% PASI reduction across trials. Results: Twenty-one studies were included in the network analysis. Infliximab had significantly greater odds of producing > 75% reduction in the PASI compared to all treatments. All treatments conferred greater odds of > 75% PASI reduction compared to placebo. Conclusion: Although infliximab had the highest efficacy relative to other systemic treatments for psoriasis, adverse effects, cost, and patient preferences should also be considered when deciding on treatment.

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