Publications by authors named "S J Rozzo"
Objective: Tildrakizumab is an anti-interleukin-23p19 monoclonal antibody approved to treat moderate to severe plaque psoriasis. This study evaluated the efficacy and safety of tildrakizumab in patients with ankylosing spondylitis (AS).
Methods: In this randomized, double-blind, parallel-group, multinational trial ( clinicaltrials.
Background: Limited data are available on long-term efficacy and safety of biologics in patients with psoriasis and metabolic syndrome (MetS), a common comorbidity.
Objectives: This analysis updates tildrakizumab efficacy and safety for up to 5 years in patients with and without MetS.
Methods: This was a post hoc analysis of the double-blind, randomized, placebo-controlled, phase 3 reSURFACE 1 (NCT01722331) and reSURFACE 2 (NCT01729754) trials in adult patients with moderate to severe chronic plaque psoriasis.
Article Synopsis
- The study investigates the real-world usage and costs of biologic treatments for plaque psoriasis when patients exceed the recommended maintenance dosage by at least 10%.
- Based on an analysis of 6,453 patients, it was found that a significant portion (46% for etanercept and 11% for adalimumab) utilized above-label dosing, with an average duration of such use ranging from 130 to 196 days across different treatments.
- Although additional costs were incurred (ranging from $124 to $16,475 annually depending on the drug), above-label use did not generally raise major safety concerns, except for a higher incidence of gastrointestinal and non-respiratory infections in patients on adalimumab.
Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study.
Ann Rheum Dis
September 2021
Objectives: To evaluate efficacy and safety of the anti-interleukin-23p19 monoclonal antibody tildrakizumab in patients with psoriatic arthritis (PsA).
Methods: In this randomised, double-blind, placebo-controlled, phase IIb study, patients with active PsA were randomised 1:1:1:1:1 to tildrakizumab 200 mg every 4 weeks (Q4W); tildrakizumab 200, 100 or 20 mg Q12W; or placebo Q4W. Patients receiving tildrakizumab 20 mg or placebo switched to tildrakizumab 200 mg Q12W at W24; treatment continued to W52.