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.

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. The primary efficacy endpoint was proportion of patients with ACR20 response (≥20% improvement by American College of Rheumatology criteria) at W24. Secondary efficacy endpoints were assessed without adjustment for multiplicity. Safety was evaluated from treatment-emergent adverse events (TEAEs). RESULTS: 391/500 patients screened were randomised and treated. At W24, 71.4%-79.5% of tildrakizumab-treated versus 50.6% of placebo-treated patients achieved ACR20 (all p CONCLUSIONS: Tildrakizumab treatment significantly improved joint and skin manifestations of PsA other than dactylitis and enthesitis. Treatment was generally well tolerated through W52. Clinicaltrials.gov NCT02980692

Central sensitization in knee osteoarthritis and fibromyalgia: Beyond depression and anxiety

Objectives: To determine the psychopathological profile of patients with central sensitization (CS) in a sample of knee osteoarthritis, with and without CS, and fibromyalgia, and to compare their psychopathological profiles. Methods: The final sample consists of 19 patients with osteoarthritis and CS (mean 66.37 years ± 8.77), 41 osteoarthritis patients without CS (mean 66.8 ± 7.39 years), 47 fibromyalgia patients (mean 46.47 years ± 7.92) and 26 control subjects (mean 51.56 years ± 11.41). The psychopathological profile was evaluated with the Millon Multiaxial Clinical Inventory. Results: The average score of MCMI-III reflect higher scores in the fibromyalgia and osteoarthritis-CS groups. Patients with osteoarthritis-CS are more likely to report larger scores in Borderline and Major Depression scales. Fibromyalgia patients are more likely to report more increased scores in Somatoform and Major Depression, versus osteoarthritis-CS group. Fibromyalgia patients versus osteoarthritis without CS are more likely to report higher scores in Schizoid, Depression, Histrionic, Sadistic, Borderline, Somatoform, Posttraumatic Stress Disorder and Major Depression scales. Discussion: Patients with CS have less differences in their psychopathological profiles as well as in both osteoarthritis groups and greatest differences are obtained between the fibromyalgia and osteoarthritis without CS, so perhaps presence of CS is the key to differentiate those groups and not chronic pain. An exhaustive assessment brings more accurate psychopathological profiles, thus better psychological treatment could be applied.This work was partially supported by the Ministry of Economy and Competitiveness (Grant PSI2014-53524-P and PSI2017-83777) and the Agency of University and Research Funding Management of the Catalonia Government (Research Groups SGR2017-1198). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript