Effectiveness and Safety of Tildrakizumab in Elderly and Frail Elderly Psoriatic Patients Up to 2 years

Luca Mastorino,1 Paolo Dapavo,1 Martina Burlando,2 Paolo Gisondi,3 Carlo Alberto Maronese,4,5 Angelo Ruggiero,6 Marco Galluzzo,7,8 Maria Carla Pisani,9 Lidia Sacchelli,10 Giacomo Caldarola,11 Gianluca Avallone,1,4 Angelo Valerio Marzano,4,5 Matteo Megna,6 Elena Campione,7,8 Francesco Loconsole,9 Federico Bardazzi,10 Clara De Simone,11 Pietro Quaglino,1,* Simone Ribero,1,* Collaborators from the working group for Frail-PsO Group: Angela Fico and Fabio Artosi. Both are affiliated with Department of Systems Medicine, University of Rome “Tor Vergata”, Rome, Italy and Dermatology Unit, Fondazione Policlinico Tor Vergata, Rome, Italy. On behalf of Frail-PsO Group1Dermatologic Clinic, Department of Medical Sciences, University of Turin, Turin, Italy; 2Dipartimento di Scienze Della Salute, DISSAL, University of Genoa, Genoa, Italy; 3Department of Medicine, Section of Dermatology and Venereology, University of Verona, Verona, Italy; 4Dermatology Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy; 5Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy; 6Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy; 7Department of Systems Medicine, University of Rome “Tor Vergata”, Rome, Italy; 8Dermatology Unit, Fondazione Policlinico Tor Vergata, Rome, Italy; 9Department of Dermatology, University of Bari, Bari, Italy; 10IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 11Department of Translational Medicine and Surgery, IRCCS A. Gemelli University Polyclinic Foundation, Sacred Heart Catholic University, Rome, Italy*These authors contributed equally to this workCorrespondence: Luca Mastorino, Dermatologic Clinic, Department of Medical Sciences, University of Turin, Via Cherasco 23, Turin, 10121, Italy, Email [email protected]: Elderly patients with age ≥ 65 years represent an increasing percentage of the population with moderate-severe psoriasis. The definition of “frail elderly” is not easily framed, generally meaning a patient with unstable homeostasis. To date, there is no study in the literature examining possible differences between frail and non-frail elderly with psoriasis being treated with tildrakizumab.Patients and Methods: The present multicentre retrospective study evaluated the effectiveness, drug survival and safety up to 2 years of treatment with tildrakizumab in the elderly (≥ 65 years) comparing frail and non-frail patients. Frail patients were defined as those with: i) 2 major comorbidities, or 1 major comorbidity and low economic level ii) and/or 2 of the following 5 parameters: weight loss, weakness, sluggishness, low activity level, and exhaustion.Results: A total of 217 patients aged ≥ 65 years were enrolled, of whom 89 (41%) were grouped in the frail patient category. In the entire population, 2-year drug survival was ≥ 80%, and PASI 90 and ≤ 2 was achieved in 75% and 87.5% of patients, respectively. No difference in effectiveness or safety was found between frail and non-frail populations. Adjusting for baseline characteristics at Cox-regression, frail patients did not show a greater risk of discontinuation (HR 0.51, p=0.091).Conclusion: Tildrakizumab showed good safety and effectiveness at 2 years in the elderly population with or without frailty, confirming it as a possible treatment of choice in psoriatic patients with significant comorbidities and older frail patients who deserve systemic treatments.Keywords: psoriasis, tildrakizumab, elderly, safety, real-life