Alarico Ariani1, Simone Parisi2, Patrizia Del Medico3, Antonella Farina4, Elisa Visalli5, Aldo Biagio Molica Colella6, Federica Lumetti7, Rosalba Caccavale8, Palma Scolieri9, Romina Andracco10, Francesco Girelli11, Elena Bravi12, Matteo Colina13, Alessandro Volpe14, Aurora Ianniello15, Veronica Franchina16, Ilaria Platè12, Eleonora Di Donato17, Giorgio Amato5, Carlo Salvarani18, Gianluca Lucchini17, Francesco De Lucia5, Francesco Molica Colella19, Daniele Santilli17, Giulio Ferrero20, Antonio Marchetta14, Eugenio Arrigoni12, Flavio Mozzani17, Rosario Foti5, Gilda Sandri18, Vincenzo Bruzzese9, Marino Paroli8, Enrico Fusaro2, Andrea Becciolini17. 1. Internal Medicine and Rheumatology Unit, University Hospital of Parma, Parma, Italy. dott.alaricoariani@libero.it. 2. Rheumatology Department, Azienda Ospedaliera Universitaria Città Della Salute E Della Scienza Di Torino, Turin, Italy. 3. Rheumatology Outpatient Clinic, Internal Medicine Unit, Civitanova Marche Hospital, Civitanova Marche, Italy. 4. Internal Medicine Unit, Rheumatology Outpatient Clinic, Ospedale "A. Murri", Fermo, Italy. 5. Rheumatology Unit, Policlinico San Marco University Hospital of Catania, Catania, Italy. 6. Rheumatology Unit, Azienda Ospedaliera Papardo, Messina, Italy. 7. Rheumatology Unit, Azienda USL of Modena and University Hospital, "Policlinico Di Modena", Modena, Italy. 8. Department of Biotechnology and Medical-Surgical Sciences, Sapienza University of Rome, Polo Pontino, Latina, Italy. 9. Unit of Internal Medicine and Rheumatology, "Nuovo Regina Margherita / S. Spirito" Hospital, ASL Roma 1, Rome, Italy. 10. Internal Medicine Unit, Imperia Hospital, Imperia, Italy. 11. Rheumatology Unit, Ospedale GB Morgagni - L Pierantoni, Forlì, Italy. 12. Internal Medicine and Rheumatology Unit, Ospedale G. Da Saliceto, Piacenza, Italy. 13. Rheumatology Service, Section of Internal Medicine, Department of Medicine and Oncology Unit, Ospedale Santa Maria della Scaletta, Imola, Italy. 14. Unit of Rheumatology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar, Verona, Italy. 15. Rheumatology Outpatient Unit, ASL Novara, Novara, Italy. 16. UOC Oncologia Medica Azienda Ospedaliera Papardo, Messina, Italy. 17. Internal Medicine and Rheumatology Unit, University Hospital of Parma, Parma, Italy. 18. Rheumatology Unit, University of Modena and Reggio Emilia, Azienda Ospedaliero-Universitaria, Policlinico Di Modena, Modena, Italy. 19. Internal Medicine Unit, University of Milano-Bicocca, Milan, Italy. 20. Unit of Diagnostic and Interventional Radiology, Santa Corona Hospital, Pietra Ligure, Italy.
Abstract
OBJECTIVE: There are few real-world setting studies focused on apremilast effectiveness (i.e., retention rate) in psoriatic arthritis (PsA). The main aim of this retrospective observational study is the assessment of apremilast 3-year retention rate in real-world PsA patients. Moreover, the secondary objective is to report the reasons of apremilast discontinuation and the factors related to treatment persistence. METHODS: In fifteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline were recorded. The Kaplan-Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value < 0.05 was considered statistically significant. RESULTS: The 356 enrolled patients (median age 60 [interquartile range IQR 52-67] yrs; male prevalence 42.7%) median observation period was 17 [IQR 7-34] months (7218 patients-months). The apremilast retention rate at 12, 24, and 36 months was, respectively, 85.6%, 73.6%, and 61.8%. The main discontinuation reasons were secondary inefficacy (34% of interruptions), gastro-intestinal intolerance (24%), and primary inefficacy (19%). Age and oligo-articular phenotype were related to treatment persistence (respectively hazard ratio 0.98 IQR 0.96-0.99; p = 0.048 and 0.54 IQR 0.31-0.95; p = 0.03). CONCLUSION: Almost three-fifths of PsA patients receiving apremilast were still in treatment after 3 years. This study confirmed its effectiveness and safety profile. Apremilast appears as a good treatment choice in all oligo-articular PsA patients and in those ones burdened by relevant comorbidities. Key Points • Apremilast retention rates in this real-life cohort and trials are comparable. • The oligo-articular phenotype is associated with long-lasting treatment (i.e., 3 years). • No different or more prevalent adverse events were observed.
OBJECTIVE: There are few real-world setting studies focused on apremilast effectiveness (i.e., retention rate) in psoriatic arthritis (PsA). The main aim of this retrospective observational study is the assessment of apremilast 3-year retention rate in real-world PsA patients. Moreover, the secondary objective is to report the reasons of apremilast discontinuation and the factors related to treatment persistence. METHODS: In fifteen Italian rheumatological referral centers, all PsA consecutive patients who received apremilast were enrolled. Anamnestic data, treatment history, and PsA disease activity (DAPSA) at baseline were recorded. The Kaplan-Meier curve and the Cox analysis computed the apremilast retention rate and treatment persistence-related risk factors. A p-value < 0.05 was considered statistically significant. RESULTS: The 356 enrolled patients (median age 60 [interquartile range IQR 52-67] yrs; male prevalence 42.7%) median observation period was 17 [IQR 7-34] months (7218 patients-months). The apremilast retention rate at 12, 24, and 36 months was, respectively, 85.6%, 73.6%, and 61.8%. The main discontinuation reasons were secondary inefficacy (34% of interruptions), gastro-intestinal intolerance (24%), and primary inefficacy (19%). Age and oligo-articular phenotype were related to treatment persistence (respectively hazard ratio 0.98 IQR 0.96-0.99; p = 0.048 and 0.54 IQR 0.31-0.95; p = 0.03). CONCLUSION: Almost three-fifths of PsA patients receiving apremilast were still in treatment after 3 years. This study confirmed its effectiveness and safety profile. Apremilast appears as a good treatment choice in all oligo-articular PsA patients and in those ones burdened by relevant comorbidities. Key Points • Apremilast retention rates in this real-life cohort and trials are comparable. • The oligo-articular phenotype is associated with long-lasting treatment (i.e., 3 years). • No different or more prevalent adverse events were observed.
Authors: Philip J Mease; Dafna D Gladman; Juan J Gomez-Reino; Stephen Hall; Arthur Kavanaugh; Eric Lespessailles; Georg Schett; Maria Paris; Nikolay Delev; Lichen Teng; Jürgen Wollenhaupt Journal: ACR Open Rheumatol Date: 2020-07-25
Authors: Laure Gossec; Xenofon Baraliakos; Andreas Kerschbaumer; Maarten de Wit; Iain McInnes; Maxime Dougados; Jette Primdahl; Dennis G McGonagle; Daniel Aletaha; Andra Balanescu; Peter V Balint; Heidi Bertheussen; Wolf-Henning Boehncke; Gerd R Burmester; Juan D Canete; Nemanja S Damjanov; Tue Wenzel Kragstrup; Tore K Kvien; Robert B M Landewé; Rik Jozef Urbain Lories; Helena Marzo-Ortega; Denis Poddubnyy; Santiago Andres Rodrigues Manica; Georg Schett; Douglas J Veale; Filip E Van den Bosch; Désirée van der Heijde; Josef S Smolen Journal: Ann Rheum Dis Date: 2020-06 Impact factor: 27.973