Caterina Palleria1, Luigi Iannone1, Christian Leporini1, Rita Citraro1, Antonia Manti1, Maurizio Caminiti2,3, Pietro Gigliotti2,4, Rosa Daniela Grembiale1, Massimo L'Andolina2,5, Giuseppe Muccari2,6, Maria Diana Naturale1, Domenico Olivo2,7, Giuseppa Pagano Mariano2,3, Roberta Pellegrini2,8, Giuseppe Varcasia2,9, Karim Abdalla10, Emilio Russo1, Francesco Ursini1,2, Giovambattista De Sarro1. 1. Department of Health Sciences, University of Catanzaro "Magna Graecia", Catanzaro, Italy. 2. Associazione Calabrese per la Ricerca in Reumatologia (ACRR), Catanzaro, Italy. 3. Rheumatology Unit, Grande Ospedale Metropolitano "Bianchi-Melacrino-Morelli", Reggio Calabria, Italy. 4. Rheumatology Outpatient Clinic, Azienda Ospedaliera Provinciale Cosenza, Cosenza, Italy. 5. Rheumatology Outpatient Clinic, Azienda Sanitaria Provinciale Vibo Valentia, Vibo Valentia, Italy. 6. Rheumatology Outpatient Clinic, Azienda Ospedaliera "Pugliese-Ciaccio", Catanzaro, Italy. 7. Rheumatology Outpatient Clinic, Azienda Sanitaria Provinciale Crotone, Crotone, Italy. 8. Rheumatology Unit, Azienda Ospedaliera "SS Annunziata", Cosenza, Italy. 9. Rheumatology Unit, Ospedale Castrovillari, Castrovillari, Italy. 10. Department of Medical and Surgical Sciences, University of Catanzaro "Magna Graecia", Catanzaro, Italy.
Abstract
INTRODUCTION: Post-marketing surveillance activities (namely pharmacovigilance) are crucial to favor the early detection of unexpected adverse events (AEs) and/or serious adverse reactions (SAEs). Indeed, spontaneous reporting of AEs has been demonstrated to underestimate the number of events in different clinical settings. Aim of the present study is to report the preliminary data of a Regional (Calabria, Italy) Pharmacovigilance Program (CBPP) aimed at improving AEs' reporting associated with biologics use in rheumatology. MATERIALS AND METHODS: We developed a simple, cost-effective pharmacovigilance program based on regular training sessions for physicians (stimulated reporting), periodical phone calls by a clinical pharmacologist aimed at identifying new events and stimulating self-awareness and encouraging reporting to the physician during the subsequent follow-up visit for minor AEs. To test this approach, all consecutive patients undergoing treatment with one biologic agent at eight rheumatology centers during a two-years period were invited to participate. Collected AEs were compared to the number of AEs spontaneously reported for the same molecules in the same centers before starting the protocol. RESULTS: During the study period, 399 patients (245 females; mean age: 58 ± 11 years) were started on treatment with biologics for active RA (n = 211, 52.9%), PsA (n = 119, 29.8%) or AS (n = 69, 17.3%) at eight rheumatology centers. A total of 125 AEs (31.3%) and 9 SAEs (2.3%) were reported during the two-years study period. In the control cohort (comprising 368 consecutive patients started on treatment with bDMARDs during a two-years period before CBPP study) only 42 (11.4%) AEs and no SAEs were reported (p < 0.0001). The most common AEs were injection site reactions and skin disorders. CONCLUSIONS: In conclusion, our study provides further evidence of a critical role of active pharmacovigilance in detection, reporting and analysis of AEs in rheumatology.
INTRODUCTION: Post-marketing surveillance activities (namely pharmacovigilance) are crucial to favor the early detection of unexpected adverse events (AEs) and/or serious adverse reactions (SAEs). Indeed, spontaneous reporting of AEs has been demonstrated to underestimate the number of events in different clinical settings. Aim of the present study is to report the preliminary data of a Regional (Calabria, Italy) Pharmacovigilance Program (CBPP) aimed at improving AEs' reporting associated with biologics use in rheumatology. MATERIALS AND METHODS: We developed a simple, cost-effective pharmacovigilance program based on regular training sessions for physicians (stimulated reporting), periodical phone calls by a clinical pharmacologist aimed at identifying new events and stimulating self-awareness and encouraging reporting to the physician during the subsequent follow-up visit for minor AEs. To test this approach, all consecutive patients undergoing treatment with one biologic agent at eight rheumatology centers during a two-years period were invited to participate. Collected AEs were compared to the number of AEs spontaneously reported for the same molecules in the same centers before starting the protocol. RESULTS: During the study period, 399 patients (245 females; mean age: 58 ± 11 years) were started on treatment with biologics for active RA (n = 211, 52.9%), PsA (n = 119, 29.8%) or AS (n = 69, 17.3%) at eight rheumatology centers. A total of 125 AEs (31.3%) and 9 SAEs (2.3%) were reported during the two-years study period. In the control cohort (comprising 368 consecutive patients started on treatment with bDMARDs during a two-years period before CBPP study) only 42 (11.4%) AEs and no SAEs were reported (p < 0.0001). The most common AEs were injection site reactions and skin disorders. CONCLUSIONS: In conclusion, our study provides further evidence of a critical role of active pharmacovigilance in detection, reporting and analysis of AEs in rheumatology.
Authors: Désirée van der Heijde; Sofia Ramiro; Robert Landewé; Xenofon Baraliakos; Filip Van den Bosch; Alexandre Sepriano; Andrea Regel; Adrian Ciurea; Hanne Dagfinrud; Maxime Dougados; Floris van Gaalen; Pál Géher; Irene van der Horst-Bruinsma; Robert D Inman; Merryn Jongkees; Uta Kiltz; Tore K Kvien; Pedro M Machado; Helena Marzo-Ortega; Anna Molto; Victoria Navarro-Compàn; Salih Ozgocmen; Fernando M Pimentel-Santos; John Reveille; Martin Rudwaleit; Jochen Sieper; Percival Sampaio-Barros; Dieter Wiek; Jürgen Braun Journal: Ann Rheum Dis Date: 2017-01-13 Impact factor: 19.103
Authors: Tzu-Chieh Lin; Kazuki Yoshida; Sara K Tedeschi; Mirhelen Mendes de Abreu; Nikroo Hashemi; Daniel H Solomon Journal: Arthritis Care Res (Hoboken) Date: 2018-04-12 Impact factor: 4.794
Authors: Maria Antonietta Barbieri; Giuseppe Cicala; Paola Maria Cutroneo; Elisabetta Gerratana; Caterina Palleria; Caterina De Sarro; Ada Vero; Luigi Iannone; Antonia Manti; Emilio Russo; Giovambattista De Sarro; Fabiola Atzeni; Edoardo Spina Journal: J Clin Med Date: 2020-04-24 Impact factor: 4.241
Authors: Kissa W Mwamwitwa; Adam M Fimbo; Elias M Bukundi; Alex F Nkayamba; Deus Buma; Eva P Muro; Betty A Maganda; Danstan H Shewiyo; Morven C Shearer; Andrew D Smith; Eliangiringa A Kaale Journal: Sci Rep Date: 2022-09-27 Impact factor: 4.996
Authors: Luigi Francesco Iannone; Luigi Bennardo; Caterina Palleria; Roberta Roberti; Caterina De Sarro; Maria Diana Naturale; Stefano Dastoli; Luca Donato; Antonia Manti; Giancarlo Valenti; Domenico D'Amico; Santo D'Attola; Adele Emanuela De Francesco; Vincenzo Bosco; Eugenio Donato Di Paola; Steven Paul Nisticò; Rita Citraro; Emilio Russo; Giovambattista De Sarro Journal: PLoS One Date: 2020-11-03 Impact factor: 3.240