title: Drug survival of adalimumab in patients with rheumatoid arthritis over 10 years in the real-world settings: high rate remission together with normal function ability.
abstract: The purpose of the study was to estimate the clinical profile of naïve biological patients with rheumatoid arthritis (RA) starting adalimumab through 3-year calendar periods and their clinical outcomes such as drug survival and global clinical disease control (GCDC). RA patients starting adalimumab as first biological drug between 2003 and 2012 were subdivided in 3-year calendar periods. Survival on therapy was estimated using the Kaplan-Meier analysis. One and 2-year clinical response was assessed by calculating percentage of patients attaining GCDC (28-joint Disease Activity Score (DAS28) ≤ 2.6 + Health Assessment Questionnaire (HAQ) ≤ 0.5), low disease activity (DAS28 ≤ 3.2), remission (DAS28 ≤ 2.6) and good European League Against Rheumatism (EULAR) response. Multivariate regression models were used to assess baseline predictors of drug discontinuation or achievement of clinical remission. We recruited 1695 RA patients. Overall drug persistence at 3 years was 40.6 %, while the global rate of nonswitching patients was 54.7 %. Compared to 2003-2005, initiators in more recent years had a significantly lower 3-year crude drug retention rate (log rank, p < 0.0001) and a significantly higher rate of switching to alternative biologics (log rank, p < 0.0001). No difference in adverse events or effectiveness rate among the calendar periods was found. A substantial proportion of patients (up to 27 %) achieved GCDC at 2 years, regardless of the calendar period. In real-life setting, RA patients starting adalimumab in more recent years had a higher rate of drug discontinuation not related to ineffectiveness or side effects but to switching, probably due to a wider availability of biologics. A meaningful proportion of patients attained GCDC without any difference across calendar periods.
authors.affiliation: Interdisciplinary Department of Medicine-Rheumatology Unit, Policlinico, University of Bari, Piazza G. Cesare 11, 70124, Bari, Italy. florenzo.iannone@uniba.it.
authors.forename: Florenzo
authors.initials: F
authors.lastname: Iannone
authors.affiliation: Rheumatology Unit, Ospedale G Pini, Milan, Italy.
authors.forename: Lugi
authors.initials: L
authors.lastname: Sinigaglia
authors.affiliation: Rheumatology Unit, Ospedale G Pini, Milan, Italy.
authors.forename: Ennio Giulio
authors.initials: EG
authors.lastname: Favalli
authors.affiliation: Rheumatology Unit, Ospedale Sacco, Milan, Italy.
authors.forename: Piercarlo
authors.initials: P
authors.lastname: Sarzi-Puttini
authors.affiliation: Rheumatology Unit, Ospedale Sacco, Milan, Italy.
authors.forename: Fabiola
authors.initials: F
authors.lastname: Atzeni
authors.affiliation: Rheumatology Unit, University of Pavia, Pavia, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Caporali
authors.affiliation: Rheumatology Unit, University of Pavia, Pavia, Italy.
authors.forename: Veronica
authors.initials: V
authors.lastname: Codullo
authors.affiliation: Rheumatology Unit, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ferraccioli
authors.affiliation: Rheumatology Unit, Catholic University of the Sacred Heart, Rome, Italy.
authors.forename: Elisa
authors.initials: E
authors.lastname: Gremese
authors.affiliation: Rheumatology Unit, University of Verona, Verona, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Carletto
authors.affiliation: Rheumatology Unit, University of Verona, Verona, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Giollo
authors.affiliation: Rheumatology Unit, University of Ferrara, Ferrara, Italy.
authors.forename: Marcello
authors.initials: M
authors.lastname: Govoni
authors.affiliation: Rheumatology Unit, University of Ferrara, Ferrara, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Bergossi
authors.affiliation: Rheumatology Unit, University of Siena, Siena, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Galeazzi
authors.affiliation: Rheumatology Unit, University of Siena, Siena, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Cantarini
authors.affiliation: Rheumatology Unit, Università Politecnica delle Marche, Jesi, Italy.
authors.forename: Fausto
authors.initials: F
authors.lastname: Salaffi
authors.affiliation: Rheumatology Unit, Università Politecnica delle Marche, Jesi, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Di Carlo
authors.affiliation: Rheumatology Unit, University of Brescia, Brescia, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Bazzani
authors.affiliation: Rheumatology Unit, Ospedale Mauriziano, Torino, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Pellerito
authors.affiliation: Rheumatology Unit, University of Modena e Reggio Emilia, Modena, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Sebastiani
authors.affiliation: Rheumatology Unit, University of Padova, Padova, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Ramonda
authors.affiliation: Interdisciplinary Department of Medicine-Rheumatology Unit, Policlinico, University of Bari, Piazza G. Cesare 11, 70124, Bari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lapadula
mesh_terms: D000203:Activities of Daily Living; D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001688:Biological Products / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D000068879:Adalimumab
keywords: Drug survival; GISEA; HAQ; LORHEN