title: Changes in first-line injectable disease-modifying therapy for multiple sclerosis: predictors of non-adherence, switching, discontinuation, and interruption of drugs.
abstract: This study was aimed to describe changes of Disease-Modifying Treatments (DMT) in an Italian cohort of patients with multiple sclerosis (MS) and to identify predictors of therapeutic modifications. Patients with MS and treated with the first-line injectable DMT (interferons-IFNs or glatiramer) between 1/7/2009 and 31/10/2012 were selected from administrative databases of the MS Center of Cagliari (Sardinia, Italy). Socio-demographic, therapeutic, and clinical information was collected in the 6 months preceding the index date. All patients were followed for 36 months to evaluate therapeutic changes in terms of non-adherence, switch, temporary discontinuation, and permanent interruption. Predictors of changes were estimated by multivariable regression models. Data on 1698 patients were collected: glatiramer was prescribed in 27% of cases, IFNβ-1b in 22%, IFNβ-1a-im in 20%, IFNβ-1a-sc-44mcg in 19%, and IFNβ-1a-sc-22mcg in 12%. Non-adherence was observed in 25% of cases, therapeutic switch in 30%, discontinuation in 37%, and permanent interruption in 28%. The risk of non-adherence was higher for IFNβ-1b, compared with IFNβ-1a-im (adjOR = 1.73). Therapeutic switch occurred especially in patients recently diagnosed (each year from diagnosis causes a decrease of this risk adjHR = 0.97); the risk of discontinuation was higher with EDSS = 4-6 and 7-9 (adjHR = 1.52 and 4.42, respectively). The risk of permanent interruption increased with the augmentation of disability (adjHR = 1.67 and 5.43 for EDSS 4-6 and 7-9). This study mirrored a detailed framework of DMT prescription and identified factors related to changes in the MS therapy. These findings could support healthcare providers in the evaluation and maximization of benefits associated with a long-term DMT.
authors.affiliation: Clicon Srl, Health, Economics, and Outcomes Research, Via Salara, 36, 48100, Ravenna, Italy. luca.degliesposti@clicon.it.
authors.forename: Luca
authors.initials: L
authors.lastname: Degli Esposti
authors.affiliation: Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Piccinni
authors.affiliation: Clicon Srl, Health, Economics, and Outcomes Research, Via Salara, 36, 48100, Ravenna, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Sangiorgi
authors.affiliation: Clicon Srl, Health, Economics, and Outcomes Research, Via Salara, 36, 48100, Ravenna, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Perrone
authors.affiliation: Clicon Srl, Health, Economics, and Outcomes Research, Via Salara, 36, 48100, Ravenna, Italy.
authors.forename: Lucia
authors.initials: L
authors.lastname: Aledda
authors.affiliation: Dipartimento di Scienze Mediche, University of Cagliari, Cagliari, Italy.
authors.forename: Maria Giovanna
authors.initials: MG
authors.lastname: Marrosu
authors.affiliation: Farmacia Ospedale R. Binaghi, Azienda Sanitaria Locale di Cagliari, Cagliari, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Lombardo
mesh_terms: D000328:Adult; D015331:Cohort Studies; D016208:Databases, Factual; D004185:Disability Evaluation; D057915:Drug Substitution; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage*; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D007558:Italy / Q000453:epidemiology; D008297:Male; D055118:Medication Adherence; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D010352:Patient Dropouts; D011379:Prognosis
chemical_list: D007155:Immunologic Factors
keywords: Adherence; Discontinuation; Disease-modifying drugs; Interruption; Multiple sclerosis; Switch