1. A multicentRE observational analysiS of PErsistenCe to Treatment in the new multiple sclerosis era: the RESPECT study
- Author
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Massimiliano Calabrese, Eleonora Cocco, Roberta Fantozzi, Viviana Nociti, Antonio Gallo, Laura Boffa, Alice Laroni, Claudio Solaro, Valentina Torri Clerici, Giancarlo Coghe, Simona Malucchi, Massimiliano Di Filippo, Valentina Tomassini, Marcello Moccia, Pietro Annovazzi, Federica Pinardi, Carla Tortorella, Paola Cavalla, Ilaria Pesci, Luca Prosperini, Giorgia Teresa Maniscalco, Alberto Gajofatto, Claudio Gasperini, Roberta Lanzillo, Fabio Buttari, Paolo Ragonese, Marta Radaelli, Maria Chiara Buscarinu, Lanzillo, Roberta, Prosperini, Luca, Gasperini, Claudio, Moccia, Marcello, Fantozzi, Roberta, Tortorella, Carla, Nociti, Viviana, Annovazzi, Pietro, Cavalla, Paola, Radaelli, Marta, Malucchi, Simona, Clerici, Valentina Torri, Boffa, Laura, Buttari, Fabio, Ragonese, Paolo, Maniscalco, Giorgia Teresa, Di Filippo, Massimiliano, Buscarinu, Maria Chiara, Pinardi, Federica, Gallo, Antonio, Coghe, Giancarlo, Pesci, Ilaria, Laroni, Alice, Gajofatto, Alberto, Calabrese, Massimiliano, Tomassini, Valentina, Cocco, Eleonora, Solaro, Claudio, Lanzillo R., Prosperini L., Gasperini C., Moccia M., Fantozzi R., Tortorella C., Nociti V., Annovazzi P., Cavalla P., Radaelli M., Malucchi S., Clerici V.T., Boffa L., Buttari F., Ragonese P., Maniscalco G.T., Di Filippo M., Buscarinu M.C., Pinardi F., Gallo A., Coghe G., Pesci I., Laroni A., Gajofatto A., Calabrese M., Tomassini V., Cocco E., and Solaro C.
- Subjects
Male ,Injection ,Time Factors ,Patient Dropout ,disease-modifying therapies ,multiple sclerosis ,outcome measurement ,persistence to treatment ,quality of life ,Administration, Oral ,Self Administration ,Sex Factor ,Kaplan-Meier Estimate ,Relapsing-Remitting ,Immunologic Factor ,0302 clinical medicine ,Quality of life ,Retrospective Studie ,Risk Factors ,Medicine ,030212 general & internal medicine ,Disease-modifying therapie ,Disease-modifying therapies, Multiple sclerosis, Outcome measurement, Persistence to treatment, Quality of life, Administration, Oral, Adult ,Female, Follow-Up Studies, Humans, Immunologic Factors, Injections, Kaplan-Meier Estimate,Male, Multiple Sclerosis, Relapsing-Remitting, Patient Dropouts, Prognosis, Proportional Hazards Models, Retrospective Studies, Risk Factors, Self Administration, Sex Factors, Time Factors ,Hazard ratio ,Prognosis ,Neurology ,Tolerability ,Administration ,Settore MED/26 - Neurologia ,Female ,Human ,Oral ,Adult ,medicine.medical_specialty ,Patient Dropouts ,Time Factor ,Prognosi ,Follow-Up Studie ,Injections ,03 medical and health sciences ,Route of administration ,Multiple Sclerosis, Relapsing-Remitting ,Sex Factors ,Internal medicine ,Humans ,Immunologic Factors ,Multiple sclerosi ,Adverse effect ,Proportional Hazards Models ,Retrospective Studies ,business.industry ,Proportional hazards model ,Risk Factor ,Retrospective cohort study ,Discontinuation ,Disease-modifying therapies ,Multiple sclerosis ,Outcome measurement ,Persistence to treatment ,Follow-Up Studies ,Proportional Hazards Model ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
In this independent, multicenter, retrospective study, we investigated the short-term persistence to treatment with first-line self-injectable or oral disease-modifying treatments (DMTs) in patients with relapsing–remitting multiple sclerosis. Data of patients regularly attending 21 Italian MS Centres who started a self-injectable or an oral DMT in 2015 were collected to: (1) estimate the proportion of patients discontinuing the treatment; (3) explore reasons for discontinuation; (3) identify baseline predictors of treatment discontinuation over a follow-up period of 12months. We analyzed data of 1832 consecutive patients (1289 women, 543 men); 374 (20.4%) of them discontinued the prescribed DMT after a median time of 6 months (range 3days to 11.5months) due to poor tolerability (n = 163; 43.6%), disease activity (n = 95; 25.4%), adverse events (n = 64; 17.1%), convenience (i.e. availability of new drug formulations) and pregnancy planning (n = 21; 1.1%). Although the proportion of discontinuers was higher with self-injectable (n = 107; 22.9%) than with oral DMT (n = 215; 16.4%), the Cox regression model revealed no significant between-group difference (p = 0.12). Female sex [hazard ratio (HR) = 1.39, p = 0.01] and previous exposure to ≥ 3 DMTs (HR = 1.71, p = 0.009) were two independent risk factors for treatment discontinuation, regardless of prescribed DMTs. Our study confirms that persistence to treatment represents a clinical challenge, irrespective of the route of administration.
- Published
- 2018