Contributions
Abstract: 216
Type: Oral
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Because of a rapidly changing MS therapeutic scenario, guidelines for treatment switch have not been clearly established and no broad consensus on therapeutic algorithms has been reached.
GOALS: To provide a snapshot of switch patterns from first therapy prior to the introduction of new therapies in an Italian MS population.
Methods: Newly diagnosed patients (2010-2014) were included. Association of probability of switch for inefficacy and for intolerance with baseline demographic, clinical, MRI datawere evaluated.
Multivariate Cox model was used to test the association of baseline covariate with time to switch.
Results: Data on 1452 patients from 17 Italian MS centres were collected (female=62.2%, mean age at diagnosis 35years, median EDSS=2 (range 0-7)). Switch for inefficacy: 17.8% after 2 years, 27.7% after 3 years and 40% after 5 years; Switch for tolerability: respectively 10.2%, 17.1% and 25.6%. 37.7% patients switched among IFNs and GA and 51% escalated to a second line therapy (FTY, NTZ or immunosuppressant).
The main predictor of switch for inefficacy was IFNs/GA as first drug (HR=33;p< 0.001).Among these patients(n=1034), predictors of switch for inefficacy were younger age (HR=0.96;p< 0.001), more recent diagnosis(HR=1.23;p=0.001), lower diagnosis delay (HR=1.04;p=0.036) and spinal cord lesions (HR=1.36;p=0.028). Switch for tolerability was associated with more recent diagnosis (HR=1.34,p=0.001),FTY/NTZ as first therapy (HR=1.85;p=0.013),the North-Italy region (HR=1.80;p=0.002), baseline comorbidities (HR=1.52;p=0.041) and spinal cord lesions (HR=1.69; p=0.03). The percentage of switch for “MRI related” inefficacy was lower for vertical switches (OR=0.2; p< 0.001) but with a significant increase in more recent years (p for time by time of switch interaction = 0.045).
Conclusions: These data are part of an ongoing study that will include patients diagnosed during 2015-2017, to evaluate the impact of new drugs approval on therapeutic choices. For the time being, our data show that almost half of patients have their treatment changed, mainly for inefficacy, after 3 years from treatment start.
Disclosure:
M. Clerico: received personal compensation from Biogen Idec and Merck Serono for public speaking, editorial work and advisory boards.
A. Signori: None.
G. Maniscalco: None.
F. Saccà: Francesco Saccà received personal compensation from Novartis, Almirall, Genzyme, Forward Pharma and TEVA for public speaking, editorial work and advisory boards.
R. Lanzillo: None.
S. Lo Fermo: he received honoraria for speaking activities from Biogen Idec, Merck Serono; he also received grants for congress participation from Bayer Schering, Biogen Idec, Merck Serono and Sanofi Aventis.
P. Annovazzi: None.
L. Prosperini: has received consulting fees and/or fees, and/or travel grants from Bayer Schering, Biogen Idec, Genzyme, Novartis, Teva.
E. Cocco: None.
S. Bonavita: None.
V. Torri Clerici: None.
A. Laroni: None.
A. Repice: None.
I. R. Zarbo: None.
R. Cerqua: None.
A. Di Sapio: received personal compensation for speaking and consulting by Biogen-Dompe, Novartis and Teva. In addition, Dr. di Sapio has been reimbursed by Merck-Serono, Biogen-Dompe, and Aventis for attending several conferences.
S. Pontecorvo: None.
L. Lavorgna: None.
C. Barrillà: None.
C. Cordioli: travel grant for congress from Genzyme; consulting fee from Biogen Idec.
A. Sartori: none.
E Signoriello: none.
S La Gioia: none.
B. Fregeni: none.
P. Iaffaldano: none.
A. Di Liberto: none. J
Frau: none.
F. Gallo: None.
M. Sormani: received personal compensation for consulting services and for speaking activities from Novartis, Roche, Genzyme, Merck Serono, Teva, Synthon and Biogen Idec.
Abstract: 216
Type: Oral
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Because of a rapidly changing MS therapeutic scenario, guidelines for treatment switch have not been clearly established and no broad consensus on therapeutic algorithms has been reached.
GOALS: To provide a snapshot of switch patterns from first therapy prior to the introduction of new therapies in an Italian MS population.
Methods: Newly diagnosed patients (2010-2014) were included. Association of probability of switch for inefficacy and for intolerance with baseline demographic, clinical, MRI datawere evaluated.
Multivariate Cox model was used to test the association of baseline covariate with time to switch.
Results: Data on 1452 patients from 17 Italian MS centres were collected (female=62.2%, mean age at diagnosis 35years, median EDSS=2 (range 0-7)). Switch for inefficacy: 17.8% after 2 years, 27.7% after 3 years and 40% after 5 years; Switch for tolerability: respectively 10.2%, 17.1% and 25.6%. 37.7% patients switched among IFNs and GA and 51% escalated to a second line therapy (FTY, NTZ or immunosuppressant).
The main predictor of switch for inefficacy was IFNs/GA as first drug (HR=33;p< 0.001).Among these patients(n=1034), predictors of switch for inefficacy were younger age (HR=0.96;p< 0.001), more recent diagnosis(HR=1.23;p=0.001), lower diagnosis delay (HR=1.04;p=0.036) and spinal cord lesions (HR=1.36;p=0.028). Switch for tolerability was associated with more recent diagnosis (HR=1.34,p=0.001),FTY/NTZ as first therapy (HR=1.85;p=0.013),the North-Italy region (HR=1.80;p=0.002), baseline comorbidities (HR=1.52;p=0.041) and spinal cord lesions (HR=1.69; p=0.03). The percentage of switch for “MRI related” inefficacy was lower for vertical switches (OR=0.2; p< 0.001) but with a significant increase in more recent years (p for time by time of switch interaction = 0.045).
Conclusions: These data are part of an ongoing study that will include patients diagnosed during 2015-2017, to evaluate the impact of new drugs approval on therapeutic choices. For the time being, our data show that almost half of patients have their treatment changed, mainly for inefficacy, after 3 years from treatment start.
Disclosure:
M. Clerico: received personal compensation from Biogen Idec and Merck Serono for public speaking, editorial work and advisory boards.
A. Signori: None.
G. Maniscalco: None.
F. Saccà: Francesco Saccà received personal compensation from Novartis, Almirall, Genzyme, Forward Pharma and TEVA for public speaking, editorial work and advisory boards.
R. Lanzillo: None.
S. Lo Fermo: he received honoraria for speaking activities from Biogen Idec, Merck Serono; he also received grants for congress participation from Bayer Schering, Biogen Idec, Merck Serono and Sanofi Aventis.
P. Annovazzi: None.
L. Prosperini: has received consulting fees and/or fees, and/or travel grants from Bayer Schering, Biogen Idec, Genzyme, Novartis, Teva.
E. Cocco: None.
S. Bonavita: None.
V. Torri Clerici: None.
A. Laroni: None.
A. Repice: None.
I. R. Zarbo: None.
R. Cerqua: None.
A. Di Sapio: received personal compensation for speaking and consulting by Biogen-Dompe, Novartis and Teva. In addition, Dr. di Sapio has been reimbursed by Merck-Serono, Biogen-Dompe, and Aventis for attending several conferences.
S. Pontecorvo: None.
L. Lavorgna: None.
C. Barrillà: None.
C. Cordioli: travel grant for congress from Genzyme; consulting fee from Biogen Idec.
A. Sartori: none.
E Signoriello: none.
S La Gioia: none.
B. Fregeni: none.
P. Iaffaldano: none.
A. Di Liberto: none. J
Frau: none.
F. Gallo: None.
M. Sormani: received personal compensation for consulting services and for speaking activities from Novartis, Roche, Genzyme, Merck Serono, Teva, Synthon and Biogen Idec.