Contributions
Abstract: EP1692
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background and aims: Adherence is crucial for therapeutic success in chronic diseases. The electronic autoinjector RebiSmartTM is a unique device allowing objective assessment of interferon (IFN)β-1a sc administration. Our study investigated adherence pattern and cognitive-behavioral variables in RRMS patients using this device.
Methods: Prospective, 24-month, non-interventional, multi-centre study assessing quantitative (percentage of administered relative to prescribed injections) and qualitative adherence (percentage of weeks with three evenly-timed injections) in RRMS patients (18-65 yr) at months 3/6/12/18/24 after baseline (BL). EDSS, clinical self-rating/NRS, quality of life/MusiQoL, fatigue/FSMC, depression/BDI, information processing/SDMT and word fluency/RWT were assessed at months 3/6/12/18/24 and at BL. 188 patients entered the study (intent-to-treat group/ITT), 129 provided complete adherence data over 12 months (per-protocol study group1 ST1) and 62 over 24 months (ST2). 42 discontinued therapy within 12 month, another 50 within 2nd year, 34 without clear data. 67/188 patients entered an additional support program of the Europa Apotheek Venlo (EAV).
Results: In ST1-group quantitative and qualitative adherence was 96,3% and 88,9%, respectively, and in ST2-group 93,4 and 84,6%. 82% of patients in ST1 and 74% in ST2 reached qualitative adherence of at least 80%. Adherence did not significantly differ in the EAV-group. EDSS, NRS, QoL, depression and cognition (verbal fluency, SDMT) remained stable within normal ranges throughout the observation period. FSMC motor and cognitive score increased by 9.4% and 10.0%, respectively, across 12 months (ST1: p< 0.002; p< 0.035), and only cognitive fatigue by 8,4% (p< 0,038) in the ST2 group. ANCOVA indexed fatigue at baseline as a significant predictor of fatigue increase, but not the factors sex, premedication, age, disease duration or EDSS. Dropout analysis revealed no significant differences between adherent and non-adherent patients; dropout in the EAV-group was non significantly lower than that in non-EAVs. Possible predictors of non-adherence will be validated.
Conclusion:
(1) Autoinjector RebiSmartTM proves high adherence for injectable DMTs in RRMS patients.
(2) High adherence results in stable clinical, cognitive and behavioral parameters.
(3) Causes of fatigue increase are to be further explored.
(4) Findings might indicate an advantage of a support-programm concerning persistence.
Disclosure:
DR: Travel grants from Teva, Merck, Novartis and Genzyme.
HS: Research grants from Bayer, Biogen and Teva. Honoraria (sepaker fees, symposia, adboards) and travel grants from Biogen, Genzyme, Merck, Novartis and Teva.
ML: Research grants from Bayer, Biogen and Teva. Honoraria (sepaker fees, symposia, adboards) and travel grants from Biogen, Genzyme, Merck, Novartis and Teva.
FR; KKG: nothing to disclose.
SB: research grants and honoraria from Bayer, Biogen, Genzyme, Merck, Novartis and Teva.
AB: research grants from Novartis, Biogen and Genzyme.
AK: travel grants from Genzyme.
EAV: received no grants from any third party
Funding: The study has been supported by MerckSerono GmbH
Abstract: EP1692
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background and aims: Adherence is crucial for therapeutic success in chronic diseases. The electronic autoinjector RebiSmartTM is a unique device allowing objective assessment of interferon (IFN)β-1a sc administration. Our study investigated adherence pattern and cognitive-behavioral variables in RRMS patients using this device.
Methods: Prospective, 24-month, non-interventional, multi-centre study assessing quantitative (percentage of administered relative to prescribed injections) and qualitative adherence (percentage of weeks with three evenly-timed injections) in RRMS patients (18-65 yr) at months 3/6/12/18/24 after baseline (BL). EDSS, clinical self-rating/NRS, quality of life/MusiQoL, fatigue/FSMC, depression/BDI, information processing/SDMT and word fluency/RWT were assessed at months 3/6/12/18/24 and at BL. 188 patients entered the study (intent-to-treat group/ITT), 129 provided complete adherence data over 12 months (per-protocol study group1 ST1) and 62 over 24 months (ST2). 42 discontinued therapy within 12 month, another 50 within 2nd year, 34 without clear data. 67/188 patients entered an additional support program of the Europa Apotheek Venlo (EAV).
Results: In ST1-group quantitative and qualitative adherence was 96,3% and 88,9%, respectively, and in ST2-group 93,4 and 84,6%. 82% of patients in ST1 and 74% in ST2 reached qualitative adherence of at least 80%. Adherence did not significantly differ in the EAV-group. EDSS, NRS, QoL, depression and cognition (verbal fluency, SDMT) remained stable within normal ranges throughout the observation period. FSMC motor and cognitive score increased by 9.4% and 10.0%, respectively, across 12 months (ST1: p< 0.002; p< 0.035), and only cognitive fatigue by 8,4% (p< 0,038) in the ST2 group. ANCOVA indexed fatigue at baseline as a significant predictor of fatigue increase, but not the factors sex, premedication, age, disease duration or EDSS. Dropout analysis revealed no significant differences between adherent and non-adherent patients; dropout in the EAV-group was non significantly lower than that in non-EAVs. Possible predictors of non-adherence will be validated.
Conclusion:
(1) Autoinjector RebiSmartTM proves high adherence for injectable DMTs in RRMS patients.
(2) High adherence results in stable clinical, cognitive and behavioral parameters.
(3) Causes of fatigue increase are to be further explored.
(4) Findings might indicate an advantage of a support-programm concerning persistence.
Disclosure:
DR: Travel grants from Teva, Merck, Novartis and Genzyme.
HS: Research grants from Bayer, Biogen and Teva. Honoraria (sepaker fees, symposia, adboards) and travel grants from Biogen, Genzyme, Merck, Novartis and Teva.
ML: Research grants from Bayer, Biogen and Teva. Honoraria (sepaker fees, symposia, adboards) and travel grants from Biogen, Genzyme, Merck, Novartis and Teva.
FR; KKG: nothing to disclose.
SB: research grants and honoraria from Bayer, Biogen, Genzyme, Merck, Novartis and Teva.
AB: research grants from Novartis, Biogen and Genzyme.
AK: travel grants from Genzyme.
EAV: received no grants from any third party
Funding: The study has been supported by MerckSerono GmbH