Contributions
Abstract: EP1515
Type: ePoster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Adherence to treatment of chronic disease is essential but often difficult for patients to maintain over time. Identifying and managing elements relevant to adherence is crucial for effective therapy.
Objectives: Primary study objective is to investigate influence of factors on adherence to interferon beta-1b treatment in patients with MS, including nurse contact and clinical parameters.
Methods: BEACON is a 24 months multinational observational study that enrolled patients with CIS and RRMS treated with interferon beta-1b. Site visits were scheduled every 6 months in addition to a nurse interview at study start and monthly nurse calls. Clinical parameters were assessed at baseline and each visit and the Hospital Anxiety and Depression Scale was completed.
Results: The ITT cohort of 1545 patients included 67.4% females. Median age was 34.0 yrs (Q1 27.0;Q3 43.0), time since disease onset 1.33 yrs (Q1 0.46;Q3 3.57), EDSS 2.0 (Q1 1.0;Q3 3.0). Annualized relapse rate (ARR) decreased from mean 0.97 (SD 0.52) during the 2 yrs before study entry to 0.347
(SD 1.345) on study. 85.9% of patients had stable or improved EDSS, 74% were both relapse- and progression-free. 3.5% developed secondary progressive MS. 31.3% reported clinical levels of anxiety symptoms on baseline HADS and 15% clinically significant depressive symptoms. Anxiety and depression scores did not change between baseline and last visit (anxiety median change 0, Q1 -3.0;Q3 2.0; depression median change 0, Q1 -2.0;Q3 2.0). Patients who had at least one nurse interview (n=1204) were significantly more likely to continue treatment than subjects with no nurse interview
(n= 442) (p< 0.001). Furthermore in regression models, the baseline variables of higher age, CIS stage, lower EDSS, and absence of gd enhancing lesions significantly increased the likelihood of continuing treatment. Higher HADS depression scores were related to reduced adherence (p=0.0201). Most frequently reported adverse events were influenza-like illness (39 subjects), headache (32), depression (19), relapse (18), injection site erythema (11).
Conclusion: Data from this large study indicated that older patients with milder disease were most adherent. Nurse support and treating depression are likely to enhance adherence. The study cohort showed stable clinical disease activity and disability over 2 yrs, with no increase in depression and anxiety. No unexpected safety signals were reported.
Disclosure:
FP served Almirall, Bayer, Biogen, Merck, Novartis, Sanofi Genzyme and TEVA as an advisor and received grants for speaking activities from the same companies.
DWL has participated on advisory boards/received consultancy/research grants or is in the speaker Bureau for: Bayer, Novartis, Teva, Excemed, Roche, Merck and Biogen.
TB reports receiving consulting fees and speaking fees from Biogen Idec, Sanofi Aventis, Genzyme, Teva Pharma, Bayer Schering, Merck Serono, Roche, Almirall and Novartis, Roche.
LZ is a salaried employee at Parexel.
EMW is a salaried employee at Bayer Pharma AG
Abstract: EP1515
Type: ePoster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Adherence to treatment of chronic disease is essential but often difficult for patients to maintain over time. Identifying and managing elements relevant to adherence is crucial for effective therapy.
Objectives: Primary study objective is to investigate influence of factors on adherence to interferon beta-1b treatment in patients with MS, including nurse contact and clinical parameters.
Methods: BEACON is a 24 months multinational observational study that enrolled patients with CIS and RRMS treated with interferon beta-1b. Site visits were scheduled every 6 months in addition to a nurse interview at study start and monthly nurse calls. Clinical parameters were assessed at baseline and each visit and the Hospital Anxiety and Depression Scale was completed.
Results: The ITT cohort of 1545 patients included 67.4% females. Median age was 34.0 yrs (Q1 27.0;Q3 43.0), time since disease onset 1.33 yrs (Q1 0.46;Q3 3.57), EDSS 2.0 (Q1 1.0;Q3 3.0). Annualized relapse rate (ARR) decreased from mean 0.97 (SD 0.52) during the 2 yrs before study entry to 0.347
(SD 1.345) on study. 85.9% of patients had stable or improved EDSS, 74% were both relapse- and progression-free. 3.5% developed secondary progressive MS. 31.3% reported clinical levels of anxiety symptoms on baseline HADS and 15% clinically significant depressive symptoms. Anxiety and depression scores did not change between baseline and last visit (anxiety median change 0, Q1 -3.0;Q3 2.0; depression median change 0, Q1 -2.0;Q3 2.0). Patients who had at least one nurse interview (n=1204) were significantly more likely to continue treatment than subjects with no nurse interview
(n= 442) (p< 0.001). Furthermore in regression models, the baseline variables of higher age, CIS stage, lower EDSS, and absence of gd enhancing lesions significantly increased the likelihood of continuing treatment. Higher HADS depression scores were related to reduced adherence (p=0.0201). Most frequently reported adverse events were influenza-like illness (39 subjects), headache (32), depression (19), relapse (18), injection site erythema (11).
Conclusion: Data from this large study indicated that older patients with milder disease were most adherent. Nurse support and treating depression are likely to enhance adherence. The study cohort showed stable clinical disease activity and disability over 2 yrs, with no increase in depression and anxiety. No unexpected safety signals were reported.
Disclosure:
FP served Almirall, Bayer, Biogen, Merck, Novartis, Sanofi Genzyme and TEVA as an advisor and received grants for speaking activities from the same companies.
DWL has participated on advisory boards/received consultancy/research grants or is in the speaker Bureau for: Bayer, Novartis, Teva, Excemed, Roche, Merck and Biogen.
TB reports receiving consulting fees and speaking fees from Biogen Idec, Sanofi Aventis, Genzyme, Teva Pharma, Bayer Schering, Merck Serono, Roche, Almirall and Novartis, Roche.
LZ is a salaried employee at Parexel.
EMW is a salaried employee at Bayer Pharma AG