Comparison of adherence and persistence among multiple sclerosis patients treated with disease-modifying therapies: a retrospective administrative claims analysis

Rachel Halpern1, Sonalee Agarwal2, Carole Dembek2, Leigh Borton1, Maria Lopez-Bresnahan31Health Economics and Outcomes Research, i3 Innovus, Eden Prairie, MN, USA; 2Health Outcomes and Pharmacoeconomics, Biogen Idec, Wellesley, MA, USA; 3Medical and Scientific Affairs, i3 Research, Waltham, MA, USAPurpose: To compare adherence and persistence among patients with multiple sclerosis (MS) initiated on disease-modifying therapy (DMTs), including intramuscular (IM) interferon beta-1a (IFNβ-1a), subcutaneous (SC) IFNβ-1a, IFNβ-1b, or glatiramer acetate (GA).Methods: MS patients initiated on IM-IFNβ-1a, SC-IFNβ-1a, IFNβ-1b, or GA between January 1, 2000 and January 2, 2008 were identified from a retrospective claims database study associated with a large US health plan. The date of DMT initiation was the index date; patients were observed for 6 months before and 12–36 months after the index date. Adherence to the index DMT was measured with a medication possession ratio (MPR), the proportion of days patients possessed their index DMTs; MPR ≥0.80 was considered adherent. Persistence was time in days from index date until the earlier of a minimum 60-day gap in DMT therapy or the last DMT claim during follow-up. Adherence and persistence were modeled with logistic and Cox proportional hazard regressions, respectively.Results: The study population comprised 6,680 patients in the DMT cohorts: IM-IFNβ-1a (N = 2,305, 34.5%); IFNβ-1b (N = 894, 13.4%); GA (N = 2,270, 34.0%); and SC-IFNβ-1a (N = 1,211, 18.1%). The IM-IFNβ-1a cohort had significantly higher regression-adjusted odds of adherence relative to the other cohorts: 52.4% higher odds versus the IFNβ-1b cohort (OR = 0.656, CI = 0.561–0.768); 33.5% higher odds versus the GA cohort (OR = 0.749, CI = 0.665–0.844); and 20.6% higher odds versus the SC-IFNβ-1a cohort (OR = 0.829, CI = 0.719–0.957). There were no consistent differences in persistence between the cohorts.Conclusion: IM-IFNβ-1a patients had significantly higher odds of adherence compared with other DMT cohorts, possibly attributable to IM-IFNβ-1a’s less frequent dosing schedule. The benefits of adherence may include better quality of life, lower risk of relapse, and fewer hospitalizations and emergency visits, making adherence a critical component of MS management.Keywords: multiple sclerosis, immunomodulatory therapy, patient complianc

Impact of Natalizumab on Patient-Reported Outcomes in a Clinical Practice Setting: A Cross-Sectional Survey

Objective: To assess multiple sclerosis (MS) patients' experience with natalizumab (TYSABRI, Biogen Idec, Inc. and Elan Pharmaceuticals, Inc.) in a clinical practice setting. Abstract: Methods: MS patients who were enrolled in the TOUCH (TYSABRI Outreach Unified Commitment to Health) prescribing program and who had received their third natalizumab infusion participated in this study. Patient-reported measures included an overall quality-of-life (QOL) assessment, an adapted version of the Multiple Sclerosis Impact Scale-29 (MSIS-29), and pre-/post-disease level and functional status scores. MSIS-29 responses were modified to measure patient-perceived change since initiating natalizumab. Paired t-tests assessed pre-/post- changes in disease level and functional status, where negative change indicated improvement. Abstract: Results: Results from 451 patients in this study indicated that 73% were female and, on average, were diagnosed with MS >11 years previously. Almost all (96%) patients had used one or more MS drugs prior to natalizumab initiation. After receiving natalizumab, 97% of all patients reported an improvement or remained stable in their overall QOL. Despite the short treatment duration, there were significant improvements (mean ± SD change) in disease level (-0.26 ± 0.99, paired t-test - 5.47; p < 0.001) and functional status (-0.33 ± 0.73, paired t-test - 9.40; p < 0.001) scores. More than 80% of patients reported an improvement in one or more MSIS-29 physical items. The physical item on the adapted MSIS-29 with the highest reported improvement (58%) was 'the ability to do physically demanding tasks'. The physical item with the lowest reported improvement (32%) was 'problems using transport'. Abstract: Conclusion: Overall, the experiences of MS patients with natalizumab were positive in a clinical practice setting. Patients reported improvements in overall QOL, ambulation and functional status as early as after three natalizumab infusions. While preliminary, these early results are suggestive of a beneficial effect of natalizumab in patients with MS and warrant further long-term investigation of the impact of this treatment on patient outcomes.

Impact of natalizumab on patient-reported outcomes in multiple sclerosis: a longitudinal study

Abstract Background Natalizumab (Tysabri, Biogen Idec and Elan Pharmaceuticals) significantly reduces the relapse rate and disability progression, and improves health-related quality of life (HRQoL), in patients with relapsing-remitting multiple sclerosis. We investigated the impact of natalizumab on patient-reported outcomes (PROs) in a real-world setting. Methods PRO data were collected from patients enrolled in a longitudinal real-world study using validated measures administered as surveys before the patients initiated natalizumab treatment and after the 3rd, 6th, and 12th monthly infusion. HRQoL, ability to carry out daily activities, disability level, and impact on cognitive functioning and fatigue were assessed. Results A total of 333 patients completed 12 months of assessments. After 12 months of natalizumab treatment, 69% to 88% of patients reported a positive outcome (either an improvement or no further decline) in all PRO measures assessed. Significant improvements in general and disease-specific HRQoL were observed after three infusions, both with physical (p  Conclusions PRO measures were improved with natalizumab in a real-world setting. The improvements were observed as early as after 3 months and sustained over a 12-month period. The improvements in PROs show that, in clinical practice, the clinical benefits of natalizumab are translated into patient-reported benefits.</p

Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine

BACKGROUND: Multiple sclerosis (MS) is a debilitating disease that negatively impacts patients' lives. OBJECTIVE: ENABLE assessed the effect of long-term prolonged-release (PR) fampridine (dalfampridine extended release in the United States) treatment on patient-perceived health impact in patients with MS with walking impairment. METHODS: ENABLE was a 48-week, open-label, Phase 4 study of PR-fampridine 10 mg twice daily. Patients who showed any improvement in Timed 25-Foot Walk walking speed at weeks 2 and 4 and any improvement in 12-item MS Walking Scale score at week 4 remained on treatment. The primary endpoint was change from baseline in 36-Item Short-Form Health Survey (SF-36) physical component summary (PCS) score. RESULTS: At week 4, 707/901 (78.5%) patients met the criteria to remain on treatment. Patients on treatment demonstrated significant and clinically meaningful improvements in SF-36 PCS scores from baseline (mean change (95% confidence interval)) to week 12 (4.30 (3.83, 4.78); p < 0.0001), week 24 (3.75 (3.23, 4.27); p < 0.0001), week 36 (3.46 (2.95, 3.97); p < 0.0001), and week 48 (3.24 (2.72, 3.77); p < 0.0001). Significant improvements from baseline were also demonstrated in secondary health measures in patients on treatment. CONCLUSION: PR-fampridine improved patient-perceived physical and psychological health impact of MS measured in a real-life setting