Author Of 3 Presentations
P0845 - Characteristics of patients initiating ocrelizumab vs other disease-modifying therapies in a US national multiple sclerosis registry (ID 1224)
Abstract
Background
Ocrelizumab (OCR) was approved in 2017 in the United States (US) for the treatment of relapsing and primary progressive forms of multiple sclerosis (MS). Real-world data describing the characteristics of patients initiating OCR are limited. The Corrona MS Registry is a US prospective observational registry that, as of August 2019, encompasses 11 private and academic sites and 781 patients aged ≥18 years, including 631 patients receiving a disease-modifying treatment (DMT) at the time of enrollment.
Objectives
To describe the characteristics of patients enrolled in the Corrona MS Registry who initiated OCR vs other MS DMTs.
Methods
This analysis included patients who initiated a DMT ≤24 months before or at registry enrollment (which began in August 2017) to ensure comparable treatment availability across groups, considering the 2017 approval of OCR. Enrollment visit characteristics were calculated separately for patients initiating OCR, oral/injectable DMTs or other intravenous (IV) DMTs. Patient Global Impression of Change (PGIC) score was reported for patients who started DMT before enrollment.
Results
The analysis population included 326 patients (52% of treated registry patients); 71% initiated OCR (n=233), 16% initiated oral (n=43) or injectable (n=9) DMTs and 13% initiated another IV DMT (n=41). Most patients (n=299) initiated a DMT before enrollment. Compared with patients initiating OCR, those initiating oral/injectable or other IV DMTs were more likely to have a relapsing-remitting disease course (80% vs 89% and 88%, respectively), were younger (mean [SD] age, 51 [11] vs 48 [11] and 44 [12] years, respectively) and had a shorter mean disease duration (13 vs 10 and 8 years, respectively). Fewer patients in the OCR group initiated treatment as a first- or second-line therapy (36%) than in the oral/injectable (67%) or other IV groups (59%). Mild disability (scores ≤1) on the Patient Determined Disease Steps was reported by 49% of patients in the OCR group and 65% and 54% in the oral/injectable and other IV DMT groups, respectively. Improvement on the PGIC was reported by 50%, 27% and 63% in the OCR, oral/injectable and other IV groups, respectively.
Conclusions
In these unadjusted analyses of Corrona registry data, patients initiating ocrelizumab in the 2 years after launch were older and had higher disability levels at the time of enrollment than those initiating other DMTs. Real-world outcomes will continue to be examined as the registry matures.
P0897 - Persistence and adherence to ocrelizumab compared with other disease-modifying therapies for multiple sclerosis for up to 18 months in the US (ID 1222)
Abstract
Background
Adherence to disease-modifying therapy (DMT) is critical for achieving therapeutic goals in multiple sclerosis (MS). Real-world evidence on persistence and adherence with ocrelizumab (OCR) is limited.
Objectives
This analysis aimed to examine the persistence and adherence to OCR compared with other MS DMTs.
Methods
This analysis was conducted in the PharMetrics Plus commercial claims database and included patients with MS who initiated a new DMT between April 2017 and September 2018. Patients were required to have health plan enrollment for ≥12 months before and after DMT initiation. Persistence and adherence were measured in patients with ≥12 months and ≥18 months of follow-up. Persistence was defined as no switch to other DMTs and no gap in supply of initiated DMT for ≥60 days. Adherence was assessed using the proportion of days covered (PDC), calculated as the total days of supply of DMT during the postinitiation period divided by either 365 days (12-month analysis) or 548 days (18-month analysis). Multivariable Poisson regression models were used to compare discontinuation of (nonpersistence) and nonadherence (PDC <0.80) with OCR vs oral, injectable, and other intravenous (IV) DMTs.
Results
A total of 4,587 (OCR, 1,319; injectable, 1,051; oral, 1,876; IV, 341) patients were included. At 12 months, patients initiating OCR had the highest mean PDC (93.4%) compared with other groups (injectable, 69%; oral, 74%; IV, 76%) and the highest proportion of patients persistent with therapy (92% vs 57%, 68% and 72%, respectively). Compared with OCR, adjusted relative risks of 12-month discontinuation (95% CI) were 5.5 (4.1–7.5), 3.8 (3.0–4.9) and 3.3 (2.3–4.6) in patients initiating injectable, oral and IV DMTs, respectively, and relative risks of nonadherence were 6.8 (5.0–9.3), 5.1 (3.9–6.6) and 4.9 (3.6–6.8), respectively. Among patients with 18 months of follow-up (n=2,319), 83% of OCR patients demonstrated persistence vs 45%, 59% and 60% of injectable, oral and IV patients, respectively. Trends in discontinuation and nonadherence for the DMT groups over 18 months were consistent with 12-month results in fully adjusted models.
Conclusions
Patients initiating ocrelizumab had superior persistence and adherence at both 12 and 18 months of follow-up compared with other groups of MS DMTs. Long-term persistence and adherence should be monitored as ocrelizumab experience accrues in a real-world setting.
P1009 - Characteristics and patient-reported outcomes of patients initiating ocrelizumab in the NARCOMS Registry from 2017 to 2019 (ID 1221)
Abstract
Background
Ocrelizumab (OCR) was approved for relapsing and primary progressive forms of multiple sclerosis (MS) in 2017. Patient-reported outcome data among patients initiating OCR in clinical practice is limited.
Objectives
To evaluate the characteristics, experience and outcomes of participants in the North American Research Committee on Multiple Sclerosis (NARCOMS) registry who initiated OCR.
Methods
NARCOMS is a voluntary registry enrolling persons with MS who update their information using semi-annual surveys. This analysis included participants initiating OCR between April 2017 and April 2019, including a subset of participants who completed 1-year follow-ups. Outcomes included Patient Determined Disease Steps (PDDS), relapses, health care utilization and employment (i.e. employed/unemployed status, absenteeism). Changes from baseline for the subgroup who completed 1-year surveys were evaluated using the nonparametric Wilcoxon-Signed Rank or McNemar’s tests.
Results
During the study period 829 participants initiated OCR. They had a mean [SD] age of 56.6 [10.6] years and time since diagnosis of 18.7 [9.9] years. Most participants were female (75.3%). The most common clinical course was relapsing-remitting (45.4%) followed by secondary progressive (32.1%) and primary progressive (22.6%). The median (interquartile range [IQR]) PDDS was 5.0 [3.0–6.0]. Similar baseline characteristics were observed in the subgroup of 435 participants who had ≥1 year of follow-up (median [IQR] follow-up, 1.5 [1.0–2.0] years). In this subgroup, participants were less likely to report a steroid-treated relapse at 1 year (7.7%) compared with baseline (1-year lookback, 4.7%; p=0.04), although no differences were observed with respect to emergency room or hospital admissions. More than half of participants reported either improvement (40.7%) or no change (15.3%) on the PDDS; 44% reported worsening. Among employed participants at baseline (n=139), 8% reported leaving the workforce during follow-up; among those who remained employed, fewer reported missing work in the follow-up year (33.9%) compared with baseline (1-year lookback; 46.5%; p=0.003).
Conclusions
Participants initiating ocrelizumab in the NARCOMS registry are representative of a prevalent MS population, consistent with the full registry population. Patients with longitudinal follow-up on ocrelizumab reported fewer relapses and lower work absenteeism, with no differences in health resource utilization compared to baseline.
Presenter Of 1 Presentation
P0897 - Persistence and adherence to ocrelizumab compared with other disease-modifying therapies for multiple sclerosis for up to 18 months in the US (ID 1222)
Abstract
Background
Adherence to disease-modifying therapy (DMT) is critical for achieving therapeutic goals in multiple sclerosis (MS). Real-world evidence on persistence and adherence with ocrelizumab (OCR) is limited.
Objectives
This analysis aimed to examine the persistence and adherence to OCR compared with other MS DMTs.
Methods
This analysis was conducted in the PharMetrics Plus commercial claims database and included patients with MS who initiated a new DMT between April 2017 and September 2018. Patients were required to have health plan enrollment for ≥12 months before and after DMT initiation. Persistence and adherence were measured in patients with ≥12 months and ≥18 months of follow-up. Persistence was defined as no switch to other DMTs and no gap in supply of initiated DMT for ≥60 days. Adherence was assessed using the proportion of days covered (PDC), calculated as the total days of supply of DMT during the postinitiation period divided by either 365 days (12-month analysis) or 548 days (18-month analysis). Multivariable Poisson regression models were used to compare discontinuation of (nonpersistence) and nonadherence (PDC <0.80) with OCR vs oral, injectable, and other intravenous (IV) DMTs.
Results
A total of 4,587 (OCR, 1,319; injectable, 1,051; oral, 1,876; IV, 341) patients were included. At 12 months, patients initiating OCR had the highest mean PDC (93.4%) compared with other groups (injectable, 69%; oral, 74%; IV, 76%) and the highest proportion of patients persistent with therapy (92% vs 57%, 68% and 72%, respectively). Compared with OCR, adjusted relative risks of 12-month discontinuation (95% CI) were 5.5 (4.1–7.5), 3.8 (3.0–4.9) and 3.3 (2.3–4.6) in patients initiating injectable, oral and IV DMTs, respectively, and relative risks of nonadherence were 6.8 (5.0–9.3), 5.1 (3.9–6.6) and 4.9 (3.6–6.8), respectively. Among patients with 18 months of follow-up (n=2,319), 83% of OCR patients demonstrated persistence vs 45%, 59% and 60% of injectable, oral and IV patients, respectively. Trends in discontinuation and nonadherence for the DMT groups over 18 months were consistent with 12-month results in fully adjusted models.
Conclusions
Patients initiating ocrelizumab had superior persistence and adherence at both 12 and 18 months of follow-up compared with other groups of MS DMTs. Long-term persistence and adherence should be monitored as ocrelizumab experience accrues in a real-world setting.