Contributions
Abstract: EP1594
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Multiple sclerosis (MS) relapse adversely impacts short-term functioning, and accumulation of associated residual deficits results in neurological disability. As such, relapse resolution represents a critical measure of treatment effectiveness. While corticosteroids (CS) are routinely used to treat relapse, alternatives are available where CS are inappropriate (e.g. non-response/intolerance), including repository corticotropin injection (RCI; H.P. Acthar® Gel), intravenous immunoglobulin (IVIG), or plasmapheresis (PMP).
Objectives: To characterize relapse episodes and relapse resolution with CS alternatives
Methods: Analyses were conducted using administrative health insurance claims data from HealthCore from 1/1/06-11/30/16. A relapse was defined per convention as: 1) hospitalization with a principal diagnosis OR outpatient visit with any diagnosis of MS (ICD-9/10-CM=340.xx/G35) plus 2) receipt of RCI, IVIG, or PMP ≤30 days. Relapses ≤30 days were considered one episode, with the end date as the date of the last relapse plus 30 days. Continuous enrollment was required. IVIG and PMP treatments ≤7- and ≤14- days of the initial treatment were considered a course. Relapse resolution was evaluated based on all treatments received during the first episode, including CS; the first treatment was used for group assignment, i.e. RCI or PMP/IVIG. Treatment was assumed ineffective and the relapse unresolved, if another treatment followed. Comparative effectiveness analyses were conducted, using chi-square tests for categorical variables and t-tests for continuous variables.
Results: Approximately 60.2% (n=240) and 39.8% (n=159) of patients first received RCI and PMP/IVIG during their first episode, with mean number of days of 38.1 and 47.4 for each (p< 0.001). Relapse resolution differed by treatment (p< 0.001); 78.3% and 56.0% of patients receiving RCI and PMP/IVIG did not require additional relapse treatment. For RCI, 17.9% and 3.8% of patients required 1 and 2+ additional treatments to resolve their relapse, vs. 27.0% and 17.0% for PMP/IVIG.
Conclusions: RCI resolved the relapse episode more quickly and at a significantly higher rate, vs. PMP/IVIG, and can be self-administered. Consistent with prior findings, treatment effectiveness is greater with RCI vs. PMP/IVIG and RCI may be considered first for appropriate patients. Claims limitations apply.
Disclosure: Tara Nazareth is an employee and stockholder of Mallinckrodt Pharmaceuticals (MNK), a life sciences company, Bedminster, New Jersey, USA. MNK provided funding for this research.
Xian Zhang is currently employed by HealthCore, which is a consultancy whose activities on research projects were funded by various pharmaceutical/biotech/medical device companies. This project received funding from Mallinckrodt Pharmaceuticals.
Tzy-Chyi Yu is an employee and stockholder of Mallinckrodt Pharmaceuticals (MNK), a life sciences company, Bedminster, New Jersey, USA. MNK provided funding for this research.
Tao Gu was an employee at HealthCore, which received research fund from Mallinckrodt Pharmaceuticals for this study.
Gaurav Deshpande is employed by HealthCore, which is a consultancy whose activities on research projects were funded by various pharmaceutical/biotech/medical device companies. This project received funding from Mallinckrodt Pharmaceuticals.
Nancy Ho Mahler, is an employee and stockholder of Mallinckrodt Pharmaceuticals (MNK), a life sciences company, Bedminster, New Jersey, USA. MNK provided funding for this research.
Royce Waltrip is an employee and stockholder of Mallinckrodt Pharmaceuticals (MNK), a life sciences company, Bedminster, New Jersey, USA. MNK provided funding for this research.
Hiangkiat Tan is employed by HealthCore, which is a consultancy whose activities on research projects were funded by various pharmaceutical/biotech/medical device companies. This project received funding from Mallinckrodt Pharmaceuticals.
Abstract: EP1594
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Multiple sclerosis (MS) relapse adversely impacts short-term functioning, and accumulation of associated residual deficits results in neurological disability. As such, relapse resolution represents a critical measure of treatment effectiveness. While corticosteroids (CS) are routinely used to treat relapse, alternatives are available where CS are inappropriate (e.g. non-response/intolerance), including repository corticotropin injection (RCI; H.P. Acthar® Gel), intravenous immunoglobulin (IVIG), or plasmapheresis (PMP).
Objectives: To characterize relapse episodes and relapse resolution with CS alternatives
Methods: Analyses were conducted using administrative health insurance claims data from HealthCore from 1/1/06-11/30/16. A relapse was defined per convention as: 1) hospitalization with a principal diagnosis OR outpatient visit with any diagnosis of MS (ICD-9/10-CM=340.xx/G35) plus 2) receipt of RCI, IVIG, or PMP ≤30 days. Relapses ≤30 days were considered one episode, with the end date as the date of the last relapse plus 30 days. Continuous enrollment was required. IVIG and PMP treatments ≤7- and ≤14- days of the initial treatment were considered a course. Relapse resolution was evaluated based on all treatments received during the first episode, including CS; the first treatment was used for group assignment, i.e. RCI or PMP/IVIG. Treatment was assumed ineffective and the relapse unresolved, if another treatment followed. Comparative effectiveness analyses were conducted, using chi-square tests for categorical variables and t-tests for continuous variables.
Results: Approximately 60.2% (n=240) and 39.8% (n=159) of patients first received RCI and PMP/IVIG during their first episode, with mean number of days of 38.1 and 47.4 for each (p< 0.001). Relapse resolution differed by treatment (p< 0.001); 78.3% and 56.0% of patients receiving RCI and PMP/IVIG did not require additional relapse treatment. For RCI, 17.9% and 3.8% of patients required 1 and 2+ additional treatments to resolve their relapse, vs. 27.0% and 17.0% for PMP/IVIG.
Conclusions: RCI resolved the relapse episode more quickly and at a significantly higher rate, vs. PMP/IVIG, and can be self-administered. Consistent with prior findings, treatment effectiveness is greater with RCI vs. PMP/IVIG and RCI may be considered first for appropriate patients. Claims limitations apply.
Disclosure: Tara Nazareth is an employee and stockholder of Mallinckrodt Pharmaceuticals (MNK), a life sciences company, Bedminster, New Jersey, USA. MNK provided funding for this research.
Xian Zhang is currently employed by HealthCore, which is a consultancy whose activities on research projects were funded by various pharmaceutical/biotech/medical device companies. This project received funding from Mallinckrodt Pharmaceuticals.
Tzy-Chyi Yu is an employee and stockholder of Mallinckrodt Pharmaceuticals (MNK), a life sciences company, Bedminster, New Jersey, USA. MNK provided funding for this research.
Tao Gu was an employee at HealthCore, which received research fund from Mallinckrodt Pharmaceuticals for this study.
Gaurav Deshpande is employed by HealthCore, which is a consultancy whose activities on research projects were funded by various pharmaceutical/biotech/medical device companies. This project received funding from Mallinckrodt Pharmaceuticals.
Nancy Ho Mahler, is an employee and stockholder of Mallinckrodt Pharmaceuticals (MNK), a life sciences company, Bedminster, New Jersey, USA. MNK provided funding for this research.
Royce Waltrip is an employee and stockholder of Mallinckrodt Pharmaceuticals (MNK), a life sciences company, Bedminster, New Jersey, USA. MNK provided funding for this research.
Hiangkiat Tan is employed by HealthCore, which is a consultancy whose activities on research projects were funded by various pharmaceutical/biotech/medical device companies. This project received funding from Mallinckrodt Pharmaceuticals.