This study was funded by Novartis Pharmaceuticals. Novartis employees were involved in all aspects of this study. Vegesna and Sasane are employed by and own stock in Novartis. Nazareth and Ko were employees of Novartis at the time of this study. Frois, Demean, Carpenter, and Wu are or have been employed by Analysis Group, which received a grant from Novartis for this research. Navarro received consulting fees from Novartis for his involvement in this research. Study concept and design were contributed by Sasane, Frois, Nazareth, and Wu. Navarro, Demean, and Frois took the lead in data collection, assisted by Carpenter, Ko, and Nazareth. Data interpretation was provided by Frois, Carpenter, Nazareth, and Ko, along with Sasane, Demean, Wu, and Navarro. The manuscript was written by Frois, Demean, Nazareth, and Ko, along with Sasane, Carpenter, Wu, and Navarro, and revised by Frois, Ko, and Vegesna, along with Sasane, Nazareth, Wu, and Navarro.

Background: Underestimation of relapse in multiple sclerosis (MS) is detrimental to the patient as well as to their relationship with their MS healthcare professional (HCP). Objective: To obtain direct insight into relapse prevalence, symptoms, and HCP engagement from patients with MS who responded to the Multiple Sclerosis in America (MSIA) 2017 survey. Methods: Information on patient demographics, health insurance coverage, symptoms, disability, relapses, and related HCP interactions were captured. Descriptive analyses were conducted and relapses were annualized. Chisquare tests were used to evaluate frequency of patient engagement, i.e. speaking with or seeing their HCP during relapse with annualized relapse frequency and topics discussed. Results: Of the 5,311 patient-respondents, the mean age was 51.2 years (84.3% female, 89.3% Caucasian); 40.1% were on disability, and 96.8% had health insurance coverage. A total of 72.2% of patients were diagnosed with relapsingremitting MS (RRMS); 74.8% of patients not reporting a diagnosis of primary progressive MS (PPMS) (n = 4819) were using disease-modifying therapy. In the 2 years preceding the survey, 73.1% experienced a relapse for a median number of 2 relapses; this corresponded to an annualized relapse distribution among all patients of 44.1% with < 1 relapse, 35.5% with 1-2 relapses, and 20.2% with > 2 relapses. In patients reporting relapses, 62.5% cited an average relapse duration of < 1 month, 10.9% cited 1-2 months, and 13.6% cited > 2 months (12.9% were unsure/didn't recall). Leading symptoms experienced with MS relapse were fatigue (77.4%), numbness/tingling (70.0%), and walking or balance issues (68.8%). With respect to HCP engagement during relapse, 46.9% of patients reported doing so always/often, vs. sometimes (27.3%), rarely (18.5%), and never (7.3%). The most common reasons cited for not engaging an HCP were that the relapse was not severe enough (57.9%), the HCP was unhelpful or didn't specifically tell the patient to contact them (30.9%), the treatment didn't work well or wasn't tolerated (25.6%), or the preference to manage alone (24.4%). A higher percentage of patients with 1 relapse coincided with the highest frequency of HCP engagement during relapse, and the highest percentage of patients with ≥ 5 relapses coincided with the lowest frequency of HCP engagement during relapse. Key relapse-related and MS-related topics were discussed more by patients who always/often engage their HCP during relapse. HCP follow-up after relapse was variable, with 35.0% of patients reporting follow-up within 1 month of first contact, 50.3% reporting follow-up at the next office visit, and 14.7% reporting no follow-up. Conclusion: MS relapse remains particularly challenging for certain patients; some experience > 2 relapses in 1 year, relapse durations > 1 month, and relapse symptoms that interfere with daily functioning (e.g. walking/ balance by 68.8%). Approximately 25% of patients reported rarely or never engaging their HCP during relapse. Common reasons for not e...

IntroductionTimely and effective resolution of multiple sclerosis (MS) relapse is critical to minimizing residual deficits, which can result in neurologic disability. Oral corticosteroids (OCS) and intravenous corticosteroids [intravenous methylprednisolone (IVMP)] are earlier line treatments; alternatives include repository corticotropin injection (RCI; H.P. Acthar® Gel), plasmapheresis (PMP), and intravenous immunoglobulin (IVIG). Contemporary insight into the use of relapse treatments and their effectiveness is needed.ObjectiveTo evaluate relapse rates, frequency of treatments used, and treatment effectiveness (i.e., relapse resolution).MethodsA retrospective analysis of patients ages 18–89 years experiencing MS relapse from 1 January 2008 to 30 June 2015 was conducted using administrative claims data. MS relapse was defined based on established claims-based methodology. The first claim for relapse treatment (i.e., prescription or administration) was used to designate the treatment group and relapse date, respectively. Relapses occurring ≤ 30 days were considered an episode. The first relapse episode was identified for every patient. Treatment was deemed effective in resolving the relapse if no additional relapses followed within the episode; otherwise, the relapse was considered unresolved. A 5-day OCS taper following IVMP administration, designated IVMP ± OCS, was allowed. Relapse frequency, treatment use, and relapse resolution were quantified. Relapse resolution was likewise evaluated in patients continuously enrolled for 12 months before and after first treatment with RCI or PMP/IVIG, with PMP/IVIG administrations within 7 days of each other being considered a single course of therapy.ResultsDuring the study period, 9574 patients experienced ≥ 1 relapse; 26.0% of patients had ≥ 2 relapses/year. The mean number of relapse episodes was 2.6 over a mean follow-up of 2.7 years for an annualized relapse rate of 1.0. Corticosteroids were the first treatment used in 90.4% of relapses (OCS = 51.8%, IVMP = 38.6%), followed by IVIG (6.0%), RCI (2.2%) and PMP (1.5%). The proportion of patients achieving relapse resolution with their first treatment was 90.5% with OCS (n = 5710), 47.8% with IVMP ± OCS (n = 3425), 96.9% with RCI (n = 195), 50.7% with PMP (n = 73), and 43.9% with IVIG (n = 171). Among continuously enrolled patients (n = 373), relapse resolution was 95.7% with RCI (n = 232) and 66.0% with PMP/IVIG (n = 141); significant cohort differences were observed.ConclusionsAs demonstrated in other studies, OCS were generally effective. However, real-world effectiveness varied with other treatments. Relapse resolution of the first treatment with OCS was higher than with IVMP ± OCS; similarly, relapse resolution was higher with RCI as the first treatment than with PMP/IVIG. Results demonstrate RCI’s effectiveness in appropriate patients. Limitations pertaining to claims-based research apply.FundingMallinckrodt Pharmaceuticals (Bedminster, NJ).

BackgroundPatients with chronic obstructive pulmonary disease (COPD) are at increased risk for lung infections and other pathologies (eg, pneumonia); however, few studies have evaluated the impact of pneumonia on health care resource utilization and costs in this population. The purpose of this study was to estimate health care resource utilization and costs among COPD patients with newly acquired pneumonia compared to those without pneumonia.MethodsA retrospective claims analysis using Truven MarketScan® Commercial and Medicare databases was conducted. COPD patients with and without newly acquired pneumonia diagnosed between January 1, 2004 and September 30, 2011 were identified. Propensity score matching was used to create a 1:1 matched cohort. Patient demographics, comorbidities (measured by Charlson Comorbidity Index), and medication use were evaluated before and after matching. Health care resource utilization (ie, hospitalizations, emergency room [ER] and outpatient visits), and associated health care costs were assessed during the 12-month follow-up. Logistic regression was conducted to evaluate the risk of hospitalization and ER visits, and gamma regression models and two-part models compared health care costs between groups after matching.ResultsIn the baseline cohort (N=467,578), patients with newly acquired pneumonia were older (mean age: 70 versus [vs] 63 years) and had higher Charlson Comorbidity Index scores (3.3 vs 2.6) than patients without pneumonia. After propensity score matching, the pneumonia cohort was nine times more likely to have a hospitalization (odds ratio; 95% confidence intervals [CI] =9.2; 8.9, 9.4) and four times more likely to have an ER visit (odds ratio; 95% CI =4.4; 4.3, 4.5) over the 12-month follow-up period compared to the control cohort. The estimated 12-month mean hospitalization costs ($14,353 [95% CI: $14,037–$14,690]), outpatient costs ($6,891 [95% CI: $6,706–$7,070]), and prescription drug costs ($1,104 [95% CI: $1,054–$1,142]) were higher in the pneumonia cohort than in the control cohort.ConclusionThis study demonstrated elevated health care resource use and costs in patients with COPD after acquiring pneumonia compared to those without pneumonia.