Impact of Early Mobilization on 90-Day Outcomes in Thrombectomy Patients

Introduction: Early mobilization of ischemic stroke patients receiving IV alteplase (tPA) did not worsen 90-day outcome at two urban stroke centers in a prior study, but there are no studies evaluating outcomes of early mobilization after thrombectomy. The mobility protocol used in the previous study was also utilized to mobilize stroke patients receiving thrombectomy treatment at these two centers, once minimum number of hours for groin precautions was complete and the groin puncture site was stable. The objective of this study was to determine for post-thrombectomy patients mobilized within 24 hours, whether earlier mobilization worsened outcomes. Methods: Medical records of ischemic stroke patients receiving thrombectomy at two urban stroke centers between May 2013 and December 2017 were reviewed for early mobilization (within 24 hours of groin puncture). Patients who did not expire in hospital and had complete data were included in the analysis. Ordinal regression was used to determine if, with each hour delay in time first up, patients’ functional outcomes worsened at 90 days using the modified Rankin scale (mRS), adjusting for pre-symptom onset mRS, admission NIHSS, age, sex, and post-treatment thrombolysis in cerebral infarction (TICI) grade. The mRS at 90 days was categorized as no symptoms or no significant disability (0 - 1), mild or moderate disability (2 - 3), and severe disability or death (4 - 6). Results: Of 147 patients mobilized within 24 hours, 91 patients were included in the analysis. Overall, 51% (n=46) were female, 74% (n=67) had no disability prior to their stroke, mean age was 68.0 (±14.1), mean admission NIHSS was 15.9 (±6.7), and 85% (n=78) had a post treatment TICI score of 2b or greater. Median time first mobilized was 14.1 hours [interquartile range: 9.4, 19.1]. Ordinal regression showed no evidence that earlier mobilization had an effect on patient outcomes at 90 days, patients were neither worse or better by time first mobilized within the first 24 hours (p=.706). Conclusions: Ischemic stroke patients receiving thrombectomy were mobilized within 24 hours of groin puncture by the early mobility protocol. Patients experienced no impact on outcomes at 90 days by time first mobilized. This result may have been limited by small sample size.https://digitalcommons.psjhealth.org/other_pubs/1070/thumbnail.jp

Quality of life among injectable and oral disease-modifying therapy users in the Pacific Northwest Multiple Sclerosis Registry.

BACKGROUND: Nine oral disease-modifying therapies (DMTs) have been approved for the treatment of multiple sclerosis (MS) in the United States. Few studies have examined self-reported quality of life (QoL) and functional status outcomes among patients who switch to oral medications from injectable MS therapies. This study compares self-reported QoL and disability status between participants switching from injectable to oral DMTs, to those who stay on injectable DMTs continuously for the same time period. METHODS: Longitudinal data were assessed from relapsing MS participants in the Pacific Northwest MS Registry completing a minimum of two surveys between 2012 and 2018 with a maximum of 36 months between surveys. Stayers were defined as those who remained on injectable DMTs continuously from Time 1 to Time 2; switchers were those who switched from injectable to either fingolimod, teriflunomide or dimethyl fumarate during the same time interval. Outcomes of interest were physical and psychological QoL, measured by the Multiple Sclerosis Impact Scale (MSIS-29), and disability, measured by the Patient Determined Disease Steps (PDDS). To analyze the effect of switching to oral DMT on outcomes at Time 2, a one-to-two propensity score matching (PSM) was used to match switchers to stayers. Outcomes at Time 2 were analyzed using paired t-test for QoL scores, and Stuart Maxwell test for PDDS as a categorical variable. RESULTS: Among 2385 participants who returned consecutive yearly surveys, 413 met the inclusion criteria for stayers and 66 for switchers. After one-to-two PSM, 124 stayers were matched to 62 switchers. Paired t-test showed no differences between switchers and stayers for physical (mean difference: - 0.41; [95% confidence interval CI: - 3.3-2.4]; p = 0.78) or psychological (mean difference: - 0.23; [95% CI, - 1.6- 1.1]; p = 0.74) QoL. Additionally, no differences were seen between switchers and stayers in self-reported disability status. CONCLUSIONS: MS registry participants who switched to an oral DMT from injectable showed no significant differences in QoL or self-reported disability status compared to those remaining on injectable DMT continuously in the same time period

Reported Quality of Life in those on High Efficacy Compared to First Line Disease Modifying Therapies in a Community Cohort

Introduction: In recent years, more high efficacy disease modifying treatments (DMT) have been approved and patients are placed on high efficacy DMT earlier in their disease course. Few studies have assessed the impact of high efficacy DMT on patients’ quality of life (QoL). Objective: The study objective was to determine whether participants on high efficacy DMT reported greater impact of MS on their physical and psychological QoL than those on first line DMT using survey data from the Pacific Northwest Multiple Sclerosis Registry (PNWMSR). Methods: This was a cross-sectional study using participants’ last annual follow up survey submitted between 2013 and 2019. Only participants with relapsing MS who reported use of one DMT were included in the analysis. Physical and psychological QoL was measured using the Multiple Sclerosis Impact Scale (MSIS-29). High efficacy DMT included use of alemtuzumab, natalizumab, rituximab, and ocrelizumab. First line DMT included interferons, glatiramer acetate, dimethyl fumarate, teriflunomide, and fingolimod. Multiple linear regression was used to determine the difference in QoL between those using high efficacy and those on first line DMT, adjusting for age, disease duration, sex, disability, and number of relapses in the previous 12 months. Results: Of 991 participants meeting inclusion criteria, 13% (n=127) were on a high efficacy DMT and 87% (n=864) were on a first line DMT. The mean age was 50 (±13) among high efficacy and 55 (±11) among first line DMT users; and the median disease duration was 14 years [interquartile range (IQR): 9, 20] and 16 years [IQR: 11, 21] respectively. The median physical QoL score for high efficacy DMT users was 35 [IQR: 26, 45], and 33 [IQR: 25, 44] for first line. The median psychological scores were 17 [IQR 13, 20] for high efficacy, and 16 [IQR: 12, 21] for first line. There was no evidence that MS had a greater impact on physical (β=-0.21, 95% confidence interval (CI): -2.1, 1.6) or psychological (β=-0.58, 95% CI: -1.6, 0.5) QoL for those on high efficacy compared to first line. Conclusions: We found no difference in physical or psychological QoL between those on high efficacy and first line DMT. A limitation of this study is the smaller number of those on high efficacy DMT. While imperative to consider patients’ overall QoL when prescribing high risk DMT, we have found no difference for these medications in our analysis. The topic requires continued study with larger patient cohorts. Disclosures: Tamela Stuchiner: nothing to disclose. Lindsay Lucas: nothing to disclose. Elizabeth Baraban: nothing to disclose. Chiayi Chen: nothing to disclose. Stanley Cohan has served on advisory boards or steering committees for Biogen, Novartis, Sanofi Genzyme and Pear Therapeutics; has received research support from Biogen, Novartis, Sanofi Genzyme, MedDay, Mallinckrodt, Roche Genentech, and IMS Health; has received speaker honoraria from Biogen, Novartis, Sanofi Genzyme, and Roche Genentech

No difference in quality of life (QoL) among people who switched from injectable to oral disease modifying treatment (DMT) compared to those who stayed on injectable in a community cohort: a propensity score matched (PSM) analysis

Introduction: Since the emergence of oral DMT to the market, few studies have examined patient reported outcomes of quality of life (QoL) after switching to oral DMT. Objective: The aim of this study was to evaluate the impact of switching from injectable to oral disease modifying treatment (DMT) on QoL among relapsing multiple sclerosis (MS) participants. Methods: Participants registered in the Pacific Northwest Multiple Sclerosis Registry who completed at least two annual surveys between 2012 and 2018 were included. Two cohorts were identified: “switchers”, those who switched from injectable to oral DMT, and “stayers”, those who stayed on injectable DMT. “Switchers” had to be on injectable DMT for ≥12 months at the first survey (“time one”) and on oral DMT ≥ six months at the follow-up survey (“time two”). “Stayers” had to have at least two consecutive surveys in which they stayed on the same injectable DMT and were on it for ≥12 months at the first survey. Both groups had to have a maximum of 36 months between survey responses. Physical and psychological QoL was measured using the Multiple Sclerosis Impact Scale (MSIS-29). To analyze the effect of switching from injectable to oral DMT on QoL, we used propensity score matching (PSM) to match switchers with stayers who had a similar length of time between surveys and had similar demographic and clinical characteristics at time one. A one-to-two match without replacement was used to match switchers to stayers based on closest propensity score. Outcomes were compared using paired t-tests. Results: Among 1,542 participants with relapsing MS, 427 stayers and 62 switchers were eligible for matching, and PSM resulted in 118 matched pairs. Before matching, there were significant differences in insurance status and MSIS psychological score. Matched pairs showed no differences between stayers and switchers in impact of MS on physical (mean difference: -0.95 (95% confidence interval (CI): (-3.82, 1.92; p=0.51) or psychological (mean difference: -0.71 (95% CI: -2.07, 0.64; p=0.30) MSIS scores at time two. Conclusions: After matching on demographic and clinical characteristics as well as time one QoL, no significant differences were found in impact of MS on QoL in participants switching to oral DMT from injectable DMT. Results suggest QoL is not impacted after switching to oral medications for registry participants. This study was supported by Sanofi Genzyme. Tamela Stuchiner: nothing to disclose. Lindsay Lucas: nothing to disclose. Elizabeth Baraban: nothing to disclose. Chiayi Chen: nothing to disclose. SC has served on advisory boards or steering committees for Biogen, Novartis, Sanofi Genzyme and Pear Therapeutics; has received research support from Biogen, Novartis, Sanofi Genzyme, MedDay, Mallinckrodt, Roche Genentech, and IMS Health; has received speaker honoraria from Biogen, Novartis, Sanofi Genzyme, and Roche Genentech

Clinical outcomes of patients with multiple sclerosis treated with ocrelizumab in a US community MS center: an observational study.

Background: To monitor long-term outcomes of ocrelizumab treatment. Objective: To evaluate safety and treatment outcomes of ocrelizumab in a community-based multiple sclerosis (MS) population. Methods: Adult patients with MS prescribed ocrelizumab were eligible. Chart reviews were conducted at the start of ocrelizumab treatment and every 6 months thereafter. Results: Of the 355 patients enrolled, 71.9% were female; mean (SD) age was 51.8 (12.5) years; 78.3% had relapsing MS (RMS). Median baseline Expanded Disability Status Scale (EDSS) (IQR) was 3.0 (2.0-4.0) for RMS, 6.5 (6.0-7.5) for secondary progressive MS, and 6.5 (6.0-7.0) for primary progressive MS. Respiratory infections occurred in 40.1% and urinary tract infections in 33.1% of patients. There was no difference in the percentage of infections among patients \u3c55 \u3e(68.5%, n=122), and those ≥55 of age (67.5%, n=104) (p=0.94). Twenty-five hospitalisations were due to infections; 69.2% of these patients were ≥55 with a mean EDSS of 5.7 (±1.86). Four patients have died. Serum IgM and IgG levels did not predict infection risk. Annualised relapse rate was 0.34 for the patients with RMS in the preceding 2 years and 0.09 in patients who received ≥2 ocrelizumab 600 mg courses. The first on-treatment MRI was stable in 262 (90.0%) patients, 6.9% had new T2 lesions, 2.7% had enlarging T2 lesions and 1.4% had gadolinium-enhancing lesions. Median EDSS at 12 months was unchanged. Conclusion: Ocrelizumab effectively controlled relapse risk and disability worsening. Although only 12.1% of patients have discontinued ocrelizumab, infections resulting in hospitalisation are a concern, especially in older and disabled patients

Three-year clinical outcomes of relapsing multiple sclerosis patients treated with dimethyl fumarate in a United States community health center.

BACKGROUND: Following approval of dimethyl fumarate (DMF), we established a registry of relapsing multiple sclerosis (RMS) patients taking DMF at our community MS center. OBJECTIVE: To track DMF patients\u27 tolerability, disease progression, and lymphopenia. METHODS: Patients prescribed DMF for RMS from March 2013 to March 2016 were prospectively enrolled ( N = 412). Baseline data, clinical relapses, magnetic resonance imaging (MRI) activity, discontinuation, and lymphocyte counts were captured through chart review. RESULTS: The mean age of patients starting DMF was 49.4 ± 12.0 years and 70% transitioned from a previous disease-modifying therapy (DMT). Of the patients, 38% discontinued DMF, 76% of whom discontinued due to side effects. Clinical relapse and MRI activity were low. Comparing patients who transitioned from interferon-β (IFN), glatiramer acetate (GA), or natalizumab (NTZ), patients previously on NTZ had higher rates of relapse than those previously on GA (annualized relapse rate p = 0.039, percent relapse p = 0.021). Grade III lymphopenia developed in 11% of patients. Lymphopenia was associated with older age ( p \u3c 0.001) and longer disease duration ( p \u3c 0.001). CONCLUSION: Given the high rates of lymphopenia and discontinuation, it has become our clinical practice to more closely scrutinize older patients and those with a longer disease duration who are potential candidates for initiating DMF therapy

Advancing Care and Outcomes for African American Patients With Multiple Sclerosis.

Multiple sclerosis (MS) has historically been underdiagnosed and undertreated among African Americans. Recent evidence suggests that African Americans with MS have a different clinical presentation, increased disease incidence and burden, and worsened long-term outcomes versus their White counterparts. Due to limited data available for African Americans in MS clinical trials, it is difficult to make informed, generalizable conclusions about the natural history, prognosis, and therapeutic response in this population. In this narrative review, we highlight the nature and magnitude of the health disparities experienced by African Americans with MS and underscore the pressing need to increase knowledge about and understanding of MS disease manifestations in this group. Additionally, we describe the mission and objectives of the recently established National African Americans with Multiple Sclerosis Registry (NAAMSR), which is intended to be a platform to advance the care of African Americans with MS and address health disparities they may experience

The natural history of ALS: Baseline characteristics from a multicenter clinical cohort

Amyotrophic lateral sclerosis (ALS) is a rare disease with urgent need for improved treatment. Despite the acceleration of research in recent years, there is a need to understand the full natural history of the disease. As only 40% of people living with ALS are eligible for typical clinical trials, clinical trial datasets may not generalize to the full ALS population. While biomarker and cohort studies have more generous inclusion criteria, these too may not represent the full range of phenotypes, particularly if the burden for participation is high. To permit a complete understanding of the heterogeneity of ALS, comprehensive data on the full range of people with ALS is needed. The ALS Natural History Consortium (ALS NHC) consists of nine ALS clinics and was created to build a comprehensive dataset reflective of the ALS population. At each clinic, most patients are asked to participate and about 95% do. After obtaining consent, a minimum dataset is abstracted from each participant’s electronic health record. Participant burden is therefore minimal. Data on 1925 ALS patients were submitted as of 9 December 2022. ALS NHC participants were more heterogeneous relative to anonymized clinical trial data from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database. The ALS NHC includes ALS patients of older age of onset and a broader distribution of El Escorial categories, than the PRO-ACT database. ALS NHC participants had a higher diversity of diagnostic and demographic data compared to ALS clinical trial participants.Key MessagesWhat is already known on this topic: Current knowledge of the natural history of ALS derives largely from regional and national registries that have broad representation of the population of people living with ALS but do not always collect covariates and clinical outcomes. Clinical studies with rich datasets of participant characteristics and validated clinical outcomes have stricter inclusion and exclusion criteria that may not be generalizable to the full ALS population.What this study adds: To bridge this gap, we collected baseline characteristics for a sample of the population of people living with ALS seen at a consortium of ALS clinics that collect extensive, pre-specified participant-level data, including validated outcome measures.How this study might affect research, practice, or policy: A clinic-based longitudinal dataset can improve our understanding of the natural history of ALS and can be used to inform the design and analysis of clinical trials and health economics studies, to help the prediction of clinical course, to find matched controls for open label extension trials and expanded access protocols, and to document real-world evidence of the impact of novel treatments and changes in care practice. What is already known on this topic: Current knowledge of the natural history of ALS derives largely from regional and national registries that have broad representation of the population of people living with ALS but do not always collect covariates and clinical outcomes. Clinical studies with rich datasets of participant characteristics and validated clinical outcomes have stricter inclusion and exclusion criteria that may not be generalizable to the full ALS population. What this study adds: To bridge this gap, we collected baseline characteristics for a sample of the population of people living with ALS seen at a consortium of ALS clinics that collect extensive, pre-specified participant-level data, including validated outcome measures. How this study might affect research, practice, or policy: A clinic-based longitudinal dataset can improve our understanding of the natural history of ALS and can be used to inform the design and analysis of clinical trials and health economics studies, to help the prediction of clinical course, to find matched controls for open label extension trials and expanded access protocols, and to document real-world evidence of the impact of novel treatments and changes in care practice.</p