A Descriptive Study Using Rasch Analysis and Hypothesis Testing to Evaluate the Psychometric Properties of the UMOVE Mobility Screen Tested With Hospitalized Older Adults.

The purpose of this study was to test the reliability and validity of the UMOVE Mobility Screen in older adults living with dementia using a Rasch analysis and hypothesis testing. The UMOVE Mobility Screen (UMOVE) focuses on nine activities: following commands, muscle strength, and basic functional mobility tasks. Trained evaluators completed assessments on 244 patients, the majority of whom were female (62%), and White (71%). Based on Rasch Analysis, there was evidence of good item and person reliability (indexes > 0.80), good INFIT statistics, and only one item fitting the model based on OUTFIT statistics. Validity was supported based on hypothesis testing. There was no evidence of Differential Item Functioning between races and genders. Item mapping raised concerns about the spread of the items across the full spectrum of mobility assessed in the UMOVE Mobility Screen. Future testing should consider adding some easier and some more difficult items.

Factors Associated With Function-Focused Care Among Hospitalized Older Adults Living With Dementia.

This article reports a study that was designed to describe the incidence of pain among older hospitalized patients with dementia and to evaluate the factors that influence pain among these individuals. It was hypothesized that function, behavioral and psychological symptoms of dementia, delirium, pain treatment, and patient exposure to care interventions would be associated with pain. Patients who performed more functional activities had less delirium. They also experienced higher quality-of-care interactions and were less likely to have pain. The findings from this study support the relationship between function, delirium, and quality-of-care interactions and pain. It suggests that it may be useful to encourage patients with dementia to engage in functional and physical activity to prevent or manage pain. This study serves as a reminder to avoid neutral or negative care interactions among patients with dementia as a strategy to mediate delirium and pain.

Testing Function Focused Care for Acute Care using the Evidence Integration Triangle: Protocol description.

This manuscript provides the protocol for a National Institute of Aging-funded cluster randomized clinical trial that focuses on helping nurses in acute care to engage patients with dementia in physical activity while hospitalized using an approach referred to as function-focused care. Physical activity is defined as bodily movement produced by skeletal muscles resulting in the expenditure of energy and includes functional tasks such as bathing and dressing, leisure activity, ambulation, and moderate and vigorous intensity physical activity such as dancing, bike riding, or walking upstairs. The development of Function Focused Care for Acute Care (FFC-AC) was based on the Social Ecological Model and Social Cognitive Theory and includes four steps: (1) Environment and Policy Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of Staff (all levels of nursing staff), Patients, and Families. Function-focused care activities include motivating older patients to participate in bed mobility; personal care activities such as bathing, dressing, ambulating as they are able; and other types of physical activities. The integration of the intervention among the nurses on the units is guided by the Evidence Integration Triangle (EIT), which includes the participation of a stakeholder team and practical outcome measures. The intervention is therefore referred to as FFC-AC-EIT. In addition to describing the protocol developed to test the effectiveness and feasibility of FFC-AC-EIT, a description of ways to overcome some of the barriers and challenges that can be encountered with this study is provided.

Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis.

OBJECTIVES: To determine s.c. tocilizumab (s.c.-TCZ) dosing regimens for systemic JIA (sJIA) and polyarticular JIA (pJIA). METHODS: In two 52-week phase 1 b trials, s.c.-TCZ (162 mg/dose) was administered to sJIA patients every week or every 2 weeks (every 10 days before interim analysis) and to pJIA patients every 2 weeks or every 3 weeks with body weight ≥30 kg or <30 kg, respectively. Primary end points were pharmacokinetics, pharmacodynamics and safety; efficacy was exploratory. Comparisons were made to data from phase 3 trials with i.v. tocilizumab (i.v.-TCZ) in sJIA and pJIA. RESULTS: Study participants were 51 sJIA patients and 52 pJIA patients aged 1-17 years who received s.c.-TCZ. Steady-state minimum TCZ concentration (Ctrough) >5th percentile of that achieved with i.v.-TCZ was achieved by 49 (96%) sJIA and 52 (100%) pJIA patients. In both populations, pharmacodynamic markers of disease were similar between body weight groups. Improvements in Juvenile Arthritis DAS-71 were comparable between s.c.-TCZ and i.v.-TCZ. By week 52, 53% of sJIA patients and 31% of pJIA patients achieved clinical remission on treatment. Safety was consistent with that of i.v.-TCZ except for injection site reactions, reported by 41.2% and 28.8% of sJIA and pJIA patients, respectively. Infections were reported in 78.4% and 69.2% of patients, respectively. Two sJIA patients died; both deaths were considered to be related to TCZ. CONCLUSION: s.c.-TCZ provides exposure and risk/benefit profiles similar to those of i.v.-TCZ. S.c. administration provides an alternative administration route that is more convenient for patients and caregivers and that has potential for in-home use. TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT01904292 and NCT01904279.

Safety and Feasibility of Early Physical Therapy for Patients on Extracorporeal Membrane Oxygenator: University of Maryland Medical Center Experience.

OBJECTIVES: To examine the feasibility and safety of mobilizing patients while on extracorporeal membranous oxygenation support. DESIGN: Retrospective cohort study. SETTING: Medical and Surgical ICUs in a large tertiary care hospital in the United States. PATIENTS: Adults supported on extracorporeal membranous oxygenation from January 2014 to December 2015. MEASUREMENTS AND MAIN RESULTS: We reviewed the medical records from physical therapy, perfusion, and intensivists to obtain the number and type of physical therapy interventions and discharge status; extracorporeal membranous oxygenation type and description of support, cannulation sites; and risk management details of adverse effects, if any. Of 254 patients supported on extracorporeal membranous oxygenation, 167 patients (66.7%) received a total of 607 physical therapy sessions while on extracorporeal membranous oxygenation support. In this cohort, 134 patients (80.2%) had at least one femoral cannula during physical therapy intervention. Sixty-six of the 167 patients (39.5%) were supported on extracorporeal membranous oxygenation with bifemoral cannulas, and 44 (26.3%) were on veno-arterial extracorporeal membranous oxygenation. A dual lumen catheter was only used in five cases. Twenty-five patients (15%) (13 bifemoral cases) participated in standing or ambulation activities. Seventy-five patients (68.8%) who were successfully weaned from extracorporeal membranous oxygenation were discharged to a rehabilitation facility; 26 patients (23.8%) went home. Three minor events (< 0.5%) involving two episodes of arrhythmias and a hypotension event interrupted the therapy sessions, but mobility activities and exercises resumed that day. No major events were reported. CONCLUSIONS: With a highly trained multidisciplinary team and a focus on restoring function, it is feasible and safe to deliver early rehabilitation including standing and ambulation to patients on extracorporeal membranous oxygenation support even those with femoral cannulation sites with veno-arterial extracorporeal membranous oxygenation and veno-venous extracorporeal membranous oxygenation.

The Impact of Pain Management with Opioids among Older Adults Post Orthopedic Trauma.

Pain has a significant effect on physical and psychological outcomes for older adults post orthopedic trauma. The purpose of this study was to describe the management of pain among older trauma patients and consider differences between those who received 3 or more dosages daily of opioids versus those who did not. This was a secondary data analysis using data from an intervention study testing the effect of Function Focused Care among older orthopedic trauma patients (FFC-AC). The FFC-AC study was done on trauma units in two acute care settings designated as Level I or II trauma centers from September 2014 to September 2015. All participants from the parent FFC-AC study were included. Data collection for the parent study was done within 24 hours of admission and within 24 hours of discharge and included demographics, medications, assessment of function, physical activity, mood, physical resilience, and whether the patient had pain and their pain intensity. Patient records included all 89 individuals from the parent study, 59 (66%) of whom were female and 82 (92%) were white. Records indicated that those who received more than three dosages per day of opioids had a shorter length of stay, were younger, had more intense pain, and were more resilient compared with those who received less than three dosages per day. This secondary data analysis provides support for the importance of considering pain and pain management among older adults post trauma.

Feasibility and Efficacy of Function-Focused Care for Orthopedic Trauma Patients.

To overcome challenges associated with optimizing function and physical activity among hospitalized older adults, we developed function-focused care for acute care (FFC-AC). The purpose of this study was to test the feasibility and preliminary effectiveness of this intervention. We hypothesized that hospitalized trauma patients exposed to FFC-AC would (1) maintain or improve function, spend more time in physical activity, and have fewer adverse events between admission and discharge; and (2) maintain or improve function, have less fear of falling, fewer depressive symptoms, less pain, be more physically resilient, and be less likely to experience adverse events at 1 month postdischarge compared with those exposed to FFC-education only (EO). FFC-AC was implemented by a research function-focused care nurse who worked on the participating units for 20 hr a week for 16 months to implement the three components of FFC-AC. The sample included 89 older orthopedic trauma patients the majority of whom were female (N = 59, 66%), white (N = 82, 92%), and not married (N = 53, 59%). At discharge and/or 30 days postdischarge, participants in the treatment site showed greater improvement in function, less fear of falling, and better physical resilience when compared with those in the FFC-EO site. Future research is needed to continue to work on engaging staff in function-focused care approaches and optimizing the hospital environment and policies to support nurses in this type of care approach.

Length of hospital stay and discharge disposition in older trauma patients.

As the number of older adults increases and life expectancies are increasing, more incidences of traumatic injury are expected in this population. In this study, the relationships between demographic variables, pain, days from admission to therapy evaluation, length of stay and discharge disposition were examined in 132 older adults who had experienced a traumatic event. Results showed that significant relationships existed between pain, age, comorbidities, injury severity and days from admission to therapy evaluation and length of stay; those with less pain, greater age and had more days between admission and when the first therapy evaluation occurred had longer lengths of stay. In addition, demographic variables, overall length of stay and pain intensity during therapy were associated with discharge location; for longer lengths of stay and higher pain, older trauma patients were less likely to be discharged to home.

Implementation of the UMove Mobility Program to Promote Safe Patient Mobility and Reduce Falls in the Hospital Setting.

The purpose of the current quality improvement (QI) project was to implement the UMove Early Mobility Program to engage patients in safe out of bed (OOB) activities and reduce falls, specifically focusing on toileting-related falls, during the hospital stay. Eight nursing units implemented the UMove program, including the UMove Mobility Screen (UMove MS), to select strategies to reduce toileting-related falls while increasing mobility. De-identified, unit-based data were collected from hospital reports. Nursing had a 95% documentation compliance rate for the UMove MS, and OOB activities and ambulation were documented at 50% and 57%, respectively. There was no statistical difference found in reducing toileting-related falls or sustaining increased OOB activities across the 15-month QI project. Toileting-related falls approached significance with a rate reduction from 1.77 pre-implementation to 0.23 at 6 months and no toileting-related falls at 12 months. Despite no significant findings, there is evidence that clinical changes occurred with nurses assessing and promoting mobility, while implementing strategies to reduce toileting-related falls. [Research in Gerontological Nursing, 17(1), 19-29.].

Measurement of Physical Activity Among Hospitalized Older Adults Living With Dementia.

ABSTRACT: The purpose of this secondary data analysis was to describe physical activity and the factors associated with physical activity among older adults living with dementia on medical units in acute care settings. Measures included accelerometry data from the MotionWatch 8, behavioral and psychological symptoms associated with dementia, use of psychotropic medications, subjective reports of activities of daily living and other types of physical activity (e.g., walking to the bathroom, participating in therapy), delirium severity, and medications. The majority of the 204 participants were White (70%) and female (62%), with a mean age of 83 years. Over 24 hours of assessment, participants engaged in 15 ( SD = 46) minutes of vigorous activity, 43 ( SD = 54) minutes of moderate activity, 2 hours 50 ( SD = 2) minutes of low-level activity, and 20 ( SD = 3) hours of sedentary activity. Subjective walking activities, toileting, evidence of disinhibition, delirium severity, agitation, and use of psychotropic medications were associated with increased physical activity based on the MotionWatch 8. The findings provide information for rehabilitation nurses regarding factors associated with physical activity among patients with dementia admitted to acute care settings as well as some of the challenges associated with measurement of physical activity. Future research needs to continue to explore the impact of behavioral symptoms associated with dementia on physical activity and increase participation in activities that are functionally relevant.

Behavioral Assessment With the Coma Recovery Scale-Revised Is Safe and Feasible in Critically Ill Patients With Disorders of Consciousness.

OBJECTIVES: Accurate classification of disorders of consciousness (DoC) is key in developing rehabilitation plans after brain injury. The Coma Recovery Scale-Revised (CRS-R) is a sensitive measure of consciousness validated in the rehabilitation phase of care. We tested the feasibility, safety, and impact of CRS-R-guided rehabilitation in the ICU for patients with DoC after acute hemorrhagic stroke. DESIGN: Retrospective cohort study. SETTING: This single-center study was conducted in the neurocritical care unit at the University of Maryland Medical Center. PATIENTS: We analyzed records from consecutive patients with subarachnoid hemorrhage (SAH) or intracerebral hemorrhage (ICH), who underwent serial CRS-R assessments during ICU admission from April 1, 2018, to December 31, 2021, where CRS-R less than 8 is vegetative state/unresponsive wakefulness syndrome (VS/UWS); CRS-R greater than or equal to 8 is a minimally conscious state (MCS). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Outcomes included adverse events during CRS-R evaluations and associations between CRS-R and discharge disposition, therapy-based function, and mobility. We examined the utility of CRS-R compared with other therapist clinical assessment tools in predicting discharge disposition. Seventy-six patients (22 SAH, 54 ICH, median age = 59, 50% female) underwent 276 CRS-R sessions without adverse events. Discharge to acute rehabilitation occurred in 4.4% versus 41.9% of patients with a final CRS-R less than 8 and CRS-R greater than or equal to 8, respectively (odds ratio [OR] 13.4; 95% CI, 2.7-66.1; p < 0.001). Patients with MCS on final CRS-R completed more therapy sessions during hospitalization and had improved mobility and functional performance. Compared with other therapy assessment tools, the CRS-R had the best performance in predicting discharge disposition (area under the curve: 0.83; 95% CI, 0.72-0.94; p < 0.0001). CONCLUSIONS: Early neurorehabilitation guided by CRS-R appears to be feasible and safe in the ICU following hemorrhagic stroke complicated by DoC and may enhance access to inpatient rehabilitation, with the potential for lasting benefit on recovery. Further research is needed to assess generalizability and understand the impact on long-term outcomes.

Psychometrics of the Physical Resilience Scale in Older Adults Living with Dementia: Proxy Responses.

Objectives: The purpose of this study was to determine if proxies can complete the Physical Resilience Scale for older adults living with dementia. Methods: This was a descriptive study using Rasch analysis and baseline data from the Function Focused Care for Acute Care Using the Evidence Integration Triangle trial. The first 240 patients living with dementia were included in this analysis. Results: There was evidence of reliability based on person and item separation index. There was no evidence of Differential Item Functioning (DIF) between genders and a DIF by race on Item 7. Validity was supported based on items fitting the model with the exception of one item, and a significant relationship between physical resilience and pain and function. Discussion: There is some evidence that the Physical Resilience Scale is reliable and valid when completed by proxy reports. Future use should remove one of the items due to redundancy.

Factors Associated With Function-Focused Care Among Hospitalized Older Adults With Dementia.

BACKGROUND: Function-focused care is an approach used to increase physical activity in hospitalized older adults with dementia. OBJECTIVE: To explore factors associated with participation in function-focused care in this patient population. METHODS: This was a cross-sectional descriptive study using baseline data from the first 294 participants in an ongoing study on testing function-focused care for acute care using the evidence integration triangle. Structural equation modeling was used for model testing. RESULTS: The mean (SD) age of the study participants was 83.2 (8.0) years, and the majority were women (64%) and White (69%). Sixteen of the 29 hypothesized paths were significant and explained 25% of the variance in participation in function-focused care. Cognition, quality of care interactions, behavioral and psychological symptoms associated with dementia, physical resilience, comorbidities, tethers, and pain were all indirectly associated with function-focused care through function and/or pain. Tethers, function, and quality of care interactions were all directly associated with function-focused care. The χ2/df was 47.7/7, the normed fit index was 0.88, and the root mean square error of approximation was 0.14. CONCLUSION: For hospitalized patients with dementia, the focus of care should be on treating pain and behavioral symptoms, reducing the use of tethers, and improving the quality of care interactions in order to optimize physical resilience, function, and participation in function-focused care.

Differences in Medication Use by Gender and Race in Hospitalized Persons Living with Dementia.

The purpose of this study was to describe differences in treatment of White versus Black older adults, males versus females, and those living at home, assisted living, or nursing home communities with regard to the use of psychotropic, pain, and cardiovascular medications. Baseline data from the first 352 participants in the study, implementation of Function-Focused Care for Acute Care Using the Evidence Integration Triangle, were used. Data included age, gender, race, comorbidities, admission diagnosis, and living location prior to hospitalization, the Saint Louis University Mental Status exam, the modified Charlson Comorbidity Index, the Pain Assessment in Advanced Dementia scale, the Confusion Assessment Method, and medications prescribed. Generalized linear mixed model analyses were done, controlling for race or gender (depending on which comparison analysis was being done), age, cognitive status, hospital, delirium, and comorbidities. Medication use was significantly higher for White older adults, compared to Black older adults, for antidepressants, anxiolytics, non-opioid pain medications, and opioids and lower for antihypertensives. Females received more anxiolytics than their male counterparts. There were differences in medication use by living location with regard to non-opioid pain medication, antipsychotics, statins, and anticoagulants. The findings provide some current information about differences in medication use across groups of individuals and can help guide future research and hypothesis testing for approaches to minimizing these differences in treatment.

Combining exercise, protein supplementation and electric stimulation to mitigate muscle wasting and improve outcomes for survivors of critical illness-The ExPrES study.

BACKGROUND: Neuromuscular electrical stimulation (NMES) with high protein supplementation (HPRO) to preserve muscle mass and function has not been assessed in ICU patients. We compared the effects of combining NMES and HPRO with mobility and strength rehabilitation (NMES+HPRO+PT) to standardized ICU care. OBJECTIVES: To assess the effectiveness of combined NMES+HPRO+PT in mitigating sarcopenia as evidenced by CT volume and cross-sectional area when compared to usual ICU care. Additionally, we assessed the effects of the combined therapy on select clinical outcomes, including nutritional status, nitrogen balance, delirium and days on mechanical ventilation. METHODS: Participants were randomized by computer generated assignments to receive either NMES+HPRO+PT or standard care. Over 14 days the standardized ICU care group (N = 23) received usual critical care and rehabilitation while the NMES+HPRO+PT group (N = 16) received 30 min neuromuscular electrical stimulation of quadriceps and dorsiflexors twice-daily for 10 days and mean 1.3 ± 0.4 g/kg body weight of high protein supplementation in addition to standard care. Nonresponsive participants received passive exercises and, once responsive, were encouraged to exercise actively. Primary outcome measures were muscle volume and cross-sectional area measured using CT-imaging. Secondary outcomes included nutritional status, nitrogen balance, delirium and days on mechanical ventilation. RESULTS: The NMES+HPRO+PT group (N = 16) lost less lower extremity muscle volume compared to the standard care group (N = 23) and had larger mean combined thigh cross-sectional area. The nitrogen balance remained negative in the standard care group, while positive on days 5, 9, and 14 in the NMES+HPRO+PT group. Standard care group participants experienced more delirium than the NMES+HPRO+PT group. No differences between groups when comparing length of stay or mechanical ventilation days. CONCLUSIONS: The combination of neuromuscular electrical stimulation, high protein supplementation and mobility and strength rehabilitation resulted in mitigation of lower extremity muscle loss and less delirium in mechanically ventilated ICU patients. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02509520. Registered July 28, 2015.

Psychotropic Medication Use and Changes During Hospitalization for Older Adults Living With Dementia.

To describe the use of psychotropic medications among older hospitalized patients. This was a descriptive study using baseline data from the first 308 older patients in a function focused care intervention study. Age, gender, race, comorbidities, admitting diagnosis, and medications (antidepressants, antianxiety medications, anticonvulsants, dementia drugs, antipsychotics, sedative-hypnotics, and opioids) were obtained at baseline and discharge. To compare change over time, generalized estimating equations were used. Participants were mostly female (63%) and White (69%) and were 83.1 years old on average. Antidepressant, antianxiety, anticonvulsant, dementia medication, sedative-hypnotic, and opioid use remained essentially unchanged between admission and discharge. Antipsychotic medication use increased significantly from 16% to 21% at discharge. There was persistent use of psychotropic medication among hospitalized older adults living with dementia and little evidence of deprescribing. There was some indication of changes made during hospitalization that may be appropriate, even without a focused deprescribing initiative.

Reliability and Validity of the UMove Mobility Screen.

Background: The UMove Mobility Screen (UMove) was developed to help bedside nurses accurately assess patient's mobility. Objectives: The purpose of this study was to assess reliability and validity of the UMove. Methods: Interclass correlation coefficient (ICC) and alpha coefficient was completed to assess was based on internal consistency and inter-rater reliability. Construct validity was determined by ICC using two-way random model. Results: Among the 176 participants the mean age was 57 years (SD = 15), and 60% were men (N = 105). Internal consistency and inter-rater reliability were acceptable (alpha coefficient of .94 and an intraclass correlation of .98). There was evidence of construct validity with an intraclass correlation of .95 between the UMove and the standard therapists' evaluation of patient functional mobility. Conclusion: There was evidence for reliability and validity of UMove. Future work should focus on the effectiveness of UMove on clinical outcomes.

APTA Cross Sections and Academies Recommendations for COVID-19 Core Outcome Measures.

The novel coronavirus (COVID-19) emerged as a major health concern within the United States in early 2020. Because this is a novel virus, little guidance exists for best practice to evaluate this population within the field of physical therapy. Methods: An expert task force appointed by the leadership of 9 different academies or sections of the American Physical Therapy Association was formed to develop recommendations for a set of core outcome measures for individuals with or recovering from COVID-19. Results: This perspective provides guidance on a best practice recommendation to physical therapists and researchers regarding the use of core outcome measures for individuals with or recovering from COVID-19. The process for the selection of core measures for this population is presented and discussed. Conclusions: Core outcome measures improve the ability to track progress and change across the continuum of care at both the patient and population levels.

The Effect of High Protein and Mobility-Based Rehabilitation on Clinical Outcomes in Survivors of Critical Illness.

BACKGROUND: Protein supplementation and mobility-based rehabilitation programs (MRP) individually improve functional outcomes in survivors of critical illness. We hypothesized that combining MRP therapy with high protein supplementation is associated with greater weaning success from prolonged mechanical ventilation (PMV) and increased discharge home in this population. METHODS: We conducted a retrospective analysis assessing the effects of an MRP on a cohort of survivors of critical illness. All received usual care (UC) rehabilitation. The MRP group received 3 additional MRP sessions each week for a maximum of 8 weeks. Subjects were prescribed nutrition and classified as receiving high protein (HPRO) or low protein (LPRO), based on a recommended 1.0 g/kg/d, and then the subjects were categorized into 4 groups: MRP+HPRO, MRP+LPRO, UC+HPRO, and UC+LPRO. RESULTS: A total of 32 subjects were enrolled. The MRP+HPRO group had greater weaning success (90% vs 38%, P = .045) and a higher rate of discharge home (70% vs 13%, P = .037) compared to UC+LPRO group. The MRP+HPRO group had a higher, nonsignificant rate of discharge home compared to the MRP+LPRO (70% vs 20%, P = .10). CONCLUSIONS: Combining high protein with mobility-based rehabilitation was associated with increased rates of discharge home and ventilator weaning success in survivors of critical illness. Further studies are needed to evaluate the role of combined exercise and nutrition interventions in this population.

Efficacy and Safety of Tocilizumab for Polyarticular-Course Juvenile Idiopathic Arthritis in the Open-Label Two-Year Extension of a Phase III Trial.

OBJECTIVE: To report the 2-year efficacy and safety of tocilizumab (TCZ) in patients with polyarticular-course juvenile idiopathic arthritis (JIA). METHODS: Patients ages 2-17 years with active polyarticular-course JIA, in whom treatment with methotrexate was unsuccessful, received 16 weeks of open-label intravenous TCZ in part 1 (once every 4 weeks: 8 mg/kg or 10 mg/kg for body weight [BW] <30 kg; 8 mg/kg for BW ≥30 kg). Assessments were based on the JIA-American College of Rheumatology (ACR) response (defined as percentage of improvement in ≥3 of the 6 JIA core response variables [CRVs]). Patients with at least a JIA-ACR30 response (defined as ≥30% improvement in ≥3 of the 6 JIA CRVs without worsening in >1 of the remaining JIA CRVs by >30%) at week 16 were randomly assigned (1:1) to receive TCZ or placebo in part 2. Patients remained in part 2 until either week 40 or the occurrence of JIA flare. Upon starting part 3, all patients received open-label TCZ. At week 104 of the study, efficacy was assessed using JIA-ACR50/70/90 response rates (defined as 50%, 70%, or 90% improvement, respectively), achievement of inactive disease, and the Juvenile Arthritis Disease Activity Score in 71 joints (JADAS-71). Safety was assessed in the all-exposure population per 100 patient-years of exposure. RESULTS: Overall, 188 patients entered part 1, 166 patients entered part 2, and 160 patients entered part 3. By week 104, among the 188 patients in the modified intent-to-treat group who received TCZ, JIA-ACR50/70/90 response rates were 80.3%/77.1%/59.6%, respectively, the median JADAS-71 score decreased from 3.6 at week 40 to 0.7 at week 104, 51.1% of patients had achieved inactive disease, and 31 of 66 patients who had been receiving glucocorticoids discontinued them. Adverse event (AE) and serious AE rates were 406.5 per 100 patient-years and 11.1 per 100 patient-years, respectively. The infection rate was 151.4 per 100 patient-years, and the serious infection rate was 5.2 per 100 patient-years. CONCLUSION: Patients treated with TCZ for polyarticular-course JIA showed high-level disease control for up to 2 years. The TCZ safety profile was consistent with that previously reported.