RESUMEN
Bronchiolitis obliterans syndrome (BOS) occurring after allogeneic hematopoietic cell transplantation (HCT) is a high-risk manifestation of chronic graft-versus-host disease. In this prospective, multicenter phase 2 trial (ClinicalTrials.gov, NCT03674047), adult participants with BOS were treated with ruxolitinib 10mg twice daily, continuously in 28-day cycles for up to 12 cycles. Participants enrolled into newly diagnosed (<6 months since BOS diagnosis, cohort A) or established (≥6 months since BOS diagnosis, cohort B) disease cohorts, respectively. The primary objective was to evaluate the early treatment effect of ruxolitinib, assessed by the change in forced expiratory volume in 1 second (FEV1) at 3 months compared to enrollment. The primary endpoint differed according to cohort (Cohort A: improvement, defined as ³10% increase in FEV1; Cohort B: stabilization, defined as absence of ³10% decrease in FEV1). Between 2019 and 2022, 49 participants meeting criteria for BOS were enrolled and treated (cohort A, n=36; cohort B, n=13). The primary endpoint was achieved by 27.8% of participants with new BOS and 92.3% of participants with established BOS. According to the 2014 NIH Consensus Criteria, the best lung-specific overall response rate on ruxoltinib for the 49 participants was 34.7% (16.3% complete response, 18.4% partial response), with most responses occurring in mild or moderate disease. Non-infectious severe (grade ≥3) treatment-emergent adverse events were infrequent. Nine severe infectious events occurred and were largely respiratory in nature. These results support the use of ruxolitinib in the management of BOS after allogeneic HCT.
RESUMEN
STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To examine how community-level economic disadvantage impacts short-term outcomes following posterior cervical decompression and fusion (PCDF) for cervical spondylotic myelopathy. SUMMARY OF BACKGROUND DATA: The effects of socioeconomic factors, measured by the Distress Community Index (DCI), on postoperative outcomes after PCDF are underexplored. By understanding the impact of socioeconomic status (SES) on PCDF outcomes, disparities in care can be addressed. MATERIALS AND METHODS: Retrospective review of 554 patients who underwent PCDF for cervical spondylotic myelopathy between 2017 and 2022. SES was assessed using DCI obtained from patient zip codes. Patients were stratified into quintiles from Prosperous to Distressed based on DCI. Bivariate analyses and multivariate regressions were performed to evaluate the associations between social determinants of health and surgical outcomes including length of stay, home discharge, complications, and readmissions. RESULTS: Patients living in At-Risk/Distressed communities were more likely to be Black (53.3%). Patients living in At-Risk/Distressed communities had the longest hospitalization (6.24 d vs. Prosperous: 3.92, P=0.006). Significantly less At-Risk/Distressed patients were discharged home without additional services (37.3% vs. Mid-Tier: 52.5% vs. Comfortable: 53.4% vs. Prosperous: 56.4%, P<0.001). On multivariate analysis, residing in an At-Risk/Distressed community was independently associated with non-home discharge (odds ratio (OR): 2.28, P=0.007) and longer length of stay (E:1.54, P=0.017). CONCLUSION: Patients from socioeconomically disadvantaged communities experience longer hospitalizations and are more likely to be discharged to a rehabilitation or skilled nursing facility following PCDF. Social and economic barriers should be addressed as part of presurgical counseling and planning in elective spine surgery to mitigate these disparities and improve the quality and value of health care delivery, regardless of socioeconomic status.