Dataset Information

Comparison of Adverse Events Among Home- vs Facility-Administered Biologic Infusions, 2007-2017.

ABSTRACT:

Importance

Infusion reactions occur in 7% to 20% of patients receiving biologics. Home infusions are convenient and incur lower costs but may be associated with more adverse events; the safety of receiving biologic infusions for immune-mediated diseases at home remains unclear.

Objective

To assess whether patients receiving home biologic infusions have increased adverse events requiring emergency department (ED) or hospital admission compared with patients receiving facility infusions.

Design, setting, and participants

This retrospective cohort study used administrative claims data from a large national insurer for adult patients who received biologic infusions for immune-mediated disease between January 2007 and December 2017. Patients with hematologic malignant neoplasms or bone marrow transplantation were excluded. Data were analyzed from August 2019 to October 2020.

Main outcomes and measures

ED or hospital admission on the same or next day after administration of a biologic infusion at home vs at a facility; secondary outcomes included discontinuation of the biologic after an ED or hospital admission and postinfusion mortality.

Results

Of a total of 57 220 patients (mean [SD] age, 50.1 [14.8] years; 512 314 [68.1%] women) who received 752 150 biologic infusions (34 078 home infusions [4.5%] to 3954 patients and 718 072 facility infusions [95.5%] to 54 770 patients), patients who received home infusions were younger (mean [SD] age, 43.2 [13.2] vs 51.3 [14.8] years), more likely to be men (14 031 [41.2%] vs 225 668 [31.4%]), and had a lower Charlson comorbidity score compared with patients who received facility infusions (mean [SD] score, 0.5 [1.0] vs 1.1 [1.3]). Home infusions were associated with 25% increased odds of ED or hospital admission on the same or next day after the infusion (odds ratio [OR], 1.25; 95% CI, 1.09-1.44; P = .002) and 28% increased odds of discontinuation of the biologic after the ED or hospital admission (OR, 1.28; 95% CI, 1.08-1.51; P = .005). There was no difference in postinfusion mortality between home or facility infusions. The rates of adverse events were highest with home infusions of tocilizumab (48 of 481 infusions [10.0%]), vedolizumab (150 of 2681 infusions [5.6%]), and infliximab (1085 of 20 653 infusions [5.3%]), although the number of tocilizumab and vedolizumab infusions was low.

Conclusions and relevance

In this study, biologic infusions administered at home, compared with those administered at a facility, were associated with increased adverse events requiring escalation of care. Because the number of home infusions has increased and is expected to continue to rise, the safety implications of administering biologic infusions at home needs to be further assessed.

SUBMITTER: Baker MC

PROVIDER: S-EPMC8176330 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ImportanceUse of postacute care is common and costly in the United States, but there is significant uncertainty about whether the choice of postacute care setting matters. Understanding these tradeoffs is particularly important as new alternative payment models push patients toward lower-cost settings for care.ObjectiveTo investigate the association of patient outcomes and Medicare costs of discharge to home with home health care vs discharge to a skilled nursing facility.Design, setting, and participantsA retrospective cohort study used Medicare claims data from short-term acute-care hospitals in the United States and skilled nursing facility and home health assessment data from January 1, 2010, to December 31, 2016, on Medicare beneficiaries who were discharged from the hospital to home with home health care or to a skilled nursing facility. To address the endogeneity of treatment choice, an instrumental variables approach used the differential distance between the beneficiary's home zip code and the closest home health agency and the closest skilled nursing facility as an instrument.ExposuresReceipt of postacute care at home vs in a skilled nursing facility.Main outcomes and measuresReadmission within 30 days of hospital discharge, death within 30 days of hospital discharge, improvement in functional status during the postacute care episode, and Medicare payment for postacute care and total payment for the 60-day episode.ResultsA total of 17 235 854 hospitalizations (62.2% women and 37.8% men; mean [SD] age, 80.5 [7.9] years) were discharged either to home with home health care (38.8%) or to a skilled nursing facility (61.2%) during the study period. Discharge to home was associated with a 5.6-percentage point higher rate of readmission at 30 days compared with discharge to a skilled nursing facility (95% CI, 0.8-10.3; P = .02). There were no significant differences in 30-day mortality rates (-2.0 percentage points; 95% CI, 0.8-10.3; P = .12) or improved functional status (-1.9 percentage points; 95% CI, -12.0 to 8.2; P = .71). Medicare payment for postacute care was significantly lower for those discharged to home compared with those discharged to a skilled nursing facility (-$5384; 95% CI, -$6932 to -$3837; P < .001), as was total Medicare payment within the first 60 days after admission (-$4514; 95% CI, -$6932 to -$3837; P < .001).Conclusions and relevanceAmong Medicare beneficiaries eligible for postacute care at home or in a skilled nursing facility, discharge to home with home health care was associated with higher rates of readmission, no detectable differences in mortality or functional outcomes, and lower Medicare payments.

Project description:Data regarding the safety of anti-vascular endothelial growth factor (anti-VEGF) treatment is limited.To compare the adverse events (AEs) induced by aflibercept and ranibizumab using a spontaneous reporting system and determine the signals.We used data from the Korea Institute of Drug Safety & Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD), collected between 2007 and 2016. Differences in patient demographics, report type, reporter, causality, and serious-AEs between aflibercept and ranibizumab were compared. Metrics including proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC), were used to compare signals with the AEs on the drug labels in the United States of America and Korea. Logistic regression analysis was performed to identify AEs that are more likely to occur with drug use.A total of 32 aflibercept and 103 ranibizumab cases of AEs were identified. The proportion of AEs that were reported voluntarily was higher with aflibercept (50.5%) use than ranibizumab (4.9%), whereas the AEs reported by post-marketing surveillance were higher with ranibizumab (46.6%) use than aflibercept (31.3%). The percentage of AEs in patients >60 years old, reports by consumers, and the ratio of SAEs to AEs associated with aflibercept (84. %, 9.4%, and 75.0%, respectively) were higher than those of ranibizumab (77.7%, 1.9%, and 19.4%, respectively). The number of newly detected AEs after aflibercept and ranibizumab treatment was 3 and 8, respectively. Among these, conjunctivitis and medicine ineffective were not included on the aflibercept and ranibizumab labels, respectively. Endophthalmitis (OR 6.96, 95% CI 2.74-17.73) was more likely to be reported in patients with aflibercept than in patients without aflibercept, whereas medicine ineffective (OR 18.49, 95% CI 2.39-143.29) and retinal disorder (OR 7.03, 95% CI 1.60-30.96) were more likely to be reported in patients with ranibizumab than in patients without ranibizumab.New signals have been identified for aflibercept and ranibizumab. Further research is necessary to evaluate the causality of AEs that were detected as signals in this study.

Project description:Background:Poor oral hygiene is strongly associated with oral and systemic diseases. Alongside mechanical tooth cleaning, the adjunctive use of mouthrinses has been widely advocated. Although research on the efficacy of various mouthrinse formulations is very active, there are a lack of conclusive data regarding their adverse effects. Methods:We undertook a systematic review in accordance wih PRISMA guidelines of electronic databases of clinical trials of any duration with daily home use of mouthwashes, presenting clinical and subjective side effects (PROSPERO registration: CRD42016054037). Results:After evaluating 614 titles and abstracts, 154 studies were selected for full-text analysis; 85 final papers were included. Based on the active ingredient in the test product, nine categories were created: cetyl pyridinium chloride, essential oils, chlorhexidine, triclosan, natural products, diclofenac, fluorides, delmopinol, and miscellaneous active substances. Most of the studies were of short duration (less than 6 months) with a defective 'methods' description; the reporting of adverse events often being overlooked. Both local morphological (oral mucosa and dental-crown staining, mucosal lesions) and functional (taste modifications, abnormal oral sensation) alterations were reported. Tooth staining was the most commonly listed adverse event, but it was quantitatively assessed only in a very small number of papers; most studies relied on patient reports. Staining was time associated; the longer the study, the higher its reported incidence and severity. Conclusions:The reduced report of side effects may partly be due to a lack of an objective measure and lack of general guidelines that demand studies report their adverse events. The most frequently reported adverse effect was teeth staining. As in most studies, the effect was associated with trial duration; clinical trials should be of sufficient duration. New investigations meeting the suggested criteria of a minimal duration of 6 months should be planned.

Project description:ImportanceMultiple states have laws requiring abortion facilities to meet ambulatory surgery center (ASC) standards. There is limited evidence regarding abortion-related morbidities and adverse events following abortions performed at ASCs vs office-based settings.ObjectiveTo compare abortion-related morbidities and adverse events at ASCs vs office-based settings.Design, setting, and participantsRetrospective cohort study of women with US private health insurance who underwent induced abortions in an ASC or office-based setting (January 1, 2011-December 31, 2014). Outcomes were abstracted from a large national private insurance claims database during the 6 weeks following the abortion (date of final follow-up, February 11, 2015).ExposuresFacility type for abortion (ASCs vs office-based settings, including facilities such as abortion clinics, nonspecialized clinics, and physician offices).Main outcomes and measuresThe primary outcome was any abortion-related morbidity or adverse event (such as retained products of conception, abortion-related infection, hemorrhage, and uterine perforation) within 6 weeks after an abortion. Two secondary outcomes, both subsets of the primary outcome, were major abortion-related morbidities and adverse events (such as hemorrhages treated with a transfusion, missed ectopic pregnancies treated with surgery, and abortion-related infections that resulted in an overnight hospital admission) and abortion-related infections.ResultsAmong 49 287 women (mean age, 28 years [SD, 7.3]) who had 50 311 induced abortions, (23 891 [47%] first-trimester aspiration, 13 480 [27%] first-trimester medication, and 12 940 [26%] second trimester or later), 5660 abortions (11%) were performed in ASCs and 44 651 (89%) in office-based settings. Overall, 3.33% had an abortion-related morbidity or adverse event; 0.32% had a major abortion-related morbidity or adverse event; and 0.74% had an abortion-related infection. In adjusted analyses, there was no statistically significant difference between ASCs vs office-based settings, respectively, in the rates of abortion-related morbidities or adverse events (3.25% vs 3.33%, difference, -0.08%; [corrected] 95% CI, -0.58% to 0.43%; adjusted OR, 0.97; 95% CI, 0.81-1.17), major morbidities or adverse events (0.26% vs 0.33%; difference, -0.06%; 95% CI, -0.18% to 0.06%; adjusted OR, 0.78; 95% CI, 0.45-1.37), or infections (0.58% vs 0.77%; difference, -0.16%; 95% CI, -0.35% to 0.03%; adjusted OR, 0.75; 95% CI, 0.52-1.09).Conclusions and relevanceAmong women with private health insurance who had an induced abortion, performance of the abortion in an ambulatory surgical center compared with an office-based setting was not associated with a significant difference in abortion-related morbidities and adverse events. These findings, in addition to individual patient and individual facility factors, may inform decisions about the type of facility in which induced abortions are performed.