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Study Objective Immediately prior to the COVID-19 pandemic, in early 2020, our public hospital implemented an enhanced recovery after surgery (ERAS) protocol. The purpose of this study was to evaluate ERAS outcomes for hysterectomy patients at our public hospital given concerns about barriers to care in our underserved population. Design A retrospective analysis was performed comparing outcomes (% outpatient cases, length of stay, peri-operative opioids, % ED return) for hysterectomy patients for pre- and post- intervention periods (2019 and 2021). Outcomes were compared using Fisher's exact or t-test. Setting A tertiary care public hospital. Patients or Participants All patients who underwent hysterectomy in the years 2019 and 2021 at our medical center. Interventions ERAS protocol was implemented in early 2020. Measurements and Main Results 356 pre-intervention and 285 post-intervention hysterectomy cases were analyzed. The majority of patients were Hispanic/Latinx in both groups (80% vs. 78%;p=0.43). There was no significant change in the percentage of minimally invasive procedures (71% vs 68%;p=0.49). The percentage of outpatient hysterectomies increased from 0% to 49% (p<0.0001), and the mean length of stay (LOS) decreased from 1.7 days to 1.1 days (p<0.0001). Peri-operative mean morphine milligram equivalents (MME) decreased from 77 to 60 (p<0.0001). Mean post anesthesia care unit stay increased from 178 to 261 minutes (p<0.0001). There was no increase in returns to the emergency department <30 days (12% vs 9%;p=0.31) or mean number of opioid pills prescribed (12 vs 13;p=0.14). Conclusion ERAS implementation for hysterectomy patients at our public hospital decreased LOS and peri-operative opioids without increasing ED returns. Although there was initial hesitation in adopting the ERAS protocol, these changes proved to be feasible and safe in our underserved patient population. The COVID-19 pandemic likely helped to expedite the integration of outpatient management, which resulted in a decrease utilization of our limited inpatient resources, at a crucial time for our health system.
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Background: We recently reported an attenuate immunogenicity in patients with autoimmune rheumatic diseases. However, the effect of spondyloarthritis (SpA) and its treatment on COVID-19 vaccine immunogenicity remains to be determined for this group of patients. We therefore aimed to evaluate humoral immune responses to inactivated SARS-CoV-2 vaccine (CoronaVac) in patients with SpA (axial spondyloarthritis and psoriatic arthritis) taking DMARDs and commonly used targeted biological therapies, compared with a control group(CG). Objectives: Evaluate immunogenicity and safety of CORONAVAC (Sninovac, Beijing) in Spondyloarthritis (SpA) patients. Methods: Prospective observational cohort patients diagnosed with 194 SpA and 183 CG were vaccinated with CoronaVac in two doses with a 28-days interval. 194 patients completed the study and could be paired with CG for immunogenicity analysis. Blood samples were collected in the days 0, 28 and 69 (D69) to evaluate anti-SARS-CoV-2 IgG seroconversion(SC) and presence of neutralizing antibodies (NAb) in participants with negative IgG and NAb at baseline. Results: Patients and GC were comparable regarding age (p=0.93) and sex (p=1.00). Immunogenicity at D69 showed a moderate/high SC (80.2% vs. 95.7%, p<0.0001) and Nab positivity (61.6% vs. 82.7%, p<0.0001) in SpA but lower than CG. Factors associated with lower immunogenicity were older age (56.8 vs. 51.4;p=0.03318) and higher frequencies of prednisone (25.7% vs 4.2%;p=0.0004), methotrexate (51.4% vs 40.1%, p=0.0016) and TNF inhibitor (TNFi) (62.9% vs 34.5%, p=0.0035). Likewise, prednisone (17.6% vs. 2.8%, p=0.0013) and TNFi (50% vs 33.9%;p=0.0408) were associated with diminished NAb positivity. Sulfasalazine was associated with higher SC rates (8.6% vs. 26.8%, p=0.0246) and NAb positivity (13.2% vs. 29.4%, p=0.0168). The multivariate analysis revealed that older age (p=0.037), prednisone (p=0.001), TNFi (p=0.016), and methotrex-ate(p=0.017) were independently associated with lower SC while prednisone (p=0.006) and TNFi (p=0.027) were also associated with reduced NAb response. Conclusion: Our fnding of an excellent safety and moderate/high SC rate in SpA supports the recommendation of CoronaVac vaccination. The impaired immune response in the minority of patients under immunosuppressive and biological therapy requires novel strategies to enhance antibody response in this subgroup of patients.
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Background: Patients with rheumatoid arthritis (RA) on methotrexate have reduced vaccine responses. Temporary discontinuation has improved immuno-genicity of anti-infuenza vaccine, but this strategy has not been evaluated in anti-SARS-CoV-2 vaccines. Objectives: To evaluate the effect on immunogenicity and safety of 2-week methotrexate (MTX) discontinuation after each dose of the Sinovac-CoronaVac vaccine versus MTX maintenance in rheumatoid arthritis (RA) patients. Methods: This was a single-center, prospective, randomized, investigator-blinded, intervention study (#NCT04754698, CoronavRheum), including adult RA patients (stable CDAI≤10, prednisone ≤7.5mg/day), randomized (1:1) to withdraw MTX (MTX-hold) for 2 weeks after each vaccine dose or maintain MTX (MTX-maintain), evaluated at D0, D28 and D69. Co-primary outcomes were anti-SARS-CoV-2 S1/S2 IgG seroconversion(SC) and neutralizing antibody (NAb) positivity at D69. Secondary outcomes were geometric mean titers (GMT) and fare rates. For immunogenicity analyses, we excluded patients with baseline positive IgG/NAb, and, for safety reasons, those who fared at D28 (CDAI>10) and did not withdraw MTX twice. Results: Randomization included 138 patients with 9 exclusions (5 COVID-19, 4 protocol violations). Safety evaluation included 60 (MTX-hold) and 69 (MTX-maintain) patients. Further exclusions: 27 patients [13 (21.7%) vs. 14 (20.3%), p=0.848] with positive baseline IgG/NAb and 10 patients (21.3%) in MTX-hold with CDAI>10 at D28. At D69, MTX-hold (n=37) had a higher rate of seroconversion than MTX-maintain (n=55) group [29 (78.4%) vs 30 (54.5%), p=0.019], with parallel augmentation in GMT [34.2 (25.2-46.4) vs 16.8 (11.9-23.6), p=0.006]. No differences were observed for NAb positivity [23 (62.2%) vs 27 (49.1%), p=0.217]. At D28 fare, rates were comparable in both groups (CDAI, p=0.122;DAS28-CRP, p=0.576), whereas CDAI>10 was more frequent in MTX-hold at D69 (p=0.024). Conclusion: We provide novel data that 2-week MTX withdrawal after each Sinovac-CoronaVac vaccine dose improves anti-SARS-CoV-2 IgG response. The increased fare rates after second MTX withdrawal may be attributed to the short-term interval between vaccine doses. This strategy requires close surveillance and shared decision making due to the possibility of fares.
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Background: Some factors associated with severe COVID-19 outcomes have been identifed in patients with psoriasis (PsO) and infammatory/autoimmune rheumatic diseases, namely older age, male sex, comorbidity burden, higher disease activity, and certain medications such as rituximab. However, information about specifcities of patients with PsO, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), including disease modifying anti-rheumatic drugs (DMARDs) specifcally licensed for these conditions, such as IL-17 inhibitors (IL-17i), IL-23/IL-12 + 23 inhibitors (IL-23/IL-12 + 23i), and apremilast, is lacking. Objectives: To determine characteristics associated with severe COVID-19 outcomes in people with PsO, PsA and axSpA. Methods: This study was a pooled analysis of data from two physician-reported registries: the Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of COVID-19 Infection (PsoProtect), comprising patients with PsO/PsA, and the COVID-19 Global Rheumatology Alliance (GRA) registry, comprising patients with PsA/axSpA. Data from the beginning of the pandemic up to 25 October, 2021 were included. An ordinal severity outcome was defned as: 1) not hospitalised, 2) hospitalised without death, and 3) death. A multivariable ordinal logistic regression model was constructed to assess the relationship between COVID-19 severity and demographic characteristics (age, sex, time period of infection), comorbidities (hypertension, other cardiovascular disease [CVD], chronic obstructive lung disease [COPD], asthma, other chronic lung disease, chronic kidney disease, cancer, smoking, obesity, diabetes mellitus [DM]), rheumatic/skin disease (PsO, PsA, axSpA), physician-reported disease activity, and medication exposure (methotrexate, lefunomide, sulfasalazine, TNFi, IL17i, IL-23/IL-12 + 23i, Janus kinase inhibitors (JAKi), apremilast, glucocorticoids [GC] and NSAIDs). Age-adjustment was performed employing four-knot restricted cubic splines. Country-adjustment was performed using random effects. Results: A total of 5008 individuals with PsO (n=921), PsA (n=2263) and axSpA (n=1824) were included. Mean age was 50 years (SD 13.5) and 51.8% were male. Hospitalisation (without death) was observed in 14.6% of cases and 1.8% died. In the multivariable model, the following variables were associated with severe COVID-19 outcomes: older age (Figure 1), male sex (OR 1.53, 95%CI 1.29-1.82), CVD (hypertension alone: 1.26, 1.02-1.56;other CVD alone: 1.89, 1.22-2.94;vs no hypertension and no other CVD), COPD or asthma (1.75, 1.32-2.32), other lung disease (2.56, 1.66-3.97), chronic kidney disease (2.32, 1.50-3.59), obesity and DM (obesity alone: 1.36, 1.07-1.71;DM alone: 1.85, 1.39-2.47;obesity and DM: 1.89, 1.34-2.67;vs no obesity and no DM), higher disease activity and GC intake (remission/low disease activity and GC intake: 1.96, 1.36-2.82;moderate/severe disease activity and no GC intake: 1.35, 1.05-1.72;moderate/severe disease activity and GC intake 2.30, 1.41-3.74;vs remission/low disease activity and no GC intake). Conversely, the following variables were associated with less severe COVID-19 outcomes: time period after 15 June 2020 (16 June 2020-31 December 2020: 0.42, 0.34-0.51;1 January 2021 onwards: 0.52, 0.41-0.67;vs time period until 15 June 2020), a diagnosis of PsO (without arthritis) (0.49, 0.37-0.65;vs PsA), and exposure to TNFi (0.58, 0.45-0.75;vs no DMARDs), IL17i (0.63, 0.45-0.88;vs no DMARDs), IL-23/IL-12 + 23i (0.68, 0.46-0.997;vs no DMARDs) and NSAIDs (0.77, 0.60-0.98;vs no NSAIDs). Conclusion: More severe COVID-19 outcomes in PsO, PsA and axSpA are largely driven by demographic factors (age, sex), comorbidities, and active disease. None of the DMARDs typically used in PsO, PsA and axSpA, were associated with severe COVID-19 outcomes, including IL-17i, IL-23/IL-12 + 23i, JAKi and apremilast.
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INTRODUCTION: Immediately prior to the COVID-19 pandemic, our public hospital implemented an enhanced recovery after surgery (ERAS) protocol. The purpose of this study was to evaluate ERAS outcomes for hysterectomy patients at our public hospital, given concerns about barriers to care in our underserved population. METHODS: A retrospective analysis was performed comparing outcomes (percent of outpatient cases, length of stay, perioperative opioids, percent of emergency department [ED] return) for hysterectomy patients for pre- and post-intervention periods (January to June in 2019 and 2021). Outcomes were compared using the Fisher exact test or t-test. RESULTS: A total of 192 preintervention and 120 post-intervention hysterectomy cases were analyzed. The majority of patients were Hispanic/Latinx in both groups (82% vs. 76%;P=.25). There was no significant change in the percentage of minimally-invasive procedures (71% vs 72%;P=1.0). The percentage of outpatient hysterectomies increased from 0% to 53% (P<.0001), and the mean length of stay (LOS) decreased from 1.6 days to 0.9 days (P<.0001). Peri-operative mean morphine milligram equivalents (MME) decreased from 78 to 54 (P≤.02). Mean post anesthesia care unit stay increased from 186 to 229 minutes (P<.01). There was no significant increase in returns to the ED <30 days (10% vs 13%;P=.36) or mean number of opioid pills prescribed (13 vs 13;P=.21). CONCLUSION: ERAS implementation for hysterectomy patients at a public hospital decreased LOS and peri-operative opioids without significantly increasing ED returns. The COVID-19 pandemic likely helped to expedite the adoption of outpatient management, which was feasible and safe in our underserved patient population.
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Objective: The objective of the study was to describe the demographic and clinical characteristics found in personnel screened during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.Materials and methods: Nasal and oropharyngeal swab samples were collected in the period between May 11 and May 26, 2020, from 496 people. They were followed up by means of a questionnaire at 0, 7, and 14 days. Results: 449 people answered the surveys (73 excluded);age range: 21-63 years, mean of 39.4 years. About 77% had contact with patients with coronavirus infection, (32% had an exposure time of < 8 h a week, 24% 8-16 h a week and 20% more than 16 h a week). The most frequent comorbidity in the population was obesity (13.8%), followed by asthma (8%) and DM2 (1%). The most common symptom was headache (34%), followed by nasal obstruction (25%) and odynophagia in third place (22%);16% presented alterations in the perception of odors. Among the surveyed personnel, 17 (4.5%) tested positive for SARS-COV2 by means of reverse transcription polymerase chain reaction. Conclusions: In line with this pandemic, a screening protocol was started for asymptomatic health-care personnel for the recognition of infections caused by this virus to establish barriers that will prevent the spread and provide the basis for the standardization of this practice and the protection of healthcare personnel.