Patient and clinician perspectives of a remote monitoring program for COVID-19 and lessons for future programs.

COVID Watch is a remote patient monitoring program implemented during the pandemic to support home dwelling patients with COVID-19. The program conferred a large survival advantage. We conducted semi-structured interviews of 85 patients and clinicians using COVID Watch to understand how to design such programs even better. Patients and clinicians found COVID Watch to be comforting and beneficial, but both groups desired more clarity about the purpose and timing of enrollment and alternatives to text-messages to adapt to patients' preferences as these may have limited engagement and enrollment among marginalized patient populations. Because inclusiveness and equity are important elements of programmatic success, future programs will need flexible and multi-channel human-to-human communication pathways for complex clinical interactions or for patients who do not desire tech-first approaches.

Comparative Effectiveness of an Automated Text Messaging Service for Monitoring COVID-19 at Home.

BACKGROUND: Although most patients with SARS-CoV-2 infection can be safely managed at home, the need for hospitalization can arise suddenly. OBJECTIVE: To determine whether enrollment in an automated remote monitoring service for community-dwelling adults with COVID-19 at home ("COVID Watch") was associated with improved mortality. DESIGN: Retrospective cohort analysis. SETTING: Mid-Atlantic academic health system in the United States. PARTICIPANTS: Outpatients who tested positive for SARS-CoV-2 between 23 March and 30 November 2020. INTERVENTION: The COVID Watch service consists of twice-daily, automated text message check-ins with an option to report worsening symptoms at any time. All escalations were managed 24 hours a day, 7 days a week by dedicated telemedicine clinicians. MEASUREMENTS: Thirty- and 60-day outcomes of patients enrolled in COVID Watch were compared with those of patients who were eligible to enroll but received usual care. The primary outcome was death at 30 days. Secondary outcomes included emergency department (ED) visits and hospitalizations. Treatment effects were estimated with propensity score-weighted risk adjustment models. RESULTS: A total of 3488 patients enrolled in COVID Watch and 4377 usual care control participants were compared with propensity score weighted models. At 30 days, COVID Watch patients had an odds ratio for death of 0.32 (95% CI, 0.12 to 0.72), with 1.8 fewer deaths per 1000 patients (CI, 0.5 to 3.1) (P = 0.005); at 60 days, the difference was 2.5 fewer deaths per 1000 patients (CI, 0.9 to 4.0) (P = 0.002). Patients in COVID Watch had more telemedicine encounters, ED visits, and hospitalizations and presented to the ED sooner (mean, 1.9 days sooner [CI, 0.9 to 2.9 days]; all P < 0.001). LIMITATION: Observational study with the potential for unobserved confounding. CONCLUSION: Enrollment of outpatients with COVID-19 in an automated remote monitoring service was associated with reduced mortality, potentially explained by more frequent telemedicine encounters and more frequent and earlier presentation to the ED. PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute.

US local public health department spending between 2008 and 2016 did not increase for communities in need.

BACKGROUND: Greater US local public health department (LPHD) spending has been associated with decreases in population-wide mortality. We examined the association between changes in LPHD spending between 2008 and 2016 and county-level sociodemographic indicators of public health need. METHODS: Multivariable linear regression was used to estimate the association between changes in county-level per-capita LPHD spending and 2008 sociodemographic indicators of interest: percent of population that was over 65 years old, Black, Hispanic, in poverty, unemployed, and uninsured. A second model assessed the relationship between changes in LPHD spending and sociodemographic shifts between 2008 and 2016. RESULTS: LPHD spending increases were associated with higher percentage points of 2008 adults over 65 years of age (+$0.53 per higher percentage point; 95% CI: +$0.01 to +$1.06) and unemployment (-$1.31; 95% CI: -$2.34 to -$0.27). Spending did not increase for communities with a higher proportion of people who identified as Black or Hispanic, or those with a greater proportion of people in poverty or uninsured, using either baseline or sociodemographic shifts between 2008 and 2016. CONCLUSION: Future LPHD funding decisions should consider increasing investments in counties serving disadvantaged communities to counteract the social, political, and structural barriers which have historically prevented these communities from achieving better health.

Stigma, beliefs and perceptions regarding prostate cancer among Black and Latino men and women.

BACKGROUND: Health disparities in prostate cancer (PC) are thought to reflect the complex interplay of socioeconomics, environment and biology. The potential impact of beliefs and perceptions about PC among Black and Latino populations on clinical disparities are not well understood. This qualitative study was conducted to assess current prevalent and pervasive stigma, beliefs and perceptions regarding PC among Blacks and Latinos living in a large metropolitan area, thereby identifying potentially modifiable barriers to care. METHODS: Qualitative data were collected through four separate focus groups of self-identified Black and Latino adult men and women living in Philadelphia to better understand their perceptions of PC diagnosis, screening and treatment. Each focus group was single-sex and conducted by racial/ethnic group in order to assess possible differences in beliefs about PC based on gender and racial/ethnic affiliation. Audio recordings were transcribed verbatim by trained research assistants and qualitative data analysis was conducted using modified grounded theory. RESULTS: There were a total of 34 participants: 19 Hispanics/Latinos and 15 Blacks, with equal numbers of men and women (n=17). Median age was 57 years (range: 18 to 85 years). Dominant themes that emerged with respect to PC diagnosis included the stigma surrounding this condition and the perceived role of an "unhealthy lifestyle" and certain sexual behaviors as risk factors for PC development. While the majority of participants acknowledged the importance of PC screening and early detection, discussion centered around the barriers to both the interest in seeking medical care and the likelihood of securing it. These barriers included misunderstanding of PC etiology, distrust of the medical profession, and financial/access limitations. Men expressed substantial confusion about PC screening guidelines. In the Black female group, the role of faith and religion in the course of disease was a major theme. Both Black and Latina females discussed the role of fear and avoidance around PC screening and treatment, as well as the prevalence of misinformation about PC in their familial and social communities. CONCLUSION: Black and Latino focus groups revealed the existence of cultural beliefs, misunderstandings and fears pertaining to PC which could influence health-related behaviors. Some themes were common across groups; others suggested racial and gender predilections. Future targeted efforts focused on directly addressing prevalent misperceptions among underserved communities in urban settings could help to improve health literacy and equity in PC outcomes in these populations.

Disease activity and patient-reported outcomes in patients with rheumatoid arthritis and Sjögren's syndrome enrolled in a large observational US registry.

The objective of this study was to compare rheumatoid arthritis (RA) disease activity and patient-reported outcomes (PROs) in a national sample of patients with RA with/without Sjögren's syndrome (SS). Adults with RA from a large observational US registry (Corrona RA) with known SS status between 22 April 2010 and 31 July 2018 and a visit 12 (± 3) months after index date were identified (n = 36,256/52,757). SS status: determined from a yes/no variable reported at enrolment into the Corrona RA registry and follow-up visits. Index date: date that SS status was recorded (yes/no). Patients received biologic or targeted synthetic disease-modifying antirheumatic drugs as part of standard care. Patients with RA only were followed for ≥ 12 months to confirm the absence of SS. Patients were frequency- and propensity-score matched (PSM) 1:1 and stratified by disease duration and treatment response-associated variables, respectively. Clinical Disease Activity Index (CDAI) and PROs 12 months after index visit were compared in patients with and without SS. Baseline characteristics in 283 pairs of PSM patients were balanced. Mean change in CDAI score was numerically lower in patients with RA and SS than patients with RA only (8.8 vs 9.3). Reductions in PROs of pain, fatigue and stiffness were two- to threefold lower for patients with RA and SS versus RA only. Reductions in RA disease activity and RA-related PROs were lower in patients with RA and SS versus those with RA only. Our data indicate that SS adds to treatment challenges; physicians may wish to consider SS status when managing patients with RA.

Long-term pharmacodynamic effects of Ticagrelor versus Clopidogrel in fibrinolytic-treated STEMI patients undergoing early PCI.

The long-term pharmacodynamic effects of Ticagrelor versus Clopidogrel in patients undergoing early percutaneous coronary intervention (PCI) after fibrinolytic therapy is unknown. From May 2014 to August 2016, 212 patients undergoing PCI within 24 h of Tenecteplase (TNK), Aspirin, and Clopidogrel for ST-elevated myocardial infarction (STEMI) were randomized at four Canadian sites to receive additional Clopidogrel or Ticagrelor initiated prior to PCI. The platelet reactivity units (PRU) were measured with the VerifyNow Assay before study drug administration (baseline), at 4 and 24 h post PCI, and follow-up appointment. A mixed-model analysis with time as the repeated measure and drug as the between-subjects factor was calculated using 2 separate 1 × 4 ANOVAs, with students t-tests used to compare drugs within each time point. Complete clinical follow-up data (median 115.0 days; IQR 80.3-168.8) was available in 50 patients (23.6%) randomized to either Clopidogrel (n = 23) or Ticagrelor (n = 27). Analyses revealed significant decreases in PRU from baseline to 4 h (261.4 vs. 71.7; Mdiff = - 189.7; p < 0.001) to 24 h (71.7 vs. 27.7; Mdiff = - 44.0; p < 0.001) to end of follow-up (27.7 vs.17.9; Mdiff = - 9.9. p = 0.016) for those randomized to Ticagrelor and significant decreases in PRU only from baseline to 4 h (271.3 vs. 200.8; Mdiff = - 70.5, p = < 0.001) in patients receiving Clopidogrel, and a significantly greater proportion of patients with adequate platelet inhibition (PRU < 208) on long-term follow-up (Clopidogrel, 82.6% vs. Ticagrelor, 100.0%; p = 0.038). Our results demonstrate that in patients undergoing PCI within 24 h of fibrinolysis for STEMI, Ticagrelor provides prolonged platelet inhibition compared with Clopidogrel.

Effects of ticagrelor versus clopidogrel on platelet function in fibrinolytic-treated STEMI patients undergoing early PCI.

OBJECTIVES: Patients undergoing PCI early after fibrinolytic therapy are at high risk for both thrombotic and bleeding complications. We sought to assess the pharmacodynamic effects of ticagrelor versus clopidogrel in the fibrinolytic-treated STEMI patients undergoing early PCI. METHODS AND RESULTS: Patients undergoing PCI within 24 hours of tenecteplase (TNK), aspirin, and clopidogrel for STEMI were randomized to receive additional clopidogrel 300 mg followed by 75 mg daily or ticagrelor 180 mg followed by 90 mg twice daily. The platelet reactivity units (PRU) were measured with the VerifyNow Assay before study drug administration (baseline) at 4 and 24 hours post-PCI. The primary end point was PRU ≤208 at 4 hours. A total of 140 patients (74 in ticagrelor and 66 in clopidogrel group) were enrolled. The mean PRU values at baseline were similar for the 2 groups (257.8±52.9 vs 259.5±56.7, P=.85, respectively). Post-PCI, patients on ticagrelor, compared to those on clopidogrel, had significantly lower PRU at 4 hours (78.7±88 vs 193.6±86.5, respectively, P<.001) and at 24 hours (34.5±35.0 and 153.5±75.5, respectively, P<.001). The primary end point was observed in 87.8% (n=65) in the ticagrelor-treated patients compared to 57.6% (n=38) of clopidogrel-treated patients, P<.001. CONCLUSION: Fibrinolysis-treated STEMI patients who received clopidogrel and aspirin at the time of fibrinolysis and were undergoing early PCI frequently had PRU >208. In this high-risk population, ticagrelor provides more prompt and potent platelet inhibition compared with clopidogrel (Funded by Astra Zeneca; NCT01930591, https://clinicaltrials.gov/ct2/show/NCT01930591).

Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept.

BACKGROUND: Patients with rheumatoid arthritis (RA), including those treated with biologics, are at increased risk of some vaccine-preventable infections. We evaluated the antibody response to standard 23-valent pneumococcal polysaccharide vaccine (PPSV23) and the 2011-2012 trivalent seasonal influenza vaccine in adults with RA receiving subcutaneous (SC) abatacept and background disease-modifying anti-rheumatic drugs (DMARDs). METHODS: Two multicenter, open-label sub-studies enrolled patients from the ACQUIRE (pneumococcal and influenza) and ATTUNE (pneumococcal) studies at any point during their SC abatacept treatment cycle following completion of ≥3 months' SC abatacept. All patients received fixed-dose abatacept 125 mg/week with background DMARDs. A pre-vaccination blood sample was taken, and after 28 ± 3 days a final post-vaccination sample was collected. The primary endpoint was the proportion of patients achieving an immunologic response to the vaccine at Day 28 among patients without a protective antibody level to the vaccine antigens at baseline (pneumococcal: defined as ≥2-fold increase in post-vaccination titers to ≥3 of 5 antigens and protective antibody level of ≥1.6 µg/mL to ≥3 of 5 antigens; influenza: defined as ≥4-fold increase in post-vaccination titers to ≥2 of 3 antigens and protective antibody level of ≥1:40 to ≥2 of 3 antigens). Safety and tolerability were evaluated throughout the sub-studies. RESULTS: Pre- and post-vaccination titers were available for 113/125 and 186/191 enrolled patients receiving the PPSV23 and influenza vaccine, respectively. Among vaccinated patients, 47/113 pneumococcal and 121/186 influenza patients were without protective antibody levels at baseline. Among patients with available data, 73.9 % (34/46) and 61.3 % (73/119) met the primary endpoint and achieved an immunologic response to PPSV23 or influenza vaccine, respectively. In patients with pre- and post-vaccination data available, 83.9 % in the pneumococcal study demonstrated protective antibody levels with PPSV23 (titer ≥1.6 µg/mL to ≥3 of 5 antigens), and 81.2 % in the influenza study achieved protective antibody levels (titer ≥1:40 to ≥2 of 3 antigens) at Day 28 post-vaccination. Vaccines were well tolerated with SC abatacept with background DMARDs. CONCLUSIONS: In these sub-studies, patients with RA receiving SC abatacept and background DMARDs were able to mount an appropriate immune response to pneumococcal and influenza vaccines. TRIAL REGISTRATION: NCT00559585 (registered 15 November 2007) and NCT00663702 (registered 18 April 2008).

Patient Perspectives of Acute Pain Management in the Era of the Opioid Epidemic.

STUDY OBJECTIVE: To inform the development of interventions that could improve patient engagement around the risks and benefits of alternative approaches to pain management in the emergency department (ED), we seek to capture the perspectives and experiences of patients treated for pain in this setting. METHODS: Three trained interviewers conducted semistructured open-ended telephone interviews with patients discharged from a single urban academic ED after presenting with acute pain related to fracture, renal colic, or musculoskeletal back injury. We recruited subjects until achieving thematic saturation according to periodic review of the interview transcripts. Interviews were audio recorded, professionally transcribed, and uploaded into QSR NVivo (version 10.0) for coding and analysis using modified grounded theory. An interdisciplinary team double coded the data and convened to review emerging themes, ensure interrater reliability, and establish consensus on discrepancies. RESULTS: We had 23 completed subject interviews, the majority of which were women. Interrater reliability for coding exceeded 90%. The major themes elicited centered on domains of patient awareness of the potential for opioid dependence and patient-provider communication relating to pain management. From the patient perspective, emergency physicians typically do not present alternative pain management options or discuss the risks of opioid dependence. Patients with negative experiences related to pain management describe deficiencies in patient-provider communication leading to misunderstanding of clinical diagnoses, fragmentation of care among their health care providers, and a desire to be involved in the decisionmaking process around their pain management. Patients with positive experiences commented on regular communication with their care team, rapid pain management, and the empathetic nature of their care providers. Patients communicate fears about the risks of opioid addiction, beliefs that following a prescribed opioid regimen is protective of developing opioid dependence, and an understanding of the broader tensions that providers face relating to the prescription of opioid therapy. CONCLUSION: Patients identified a deficit of communication around opioid risk and pain management options in the ED.

Exploring public awareness and perceptions of palliative care: a qualitative study.

BACKGROUND: Research suggests that the public appear to be confused about the meaning of palliative care. Given the ageing population and associated increase in the number of patients requiring palliative care, it is vital to explore the public's understanding of this concept. Health-promoting palliative care seeks to translate hospice and palliative care ideals into broader public health practice. AIM: To explore public perceptions of palliative care and identify strategies to raise awareness. DESIGN: An exploratory qualitative approach. PARTICIPANTS: Semi-structured telephone interviews were undertaken (N = 50) with members of the public who volunteered to participate in the study. The interviews focused on knowledge and perceptions of palliative care, expectations of palliative care services and the identification of strategies to raise public awareness of palliative care. The interviews were audio recorded and content analysed. RESULTS: Most participants had a general knowledge of palliative care, largely influenced by their own personal experience. They identified that palliative care was about caring for people who were dying and maintaining comfort in the last days of life. Participant's expectations of services included the following: holistic support, symptom management, good communication and practical support to enable choice and carer support. Key aspects identified for promoting palliative care were the development of understanding and use of the term itself and targeted educational strategies. CONCLUSION: Experience of palliative care generates understanding in the general public who also have ideas for increasing knowledge and awareness. The findings can inform policymakers about strategies to raise public awareness of palliative care.

Multifocal calcifying fibrous tumor at six sites in one patient: a case report.

Calcifying fibrous tumors (CFT) are rare benign tumors. They usually affect children and young adults and the incidence is equal in males and females. The usual clinical presentation is that of a painless mass. A computed tomography scan typically reveals a well-demarcated calcified lesion. CFT usually presents as a solitary mass and the commonest sites of occurrence are in soft tissues, the pleura, or the peritoneum. Multifocal occurrences at the same site have also been reported. The first case of CFT was reported in 1988. We present a rare case of multiple calcifying fibrous tumors at multiple sites in the same patient. To the best of our knowledge, this is the first ever reported case of multifocal CFT atsix different anatomical sites in one patient.

Food and housing insecurity, COVID-19 pandemic effects on health-related activities, and care plans for children with obesity.

OBJECTIVE: To understand the association between food insecurity (FI) and housing insecurity (HI) risk, the effects of the COVID-19 pandemic on health-related activities among children with overweight or obesity, and caregivers' and clinicians' challenges and priorities related to pediatric weight management. METHODS: We conducted surveys with caregivers of children with overweight and obesity and pediatric clinicians at two academic medical centers in the Greater Boston area. We used multivariable logistic regression models to examine associations between FI and HI risk and the effects of the COVID-19 pandemic on health-related activities and descriptive statistics to summarize caregivers' and clinicians' challenges and priorities related to pediatric weight management. RESULTS: We analyzed data from surveys with 344 caregivers and 100 pediatric clinicians. Overall, 37% of caregivers endorsed both FI+HI, 18% FI alone, 10% HI alone, and 35% neither FI/HI. In the adjusted logistic regression models, combined FI+HI (reference: neither FI/HI) was significantly associated with higher odds of sleeping less (aOR 2.96 [95% confidence interval (CI): 1.46, 6.01]) and higher odds of spending less time outside (aOR 2.10 [95% CI: 1.06, 4.16]). Top priorities for pediatric weight management identified by both caregivers and clinicians were related to physical activity and availability of outdoor spaces. CONCLUSIONS: Endorsement of both FI+HI was associated with children getting less sleep and spending less time outside during the COVID-19 pandemic. Future innovations in care plans for children with overweight and obesity should be adapted to a family's social context and should incorporate caregivers' and clinicians' challenges and priorities.

Comparative effectiveness of abatacept versus TNF inhibitors in rheumatoid arthritis patients who are ACPA and shared epitope positive.

BACKGROUND: The HLA-DRB1 shared epitope (SE) is a risk factor for the development of rheumatoid arthritis (RA) and the production of anti-citrullinated protein antibodies (ACPAs) in RA patients. Our objective was to examine the real-world effectiveness of abatacept versus tumor necrosis factor inhibitors (TNFi) in patients with RA who were SE and anti-cyclic citrullinated peptide antibody (anti-CCP3) positive. METHODS: Abatacept or TNFi initiators who were SE + and anti-CCP3+ (> 20 U/mL) at or prior to treatment and had moderate or high CDAI score (> 10) at initiation were identified. The primary outcome was mean change in CDAI score over six months. Analyses were conducted in propensity score (PS)-trimmed and -matched populations overall and a biologic-experienced subgroup. Mixed-effects models were used. RESULTS: In the overall PS-trimmed (abatacept, n = 170; TNFi, n = 157) and PS-matched cohorts (abatacept, n = 111; TNFi, n = 111), there were numerically greater improvements in mean change in CDAI between abatacept and TNFi but were not statistically significant. Similar trends were seen for biologic-experienced patients, except that statistical significance was reached for mean change in CDAI in the PS-trimmed cohort (abatacept, 12.22 [95% confidence interval (95%CI) 10.13 to 14.31]; TNFi, 9.28 [95%CI 7.08 to 11.48]; p = 0.045). CONCLUSION: In this real world cohort, there were numerical improvements in efficacy outcomes with abatacept over TNFi in patients with RA who were SE + and ACPA+, similar to results from a clinical trial population The only statistically significant finding after adjusting for covariates was greater improvement in CDAI with abatacept versus TNFi in the bio-experienced PS-trimmed cohort..

Illness perception clusters at diagnosis predict psychological distress among women with breast cancer at 6 months post diagnosis.

OBJECTIVE: This study aimed to examine the extent to which illness perceptions and coping strategies among women diagnosed with breast cancer explain psychological distress at diagnosis and at 6 months post diagnosis relative to demographic and illness-related variables. METHODS: Women were recruited to the study shortly after diagnosis. A total of 90 women completed study materials (Illness Perception Questionnaire-Revised, the Cancer Coping Questionnaire and the Hospital Anxiety and Depression Scale) at time 1. The same questionnaires were sent approximately 6 months later to those who had consented at time 1, and completed questionnaires were returned by 72 women. RESULTS: Cluster analysis was used to identify groups of respondents who reported a similar profile of illness perception scores. Regression analysis demonstrated that one of these clusters was more likely to experience psychological distress than the other both at diagnosis and at 6 months post diagnosis. Illness perception cluster membership and positive focus type coping were the most important and consistent predictors of lower psychological distress at diagnosis and at 6 months post diagnosis. CONCLUSIONS: Illness perceptions remained relatively stable over the study period, and therefore we are unable to clarify whether changes in illness cognitions are associated with a corresponding change in psychological symptoms. Future research should evaluate the impact on psychological distress of interventions specifically designed to modify illness cognitions among women with breast cancer.

Public awareness and attitudes toward palliative care in Northern Ireland.

BACKGROUND: The World Health Organisation recognises palliative care as a global public health issue and this is reflected at strategic level. Despite this, palliative care may not be universally welcomed. Surveys over the last decade have suggested that the general public have a lack of knowledge and negative perceptions towards palliative care. A detailed and comprehensive understanding of public views is needed in order to target education and policy campaigns and to manage future needs, expectations and resourcing of end of life care. The aim of this study was to establish the current levels of awareness and attitudes towards palliative care among the general public in Northern Ireland. METHODS: A community-based cross-sectional survey with a population of 3,557 individuals aged over 17 years was performed. Information was collected using a structured questionnaire consisting of 17 items. Open questions were subject to content analysis; closed questions were subject to descriptive statistics with inferential testing as appropriate. RESULTS: A total of 600 responses were obtained (response rate 17%). Responses indicated limited knowledge about palliative care. Female gender and previous experience influenced awareness in a positive direction. Respondents who worked in healthcare themselves or who had a close relative or friend who had used a palliative care service were more aware of palliative care and the availability of different palliative care services. Findings reveal the preferred place of care was the family home. The main barriers to raising awareness were fear, lack of interaction with health services and perception of lack of resources. A number of strategies to enhance awareness, access and community involvement in palliative care were suggested. CONCLUSIONS: Public awareness of the concept of palliative care and of service availability remains insufficient for widespread effective and appropriate palliative care to be accepted as the norm. In particular, those without previous family-related experiences lack awareness. This has implications for palliative care service provision and policy. An increased awareness of palliative care is needed, in order to improve knowledge of and access to services when required, empower individuals, involve communities and ultimately to realise the objectives contained within international strategies for palliative and end-of-life care.

Comparative Effectiveness of Abatacept vs. Tofacitinib in Rheumatoid Arthritis Patients who are CCP.

INTRODUCTION: Currently there is limited data to drive clinical decision making regarding  the choice of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARD); thus, head-to-head comparisons are needed to help guide prescribing. In recent years, significant advancements have helped clarify the mechanistic basis of the clinical associations of autoantibodies in rheumatoid arthritis (RA). This study evaluated the effectiveness of abatacept versus tofacitinib in anti-cyclic citrullinated peptide (CCP+) patients with rheumatoid arthritis (RA). METHODS: CorEvitas (formerly known as CORRONA) Registry patients aged ≥ 18 years, who were CCP+ before initiating abatacept or tofacitinib (December 2012 onwards through October 2019), had 6-month follow-up data (baseline and 6-month Clinical Disease Activity Index [CDAI]), and were not in remission at index were included. Patients were frequency matched 1:1 by prior biologic use before propensity score matching (PSM). Primary (mean change [D] in CDAI) and secondary outcomes 6 months after index were compared using mixed-effects models adjusted for variables that remained unbalanced after PSM. RESULTS: Following PSM, most baseline characteristics for 291 patient pairs were well balanced between treatments, although fewer patients initiating abatacept versus tofacitinib received prior non-TNFi biologic DMARDs, and patients initiating abatacept versus tofacitinib had a higher physician global assessment score, patient-reported fatigue, and modified Health Assessment Questionnaire (mHAQ). In adjusted analyses, there were no significant differences in mean [D] from baseline in CDAI at 6 months with abatacept versus tofacitinib (P = 0.936). Patients naïve for b/tsDMARDs initiating abatacept had a numerically greater mean [D] in CDAI at 6 months versus tofacitinib, although this difference was not statistically significant (P = 0.662). There were no significant differences for any secondary outcomes. CONCLUSIONS: In adjusted analyses, CCP+ patients with RA initiating treatment with abatacept versus tofacitinib did not show a statistically significant difference in reducing disease activity or improving patient-reported outcomes.

Comparative effectiveness of treatments for rheumatoid arthritis in clinical practice: A systematic review.

OBJECTIVE: To assess real-world comparative effectiveness studies of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) in adults with rheumatoid arthritis (RA) through a systematic review. METHODS: We searched Medline for journal articles (2001-2021) and Embase® for abstracts presented at the European Alliance of Associations for Rheumatology and American College of Rheumatology (ACR) 2020 and 2021 annual meetings on non-randomized studies comparing the effectiveness of b/tsDMARDs using ACR-recommended disease activity measures, measures of functional status, and patient-reported outcomes (HAQ, PROMIS PF, patient pain, Patient and Physician Global Assessment of disease activity). Methodological heterogeneity between studies precluded meta-analyses. Risk of bias was assessed using the Cochrane Risk Of Bias In Non-randomized Studies of Interventions-I tool. RESULTS: Of 1283 records screened, 68 were selected for data extraction, of which 1 was excluded due to critical risk of bias. Most studies were multicenter observational cohort/registry studies (n = 60) and were published between 2011 and 2021 (n = 60). Mean or median reported RA duration was between 6 and 15 years. Disease Activity Score in 28 joints (46 studies), Clinical Disease Activity Index (37 studies), and Health Assessment Questionnaire-Disability Index (32 studies) were the most common outcomes used in clinical practice, with regional differences identified. The most common comparison was between tumor necrosis factor inhibitors (TNFis) and non-TNFi bDMARDs (35 studies). There were no evident differences between b/tsDMARDs in clinical effectiveness. CONCLUSION: This systematic review summarizing real-world evidence from a very large number of global studies found there are many effective options for the treatment of RA, but relatively less evidence to support the use of any one b/tsDMARD or drug class over another. Treatment for patients with RA should be tailored to suit individual clinical profiles. Further research is needed to identify whether specific patient subgroups may benefit from specific drug classes.

Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomized, double-blind, placebo-controlled, phase II trial.

OBJECTIVE: To assess the safety and efficacy of abatacept, a selective T cell costimulation modulator, in patients with psoriatic arthritis (PsA). METHODS: In this 6-month, multicenter, randomized, double-blind, placebo-controlled, phase II study, 170 PsA patients with a psoriasis target lesion (TL) ≥2 cm who had previously taken disease-modifying antirheumatic drugs (DMARDs), including anti-tumor necrosis factor (anti-TNF) agents, were randomized (1:1:1:1) to receive placebo or abatacept at doses of 3 mg/kg, 10 mg/kg, or 30/10 mg/kg (2 initial doses of 30 mg/kg, followed by 10 mg/kg) on days 1, 15, and 29 and then once every 28 days thereafter. The primary end point was the American College of Rheumatology 20% criteria for improvement (ACR20 response) on day 169. Other key end points were magnetic resonance imaging (MRI) scores for joint erosion, osteitis, and synovitis, scores on the Health Assessment Questionnaire (HAQ) and the Short Form-36 (SF-36) health survey, the investigator's global assessment of psoriasis, the TL score, and the Psoriasis Area and Severity Index (PASI) score. RESULTS: Proportions of patients achieving an ACR20 response were 19%, 33%, 48%, and 42% in the placebo, the abatacept 3 mg/kg, the abatacept 10 mg/kg, and the abatacept 30/10 mg/kg groups, respectively. Compared with placebo, improvements were significantly higher for the abatacept 10 mg/kg (P = 0.006) and 30/10 mg/kg (P = 0.022) groups, but not for 3 mg/kg group (P = 0.121). All abatacept regimens resulted in improved MRI, HAQ, and SF-36 scores, with 10 mg/kg showing the greatest improvements. Improvements in the TL and PASI scores were observed in all abatacept arms; a response according to the investigator's global assessment was seen only with 3 mg/kg of abatacept. The safety profiles were similar among the treatment arms. CONCLUSION: The results of this study suggest that 10 mg/kg of abatacept, the approved dosage for rheumatoid arthritis and juvenile idiopathic arthritis, may be an effective treatment option for PsA.

Baseline Anti-Citrullinated Protein Antibody Status and Response to Abatacept or Non-TNFi Biologic/Targeted-Synthetic DMARDs: US Observational Study of Patients with RA.

INTRODUCTION: Patients with rheumatoid arthritis (RA) may respond to treatments differently based on their underlying serology and biomarker status, but real-world data comparing treatment responses to abatacept versus other non-TNFi biologic or targeted-synthetic DMARDs by anti-citrullinated protein antibody (ACPA) status remain limited. We assessed the association between ACPA status and response to treatment in patients with RA. METHODS: Adults from CorEvitas' RA Registry were identified who initiated abatacept, rituximab, tocilizumab, or tofacitinib, and had ACPA measured at/prior to treatment initiation and at the 6-month follow-up visit. Three cohorts were included: abatacept/rituximab (2006-2019), abatacept/tocilizumab (2010-2019), and abatacept/tofacitinib (2012-2019). Patient characteristics at initiation were compared by ACPA status (positive [+], anti-cyclic citrullinated peptide-2 [anti-CCP2] ≥ 20 U/ml; negative [-], anti-CCP2 < 20 U/ml). Outcomes over 6 months: changes in Clinical Disease Activity Index (CDAI), modified Health Assessment Questionnaire (mHAQ), patient global assessment (PGA) scores, and proportion of patients achieving a clinical response. Adjusted mean differences and odds ratios were estimated using mixed-effects linear regression models. RESULTS: Overall, 982 abatacept, 246 rituximab, 404 tocilizumab, and 429 tofacitinib initiators were identified. ACPA+ (vs. ACPA-) patients had longer disease duration and more erosive disease. During most time periods adjusted mean changes in CDAI, mHAQ, and PGA scores and the proportion of patients achieving a clinical response were significantly higher for ACPA+ versus ACPA- patients initiating abatacept. Adjusted mean change in PGA score and patient fatigue were significantly higher for ACPA+ versus ACPA- patients initiating rituximab. No significant differences were seen by ACPA status for patients initiating tocilizumab or tofacitinib. CONCLUSIONS: Patients who initiated abatacept or rituximab and were ACPA+ had a greater clinical response at 6-month follow-up post index compared to patients who were ACPA- treated with the same biologic.