Patient reported side-effects of prednisone and methotrexate in a real-world sarcoidosis population.
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ABSTRACT:
SUBMITTER: Kahlmann V
PROVIDER: S-EPMC8477709 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo evaluate whether addition of low-moderate dose prednisone to methotrexate (MTX) treatment can alleviate common MTX side-effects in rheumatoid arthritis (RA) patients.MethodsWe performed a post-hoc analysis of the CAMERA-II trial which randomized (1:1) 236 early DMARD and prednisone naive RA patients to treatment with MTX + prednisone 10 mg daily, or MTX monotherapy during two years. MTX dose was increased using a treat-to-target approach. We used Generalized Estimating Equations to model the occurrence of common MTX side-effects and of any adverse event over time, controlling for disease activity and MTX dose over time and other possible predictors of adverse events. To assess whether a possible effect was prednisone-specific, we performed the same analysis in the U-ACT-EARLY trial, in which the addition of tocilizumab (TCZ) to MTX was compared to MTX monotherapy in a comparable setting.ResultsMTX side-effects were reported at 5.9% of visits in the prednisone-MTX group, compared to 11.2% in the MTX monotherapy group. After controlling for MTX dose and disease activity over time, treatment duration, age, sex, and baseline transaminase levels, addition of prednisone significantly decreased the occurrence of MTX side-effects (OR: 0.54, CI: 0.38-0.77, p = 0.001). Specifically, the occurrence of nausea (OR 0.46, CI: 0.26-0.83, p = 0.009)) and elevated ALT/AST (OR 0.29, CI: 0.17-0.49, p < 0.001) was decreased. There was a trend towards fewer overall adverse events in the prednisone-MTX arm (OR: 0.89, CI: 0.72-1.11, p = 0.30). No difference in MTX side-effects was found between TCZ-MTX and MTX monotherapy in U-ACT-EARLY (OR 1.05, CI: 0.61-1.80, p = 0.87).ConclusionAddition of 10 mg prednisone daily to MTX treatment in RA patients may ameliorate MTX side-effects, specifically nausea and elevated ALT/AST.
| S-EPMC10189989 | biostudies-literature
Project description:PurposeWe aimed to explore patient-reported outcomes (PROs) and patient and physician concordance of side effects perception across lines of therapy (LOT) in multiple myeloma (MM) within the United States of America (USA).MethodsData were drawn from the Adelphi Real World MM III Disease Specific Programme™, a point-in-time survey of hemato-oncologists/hematologists and their patients with MM conducted in the USA between August 2020 and July 2021. Physicians reported patient characteristics and side effects. Patients reported side-effect bother and health-related quality of life (HRQoL) using validated PRO tools (European Organisation for the Research and Treatment of Cancer Quality of Life Core Questionnaire/-MM Module [EORTC QLQ-C30/-MY20], EQ-5D-3L and Functional Assessment of Cancer Therapy-General Population physical item 5). Descriptive, linear regression and concordance analyses were performed.ResultsRecords from 63 physicians and 132 patients with MM were analyzed. EORTC QLQ-C30/-MY20 and EQ-5D-3L scores were consistent across LOTs. Scores tended to be worse with higher side-effect bother; patients "very much" bothered by side effects had lower median (interquartile range) global health status scores (33.3 [25.0-50.0]) than those "not at all" bothered (79.2 [66.7-83.3]). Patient and physician concordance on side-effect reporting was poor to fair. Patients frequently reported fatigue and nausea as bothersome side effects.ConclusionHRQoL of patients with MM was worse with greater side-effect bother. Discordant patient and physician reporting of side effects indicated a need for improved communication during management of MM.
| S-EPMC10238291 | biostudies-literature
Project description:Dyspnoea, a common and multifactorial symptom in patients with acute coronary syndrome, has been associated with lower quality of life and hospital readmission. Prescriber preference for antiplatelet therapy, the standard of care in this patient group, is shifting to ticagrelor due to mortality benefits demonstrated in trials compared with clopidogrel. In these trials, dyspnoea was more commonly reported in patients prescribed ticagrelor but the aetiology is still debated. An observational cohort study was conducted to quantify the rates and severity of dyspnoea reported in patients with acute coronary syndrome and newly prescribed ticagrelor compared with those prescribed clopidogrel. Dyspnoea was more commonly reported in patients prescribed ticagrelor at each follow up post-discharge (p = 0.016). Rates were higher than previously reported in clinical trials. In some patients, dyspnoea necessitated drug therapy change and was associated with readmission to hospital (p = 0.046). As ticagrelor is widely prescribed as a first-line antiplatelet agent for a range of patients with acute coronary syndrome, the incidence of dyspnoea in a generalized patient cohort may result in higher rates of drug discontinuation. This in turn could lead to higher rates of rehospitalisation and potential treatment failure than that reported from the controlled setting of a clinical trial.
| S-EPMC6166316 | biostudies-literature
Project description:ObjectiveTo assess eye drop technique and patient-reported problems with eye drop instillation in a primary care sample of eye drop users.MethodsCross-sectional observational study in 136 community pharmacies in Belgium. Patient inclusion criteria were being age ≥ 18 years and using eye drops for ≥ 1 month (to ensure that patients were already familiar with eye drop instillation). Participants demonstrated their eye drop technique and completed a self-administered questionnaire.ResultsParticipants (n = 678) had a mean age of 68.9 ± 12.4 years. During the demonstration, almost everyone (98.0%) successfully instilled at least one drop in the eye, although 14% required multiple attempts to achieve this. Only 3% of the sample exhibited perfect drop technique, meaning that they performed correctly all the steps. Most common deviations were touching the bottle to the eye or eyelid (40.7% of patients), and failing to close the eye (67.8%) and perform nasolacrimal occlusion for at least 1 min (94.7%) after drop instillation. Importantly, we found that 20% of ophthalmic suspensions were not shaken before use. Forty percent of patients reported ≥ 1 problem with eye drop instillation. Most common problems were difficulties with getting a drop in the eye (18.3% of patients), too many drops coming out of the bottle (14.6%), and difficulty squeezing the bottle (12.2%). About half of the sample recalled having had education in eye drop instillation technique.ConclusionThis study showed suboptimal eye drop technique in real-world clinical practice. A proactive role of community pharmacists in detecting and resolving these problems could be helpful.
| S-EPMC7376112 | biostudies-literature
Project description:Background:Advanced breast cancer (abc) represents a substantial burden for patients and caregivers. In the present study, we aimed to estimate quality of life (qol), utility, productivity loss, pain, health care resource utilization, and costs for patients with abc, and qol, utility, and productivity loss for their caregivers. Methods:This multicentre prospective non-interventional study was conducted in Canada. Eligible participants were postmenopausal women with estrogen receptor-positive, her2-negative unresectable abc and their caregivers. Validated questionnaires were used to measure qol, utility, productivity loss, and pain. Patients and caregivers were classified into 4 health states typically used in oncology economic modelling: first-line progression-free (1l-pf), first-line progressive disease (1l-pd), second- or subsequent-line progression-free (?2l-pf), and second- or subsequent-line progressive disease (?2l-pd). Results:Most patients and caregivers accepted to participate, with total recruitment of 202 patients and 78 caregivers. Compared with patients in pf, patients in pd had lower mean qol scores (52.9 ± 29.9 for 1l-pd vs. 68.2 ± 23.2 for 1l-pf, and 54.0 ± 23.6 for ?2l-pd vs. 66.0 ± 22.1 for ?2l-pf), lower mean utility values (0.64 ± 0.22 for 1l-pd vs. 0.73 ± 0.20 for 1l-pf, and 0.65 ± 0.25 for ?2l-pd vs. 0.74 ± 0.18 for ?2l-pf), and greater productivity loss (39.4 ± 27.7 for 1l-pd vs. 27.5 ± 30.1 for 1l-pf, and 37.6 ± 29.2 for ?2l-pd vs. 32.0 ± 29.0 for ?2l-pf). Compared with caregivers of patients in pf, caregivers of patients in pd had lower qol scores and utility values, and greater productivity loss. Conclusions:Study results indicate that, for patients and caregivers, pd health states are associated with a deterioration of qol and utility and a decrease in productivity in both 1l and ?2l.
| S-EPMC6092048 | biostudies-literature
Project description:Background and objectiveNo clinical trial has examined the risk of infection associated methotrexate and azathioprine, two advocated treatments for sarcoidosis. We aimed to compare the 6-month risk of infection after the initiation of methotrexate or azathioprine.MethodsWe conducted a retrospective target trial emulation using Swedish pre-existing data. We searched for eligible participants who were dispensed methotrexate or azathioprine in the Prescribed Drug Register (PDR) every day between January 2007 and June 2013. Adults were eligible if they had ≥2 ICD-coded visits for sarcoidosis in the National Patient Register (NPR) and were dispensed ≥1 systemic corticosteroid but no methotrexate or azathioprine in the past 6 months (PDR). Within 6 months of methotrexate or azathioprine initiation, diagnosis of infectious disease was identified (visit in the NPR where infectious disease was the primary diagnosis). We estimated RR and risk differences comparing methotrexate (n = 667) to azathioprine initiations (n = 259) using targeted maximum likelihood estimation (TMLE) adjusting for demographic factors, comorbidity and sarcoidosis severity proxies.ResultsThere were 43 infections in the methotrexate group (adjusted 6-month risk 6.8%) and 29 infections in the azathioprine group (12.0%). The RR for infectious disease at 6 months associated with methotrexate compared to azathioprine initiation was 0.57 (95% CI: 0.39, 0.82) and the risk difference was -5.2% (95% CI: -8.5%, -1.8%). The RR at 9 months was attenuated to 0.77 (95% CI: 0.52, 1.14).ConclusionMethotrexate appears to be associated with a lower risk of infection in sarcoidosis than azathioprine, but randomized trials should confirm this finding.
| S-EPMC8247001 | biostudies-literature
Project description:IntroductionAbiraterone acetate plus prednisone (AA+P) has shown to significantly improve survival. COSMiC, a Canadian Observational Study in Metastatic Cancer of the Prostate, set out to prospectively amass real-world data on metastatic castration-resistant prostate cancer (mCRPC) patients managed with AA+P in Canada. Herein, we report their patient-reported outcomes (PROs).MethodsAfter a median followup of 67.1 weeks, 254 patients were enrolled across 39 sites. Functional Assessment of Cancer Therapy-Prostate (FACT-P), Montreal Cognitive Assessment (MoCA), Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), and Current Health Satisfaction in Prostate Cancer (CHS-PCa) were evaluated at baseline, as well as at weeks 12, 24, 48, and 72 after AA+P initiation. Descriptive analysis was used with continuous variables. Changes from baseline were summarized using mean (standard deviation [SD]).ResultsAt a median age of 76.6 (8.94), baseline FACT-P total score was 111.3 (19.56) with no significant change in their functional status observed from baseline over time. The median baseline MoCA score was 25.2 (4.52), yet subsequent assessments showed an absence of cognitive decline while under treatment. Similarly, no meaningful changes were detected in BPI, BFI, and CHS-PCa during the 72-week study period, thus suggesting that patients' PROs were well-maintained throughout AA+P treatment. Prostate-specific antigen (PSA) response with >50% decline was 66.4%. Safety profile was consistent with the known side effect of AA+P.ConclusionsCOSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real-world, prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study and underscores the importance of PRO use in this complex patient population.
| S-EPMC7704085 | biostudies-literature
Project description:Background: The t:slim X2™ insulin pump with Control-IQ™ technology, an advanced hybrid closed-loop system, became available in the United States in early 2020. Real-world outcomes with use of this system have not yet been comprehensively reported. Methods: Individuals with type 1 diabetes (T1D) (≥14 years of age) who had ≥21 days of pump usage data were invited via email to participate. Participants completed psychosocial questionnaires (Technology Acceptance Scale [TAS], well-being index [WHO-5], and Diabetes Impact and Devices Satisfaction [DIDS] scale) at timepoint 1 (T1) (at least 3 weeks after starting Control-IQ technology) and the DIDS and WHO-5 at timepoint 2 (T2) (4 weeks from T1). Patient-reported outcomes (PROs) and glycemic outcomes were reviewed at each timepoint. Results: Overall, 9,085 potentially eligible individuals received the study invite. Of these, 3,116 consented and subsequently 1,435 participants completed questionnaires at both T1 and T2 and had corresponding glycemic data available on the t:connect® web application. Time in range was 78.2% (70.2%-85.1%) at T1 and 79.2% (70.3%-86.2%) at T2. PROs reflected high device-related satisfaction and reduced diabetes impact at T2. Factors contributing to high trust in the system included sensor accuracy, improved diabetes control, reduction in extreme blood glucose levels, and improved sleep quality. In addition, participants reported improved quality of life, ease of use, and efficient connectivity to the continuous glucose monitoring system as being valuable features of the system. Conclusions: Continued real-world use of the t:slim X2 pump with Control-IQ technology showed improvements in psychosocial outcomes and persistent achievement of recommended TIR glycemic outcomes in people with T1D.
| S-EPMC7868573 | biostudies-literature
Project description:IntroductionThe 6-point version of the Mayo score relies on two patient-reported outcomes (PRO2): stool frequency and rectal bleeding. We assessed the feasibility and acceptability of remote online PRO2 reporting for golimumab-treated ulcerative colitis (UC) patients.Patients and methodsThis was a UK-based, multi-centre, prospective, real-world, non-interventional pilot study. Eligible patients completed PRO2 scores at baseline and every 4 weeks over a period of 6 months. Demographics were collected at baseline and a satisfaction questionnaire was completed at study end. Each patient provided data anonymously via an online platform.ResultsFifty-two patients enrolled in the study. Mean (SD) patient age was 40.8 (13.6); 52% were male. Patients provided data on a personal computer (44%), mobile phone (38%) or tablet (18%). Forty-seven (90%) patients completed the baseline questionnaire within the accepted time range. Subsequent scores were reported on time by eligible patients with a success rate of 94%, 92%, 90%, 87%, 90% and 81% at end of months 1-6, respectively.ConclusionsRemote monitoring of PRO2 in UC was feasible amongst the sample tested. Of those initially willing to provide data in this way, attrition was low. Formal roll-out of this system could be used to support a more frequent assessment of UC symptoms without over-burdening the healthcare system.
| S-EPMC6710315 | biostudies-literature
Project description:We performed an observational study on health-related quality of life (HRQoL) in patients with AL amyloidosis diagnosed between 2012 and 2017 at our institution. A total of 81 patients were included, with a median age of 64 years. The mean FACT-G (Functional Assessment of Cancer Therapy-General) total score at baseline (?2 months from diagnosis) was 74 (±15), compared to a normative score of 80 (±18) in the general U.S. population. Significant HRQoL deficit was noted only in the functional well-being (FWB) domain of FACT-G. Using PROMIS-GH (Patient-Reported Outcomes Measurement Information System-Global Health) at baseline (n?=?18), a greater deficit was noted in the global physical health (GPH) compared to global mental health (GMH) domain. FACT-FWB and PROMIS-GPH domain scores were able to significantly discriminate between revised Mayo stages. Development and validation of an amyloid-specific PRO instrument incorporating specific domains of interest is urgently needed to pursue patient-centered drug development.
| S-EPMC6928422 | biostudies-literature