Clinical Activity Research Articles

Response to letter to the editor from Drs. Mori Y and Mori N: ‘Selection of the phase of dynamic contrast-enhanced magnetic resonance imaging and use of the voxel-based enhancement maps may facilitate the assessment of clinical disease activity in patients with rheumatoid arthritis’

Response to letter to the editor from Drs. Mori Y and Mori N: ‘Selection of the phase of dynamic contrast-enhanced magnetic resonance imaging and use of the voxel-based enhancement maps may facilitate the assessment of clinical disease activity in patients with rheumatoid arthritis’

CTNI-45. PHASE 2 STUDY OF SORAFENIB, VALPROIC ACID, AND SILDENAFIL IN THE TREATMENT OF RECURRENT HIGH-GRADE GLIOMA

Abstract PURPOSE Here we report the results of a single-center phase 2 clinical trial combining sorafenib tosylate, valproic acid, and sildenafil for the treatment of patients with recurrent high-grade glioma. PATIENTS AND METHODS Eligible patients were 18 years of age and older with an Eastern Cooperative Oncology Group performance status of 0-2 and pathologically confirmed high-grade glioma (WHO grade 3 or 4), with documented CT or MRI progression or recurrence and measurable or evaluable disease. The treatment schedule was a combination of sorafenib, valproic acid, and sildenafil, each agent administered orally, twice daily continuously. A cycle consisted of 4 weeks. RESULTS Clinical toxicities were grade 1 and grade 2, with one grade 3 toxicity for maculopapular rash (6.4%). For all evaluable patients, the median progression-free survival was 3.65 months and overall survival (OS) 10.0 months. There was promising evidence showing clinical activity and benefit. In the 33 evaluable patients, low protein levels of the chaperone GRP78 (HSPA5) was significantly associated with a better OS (p < 0.0026). A correlation between the expression of PDGFRa and OS approached significance (p < 0.0728). Five patients presently have a mean OS of 73.6 months and remain alive. CONCLUSIONS This is the first therapeutic intervention glioblastoma trial to significantly associate GRP78 expression to OS. Our data suggest that the combination of sorafenib tosylate, valproic acid, and sildenafil requires additional clinical development in the recurrent glioma population.

CTNI-47. A PHASE 1, RANDOMIZED, PERIOPERATIVE TRIAL OF VORASIDENIB AND IVOSIDENIB IN IDH1-MUTANT DIFFUSE GLIOMA: UPDATED RESULTS

Abstract BACKGROUND Vorasidenib (VOR) and ivosidenib (IVO) showed clinical activity in subjects with isocitrate dehydrogenase mutant (mIDH) gliomas. We evaluated both agents in a phase 1, randomized, open-label perioperative trial (NCT03343197). Pharmacodynamics, pharmacokinetics, and preliminary objective response rate (ORR) data as of 29-April-2020 were previously reported (Mellinghoff et al. Nat Med. 2023). Progression-free survival (PFS) data were not mature at publication time. We report here longer-term follow-up results, including mature PFS. METHODS Participants with grade 2/3 non-enhancing mIDH1 R132H mutant gliomas were randomized to VOR (50 or 10 mg QD), IVO (500 or 250 mg BID), or no treatment (control) for 4 weeks prior to planned surgery, with the option to continue treatment with VOR or IVO post-surgery. Secondary objectives included PFS, ORR assessed by Investigator in the post-surgery period, and safety profile of VOR and IVO. RESULTS Enrollment completed in April-2019. 49 participants were randomized, of which 46 participants (24 oligodendroglioma, 20 astrocytoma, 1 anaplastic oligodendroglioma, 1 anaplastic oligoastrocytoma) received treatment with either VOR (N=24) or IVO (N=22) after surgery. As of 23-September-2023 data cutoff, 11 (46%) and 5 (20%) participants remain on treatment for VOR and IVO, respectively. Median (range) post-operative treatment duration was 44.7 months (0.9–62.7) for VOR, 23.9 months (0–62.7) for IVO. Median (95% CI) PFS was 41.4 months (9.3, NE) for VOR and 38.6 months (18.3, NE) for IVO. ORR per Response Assessment in Neuro-Oncology in low-grade gliomas (RANO-LGG) was 46% for VOR and 27% for IVO. Longer safety follow up will also be presented. CONCLUSION These results provide further evidence of prolonged response using IVO and VOR immediately following surgery in predominantly non-enhancing gliomas. This longer-term follow-up is consistent with Phase 3 INDIGO study results where VOR demonstrated PFS benefit with manageable safety compared with placebo in participants with non-enhancing mIDH gliomas.

Quantitative evaluation of clinical pharmacy activities following implementation of an enhanced weekend service at a teaching hospital

Abstract Introduction Improving equity of staffing across seven-days is a strategic priority for the National Health Service (NHS).1 Development of enhanced weekend clinical pharmacy services presents opportunity to improve admission and discharge medicines reconciliation (MR), reduce medication error and increase patient counselling.2 At the study site, an enhanced weekend clinical pharmacy service was implemented in October 2021. The service was delivered 9am-5pm to all clinical specialities across 54 wards. Defined minimum staffing was 13 pharmacists and 2 medicines management pharmacy technicians (MMPT). Service specification included: clinical screen and order of medications; admission MR, review of high-risk patients (critical care patients and those prioritised by the weekday team); and discharge activities including patient counselling. Aim To evaluate provision of the enhanced weekend clinical pharmacy service post-implementation by quantification of shift fill and clinical pharmacy professional activities. Methods A quantitative study was conducted over two separate weekends one month and six months post-implementation (13th-14th November 2021 and 9-10th April 2022). Pharmacy professionals collected data using a paper activity tool validated for use at the study site. Interventions included rectification of medication error, medicines optimisation or consult. Data were collated in Microsoft Excel immediately after each study weekend. Simple descriptive statistics were performed in Microsoft Excel. The study was registered with KCH Pharmacy Research and Audit Group (07/2021), deemed service evaluation and ethics approval waived. Results Pharmacy professionals reviewed 1,056 patients over 3,645 occupied bed-days. Services were delivered by 13 pharmacists and 1 MMPT on weekend 1, 12 pharmacists and 1 MMPT on weekend 2. Data were collected for all wards on weekend 1; on weekend 2 activity data was not collected for five surgical wards (Saturday and Sunday), four post-acute medical wards (Saturday) and the acute medical unit (Sunday). Admission MR was conducted for 77% (317/412) of newly-admitted patients. Pharmacists recommended prescription amendment for 68% (217/317) of patients receiving admissions MR; affecting 517 medicines. The recorded intervention rate per patient reviewed was 0.64 (680/1056). Pharmacy professionals responded to 211 queries from healthcare professionals (HCPs), undertook 90 incidences of pro-active HCP education and counselled 92 patients/carers. Pharmacists prepared discharge medication lists or clinically screened discharge prescriptions for 205 patients. A total of 952 non-stock medicines were ordered and 313 patients own medicines checked for suitability for reuse. Discussion / Conclusion These findings add to existing evidence for seven-day clinical pharmacy services. Defined minimum staffing was not fulfilled with 90% shift fill rate. Clear benefit was demonstrated in terms of admission MR and resultant intervention, HCP education, discharge and counselling activities. The percentage of patients with a recommended prescription amendment following admission MR matched findings from a separate service evaluation during February 2021 of an enhanced weekend service introduced at our study site during the COVID-19 pandemic (68%).3 The intervention rate for reviewed patients was also comparable (0.64 compared with 0.57 during COVID-19).3 Limitations include the relatively short period of data collection at a single-site which limits generalisability of findings. There were some gaps in data collection and acceptance rate of interventions was not collected.

Residual symptoms: Unmet needs for rheumatoid arthritis patients who achieved low clinical disease activity

Residual symptoms: Unmet needs for rheumatoid arthritis patients who achieved low clinical disease activity

Safety and efficacy of filgotinib in Japanese patients with rheumatoid arthritis: Week 156 interim results in FINCH 4.

To describe safety and efficacy of filgotinib 200 or 100 mg (FIL200/FIL100) in Japanese patients with rheumatoid arthritis in a long-term extension (LTE; NCT03025308). Patients who completed any of three parent studies (NCT02889796: inadequate response [IR] to methotrexate [MTX]; NCT02873936: IR to biologic disease-modifying antirheumatic drugs; NCT02886728: MTX-naïve) without rescue therapy could enter the LTE; patients taking FIL continued their dosage, and those who received comparators were rerandomised to FIL200 or FIL100. This analysis includes week 156 interim results. Among Japanese patients, 110 received FIL200, and 97 received FIL100. Mean (SD) FIL200 and FIL100 exposure was 157.0 (51.49) and 156.0 (52.45) weeks. The exposure-adjusted incidence rates (95% CI) for FIL200/FIL100 were 2.7 (1.4, 5.2)/2.4 (1.2, 5.1) for herpes zoster, 0.9 (0.3, 2.8)/1.0 (0.3, 3.2) for malignancy (excluding nonmelanoma skin cancer), and 0.6 (0.2, 2.4)/0.3 (0.0, 2.4) for major adverse cardiovascular events. More patients receiving FIL200 with prior FIL200 exposure achieved clinical remission vs other groups (including Clinical Disease Activity Index remission in 40% vs 27% or less at week 156). FIL200 and FIL100 were generally well tolerated by Japanese patients, without new, unexpected adverse events.

Constructing a Classification Scheme - and its Consequences: A Field Study of Learning to Label Data for Computer Vision in a Hospital Intensive Care Unit

Research on data annotation for artificial intelligence (AI) has demonstrated that biases, power, and culture impact the ways that annotators apply labels to data and subsequently affect downstream AI systems. However, annotators can only apply labels that are available to them in the annotation classification scheme. Drawing on a 3-year ethnographic study of an R&D collaboration between medical and AI researchers, we argue that the construction of the classification schema itself -- decisions about what kinds of data can and cannot be collected, what activities can and cannot be detected in the data, what the possible annotation classes ought to be, and the rules by which an item ought to be classified into each class -- dramatically shape the annotation process, and through it, the AI. We draw on Bowker and Star's [9] classification theory to detail how the creation of a training data codebook for a computer vision algorithm in hospital intensive care units (ICUs) evolved from its original, clinically-driven goal of classifying complex clinical activities into a narrower goal of identifying physical objects and simpler activities in the ICU. This work reinforces how trade-offs and decisions made long before annotators begin labeling data are highly consequential to the resulting AI system.

CONTExT-RA—a cross-sectional study evaluating disease activity, quality of life and the socio-demographic profile of Irish patients with rheumatoid arthritis

Abstract Objectives CONTExT-RA is a cross-sectional, non-interventional multicentre study which enrolled patients diagnosed with rheumatoid arthritis (RA) and receiving disease-modifying anti-rheumatic drug (DMARD) treatment in a secondary care setting. The study evaluated disease control and associated disease burden amongst this Irish population. Methods Patients with RA attending six Irish rheumatology centres, were invited to participate. Each consented patient attended a single routine study visit. Disease activity was assessed using Clinical Disease Activity Index (CDAI). The primary endpoint was EuroQol-5 dimensions (EQ-5D-5L) stratified by CDAI, compared using a non-parametric Wilcoxon Rank-Sum test. Results 130 patients were included. Using CDAI, 34 (26.2%) patients were in clinical remission (CR), 42 (32.3%) had low disease activity (LDA), 41 (31.5%) had moderate disease activity (MDA) and 13 (10.0%) had high disease activity (HDA). QoL (EQ-5D-5L index (median)) scores were significantly (p < 0.001) greater for patients in CR or CR/LDA than for those with MDA/HDA, 0.866 (0.920), 0.777 (0.822) vs 0.578 (0.691), respectively. Patients in CR reported higher levels of work productivity, mean (SD) rating of 1.7 (2.52) vs those in MDA/HDA of 4.2 (3.28) (higher rating indicates greater impairment). Similar findings were observed for non-work-related activities. Conclusion Disease control for many patients with RA, treated in secondary care in Ireland, is sub-optimal with only 1 in 4 in CDAI remission. The impact of poor disease control on QoL is significant, and the superior outcomes for patients in CR provide compelling evidence that by achieving greater disease control, the burden of disease on patients can be greatly reduced.

Healthcare utilisation patterns and drivers amongst inflammatory bowel disease patients in the outpatient clinic

Objective Inflammatory bowel disease (IBD), encompassing Crohn’s disease and ulcerative colitis, impose an escalating burden on healthcare systems globally, with a rising prevalence contributing to increased costs. This study explored healthcare utilisation patterns and its drivers amongst IBD patients in an outpatient clinic. Methods A longitudinal cohort study was conducted at a Dutch academic teaching hospital. IBD patients (n = 180) were followed for 1 year and were categorised based on disease activity and consultation frequency. Healthcare utilisation was assessed through consultations and laboratory tests. Patient-reported outcomes and biochemical disease activity were measured, and subsequently the reasons for consultations were analysed. Results The frequency of outpatient healthcare utilisation exceeded the recommended IBD care guidelines by two-fold. Comorbidities were the leading reason for consultations (40.4%), followed by remission induction, medication changes and pending test results. Moreover, clinical disease activity, reported problems with self-care, daily activities and pain were predictive of an increase in annual consultations. Conclusion This study identified factors influencing healthcare utilisation in IBD outpatients. Personalised care pathways using eHealth technologies have the potential to reduce unnecessary consultations and optimise resource allocation.

Predictors of the effectiveness to first-line CTLA4-Ig in patients with rheumatoid arthritis: the FIRST registry.

This study aimed to elucidate which bio-naïve patients with rheumatoid arthritis (RA) are suitable for treatment with CTLA4-Ig. This study enrolled 953 patients with RA who were administered their first biological disease-modifying antirheumatic drug (CTLA4-Ig, n = 328; tumour necrosis factor inhibitor [TNFi], n = 625) from July 2013 to August 2022. The primary outcome was the Clinical Disease Activity Index (CDAI) remission rate at week 24 in each group, adjusted using Propensity Score-based Inverse Probability of Treatment Weighting (PS-IPTW). After minimizing selection bias using PS-IPTW, the CDAI remission showed no significant difference between the CTLA4-Ig and TNFi groups (p= 0.464). Multivariable logistic regression analysis identified low baseline Health Assessment Questionnaire-Disability Index (HAQ-DI) scores as a contributing factor to the CDAI remission rate at week 24 in both groups, along with high baseline anti-citrullinated peptide antibody (ACPA) levels in the CTLA4-Ig group. However, among patients with high baseline HAQ-DI scores and low baseline ACPA levels (≦57.2), the CDAI remission rate was significantly higher in the TNFi group (29.8%) compared with the CTLA4-Ig group (5.9%, p< 0.0001). Among patients with high baseline HAQ-DI scores and ACPA levels (>57.2), the CDAI remission rate was significantly higher in the CTLA4-Ig group (35.6%) compared with the TNFi group (22.1%, p= 0.0057). Bio-naive RA patients with low HAQ-DI scores showed high treatment efficacy with no significant difference between CTLA4-Ig and TNFi. Among patients with high baseline HAQ-DI scores, TNFi and CTLA4-Ig were more likely to be effective in those with lower and higher baseline ACPA levels, respectively.

Clinical efficacy and its influencing factors of ustekinumab in the treatment of patients with Crohn's disease

To analyze the clinical efficacy and its influencing factors of ustekinumab (UST) in the treatment of patients with Crohn's disease (CD). From January 2021 to January 2024, CD patients who received UST treatment were retrospectively collected from the Second Affiliated Hospital of Wenzhou Medical University. Harvey-Bradshaw index were applied to assess clinical activity of CD patients, C-reactive protein was used to evaluate biochemical remission rate, and simplified Crohn's disease endoscopy score was used to evaluate the degree of intestinal inflammation. Logistic regression model was used to analyze the influencing factors for the clinical response rate at week 8, as well as the clinical remission rate and endoscopic remission rate at week 32. A total of 138 CD patients were included, including 93 males and 45 females. The age of diagnosis [M (Q1, Q3)] was 24 (19, 32) years old. At week 8, the clinical response rate and biochemical remission rate was 58.0% and 49.3%, respectively. Multivariate logistic regression model analysis showed that disease behavior (stenosis or penetration) was the risk factor of the clinical response rate at week 8 (OR=0.46, 95%CI: 0.23-0.95). The clinical remission rate and endoscopic remission rate at week 32 were 56.5% and 37.7%, respectively. Multivariate logistic regression model analysis showed that disease behavior (stenosis or penetration) was the risk factor of the clinical remission rates (OR=0.18, 95%CI: 0.08-0.42) and endoscopic remission rates (OR=0.25, 95%CI: 0.11-0.55) at week 32. Failure to achieve clinical response at week 8 was the risk factor of the clinical remission rates (OR=0.21, 95%CI: 0.09-0.52) and endoscopic remission rates (OR=0.19, 95%CI: 0.07-0.50) at week 32. UST treatment has good clinical efficacy in CD patients. CD patients with intestinal stenosis or penetrating lesions can decrease the efficacy of UST treatment. Failure to achieve clinical response at week 8 can decrease the efficacy at week 32.

Exploring the suitability of a ward-based clinical pharmacy activity collection tool for ambulatory care practice: a mixed-methods study.

At a London-based hospital, a validated ward-based clinical pharmacy activity collection tool has been used to monitor activities of clinical pharmacy teams across all settings, including ambulatory care services. No data confirm its representativeness for the full range of ambulatory clinical pharmacy services, and pharmacists share this concern. This study aimed to identify the range of clinical pharmacy activities in ambulatory care, assess the suitability of the existing ward-based tool for capturing these activities, and recommend modifications. Non-participant direct observations were conducted to record pharmacists' clinical activities in ambulatory clinics and multidisciplinary meetings. These observations were compared to the existing ward-based tool to identify discrepancies. Semi-structured interviews with eight ambulatory pharmacists were transcribed verbatim and thematically analysed inductively to explore the tool's representativeness of their routine clinical activities. Twenty-nine clinical pharmacy activities were observed in ambulatory services. Only fifteen were captured by the existing tool, with therapy monitoring and recommending therapeutic changes not accurately captured. Pharmacists agreed that the tool was not fully representative and included irrelevant activities. Four common uncaptured activities were multidisciplinary meeting-specific activities, arranging laboratory tests, monitoring patient outcomes, and liaising with community healthcare professionals. This study identified 33 candidate ambulatory clinical pharmacy activities. The existing ward-based tool does not fully capture the full range of ambulatory care clinical pharmacy activities, highlighting the need for an improved tool. Pharmacists recommended including the uncaptured activities. The candidate activities provide a foundation for standardised measurement of relevant ambulatory care activities to enable effective workforce deployment and improve patient outcomes.

The impact of SARS-CoV-2 (COVID-19) pandemic on educational and professional growth of young Italian epileptologists: a survey of the Young Epilepsy Section-Italian chapter.

In March 2020, the World Health Organization declared the coronavirus-related disease SARS-CoV-2 infection pandemic. Italy was one of the most affected countries and managed the emergency also by a health care reorganization. The Education and Career Development Task Force of the Young Epilepsy Section-Italy (YES-I) designed a survey to assess the impact of the pandemic on the training and work of young epileptologists (< 40years). Fifty-three responses were collected: 45.3% were resident, 9.4% PhD students and the remainder specialists. Clinical activity changed for most (83%) during the pandemic. Educational activity at epilepsy centers was reduced for 35.8% of the survey participants, while 30.2% of research projects involving patients participation were stopped to switch mainly to COVID-19-related research. For 73.6% of survey participants, attending online courses and congresses was easier in terms of cost and organization, although for 50.9% the level of training was lower in quality. In contrast, 58.5% rated the webinars organized by YES-I very educational. Less than 50% of the clinicians used telemedicine in the pandemic period and continue to use it. Despite several positive aspects of virtual medicine, a small number (32.1%) of our interviewees were satisfied from telemedicine and few of them (30.2%) reported that it led to improvement of clinical practice. Our survey showed that the pandemic has had a negative impact on training, research and clinical activity in the epilepsy field; moreover, it underlined the critical aspects of virtual communication methods in order to improve its use for the future.

Current Status of the clinical role in Spanish interventional radiology: An online survey among the Spanish Society of Vascular and Interventional Radiology (SERVEI) members

PurposeThis work aims to provide an overview of the current reality of clinical practice in interventional radiology in Spain, evaluating clinical activity, interventional radiologists’ opinion on the importance of playing a proactive clinical role, and the barriers they encounter in doing so. Materials and MethodsThe study was based on an 18-question survey divided into four categories: general aspects, clinical activity, opinion on a proactive clinical role, and barriers. The questionnaire, validated by the Spanish Society of Vascular and Interventional Radiology (SERVEI), was distributed to all members (n = 483) via email. A descriptive statistical analysis was performed. ResultsThe response rate was 26.5% (128/483). A total of 44.5% (57/128) had admitting privileges, 70.3% (90/128) had consultations, 32.8% (42/128) did ward rounds, and 94.5% (121/128) participated in multidisciplinary committees. Most spent just 0%–10% of their workday on clinical activity. A total of 43.7% (56/128) reported providing longitudinal care for their patients. On a Likert scale from 1 to 10, the importance of performing pre-procedural consultations was rated a mean of 8.3 (IQR: 10–8), post-procedural consultations 8.1 (IQR: 10–7), and care during hospitalization 7.7 (IQR: 10–6). The main obstacles were a lack of time/excessive workload and inadequate professional resources. ConclusionsSpanish interventional radiologists demonstrated a clear awareness of the importance of providing longitudinal patient care. However, they reported only partially taking on the clinical responsibilities for the patients they treated.

Application of superb microvascular imaging technology in clinical disease activity of rheumatoid arthritis.

Detection of synovitis is essential for assessing the activity and predicting the prognosis of rheumatoid arthritis (RA). The aim of this study was to investigate the diagnostic performance of superb microvascular imaging (SMI) in RA patients with high, moderate, and low activity. One hundred four patients with active RA were selected from the hospital between May 2022 and August 2023. The study observed the correlation between bone erosion of the carpal joint, joint cavity effusion, thickness of synovial hyperplasia of the carpal joint, positivity rate of synovial blood vessels, and their semiquantitative scores with the clinical disease activity of RA using SMI examination. The detection of synovial hyperplasia thickness and joint effusion in the high-activity group was higher than that in the low-activity group, and the difference was statistically significant (P < 0.05). The quantitative SMI test demonstrated that the synovial blood flow grading and semiquantitative grade increased gradually with activity level (P<0.05). During the high, moderate, and low-activity groups, the vascular index (VI) value of the hyperplastic synovial membrane decreased gradually, showing statistical significance both between and within the groups (P<0.05). SMI technology exhibited high sensitivity and accuracy in assessing disease activity in RA. It holds significant clinical application value as a reliable auxiliary tool for assessing disease activity in RA and treatment. Key Points • Super micro-vascular imaging (SMI) demonstrated higher detection rates of microvesselsin RA patients with high disease activity compared to those with low activity, showing statistical significance. • The quantitative SMI test revealed a clear correlation between synovial blood flow grading and disease activity levels in RA patients, highlighting the potential of SMI as a valuable tool for disease activity and treatment of rheumatoid arthritis.

Implementation and effectiveness of guideline-recommended clinical activities for children with asthma: population-based cohort

BackgroundGuidelines advise minimising asthma exacerbation risk is achieved partially through good clinical practice activities, including scheduled asthma reviews, inhaler technique checks and asthma management plans. We assessed how frequently these activities are provided and how effective they are in clinical practice. Research questionDo guidelines-recommended activities such as asthma reviews, inhaler technique checks and asthma management plans prevent asthma exacerbations Study design and methodsThis is a retrospective chart review using UK primary-care medical records between 2004-2021, linked to hospital records. Children were eligible from asthma diagnosis until aged 16 years. Annual implementation of asthma review, inhaler technique check, management plan was measured. Risk factors for them not being undertaken were determined using multivariable logistic regression. Self-controlled case series (SCCS) was adopted to assess the effectiveness of each activity over 12-months; this was divided into two 6-month periods. Results126,483 children were eligible; 30-45% received each annual activity, 8% received all three together. Risk factors for not receiving activities included younger age, more socioeconomic deprivation, higher or no BMI measurement. Management plans and asthma reviews, as standalone activities, were associated with approximately 15% exacerbation reduction over 12-months and 8% over 6-months, respectively (management plan, N=4,624; 0-6 months (IRR, 95%CI): 0.87, 0.79-0.96; 6-12 months: 0.83, 0.73-0.95; asthma review, N=6,948; 0-6 months: 0.92, 0.85-0.99; 6-12 months: 0.93, 0.83-1.03). Standalone inhaler technique checks were not associated with exacerbations. Provision of all activities together was associated with approximately 30% exacerbation reduction over 12-months (N=3,643, 0-6 months: 0.76, 0.68-0.85; 6-12 months: 0.69, 0.60-0.81). InterpretationMost UK children do not receive the guideline-recommended activities to monitor their asthma. This study suggests, if implemented, they are effective in clinical practice and maximally effective when combined in the same visit.

Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial

Safety, clinical activity, pharmacodynamics, and pharmacokinetics of IMU-856, a SIRT6 modulator, in coeliac disease: a first-in-human, randomised, double-blind, placebo-controlled, phase 1 trial

Nomogram model based on clinical factors and autonomic nervous system activity for predicting residual renal function decline in patients undergoing peritoneal dialysis

Nomogram model based on clinical factors and autonomic nervous system activity for predicting residual renal function decline in patients undergoing peritoneal dialysis

Using Patient Reported Outcomes Measurement Information System (PROMIS®) Measures in Rheumatoid Arthritis Clinical Care, Research, and Trials

Patient-reported outcomes (PROs) are reports coming directly from patients about how they feel and function. PROs in the Rheumatoid Arthritis (RA) Core Set include the patient global assessment, and self-ratings of pain and physical function. As a result, these outcomes are widely collected in trials. The patient global assessment is a component included in several RA disease activity indices including the clinical disease activity index (CDAI) and the disease activity score (DAS28), which guide clinical decision-making for the initiation, maintenance, and change of disease modifying anti-rheumatic drugs (DMARDs).

Clinical effectiveness of baricitinib and abatacept in patients with rheumatoid arthritis

AbstractAimThe objective of this study was to compare the clinical effectiveness of baricitinib and abatacept in patients with rheumatoid arthritis (RA).MethodsThis study included 274 patients treated with abatacept and 241 treated with baricitinib who were followed for &gt;52 weeks. Potential treatment selection bias was addressed by using inverse probability of treatment weighting. The paired t‐test was used to assess differences in Clinical Disease Activity Index (CDAI) score relative to baseline. A generalized estimating equation was used to compare the two treatment groups.ResultsThe estimated mean CDAI score was 18.2 at baseline and significantly decreased to 12.6 at 4 weeks, 8.9 at 12 weeks, 7.4 at 24 weeks, and 6.1 at 52 weeks in the abatacept group. The estimated mean CDAI score was 18.6 at baseline and significantly decreased to 9.5 at 4 weeks, 6.5 at 12 weeks, 5.7 at 24 weeks, and 5.5 at 52 weeks in the baricitinib group. The baricitinib group had significantly lower CDAI scores at 4, 12, and 24 weeks compared to the abatacept group. Subgroup analyses revealed that this difference was evident among patients with high disease activity and without concomitant use of methotrexate but was less pronounced among those with remission to moderate disease activity status with methotrexate use.ConclusionBoth baricitinib and abatacept were effective in reducing disease activity in patients with RA. Baricitinib demonstrated potential advantages over abatacept in terms of early disease control, particularly in patients with high disease activity and without methotrexate use.