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The human endogenous retroviruses (HERVs) are a family of endogenous retroviruses that integrated into the germ cell DNA of primates over 30 million years ago. HERV expression seems impaired in several diseases, ranging from autoimmune to neoplastic disorders. The purpose of this study was to evaluate the overall endogenous retroviral transcription profile in bone marrow (BM) samples. A total of 30 paediatric high-risk leukaemia patients (lymphoid and myeloid malignancies) were tested for HERVs virus gene expression. Our findings show that HERV-K expression was significantly higher in leukaemia patients when compared to healthy donors of a similar median age. We observed a significantly high expression of HERV-K in acute lymphoblastic leukemia (ALL) patients. In this study, we also found a relative overexpression of the endogenous retrovirus HERV-K in BM cells from the majority of leukemia samples analyzed, in particular in ALL. This overexpression might be related to lymphatic leukemogenesis and it warrants further investigations.

Background: Treating rheumatic musculoskeletal diseases (RMDs) during pregnancy and breastfeeding presents significant complexities, mainly due to inconsistencies between the clinical guidance documents and the reference safety information, including the summary of product characteristics (SmPC) and the patient information leaflets (PIL). Objectives: To assess healthcare professionals’ (HCPs) prescribing behaviors, comfort levels, and challenges when advising patients, focusing on discrepancies between clinical guidance documents and SmPC/PIL. Design: Online survey entitled PRAISE (Perception of healthcare providers Regarding Antirheumatics in pregnancy and breastfeeding: advice, Information and patient perSpEctives) and disseminated through HCPs groups and social media. Methods: A cross-sectional survey was conducted among 414 HCPs globally. Respondents were divided into prescribers (n = 336) and non-prescribers (n = 78) based on their self-reported role in prescribing antirheumatic medications to pregnant or breastfeeding patients with RMDs. The survey covered demographics, clinical experience, confidence in prescribing, use of clinical guidelines, and experiences managing conflicting information between guidelines and SmPC/PIL. Results: Prescribers were more likely than non-prescribers to feel comfortable discussing medication safety during pregnancy. Most prescribers found clinical guidance documents useful, with 48% rating them as “very useful” and 38% as “extremely useful.” In case of conflicting information between clinical guidance documents and SmPC/PIL, 58% of HCPs reported that it caused confusion and tension in patient–doctor relationships, and almost 20% of them are “likely” or “very likely” to discontinue ongoing treatment. Clear communication and shared decision-making were the most common strategies used to address patient concerns. Conclusion: HCPs often face significant challenges when advising patients with RMDs on the use of medications during pregnancy and breastfeeding. Conflicting information between clinical guidance documents and SmPC/PIL can disrupt patient–doctor relationship and lead to treatment discontinuation, with potential consequences on maternal disease control. Improved alignment between clinical guidance documents and the SmPC/PIL could enhance patient care and prevent confusion among HCPs and patients. Plain language summary When the patient leaflet and the clinical guidelines say different things on the use of antirheumatic medications during pregnancy and breastfeeding: global health care providers say that conflicting information can cause confusion and tension in the patient-clinician relationship Background: When pregnant or breastfeeding, women with rheumatic musculoskeletal diseases (RMDs) face challenges in managing their condition due to conflicting information about medication safety. Healthcare providers (HCPs) often struggle with discrepancies between clinical guidelines and the safety information provided with medications, such as the Summary of Product Characteristics and Patient Information Leaflets. This discrepancy can lead to difficulties in advising patients about safe medication use during pregnancy and breastfeeding. HCPs might feel uncertain or uncomfortable discussing medication safety, which can affect the patient-doctor relationship and even lead to stopping necessary treatments. The PRAISE study: To understand these challenges better, the PRAISE study conducted an online survey among 414 HCPs worldwide. We aimed to assess how HCPs prescribe medications, their comfort levels in advising patients, and the challenges they face due to conflicting information. Our key findings include: Confidence in prescribing: HCPs who prescribe medications were more comfortable discussing medication safety during pregnancy than those who do not prescribe. Usefulness of guidelines: Most prescribers found clinical guidelines very useful in managing patient care. Conflicting information: Over half of the HCPs reported feeling confused or tense when dealing with conflicting information between guidelines and medication safety documents. This confusion can lead to discontinuing treatments, which might negatively impact disease control. Communication strategies: HCPs often use clear communication and shared decision-making to address patient concerns. In conclusion, PRAISE highlights the need for better alignment between clinical guidelines and medication safety information to improve patient care and reduce confusion. This could help ensure that pregnant and breastfeeding women with RMDs receive the best possible.

Purpose To evaluate the effects of total body irradiation (TBI) on the endocrine system in adults treated with hematopoietic cell transplantation (HCT) during childhood. Methods We studied 40 patients who underwent HCT between 1988 and 2004, mainly for childhood cancer. In 23 patients, the conditioning regimen consisted of high-dose chemotherapy and TBI (TBI+). In the other 17 patients, who did not receive TBI (TBI−), HCT was performed after high-dose chemotherapy alone. Results Overall, 34% of patients in the TBI+ group showed growth hormone deficiency, compared with none of the patients in the TBI− group ( P  < 0.05). Leydig cell failure was found in 23% of patients in the TBI+ group and in 0% of the patients in the TBI− group. Elevated FSH levels, suggesting spermatogenesis damage, were found in all the patients receiving TBI and in 36% of the patients in the TBI− group ( P  < 0.001). Also, primary hypothyroidism was more common in TBI+ (34%) than in TBI− (5.8%) patients ( P  < 0.05). Conclusions Our data indicate that endocrine late effects after HCT are more frequent in patients who received TBI, an observation that should be considered, even if the choice of the conditioning regimen is determined by the underlying condition in most cases.

ObjectiveTo identify the best evidence on the efficacy of pharmacological interventions in reducing fatigue in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and to summarise their safety in the identified studies to inform European Alliance of Associations for Rheumatology recommendations for the management of fatigue in people with I-RMDs.MethodsSystematic review of adults with I-RMDs conducted according to the Cochrane Handbook. Search strategy ran in Medline, Embase, Cochrane Library, CINAHL Complete, PEDro, OTseeker and PsycINFO. Only randomised controlled trials (RCTs) or controlled clinical trials were eligible. Assessment of risk of bias, data extraction and synthesis performed by two reviewers independently and in duplicate. Data pooled in statistical meta-analyses.ResultsFrom 4151 records, 455 were selected for full-text review, 99 fulfilled the inclusion criteria and 19 RCTs were included in meta-analyses. Adalimumab was superior to placebo in reducing fatigue at 12 and 52 weeks in rheumatoid arthritis (RA) (n=3 and 2 RCTs; mean difference (MD)= −3.03, p<0.001; MD=−2.25, p=0.03, respectively). Golimumab (n=2 RCTs; 24 weeks: MD=−5.27, p<0.001), baricitinib (n=2 RCTs; 24 weeks: MD=−4.06, p<0.001), sarilumab (n=2 RCTs; 24 weeks: MD=−3.15, p<0.001), tocilizumab (n=3 RCTs; 24 weeks: MD=−3.69, p<0.001) and tofacitinib (n=3 RCTs; 12 weeks: MD=−4.44, p<0.001) were also superior to placebo in reducing fatigue in RA. A dose/effect relationship was observed for sarilumab, tocilizumab and tofacitinib. In spondyloarthritis (excluding psoriatic arthritis), secukinumab was superior to placebo in reducing fatigue at 16 weeks (n=2 RCTs; MD=−4.15, p<0.001), with a dose/effect relationship also observed. The narrative results of the RCTs not included in the meta-analysis indicated that several other pharmacological interventions were efficacious in reducing fatigue, with reassuring safety results.ConclusionsSeveral pharmacological interventions are efficacious and generally safe for managing fatigue in people with I-RMDs.

IntroductionAlthough patient-reported outcome measures (PROMs) are increasingly used in clinical practice and research, it is unclear whether these instruments cover the perspective of young people with inflammatory arthritis (IA). The aims of this study were to explore whether PROMs commonly used in IA adequately cover the perspective of young people from different European countries.MethodsA multinational qualitative study was conducted in Austria, Croatia, Italy and the Netherlands. Young people with either rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Still’s disease, psoriatic arthritis (PsA) or spondyloarthritis (SpA), aged 18–35 years, participated in semistructured focus group interviews. Thematic analysis was used and data saturation was defined as no new emergent concepts in at least three subsequent focus groups.ResultsFifty-three patients (21 with RA/JIA/Still’s, 17 with PsA, 15 with SpA; 72% women) participated in 12 focus groups. Participants expressed a general positive attitude towards PROMs and emphasised their importance in clinical practice. In addition, 48 lower level concepts were extracted and summarised into 6 higher level concepts describing potential issues for improvement. These included: need for lay-term information regarding the purpose of using PROMs; updates of certain outdated items and using digital technology for data acquisition. Some participants admitted their tendency to rate pain, fatigue or disease activity differently from what they actually felt for various reasons.ConclusionsDespite their general positive attitude, young people with IA suggested areas for PROM development to ensure that important concepts are included, making PROMs relevant over the entire course of a chronic disease.

ObjectivesFatigue is prevalent in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and recognised as one of the most challenging symptoms to manage. The existence of multiple factors associated with driving and maintaining fatigue, and the evidence about what improves fatigue has led to a multifaceted approach to its management. However, there are no recommendations for fatigue management in people with I-RMDs. This lack of guidance is challenging for those living with fatigue and health professionals delivering clinical care. Therefore, our aim was to develop EULAR recommendations for the management of fatigue in people with I-RMDs.MethodsA multidisciplinary taskforce comprising 26 members from 14 European countries was convened, and two systematic reviews were conducted. The taskforce developed the recommendations based on the systematic review of evidence supplemented with taskforce members’ experience of fatigue in I-RMDs.ResultsFour overarching principles (OAPs) and four recommendations were developed. OAPs include health professionals’ awareness that fatigue encompasses multiple biological, psychological and social factors which should inform clinical care. Fatigue should be monitored and assessed, and people with I-RMDs should be offered management options. Recommendations include offering tailored physical activity and/or tailored psychoeducational interventions and/or, if clinically indicated, immunomodulatory treatment initiation or change. Patient-centred fatigue management should consider the individual’s needs and preferences, their clinical disease activity, comorbidities and other psychosocial and contextual factors through shared decision-making.ConclusionsThese 2023 EULAR recommendations provide consensus and up-to-date guidance on fatigue management in people with I-RMDs.

ObjectivesA EULAR task force was convened to develop points to consider (PtC) for patient education in physical activity and self-management of pain in young people with juvenile-onset rheumatic and musculoskeletal diseases during transitional care.MethodsA task force of 26 people from 10 European countries followed the EULAR Standardised Operating Procedures to establish overarching principles (OAPs) and PtC based on a literature review and expert consensus. Level of evidence (LoE), grade of recommendation (GoR) and level of agreement (LoA) were determined.ResultsTwo OAPs and seven PtC were formulated. The OAPs highlight the importance of personalised transitional care in rheumatology, ideally based on shared decision-making and incorporate interactive education to empower young individuals in managing their physical activity and pain. The PtC emphasise the clinical importance of patient education in these areas to improve readiness to transfer from paediatric to adult care. For two PtC, the GoR was moderate (grade B), based on individual cohort study (LoE 2b). For the remaining five PtC, the GoR was weak (grade D), based on expert opinion (LoE 5). The LoA among the task force was high, ranging from 9.4 to 9.8, except for one PtC that was 8.7.ConclusionThese EULAR PtC establish guidance on best practices for delivering patient education in physical activity and self-management of pain during transitional care in rheumatology. The adoption of these PtC in clinical settings is recommended to standardise and optimise transitional care across European healthcare systems. Additionally, the task force expects that these PtC will drive future research and potentially shape policies across Europe.

ObjectiveTo identify the best evidence on the efficacy of non-pharmacological interventions in reducing fatigue in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and to summarise their safety in the identified studies to inform European Alliance of Associations for Rheumatology recommendations for the management of fatigue in people with I-RMDs.MethodsSystematic review of randomised controlled trials (RCTs) including adults with I-RMDs conducted according to the Cochrane Handbook. Search strategy ran in Medline, Embase, Cochrane Library, CINAHL Complete, PEDro, OTseeker and PsycINFO. Assessment of risk of bias, data extraction and synthesis were performed by two reviewers independently. Data were pooled in meta-analyses.ResultsFrom a total of 4150 records, 454 were selected for full-text review, 82 fulfilled the inclusion criteria and 55 RCTs were included in meta-analyses. Physical activity or exercise was efficacious in reducing fatigue in rheumatoid arthritis (RA) (standardised mean differences (SMD)=−0.23, 95% CI=−0.37 to −0.1), systemic lupus erythematosus (SLE) (SMD=−0.54, 95% CI=−1.07 to −0.01) and spondyloarthritis (SMD=−0.94, 95% CI=−1.23 to −0.66); reduction of fatigue was not significant in Sjögren’s syndrome (SMD=−0.83, 95% CI=−2.13 to 0.47) and systemic sclerosis (SMD=−0.66, 95% CI=−1.33 to 0.02). Psychoeducational interventions were efficacious in reducing fatigue in RA (SMD=−0.32, 95% CI=−0.48 to −0.16), but not in SLE (SMD=−0.19, 95% CI=−0.46 to 0.09). Follow-up models in consultations (SMD=−0.05, 95% CI=−0.29 to 0.20) and multicomponent interventions (SMD=−0.20, 95% CI=−0.53 to 0.14) did not show significant reductions of fatigue in RA. The results of RCTs not included in the meta-analysis suggest that several other non-pharmacological interventions may provide a reduction of fatigue, with reassuring safety results.ConclusionsPhysical activity or exercise and psychoeducational interventions are efficacious and safe for managing fatigue in people with I-RMDs.