Key statements of the Russian clinical guidelines on the diagnosis and treatment of osteoporosis are summarized. They were developed by a task force representing the key Russian professional associations involved in the management of osteoporosis and approved by the Russian Ministry of Health.
OBJECTIVE: To summarize key statements of the Russian clinical practice guidelines for the diagnosis and treatment of osteoporosis.
METHODS: The Russian clinical guidelines on the diagnosis and treatment of osteoporosis were developed by a task force representing the key Russian professional associations involved in the management of osteoporosis: These comprised the Russian Association of Endocrinologists, the Russian Association for Osteoporosis, the Association of Rheumatologists of Russia, the Association of Orthopedic surgeons and Traumatologists of Russia, the Russian Association of Gynecologists-Endocrinologists, and the Russian Association of Gerontologists and Geriatrics. The guidelines are based on a systematic literature review and principles of evidence-based medicine and were compiled in accordance with the requirements for clinical recommendations developed by the Ministry of Health of the Russian Federation.
RESULTS: Key statements included in the Russian guidelines of osteoporosis approved by the Russian Ministry of Health in 2021 are summarized. The statements are graded based on levels of evidence and supported by short comments. The guidelines are focused on the current approach to screening, diagnosis, differential diagnosis, and treatment of osteoporosis.
CONCLUSIONS: These guidelines are a practical tool for general practitioners, as well as medical specialists, primarily endocrinologists, rheumatologists, orthopedic surgeons, and other physicians who are involved in the management of patients with osteoporosis.

BACKGROUND: With the introduction of tumor necrosis factor (TNF) alpha inhibitors, the treatment of inflammatory rheumatic diseases (IRD) has undergone a fundamental change. Several of the originally high-priced biologics are now accessible as lower cost biosimilars, removing a significant impediment to prescription.
OBJECTIVE: The present study investigated whether the availability of biosimilars is associated with an improvement in the care of IRD. Moreover, the subjective acceptance of biosimilars by physicians and patients was investigated and compared with objectifiable parameters.
METHODS: Pseudonymized claims data of the Bavarian Association of Statutory Health Insurance Physicians from 2014 to 2019 as well as a paper and pencil survey of patients and rheumatologists formed the data basis of the study.
RESULTS: During the observation period, the proportion of diagnosed patients receiving drug therapy increased from 38.5% to 43.2%. Also, the care changed in terms of the prescribed agents. Conventional drug therapy declined overall and, in particular, glucocorticoid prescriptions decreased from 39.3% in 2014 to 34.3% in 2019. At the same time, the proportion of targeted treatments increased from 12.3% to 20.4%. The median duration of basic treatment before first-time bDMARD use dropped from 3.15 years in 2014 to 2.17 years in 2019.
CONCLUSIONS: Over the observation period, in which three biosimilars entered the market, the care of patients with IRD improved both quantitatively and qualitatively. The market share of biosimilars increased in parallel with this development. With an overall high acceptance of biosimilars, the assessment of the disease course by physicians and patients indicates a slight subjectively perceived advantage of therapy with originals compared to biosimilars, which, however, is not confirmed when standardized scores are applied. A possible explanation for this might be a nocebo effect, which could be minimized by suitable communication strategies.
UNASSIGNED: HINTERGRUND: Mit Einführung der Tumornekrosefaktor(TNF)-α-Blocker hat die Behandlung entzündlich rheumatischer Erkrankungen (ERE) einen grundlegenden Wandel erfahren. Etliche der ursprünglich hochpreisigen Biologika verloren im Verlauf der Studie ihren Patentschutz und standen seitdem als kostengünstigere Biosimilars zur Verfügung, sodass ein bedeutsames Verordnungshemmnis entfallen ist.
UNASSIGNED: In der vorliegenden Studie wurde untersucht, ob die Verfügbarkeit von Biosimilars mit einer Verbesserung der Versorgung von ERE einhergeht. Zugleich wurde die subjektive Akzeptanz von Biosimilars bei Ärzten und Patienten untersucht und mit standardisierten Scores abgeglichen.
METHODS: Als Datengrundlage dienten pseudonymisierte Abrechnungsdaten der Kassenärztlichen Vereinigung Bayerns von 2014 bis 2019 sowie eine Paper-Pencil-Befragung von Patienten und Rheumatologen.
UNASSIGNED: Im Beobachtungszeitraum stieg der Anteil an diagnostizierten Patienten, die eine Arzneimitteltherapie erhielten, von 38,5 % auf 43,2 % an. Deren Versorgung veränderte sich auch in Bezug auf die verordneten Wirkstoffe. Die konventionelle medikamentöse Therapie war insgesamt rückläufig. Insbesondere die Verordnung von Glukokortikoiden sank von 39,3 % in 2014 auf 34,3 % in 2019. Zugleich stieg der Anteil zielgerichteter Behandlungen von 12,3 % auf 20,4 %. Die mediane Dauer der Basistherapie vor erstmaligem bDMARD-Einsatz verkürzte sich von 3,15 Jahren in 2014 auf 2,17 Jahre in 2019.
CONCLUSIONS: Über den Beobachtungszeitraum, in den auch der Markteintritt von 3 Biosimilars fällt, verbesserte sich die Versorgung von Patienten mit ERE quantitativ wie qualitativ. Der Versorgungsanteil von Biosimilars nahm parallel zu der aufgezeigten Entwicklung zu. Bei insgesamt hoher Akzeptanz von Biosimilars verweist die Einschätzung des Krankheitsverlaufes von Ärzten und Patienten auf einen leichten, subjektiv wahrgenommenen Vorteil der Therapie mit Originalen im Vergleich zur Biosimilar-Therapie, der sich bei Anwendung standardisierter Scores jedoch nicht bestätigt. Eine mögliche Erklärung hierfür könnte ein Nocebo-Effekt sein, der durch geeignete Kommunikationsstrategien minimiert werden könnte.

BACKGROUND: Juvenile Idiopathic Arthritis (JIA) is the most common rheumatic inflammatory disease in childhood. Optimal management requires clinicians to be up to date with the rapidly evolving evidence base. \'Living\' evidence-based clinical practice guidelines, which integrate new evidence as soon as it is available, are a novel method to enhance the translation of research into practice. To determine the most relevant questions that should be prioritised in national Australian JIA living guidelines, we invited Australian and New Zealand paediatric rheumatologists and other relevant health professionals to identify and rank their most important questions in order of priority.
METHODS: All 47 members of the Australian Paediatric Rheumatology Group (APRG) were invited to participate in a modified Delphi study comprising two rounds. The first round identified demographic information of respondents, current attitudes to guideline use and invited submission of priority management questions. The second round asked respondents to rank 27 collated and refined questions identified in round one in order of priority.
RESULTS: There were 29 (62%) and 28 (60%) responses to the first and second survey rounds respectively. About two thirds were rheumatologists or trainees (66, 68%), nearly half had more than 10 years of experience (45, 46%) and practice setting was largely hospital (79, 86%) and urban (86, 75%). Most respondents used clinical guidelines in their practice (72% sometimes, 24% often), most frequently American College of Rheumatology (ACR) (66%) and European Alliance of Associations for Rheumatology (EULAR) (59%) guidelines. Reported barriers to guideline use included that they are not up to date and access difficulties. Most respondents (83%) considered Australian guidelines were necessary and two-thirds indicated they would use them if integrated into practice software. The highest ranked topics were down-titration and discontinuation of disease modifying anti-rheumatic drugs (ranked first), best outcome measures (second) and treatment targets in JIA (third).
CONCLUSIONS: There is strong clinician support for the development of Australian living guidelines for JIA. Consensus was reached on the ten top-ranked priority questions. Our guidelines will develop evidence-based recommendations for these high priority questions that will be updated in real time as needed to facilitate rapid translation of evidence into clinical practice.

To identify consensus of rheumatologists on components of best practice rheumatology service in district health boards (DHB) in Aotearoa New Zealand (AoNZ).
A consensus survey of rheumatologists in AoNZ was informed by an initial survey inviting modifications to statements about best practice rheumatology from international literature and requested additional statements. The three-round consensus email exercise asked rheumatologists to indicate their level of agreement with each statement for a DHB serving a small or large population. Consensus for each statement was achieved when ≥80% of participants\' votes were within a pre-determined category (essential, potentially desirable, to be avoided).
Ten rheumatologists reviewed the 19 initial statements with three additional statements offered-the consensus survey had 22 statements. Twenty-six rheumatologists responded in the first consensus round, with 21/26 (81%) responding in rounds two and three. After three rounds, 16 statements met consensus as essential for both small and large DHB rheumatology services. One statement met consensus as potentially desirable for a large rheumatology service. Five statements did not reach consensus.
The component statements identified by consensus can inform policy and implementation of rheumatology services in the AoNZ health system reforms and be used for benchmarking.

OBJECTIVE: Psoriatic arthritis (PsA), a chronic inflammatory arthropathy, is often underdiagnosed in Middle Eastern countries, substantially impacting the treatment of affected individuals. This article aims to highlight current unmet clinical needs and provide consensus recommendations for region-specific evaluation methods and nonpharmacological therapies in the United Arab Emirates (UAE).
METHODS: An extensive literature review was conducted, focusing especially on global and regional guidelines for the evaluation and treatment of PsA. These form the basis of the consensus statements formulated. Additionally, an expert panel of key opinion leaders from the UAE reviewed these guidelines and available literature at an advisory board meeting to identify unmet needs, bridge clinical gaps in the UAE, and develop consensus statements for the evaluation and treatment of PsA.
RESULTS: The consensus statements were developed based on overarching principles for the management of PsA, evaluation of patients with PsA, and nonpharmacological approaches for the management of PsA. The overarching principles included adopting a targeted, multidisciplinary approach, along with collaboration between rheumatologists and dermatologists in cases of clinically significant skin involvement. The panel also highlighted the value of composite disease severity measures for characterizing clinical manifestations of PsA. In terms of nonpharmacological management approaches, lifestyle modification (comprising dietary change, exercise, and cessation of smoking) and psychotherapy were recommended.
CONCLUSIONS: The consensus statements will aid healthcare professionals in clinical decision-making in the context of PsA.

UNASSIGNED: Recent approvals for novel agents such as the small molecule Janus kinase inhibitors (JAKi), combined with the advent of biosimilars has widened the gamut of available therapeutic options in the treatment of rheumatoid arthritis (RA). This combined with the introduction of mandatory non- medical switches to biosimilars in some jurisdictions by both public and private payors has led to a significant increase in the volume of therapeutic changes for patients. Pharmacists are well positioned to ensure effective and safe transitions, however there is a significant unmet need for objective and subjective clinical guidance around therapy as well disease state monitoring in RA that facilitates best practices throughout the patient journey.
UNASSIGNED: In this paper we aim to create a consensus derived monitoring algorithm for pharmacists to facilitate best practices throughout therapeutic transitions from originator biologic to other originator biologics, biosimilars, and Janus kinase inhibitors in RA.
UNASSIGNED: The Nominal Group Technique (NGT) was used to understand if consensus could be found among the participants. Clinically relevant questions were developed to capture solutions to the identified unmet need. The faculty considered the questions as individuals, and privately generated answers/ideas. After discussion and consideration, the participants ranked the ideas and established a consensus.
UNASSIGNED: Based on the outcome of the consensus discussions, an algorithm was created to help guide pharmacists through therapeutic transitions in RA. The tool covers important topics such as pre-transition considerations, avoiding the nocebo effect for biosimilars, specific considerations for each drug or class, monitoring efficacy, and when to refer.
UNASSIGNED: New classes of anti-rheumatic drugs including JAKi, along with the introduction of biosimilars are presenting more opportunity for therapeutic changes and monitoring in patients with RA. We hope our evidence-based consensus derived guidance tool will assist frontline pharmacists in supporting their patients to a successful therapeutic transition in RA.

UNASSIGNED: International recommendations are intended to help rheumatologists in the effective management of rheumatoid arthritis (RA) through an evidence-based approach. This research aimed to evaluate management patterns and associated difficulties encountered by rheumatologists in daily practice.
UNASSIGNED: Interviewers recruited 101 Polish rheumatologists in a random quota-based, nationwide sample of outpatient clinics. Quantitative data were input online using a computer-assisted web interview tool.
UNASSIGNED: Disease-modifying antirheumatic drugs (DMARDs) are not initiated at the time of diagnosis in 15% of RA patients, most often due to difficulties in patient-provider communication. The RA activity is assessed every 4 to 6 months by 30% of rheumatologists, and 64% of patients are reported to never achieve remission. Composite indices are the most reliable indicators of remission only for 38% of responders. Despite inadequate disease control with ≥ 2 treatment schedules with synthetic DMARDs, 34% of these patients are not considered for biological DMARDs (bDMARDs). Contraindications and reimbursement barriers are the most frequently stated reasons. Therapy with glucocorticoid (GC) lasting over 3 months is reported by 70% of rheumatologists. International recommendations are stated as the most common basis for treatment decisions.
UNASSIGNED: Awareness of recommendations is not sufficient to ensure their application in clinical practice. Inadequate management of RA is quite prevalent, with a substantial contribution of non-medical factors. Daily practice mainly deviates from guidelines regarding frequency and mode of monitoring measures, time to DMARD initiation, and duration of GC treatment. Education programs and policy changes may significantly narrow the gap between evidence and practice.

BACKGROUND: Biologics are now key drugs in the management of immune-mediated inflammatory diseases. However, the increasingly complex biologics environment and growing cost pressures in the UK have led to variability in drug commissioning and inequity of patient access across regions.
OBJECTIVE: Our objectives were to provide consensus recommendations for enhancing the current situation in biologic prescribing in the UK by balancing clinical freedom with equitable distribution of biologics given the limited availability of resources.
METHODS: A modified Delphi approach was used to reach integrated, cross-specialty consensus among dermatologists, rheumatologists and gastroenterologists practising within the English National Health Service (NHS).
RESULTS: We describe the concepts of clinical freedom and clinical judgement and demonstrate how, together with patient choice, they can be exercised in the context of biologic prescribing in the NHS. We highlight that in England, local variations occur that are at odds with National Institute for Health and Care Excellence (NICE) guidance; these variably limit the degree to which clinicians can exercise clinical freedom and impact on equity of patient access to treatments. We define factors encompassing a drug\'s value and identify challenges to the measurement and interpretation of this concept, which can raise barriers to the freedom of clinical choice and appropriate prescribing decisions allowing practices of holistic and personalised medicine. Cross-specialty consensus recommendations on ensuring equitable access to biologics in the NHS while protecting appropriate and individualised drug selection for patients are provided. We have also provided strategies for improving physician-commissioner communication to harmonise equity of patient access to biologics across England and improve patient outcomes. Commentary from patient advisory groups indicates that they welcome our exploration that value does not equal cost and agree that there should be an emphasis on shared decision making, which requires the clinician to practice clinical freedom by aligning the patient\'s needs and preferences with available treatment choices.
CONCLUSIONS: This consensus highlights the need to strike a balance between clinical freedom and short-term cost restrictions to support equitable resource distribution within the English NHS. Consideration of these recommendations may help to harmonise local, regional and national services and balance equity of patient access to biologic treatments with excellence in the NHS.

Hydroxychloroquine (HCQ) retinal toxicity is an ongoing concern for rheumatologists. The revised 2016 American Academy of Ophthalmology (AAO) guidelines created controversy regarding the correct dosing and evaluation of HCQ toxicity. The current study was initiated to further understand rheumatologists\' practices regarding HCQ.
A questionnaire-based survey was distributed electronically to rheumatologists. We collected information on HCQ dosing, clinical decision-making processes, familiarity with the AAO 2016 guidelines, and perceived disparities between the AAO 2016 guidelines and rheumatological clinical practice.
78 rheumatologists completed the survey (49% from USA, 90% academic practices, 82% self-identified as lupus experts). Only lupus expert (n=64) data were included in subsequent analysis. The mean cohort size was 747 (50-6571), a total cohort 45 612 patients. HCQ was prescribed to >75% of patients with SLE by 81.3% of SLE experts, with routine counselling about ophthalmic risks. The typical dose of HCQ used was 200-400 mg/day. 17% of rheumatologists use doses up to 600 mg/day, while 6.2% use up to 6.5 mg/kg/day. HCQ adherence is routinely assessed. 479 cases of HCQ retinal toxicity (1.05%) and 9 cases of HCQ-associated blindness (1.8 per 10 000 patients) were reported. 89.1% of respondents reported familiarity with the AAO guidelines. Those aware of the guidelines cited limited dosing options (54.7%), lack of supporting evidence (57.8%) and low patient adherence (43.8%) as obstacles to greater implementation of the guidelines.
These data suggest that HCQ toxicity and blindness are rare in patients with SLE. Rheumatologists treating patients with SLE are aware of the guidelines and appreciate the importance of partnering with ophthalmologists in preventing retinal toxicity.

The Outcome Measures in Rheumatology Initiative established the Contextual Factors Working Group to guide the understanding, identification and handling of contextual factors for clinical trials. In clinical research, different uses of the term \'contextual factors\' exist. This study explores the perspectives of researchers (including clinicians) and patients in defining \'contextual factor\' and its related terminology, identifying such factors and accounting for them in trials across rheumatology.
We conducted individual semistructured interviews with researchers (including clinicians) who have experience within the field of contextual factors in clinical trials or other potentially relevant areas, and small focus group interviews with patients with rheumatic conditions. We transcribed the interviews and applied qualitative content analysis.
We interviewed 12 researchers and 7 patients. Researcher\'s and patient\'s descriptions of contextual factors were categorised into two broad themes, each comprising two contextual factors types. The \'treatment effect\' theme focused on factors explaining variations in treatment effects (A) among patients and (B) among studies. The \'outcome measurement\' theme focused on factors that explain (C) variations in the measurement result itself (apart from actual changes/differences in the outcome) and (D) variations in the outcome itself (beside treatment of interest). Methods for identifying and handling contextual factors differed among these themes and types.
Two main themes for contextual factors with four types of contextual factors were identified based on input from researchers and patients. This will guide operationalisation of contextual factors. Further research should refine our findings and establish consensus among relevant stakeholders.