RheumatologyPub Date : 2025-04-28DOI: 10.1093/rheumatology/keaf142.036
Flora McErlane, Gavin Cleary, Nicola James, Annalise Raine, Anna Burhouse
{"title":"OA36 Embedding quality improvement across paediatric and adolescent rheumatology: the JIA Learn experience","authors":"Flora McErlane, Gavin Cleary, Nicola James, Annalise Raine, Anna Burhouse","doi":"10.1093/rheumatology/keaf142.036","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.036","url":null,"abstract":"Background/Aims Juvenile idiopathic arthritis (JIA) is a relatively common chronic paediatric condition with significant potential for lifelong morbidity. Despite significant advances in medical treatment technologies, a persistent discrepancy between ‘ideal world’ (clinical research) and ‘real world’ (clinical practice) data suggests quality of care in JIA has room for improvement. Furthermore, understanding and prioritising the outcomes that matter to children and families will improve the experience of clinical care and reduce the impact of JIA on global health and well-being. Modern quality improvement approaches accelerate improvement in complex adaptive health systems because teams are empowered to test and adapt processes to suit local environments and populations. We report a novel and collaborative approach to quality improvement in paediatric JIA care across England between 2022 and 2024. The Institute for Health Improvement breakthrough series collaborative model informed development of a UK-wide learning system (termed JIA Learn) with the aim of improving care and outcomes, facilitating “social connectedness” and creating a lasting improvement culture. Methods Shared aims and an overarching driver diagram were developed following an introductory event in April 2022 with participating teams encouraged to identify related local improvement projects during the active phase of the collaborative. The collaborative included a further three formal learning events, three virtual action learning sets and individual or team support through improvement coaching. Participating teams were encouraged to collect the core set of agreed measures throughout the active learning period. Results 12 teams from across England engaged enthusiastically with the collaborative attending four learning events with an average satisfaction score of 9.8. The JIA Learn dataset, including the cJADAS10, JIA PROM and JIA PREM, was collected for 1320 discrete patient encounters (87.3% useable data) and multiple QI projects were delivered locally by participating teams. Improvements focussed on timely access to care, transitional care, patient pathways, patient education and local work with patient organisations. Participating teams reported that JIA Learn allowed them to innovate and work more effectively as a team, with learning accessible to the whole MDT. Limited time and capacity, no infrastructure for data collection and slow Caldicott approvals processes were common barriers to timely improvements. Conclusion The partnership between the clinical community, BSR, RUBIS.QI team and the many patient organisations involved in JIA Learn was central to the success of the project. The collaborative rejuvenated MDT members’ resilience and enthusiasm for improvement work, provided new mechanisms to share knowledge and learning, informed a range of local projects designed to improve the quality and experience of clinical care, and empowered paediatric rheumatology teams to be","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"31 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"E095 Implication of IL23/IL17 axis in ankylosing spondylitis","authors":"Maroua Slouma, Nour Makhlouf, Malek Dhifallah, Lobna Kharrat, Aymen Tezeghdenti, Imene Gharsallah","doi":"10.1093/rheumatology/keaf142.330","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.330","url":null,"abstract":"Background/Aims In recent years, significant attention has been directed towards the role of cytokines in the development and progression of ankylosing spondylitis (AS), particularly the pivotal involvement of interleukin-17 (IL-17) and interleukin-23 (IL-23) in the dysregulation of immune responses observed in AS, holding promise for the development of targeted therapies. Given their growing therapeutic interest, the purpose of this study was to search for evidence supporting a prognostic interest in interleukins 17 and 23. Methods We collected 41 patients with AS in our department. We measured their levels of IL-17 and IL-23 and compared them to the levels of a paired control group. We calculated the Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores in these patients, and we documented their extra-articular symptoms. We sought relationships among these data using SPSS 25.0. Results IL-17 and IL-23 levels were significantly higher in patients with AS (G1) versus the control group (G2). For IL-17: (G1=91,26±12,58 vs G2=1,14±0.27 pg/mL, p < 0.05). For IL-23: (G1=22,73±4,36 vs G2=2,6±1.27 pg/mL, p < 0.05). There was no observed correlation between BASDAI and ASDAS-CRP scores, and IL-17 and IL-23 levels. Similarly, no correlation was found between the duration of progression of AS and the levels of these cytokines. No link was found between IL-17 and IL-23 and markers of inflammation (ESR, CRP). There was no significant difference in the levels of IL-17 and IL-23 when comparing patients with uveitis (G1) and those without uveitis (G2). For IL-17: (G1=110,73±41,97 vs G2=87,92±13,1 pg/mL, p > 0.05). This was also the case for psoriasis, renal, cardiac, and pulmonary manifestations. Also, no correlation was found between IL17 and IL23 levels and the number of extra-articular manifestations. Conclusion Further research may be needed to explore these associations more comprehensively and better understand the role of interleukin-17 (IL-17) and interleukin-23 (IL-23) in AS and their prognostic significance. Disclosure M. Slouma: None. N. Makhlouf: None. M. Dhifallah: None. L. Kharrat: None. A. Tezeghdenti: None. I. Gharsallah: None.","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"27 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
RheumatologyPub Date : 2025-04-28DOI: 10.1093/rheumatology/keaf142.113
Sarah R Kingsbury, Dawn Groves-Williams, Gretl A McHugh, Elizabeth M Hensor, Christine Comer, Mark Conner, Rachel K Nelligan, Rana S Hinman, Kim L Bennell, Phillip G Conaghan
{"title":"P072 Evaluation of two electronic-rehabilitation programmes for persistent knee pain: a randomised feasibility trial","authors":"Sarah R Kingsbury, Dawn Groves-Williams, Gretl A McHugh, Elizabeth M Hensor, Christine Comer, Mark Conner, Rachel K Nelligan, Rana S Hinman, Kim L Bennell, Phillip G Conaghan","doi":"10.1093/rheumatology/keaf142.113","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.113","url":null,"abstract":"Background/Aims Persistent knee pain is a common cause of disability. Internet-delivered education and exercise may provide an appropriate and scalable treatment option. This trial evaluated the feasibility and acceptability of two electronic-rehabilitation interventions: ‘MyKneeUK’, based on the similar Australian intervention MyKneeExercise, and ‘Group E-Rehab’, developed from a previously tested one-to-one internet-delivered programme. Methods We conducted a non-blinded, randomised feasibility trial with three parallel groups. Eligible participants were aged 45 years or older, with a history of persistent knee pain consistent with clinical diagnosis of knee osteoarthritis. Participants were randomly assigned in a 1:1:1 ratio to either the intervention groups (MyKneeUK, Group E-Rehab) or the control group. The MyKneeUK group received a self-directed unsupervised internet-based home exercise programme plus short message service support (targeting exercise behaviour change) for 12-weeks; the Group E-Rehab group received 7 group-based (5-7 participants/group) physiotherapist-prescribed home exercises delivered via videoconferencing accompanied by internet-interactive educational sessions over 12-weeks; the control arm received usual physiotherapy or continued their usual self-management. Feasibility variables, patient-reported outcomes and clinical findings were measured at baseline, 3 and 9-months. Results Of 149 people screened, 97 were eligible (65.1%) and 90 were randomised (92.8%). Common reasons for ineligibility included knee pain <3-months (n = 13;25%), knee pain during walking ≤4 on 11-point NRS (n = 25;48.1%) and no activity-related joint pain (n = 18;34.6%). Participants had a mean (S.D.) age of 58.2 (7.4) years, 53 were female (58.9%), 70 (77.8%) were using medication for their knee pain and most had pain in multiple joints (mean [S.D] painful joints: 2.9 [2.5]). Of those enrolled, 74 (82.2%) completed 3-month follow-up (Usual Care, 27/30 (90.0%); MyKneeUK, 27/30 (90.0%); Group E-Rehab 20/30 (66.7%)) and 62 (68.9%) completed 9-months (Usual Care, 25/30 [83.3%]; MyKneeUK, 23/30 [76.7%]; Group E-Rehab 14/30 [46.7%]). Compared to usual care, WOMAC pain and function scores were reduced between baseline and 3-months for both MyKneeUK (treatment difference [85%CI], WOMAC pain: -0.57 [-1.71,0.57], WOMAC function, -3.40 [-6.75,-0.06]) and Group E-rehab (WOMAC pain: 0.68 [-2.01,0.65], WOMAC function, -4.38 [-8.07,-0.69]), which was sustained to 9-months. Improvements in favour of both interventions were also seen for other outcomes. There were no serious adverse events and 15 adverse events in 11 participants, reasonably balanced across arms (MyKneeUK 7, Group E-Rehab 4, Usual Care 4). Sample size calculations suggest a definitive trial would be feasible (sample sizes for WOMAC pain primary outcome, 80% power with 20% loss-to-follow-up: MyKneeUK, 144, Group E-rehab, 136). Conclusion Both electronic-rehabilitation interventions met pre-sp","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"33 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
RheumatologyPub Date : 2025-04-28DOI: 10.1093/rheumatology/keaf142.205
Sook Yan Lee, Kathryn Biddle, Caitlin Lee, Frances Humby, Bruce Kirkham
{"title":"P168 Real-world experience of IL-17 inhibitors in ankylosing spondylitis and psoriatic arthritis, including intra-class drug switching","authors":"Sook Yan Lee, Kathryn Biddle, Caitlin Lee, Frances Humby, Bruce Kirkham","doi":"10.1093/rheumatology/keaf142.205","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.205","url":null,"abstract":"Background/Aims Intra-class switching between Interleukin-17 inhibitors (IL-17i) has been studied in psoriasis, but not in inflammatory arthritis. We aim to retrospectively evaluate the use of IL-17i in our single-centre cohort of patients with axial spondyloarthropathy (axSpA) and psoriatic arthritis (PsA). Outcomes of interest included drug survival, reason for treatment discontinuation and efficacy of intra-class IL17i switching. Methods Patients commenced on IL-17i (secukinumab and ixekizumab) for axSpA or PsA in the rheumatology service at Guys & St Thomas Hospitals NHS Foundation Trust were identified. Patient demographics, comorbidities, duration of IL-17i use, and reasons for treatment cessation was collected. Kaplan-Meier and log-rank analyses were used to compare drug survival between diagnosis, drug, and line of therapy. Ethical approval was not sought as this study was untaken as part of an audit evaluation. Results 300 patients (211 PsA and 89 axSpA) initiated an IL-17i between 2007 and 2023. Patient characteristics are shown in Table 1. There was no difference between 24-month IL-17i survival in patients with axSpA versus PsA (p value 0.99) or first-line secukinumab versus ixekizumab (p value: 0.55). 49 patients switched to a second anti-IL17 drug. There was no difference between 24-month IL-17i survival in patients receiving their first versus second anti-IL-17 drug (p value 0.86). 22 patients discontinued IL-17i due to adverse events (AEs). Common AEs included eczema (n = 9), infections (n = 5) and inflammatory bowel disease (n = 4). Although fungal infections are a well-documented side-effect of IL-17i, this was not a reason for IL-17i discontinuation in our cohort. Conclusion In our cohort, IL-17i treatments in axSpA and PSA, showed similar persistence to previous studies of TNFi therapy, with an average 2-year drug survival of 60%. IL-17i were well-tolerated with 22 patients stopping treatment due to AEs. We show equivalent 24-month survival in axSpA and PsA patients with first- and second-line IL-17i, supporting the efficacy of IL17i intra-class switching. The strengths of our study include a large sample size and benefits of a single centre cohort, reducing variability in clinical practice and prescribing behaviours. Study limitations include lack of available outcome measures and exclusion of patients prescribed IL-17i through a different speciality. Disclosure S. Lee: None. K. Biddle: None. C. Lee: None. F. Humby: Consultancies; Pfizer, Roche, UCB, Genentech and Novartis. Grants/research support; Pfizer. B. Kirkham: Consultancies; Abbvie, BMS, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB. Grants/research support; Novartis and Eli Lilly.","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"8 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
RheumatologyPub Date : 2025-04-28DOI: 10.1093/rheumatology/keaf142.212
Raj Sengupta, Pedro M Machado, Philippe Goupille, Victoria Navarro Compán, Xu Huji, Mohamed Sheesh, Khai Jing Ng, Marcus Ngantcha, Hagen Russ, Gabriel Doridot, Xenofon Baraliakos
{"title":"P175 Baseline characteristics and efficacy in patients with radiographic axSpA stratified by CRP level: an analysis from the ixekizumab Phase III trial","authors":"Raj Sengupta, Pedro M Machado, Philippe Goupille, Victoria Navarro Compán, Xu Huji, Mohamed Sheesh, Khai Jing Ng, Marcus Ngantcha, Hagen Russ, Gabriel Doridot, Xenofon Baraliakos","doi":"10.1093/rheumatology/keaf142.212","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.212","url":null,"abstract":"Background/Aims Elevated baseline (BL) C-reactive protein (CRP) level can serve as a predictor for treatment response to TNF inhibitors in patients (pts) with radiographic axSpA (r-axSpA). The impact of CRP on b/tsDMARD response in r-axSpA is listed as a topic of interest on the ASAS-EULAR research agenda. Ixekizumab (IXE) has previously demonstrated efficacy in the treatment of r-axSpA in pts with normal and elevated CRP. This analysis further investigates the impact of baseline CRP levels on the ASAS40 individual components, BASDAI, and Axial Spondyloarthritis Disease Activity Score (ASDAS). Methods Biologic-naive adults with r-axSpA were enrolled in the COAST-V study (NCT02696785). At BL, pts were randomised to treatment with IXE Q4W, adalimumab (ADA), or placebo (PBO). Randomisation was stratified by baseline (BL) CRP normal (CRP ≤5 mg/L) or elevated (CRP>5 mg/L). This analysis reports change from BL (CFB) at 16 weeks for ASAS40 individual components, BASDAI, and ASDAS responses. Descriptive results for these outcomes are presented according to CRP levels. Results The mean ages of pts with normal CRP at BL were 43.3, 43.7, and 44.8 years for IXE, ADA, and PBO respectively (subsequently reported in that order, herein), whereas the mean age of pts with elevated CRP at BL was 39.6, 40.3, and 41.7 years. Gender, HLA-B27 positivity distribution and the mean duration of axSpA diagnosis was similar across both CRP groups. Pts with normal CRP had lower mean MRI-SPARCC spine score vs those with elevated CRP (6.8, 6.6, and 6.4 vs 15.8, 24.0, and 15.1 units) for IXE, ADA, and PBO respectively. At BL disease activity was comparable between pts with normal and elevated CRP. In pts treated with IXE, ASAS40 response at week 16 was driven by all 4 individual components with the largest improvements seen in morning stiffness (mean of intensity and duration of morning stiffness questions of BASDAI) and spinal pain, across both normal and elevated CRP. BASDAI 50 was achieved by 34.6%, 24.3%, and 15.4% of pts with normal CRP and by 48.1%, 39.2%, and 18.3% of pts with elevated CRP. ASDAS major improvement was achieved by 19.2% (IXE), 8.1% (ADA) and 3.8% (PBO) of pts with normal CRP and by 36.5%, 35,3% and 5.2% of pts with elevated CRP, respectively. Conclusion In pts with r-axSpA, BL clinical characteristics were similar in the normal and elevated CRP groups with pts experiencing similar disease burden. Across IXE and ADA treatment groups, the elevated CRP group tended to achieve higher treatment responses than the normal CRP group. Whereas in patients with normal CRP, CFB of ASAS individual components, BASDAI and ASDAS improvement was numerically highest in IXE Q4W followed by ADA and PBO. Disclosure R. Sengupta: Consultancies; AbbVie, Celgene, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma. Grants/research support; AbbVie, Celgene, Eli Lilly and Company, Novartis, Pfizer, and UCB Pharma. P.M. Machado: Consultancies; AbbVie, Bristol Myers Squibb,","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"31 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143880531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
RheumatologyPub Date : 2025-04-28DOI: 10.1093/rheumatology/keaf142.305
Diana Graham, Margaret Wheeler, Chrysoula Sergaki, Hannah Ronksley, Tessa Hutton
{"title":"E070 Lessons learned: developing a multidisciplinary group for paediatric chronic pain patients","authors":"Diana Graham, Margaret Wheeler, Chrysoula Sergaki, Hannah Ronksley, Tessa Hutton","doi":"10.1093/rheumatology/keaf142.305","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.305","url":null,"abstract":"Background/Aims A multidisciplinary team (MDT) approach is best practice for managing chronic pain by supporting the psychological and physical challenges faced, including difficulty attending education and social isolation. However, with varying capacity among chronic pain specialists, treatment is often delayed. The group intervention model can support multiple patients more efficiently, while increasing understanding of pain and non-pharmacological interventions. Here, we share lessons learned in the development of a paediatric chronic pain group intervention. Methods The chronic pain service at Royal Manchester Children’s Hospital (RMCH) developed a face-to-face group intervention with psychology, physiotherapy, and occupational therapy approaches for patients (11-17 years old) and their parents. We explored attendance rates and family feedback given for not opting into the group and questionnaire responses from attendees following completion of the group. Professionals provided feedback during MDT meetings following the group. Results Parents/carers and patients identified barriers to attending the group as: taking time off work, patients missing education, childcare for siblings, travel distance to RMCH, difficulty attending the group due to pain, and patient anxiety around attending a face-to-face group. Professionals identified barriers of implementing the group as: limited space, variable attendance and/or attrition rates, limited staff support to help reduce attrition, and lack of funding for a more therapeutic space. It has also been difficult to capture longer term change and social benefits within the short time frame that the group takes place. In response to parent/carer and patient barriers, multiple formats of the group have been trialled. We have developed options to access a virtual group and a self-guided pain management pack for families unable to attend in person. We also provide a 1:1 pain management course for patients who are too anxious to attend the group. The face-to-face group format was also adapted to reduce the number of sessions requiring missed work or education and to allow use of pacing skills to manage pain. We have also observed several benefits of the group, including, providing families with introductory knowledge and skills around chronic pain management in a digestible way. We have observed connections made between patients and parents who can relate about their pain experiences. Further, professionals have expressed satisfaction with working cohesively to provide more comprehensive support to families. Conclusion Ultimately, given the complexity of this patient population, individualised work is typically required in addition to the group. However, we have found that group intervention has served well as a foundational support for patients with chronic pain. Finally, we have learned that there continue to be many gaps within paediatric chronic pain services, and we hope to develop more targeted services ","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"254 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143884332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
RheumatologyPub Date : 2025-04-28DOI: 10.1093/rheumatology/keaf142.118
Ivo Valter, Peter Szeles, Adriano De Souza, Jouliana Sadek, Jessica Sykes, Jeremy Morais, Joëlle Monnet
{"title":"P078 A randomised, controlled, double-blind study to evaluate the bioequivalence of FKS518 proposed biosimilar to denosumab with the originator in postmenopausal women with osteoporosis (LUMIADE-3 Study)","authors":"Ivo Valter, Peter Szeles, Adriano De Souza, Jouliana Sadek, Jessica Sykes, Jeremy Morais, Joëlle Monnet","doi":"10.1093/rheumatology/keaf142.118","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.118","url":null,"abstract":"Background/Aims Denosumab treatment is growing with the ageing of rheumatic patients, and biosimilars can increase patients’ access to treatment. FKS518 is a candidate biosimilar to denosumab, a RANKL inhibitor used in patients with osteoporosis. To establish biosimilarity with the original biologic, the LUMIADE-3 study (NCT04934072) was designed to assess the safety and efficacy of FKS518 compared to the originator. Methods A randomised controlled, double-blind, multi-centre study on postmenopausal females aged 55-85 years with lumbar spine bone mineral density (LS-BMD) T-score between -2.5 and -4.0 measured by DXA scan. Patients were randomised at a 1:1 ratio for three 60 mg administrations. At week 52, patients receiving denosumab originator product were re-randomised to continue their treatment or switch to FKS518 for the third dose. Those receiving FKS518 continued receiving FKS518. The primary endpoints included the percent change from baseline in LS-BMD DXA at week 52 and the area under the effect curve (AUEC) of serum C-terminal cross-linking telopeptide of type 1 collagen (CTX) up to Week 26. Secondary efficacy endpoints included the percent change from baseline in BMD at femoral neck and total hip. An analysis of the covariance model was used to compare the two treatments. The difference in mean percent change from baseline to Week 52 in LS-BMD and the ratio of means of AUEC (0-W26) CTX along with corresponding 95% Confidence Intervals (CI) were calculated to assess equivalence. FKS518 was considered equivalent to the originator if the 95% CI for LS-BMD lay entirely within the equivalence interval of [-1.45%, 1.45%], and the 95% CI for AUEC (0-W26) lay within the equivalence interval of (0.89, 1.12) ng*h/L. Results 553 patients were randomised to FKS518 (n = 276) or the originator (n = 277). Clinically relevant increases in LS-BMD were evident at week 52 in both the FKS518 and originator product group; least square mean and standard error percent LS-BMD change from baseline were 5.74 (0.315) and 5.07 (0.321) for FKS518 and originator respectively. The 95% CI difference in mean percent change at Week 52 in LS-BMD was equal to [0.04%, 1.29%]. The 95% CI for the ratio of geometric least squares means for AUEC (0-W26) CTX was (0.99,1.04) ng*h/L. Therapeutic equivalence was demonstrated based on both efficacy and pharmacodynamics. All secondary study objectives were met. The safety evaluation did not indicate notable differences between the two treatments; 374 (67.6%) patients experienced treatment emergent adverse events during the 52-week core period: 185 (66.8%) in the FKS518 group and 189 (68.5%) in the originator product group. Conclusion The study demonstrated therapeutic equivalence of FKS518 with the originator and showed similar safety profiles. This study results followed positive preclinical and pharmacokinetic results corroborating the similarity of FKS518 as a proposed biosimilar to denosumab originator product, a RANKL inhibito","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"23 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143884509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"E066 The use of zoledronate in CRMO: a small case series","authors":"Madeleine C Mackay, Samundeeswari Deepak, Kapil Gargh, Satyapal Rangaraj, Kishore Warrier","doi":"10.1093/rheumatology/keaf142.301","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.301","url":null,"abstract":"Background/Aims Chronic Recurrent Multifocal Osteomyelitis (CRMO) or Chronic non-bacterial osteomyelitis (CNO) is a rare inflammatory bone disorder mainly affecting children and young adults. The time from onset of symptoms to diagnosis is often delayed due to variety of reasons. There is little evidence for treatment of this condition, which is often empiric, based on personal experience, expert opinion, case reports or small case series. In 2018, the Eurofever registry published the largest case series and complete remission of symptoms was largest in the group of patients treated with bisphosphonates (51%). Much of the available evidence about the use of bisphosphonates is with pamidronate. However, zoledronate has been increasingly used due to its efficacy in other bone disease, longer duration of action, and possibly fewer infusions. In this small case series, we aimed to review the response of patients with CRMO to zoledronate. Methods This was a retrospective study, collecting data from electronic medical records of 8 consecutive patients with CRMO treated with zoledronate by the Paediatric Rheumatology team at Nottingham Children’s Hospital since 2021. Results 8 patients treated with zoledronate were identified. Of these 3 (37.5%) were female and 5 (62.5%) were male. Additional demographic data was unavailable for 1 patient. In the remaining 7 patients the age of onset of symptoms ranged from 6 years to 14 years with a mean age of onset of 9 years. The length of symptoms before rheumatology review ranged from 2.5 months to 36 months with a mean of 13 months. The commonest sites involved were Femur (71%), followed by mandible (42%) and pelvis (29%). All 8 patients had received a trial of NSAIDS before receiving zoledronate. All patients received concurrent treatment with IV methylprednisolone along with zoledronate. The indications of zoledronate treatment were symptoms persisting despite NSAIDs and spinal lesions, even if asymptomatic. The protocol involves giving a single dose of zoledronate with subsequent doses given only if there is a clinical and / or radiological flare. No patients reported significant side effects. 7 (87.5%) patients had a response to zoledronate. 6 patients have received only 1 infusion of zoledronate. 1 patient received 3 zoledronate infusions in total with a second dose given 12 months after the first one and the third dose 16 months following the second. The other patient had two zoledronate infusions 12 months apart. Conclusion The data confirms previous evidence that bisphosphonates are a safe and effective treatment in children and adolescents with CRMO, with zoledronate specifically being effective without significant side-effects. As this is a retrospective study there were limitations to the data collected. Prospective studies looking at the treatment of CRMO are needed to help develop a standard approach to management of these patients. Disclosure M.C. Mackay: None. S. Deepak: None. K. Gargh: None. S. Ra","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"96 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143884612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
RheumatologyPub Date : 2025-04-28DOI: 10.1093/rheumatology/keaf142.117
Alistair Paterson, Katie Feather, Andrew Lambarth, Martin Siebachmeyer, Vivian Ejindu, Franklyn Howe, Alicja Rudnicka, Amara Ezeonyeji, Robbie Ramsden, Nidhi Sofat
{"title":"P077 Can we predict who responds to intra-articular corticosteroid injection in knee arthritis? A clinical trial comparing response in inflammatory arthritis and osteoarthritis","authors":"Alistair Paterson, Katie Feather, Andrew Lambarth, Martin Siebachmeyer, Vivian Ejindu, Franklyn Howe, Alicja Rudnicka, Amara Ezeonyeji, Robbie Ramsden, Nidhi Sofat","doi":"10.1093/rheumatology/keaf142.117","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.117","url":null,"abstract":"Background/Aims The global burden of knee arthritis is significant and rising. Patients can experience pain and disability over a long duration. Intra-articular corticosteroid injections (IACI) can reduce inflammation and pain in arthritis. However, there is disparity in pain reduction and efficacy duration following IACI. We aimed to identify factors that influence IACI response in knee osteoarthritis (OA) and inflammatory arthritis (IA), to aid stratification of future patients. Methods In this multi-centre prospective study, participants with knee OA and IA (rheumatoid, psoriatic or mixed arthritis on standard treatment) were recruited. At baseline, demographics, DAS28, PsARC, painDETECT and Western Ontario and McMasters Universities Arthritis Index (WOMAC) for pain, stiffness and function were completed. We classified painDETECT scores with ≥19 “sensitised” and ≤18 “non-sensitised” for pain. Sonographic assessment and IACI was performed, with synovitis/effusion categorised dichotomously (present/absent). Two musculoskeletal radiology consultants graded knee radiographs as low Kellgren-Lawrence grade 0-2 (LKLG) or high grade 3-4 (HKLG). At 3 months, all questionnaires were repeated. IACI response was defined as 20% improvement from baseline WOMAC pain. Differences between responders/non-responders were assessed using Wilcoxon (continuous variables) and Fisher’s exact tests (categorical variables). Analysis was conducted in R. Results There were 129/136 patients recruited who had IACI: 89 were analysed (62 OA, 27 IA) (Table 1), with 40 lost to follow-up. Irrespective of arthritis pathology, odds of IACI response among sensitised versus non-sensitised participants was 0.33(p = 0.051). In the LKLG-OA cohort, responders had significantly lower baseline painDETECT scores than non-responders (p = 0.015); 10/14 (71%) non-sensitised responded to IACI, compared with 0/6 (0%) of the sensitised. No difference in baseline painDETECT scores between responders and non-responders in the HKLG-OA cohort(p = 0.50) or in either inflammatory cohort(LKLG p = 0.86, HKLG p = 0.77) was detected. In the OA-synovitis/effusion cohort, responders had lower baseline painDETECT scores; while this was not statistically significant (p = 0.13), 0/6 (0%) of sensitised participants responded, versus 17/33 (52%) non-sensitised patients. Conclusion Our study suggests imaging and clinical measures can predict IACI response, with pain sensitisation conferring lower likelihood of response, particularly in OA with LKLG. Following validation studies, design of a predictive clinical model could allow patient stratification for personalised treatment, reducing IACI waiting times and optimising resource allocation. Disclosure A. Paterson: None. K. Feather: None. A. Lambarth: None. M. Siebachmeyer: None. V. Ejindu: None. F. Howe: None. A. Rudnicka: None. A. Ezeonyeji: None. R. Ramsden: None. N. Sofat: None.","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"9 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143884618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
RheumatologyPub Date : 2025-04-28DOI: 10.1093/rheumatology/keaf142.042
Stefano Rodolfi, Voon H Ong, Christopher P Denton
{"title":"OA42 Impact of immunosuppression on development and outcome of systemic sclerosis-associated pulmonary arterial hypertension","authors":"Stefano Rodolfi, Voon H Ong, Christopher P Denton","doi":"10.1093/rheumatology/keaf142.042","DOIUrl":"https://doi.org/10.1093/rheumatology/keaf142.042","url":null,"abstract":"Background/Aims Pulmonary arterial hypertension (PAH) is a severe complication of systemic sclerosis (SSc). Treatment of SSc-PAH follows the same approach of idiopathic PAH and mainly relies on the combined action of vasodilators. Although immunosuppression might be expected to have a role considering the evidence of autoimmunity and immune dysfunction in the pathogenesis of SSc-PAH, evidence for benefit in prevention or treatment is lacking. The aim of this study was to retrospectively assess whether early immunosuppression impacts development of SSc-PAH or alters survival in patients with an established diagnosis. Methods We included 629 patients meeting the 2013 ACR/EULAR classification criteria for SSc. Early immunosuppression was defined as treatment in the first 5 years since SSc onset with either prednisolone equivalent at a dose ≥10mg daily, conventional synthetic or biologic DMARDs. Pre-capillary pulmonary hypertension (PH) was defined as mean pulmonary artery pressure ≥ 25mmHg, pulmonary vascular resistance >3 WU, pulmonary wedge pressure ≤15mmHg at right-heart catheterization. In case of precapillary-PH and concomitant ILD, we considered it PAH in case of forced vital capacity >70% (i.e. INCREASE trial exclusion criteria for group 3 PH). Outcomes of interest were development of PAH, time from SSc diagnosis to PAH, and survival in patients with PAH. Descriptive statistics, logistic and linear regression, Kaplan-Meier and Cox regression analysis were performed with STATA-18®. 31st December 2023 was chosen as the censorship date for survival analysis. Variables with p value <0.05 in univariate analysis were included in multivariate analysis. P value <0.05 was defined as statistically significant. Results Complete clinical and therapy data were available for analysis in 607 patients, of whom 206 received early immunosuppression. A total of 77 patients received a diagnosis of PAH, among which 11 were in the early immunosuppression group. After adjusting for potentially significant confounding variables, early immunosuppression was not associated to reduced odds of developing PAH (OR 0.74, 95% CI 0.31-1-76; p = 0.495), and time from SSc onset to PAH diagnosis was superimposable between the three treatment groups (i.e. 10.5 years for ‘early immunosuppression’, 11 years for ‘late immunosuppression’, and 11 years for ‘never immunosuppression’; p = 0.581). Survival analysis in patients with PAH included 70 patients. Immunosuppression was associated with a reduced risk of mortality, however, this did not reach statistical significance (HR 0.41, CI 0.16 - 1.04; p = 0.60). When analysing single agents, hydroxychloroquine was associated with reduced mortality risk (HR 0.06, CI 0.01 - 0.52; p = 0.011), while all the other agents did not significantly affect mortality. Conclusion Early immunosuppression does not seem to impact development of PAH or survival in SSc-PAH, however treatment with hydroxychloroquine is associated","PeriodicalId":21255,"journal":{"name":"Rheumatology","volume":"72 1","pages":""},"PeriodicalIF":5.5,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143884279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}