Royal National Hospital for Rheumatic Diseases

CT-P13 SC, a new subcutaneous (SC) formulation of biosimilar infliximab (IFX), was approved by the European Medicines Agency in 2020 for the treatment of radiographic axial spondyloarthritis (axSpA) in adult patients. The present study aimed to assess the real-world outcomes of CT-P13 SC (SC IFX) as a treatment for both radiographic and non-radiographic axSpA. Data were drawn from the Adelphi Real World axSpA Disease Specific Programme™, a cross-sectional survey with retrospective data collection in France, Germany, Italy, Spain, and the UK between June 2023 and June 2024. Rheumatologists and their patients with axSpA completed questionnaires on patient demographics, clinical characteristics, and treatment satisfaction. Outcomes for patients on SC IFX were analyzed, with additional evaluations based on baseline characteristics and treatment patterns. Such outcomes were also compared with patients receiving other advanced therapies, including biologics and Janus kinase inhibitors. In total, 191 patients were evaluated. The mean patient age was 44.5 years, and most were male (117 [61.3%]). Baseline characteristics were similar between radiographic and non-radiographic axSpA patients, with a higher proportion of patients in the radiographic group (116 [60.7%] vs. 75 [39.3%]). Significant improvements in disease severity were observed with SC IFX from treatment initiation to data collection (severe disease: 37.4% to 3.2%), along with significantly lower levels of pain and fatigue, and fewer tender entheseal points and affected joints (all p < 0.0001). SC IFX treatment was also associated with improvements in musculoskeletal, extra-articular, systemic, and functional symptoms, and inflammatory imaging features. Subgroup analysis showed that SC IFX was effective across various patient populations with differing characteristics such as age, prior experience with advanced therapies, or coexisting conditions. SC IFX showed high treatment satisfaction for both physicians and patients. No new safety signals were reported. In this real-world study, SC IFX demonstrated clinical effectiveness in both radiographic and non-radiographic axSpA, with consistent results across diverse patient characteristics. Both physicians and patients reported high satisfaction with no new safety concerns. This analysis suggests that SC IFX can be an effective, convenient, and well-tolerated treatment option for diverse axSpA patient populations.

Immune checkpoint inhibitors (ICI) used for the treatment of malignancy are associated with immune-related adverse events, which include inflammatory arthritis. ICI-induced inflammatory arthritis (ICI-IA) is a new clinical entity that may lead to functional impairment and may be persistent even after ICI cessation. We discuss the clinical features, investigation and differential diagnosis. Management needs to consider the safety of immunosuppression in the context of the underlying cancer, and current practice will be further informed by ongoing clinical trials.

To identify and summarize existing telerehabilitation interventions for people living with rheumatic and musculoskeletal diseases (RMDs), including the rehabilitation components, the technology used, the type of health care professional (HCP) interaction, and how the effectiveness is evaluated. Scopus, Embase, and Web of Science were searched and screened for articles between 2011 and November 2021, and an updated search was completed up to March 2023. The search targeted peer-reviewed scientific publications involving adults diagnosed with an RMD, which can be considered for self-management (population), rehabilitation interventions including HCP interaction (concept), and interventions delivered via telehealth for home-based or outpatient settings (context). In total, 120 articles fulfilled the inclusion criteria with 84 unique telerehabilitation interventions identified. These interventions most commonly targeted people living with knee osteoarthritis (n = 41) and rheumatoid arthritis (n = 17). Study-specific web platforms and websites were used in 32 interventions, whereas smartphone applications and social and instant messaging applications were used in 14 and 9 interventions, respectively. Videoconferencing software and services were used to communicate with HCPs in 20 interventions. Physiotherapists had a role in delivering 47 interventions, and audio communication was observed in 43 interventions. Most interventions (n = 44) lasted between 8 and 15 weeks. A diverse range of digital technologies are being used in the delivery of remote rehabilitation for people living with RMDs. Further studies are required to explore the longevity of telerehabilitation interventions, the optimal delivery methods, and level of HCP contact needed to support people living with RMDs in their self-management.

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&amp;gt;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, Celgene, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Orphazyme, Pfizer, Roche, and UCB Pharma. P. Goupille: Consultancies; AbbVie, Biogaran, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB Pharma. V. Navarro Compán: Consultancies; AbbVie, Eli Lilly and Company, Janssen, Novartis, Pfizer, and UCB Pharma. Grants/research support; ASAS and Novartis. X. Huji: None. M. Sheesh: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. K. Ng: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. M. Ngantcha: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. H. Russ: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. G. Doridot: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. X. Baraliakos: Consultancies; AbbVie, Bristol Myers Squibb, Celgene, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche, and UCB Pharma. Grants/research support; AbbVie, Bristol Myers Squibb, Celgene, Janssen, Merck Sharp &amp; Dohme, Novartis, Pfizer, Roche, and UCB Pharma.

Abstract Background/Aims Axial Spondyloarthritis (axSpA) is characterised by chronic inflammation of the axial skeleton. C-reactive protein (CRP), as a marker of inflammation, can be a predictor of response to targeted therapies. We aim to explore whether CRP fluctuations prior to biologic drug initiation could predict the number of targeted therapies required. Methods Electronic medical records of axSpA patients (n = 244) attending the Royal National Hospital for Rheumatic Diseases and starting targeted therapies (Anti-TNF, JAK inhibitor and IL-17 inhibitor) between 2016 and 2018 were retrospectively reviewed. Patients required a minimum of three CRP results over five years pre- and post- biologic initiation to be included on the analysis. We applied clustering methods to create five clusters of CRP measurements. These cluster models were then compared in terms of their prediction accuracy to find the best prediction model. Results Table-1 shows the clusters and the mean value of up to five CRP measurements. Different clusters represent different trends of CRP. The R-Squared value of the prediction model is 68%. This indicates that the CRP trends can be used to predict the number of biologic drugs patients will likely use. The analyses demonstrate that multiple CRP measurements add value to the prediction of response to initial targeted therapies. Table-1 also shows the number of drugs used by percentage of patients in the corresponding cluster. Patients in clusters 1 and 2 used three biologics, while cluster 3 patients are more likely to be responsive to first biologic. Patients in cluster 4 and 5 used two biologics and did not require to switch to a third biologic drug. Conclusion Our study shows the benefit of assessing multiple CRP measurements before biologic drug administration to predict how many times patients would likely switch biologic treatment. Based on our current analyses, we will further investigate if specific classes of targeted therapies can be used first line, stratified by the CRP cluster model to optimise drug survival. Disclosure M. Ho: None. A. Aziz: None. E.G. Ozpolat: None. C. Vasilakis: None. E.R. Gates: None. R. Sengupta: Consultancies; Pfizer, Abbvie, Biogen, BMS, Chugai, Lilly, Novartis, UCB. Honoraria; Pfizer, Abbvie, Lilly, Novartis, UCB. Grants/research support; UCB and Novartis - paid to institution. Other; support for attending meetings - Abbvie, Lilly, UCB, Novartis.

Abstract Background/Aims Eosinophilic fasciitis (EF) is a rare disorder characterised by inflammation in the fascia that results in non-pitting oedema, followed by collagenous thickening. However, the pathogenesis is poorly understood and the condition is heterogeneous in both its symptoms and severity. Despite the name of the condition, it is important to understand that peripheral eosinophilia and the presence of eosinophils in the skin biopsy are not essential in making a diagnosis of EF. Methods A 58-year-old black woman, with hypertension, diabetes, alopecia and dilated cardiomyopathy, presented with a six-month history of bilateral progressive swelling in her forearms and calves, with skin tightening and significant weight loss, but no history of Raynaud’s. On examination, she had tender, symmetrical, thickened skin in the forearms and calves, which was shiny and indurated, with elbow and knee contractures to 120 degrees and a positive groove sign. She had no sclerodactyly, nailfold changes, calcinosis, telangiectasias or synovitis. She had preserved power throughout all limbs with normal sensation. Cardiovascular and respiratory examinations were unremarkable. Results Bloods showed ESR 34mm/h and CRP 27mg/L, with negative rheumatoid factor, anti-CCP antibodies, ANA, myositis antibody panel and ANCA. IgG was elevated (25.6g/L), with no paraprotein. She had mild leucocytosis (11.4x109/L) with neutrophilia (8.2x109/L), but normal eosinophils (0.3x109/L). CT chest/abdomen/pelvis showed no malignancy but small volume right axillary and pelvic lymph nodes. MRI forearm showed intermuscular fascial thickening and oedema, with subcutaneous oedema consistent with EF. Deep skin biopsy showed thickening of the fascia with lymphoplasmacytic inflammatory infiltrate but no eosinophils, but in keeping with EF. She was treated with prednisolone 40mg once daily, but lack of progress led to escalation of therapy with intravenous methylprednisolone 500mg for three days, followed by prednisolone 0.5mg/kg and a slow wean. Methotrexate 20mg once weekly was added, alongside hydroxychloroquine 200mg once daily. Her inflammatory markers improved with treatment (ESR 28mm/h, CRP 5mg/L) yet there was no significant change in her contractures, swelling and pain. Conclusion EF is a rare disease and it is important to have a high index of suspicion in a patient who presents with scleroderma-like skin with no history of Raynaud’s. A dual approach of MRI and deep skin biopsy helps support the diagnosis, especially in the absence of significant peripheral eosinophilia. Peripheral eosinophilia and histopathological infiltration of eosinophils in the fascia are effective, but not essential, for a diagnosis of EF. Furthermore, there is no standardised treatment pathway for EF, but whilst steroids are often effective at inducing remission, in this case steroids had a limited impact. It raises the question of whether this is secondary to the lack of peripheral eosinophilia and eosinophils on the biopsy. This may represent a subset of EF patients with poor response to standard therapy. Disclosure D. Srikantharajah: None. J. Kimpton: None. Y. Man: None.

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