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Abstract Number: 1162

Evaluating the Efficacy of Rituximab in the Treatment of Refractory Adult Idiopathic Inflammatory Myositis Using Total Improvement Score: Data from a Real-World Multi-Centre Registry in the United Kingdom

Xia Lyu1, Patrick Gordon2, Harsha Gunawardena3, Neil McHugh4, Sarah Tansley4, Athiveeraramapandian Prabu5, Peter Lanyon6, James Miller7, Voon Ong8, Anthony Isaacs9, Chee-Seng Yee10, Caroline Cotton11, Patrick Kiely12, Eleni Stathopoulou13, James Taylor14, Rachel Jeffery14, Anurag Bharadwaj15, James Lilleker16, Janine Lamb17 and hector Chinoy18, and MYOPROSP consortium, 1Department of Rheumatology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China (People's Republic), 2nhs, London, United Kingdom, 3North Bristol NHS Trust, and Academic Rheumatology, University of Bristol, Bath, United Kingdom, 4University of Bath, Bath, United Kingdom, 5Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, United Kingdom, 6Nottingham University Hospitals NHS Trust, and Lifespan and Population Health, School of Medicine, University of Nottingham, Nottingham, United Kingdom, 7Department of Neurology, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, United Kingdom, 8University College London, London, England, United Kingdom, 9Department of Rheumatology, London North West University Healthcare NHS Trust, London, United Kingdom, 10Department of Rheumatology, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Doncaster, United Kingdom, 11Department of Rheumatology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom, 12Department of Rheumatology, St George's University Hospitals NHS Foundation Trust, London, United Kingdom, 13Department of Rheumatology, Solihull Hospital, University Hospitals of Birmingham NHS FT, Birmingham, United Kingdom, 14Department of Rheumatology, Northampton General Hospital, Northampton General Hospital NHS Trust, Northampton, United Kingdom, 151Basildon University Hospital, Mid & South Essex NHS Foundation Trust, Rheumatology, Basildon, United Kingdom, Basildon, United Kingdom, 16Northern Care Alliance NHS Trust, Salford, United Kingdom, 17University of Manchester, UK, Manchester, United Kingdom, 18The University of Manchester, Manchester, United Kingdom

Meeting: ACR Convergence 2024

Keywords: B-Cell Targets, Biologicals, longitudinal studies, Myositis, Response Criteria

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Session Information

Date: Sunday, November 17, 2024

Title: Muscle Biology, Myositis & Myopathies – Basic & Clinical Science Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: B cell depletion in the form of rituximab (RTX) is an established treatment modality for idiopathic inflammatory myopathies (IIM). Treatment response is now assessed in myositis clinical trials using the internationally accepted Total Improvement Score (TIS). Data using TIS regarding RTX response in IIM remains lacking.

Methods: The MYOPROSP is a prospective observational cohort study that enrolled adult IIM cases from 23 centres in the UK during 2016-2020. We reviewed the registry to identify cases where RTX was initially administered or restarted. We also identified control cases who entered the registry during the same period but never received RTX matched by their myositis subgroups. The International Myositis Assessment and Clinical Studies Group (IMACS) core set measures were collected to generate TIS. The interval for the RTX group was limited to 60-200 days. Baseline characteristics were compared using t-test or Fisher’s exact test. Univariate logistic regression was first applied to compare response rate. Baseline covariates were balanced following the multiple imputations and inverse probability of treatment weighting (Figure 2A). Data were adjusted for concomitant drug number, average steroid dose, and follow-up interval using multivariate logistic regression.

Results: Sixty-three patients in MYOPROSP initiated or restarted RTX; 42 with computable TIS met the interval requirement. 93 controls were identified, among which 51 had a change in therapy around baseline. The RTX group was significantly younger at diagnosis and enrollment and had a longer disease duration (Table 1). There were no significant differences in gender distribution, BMI, clinical manifestations, or baseline oral steroid doses. The RTX group failed more treatment compared to the controls. Baseline physician global activity, patient global activity, and extra-muscular activity were significantly higher in the RTX group. During a median 128-day follow-up, the rituximab group had a higher TIS (median 32.50 [interquartile range 17.5-46.9] RTX vs. 17.5[7.5-40.0] controls). 30/42 (71.4%) RTX patients vs. 44/93 (47.3%) controls (Odds Ratio (OR) 2.78, 95% Confidence Interval (CI) 1.27-6.09, p=0.01, univariate logistic regression) achieved at least minimal improvement (Figure 1). However, on applying multivariate analysis, the association no longer reached statistical significance (pooled OR 3.78, 95% CI 2.57-24.92, p=0.17) (Figure 2B).

Conclusion: Using TIS in an observational setting, we have demonstrated that patients receiving RTX are more likely to respond to treatment than patients receiving conventional immunosuppressants, despite them having longer disease duration and failing more therapies.

Supporting image 1

Table 1: Overall Baseline Data and Comparison Between the Rituximab Group and Controls. N, number of non-missing values; yo, year-old; *, p <0.05. ASyS, anti-synthetase syndrome; DM, dermatomyositis; IMNM, immune-mediated necrotizing myopathies; OM, overlap myositis. PGA, patient global assessment; PhGA, physician global assessment; MMT-8, Manual Muscle Testing-8 score; VAS, visual analogue scale.

Supporting image 2

Figure 1: case selection procedure and response results

Supporting image 3

Figure 2: (A) Love plot showing covariate balance before and after weighting adjustment. (B) Forest plot of Logistic Regression results.


Disclosures: X. Lyu: None; P. Gordon: Alexion, 12, Primary investigator at King's college hospital for the NCT04999020 study (ALXN1210-DM-310). No personal payment, Argenx, 12, PI at King's College Hospital for study ARGX-113-2007 and Study ARGX-113-2011, Bristol-Myers Squibb(BMS), 12, POETYK SLE study (NCT05620407), Chief investigator for UK and site PI at King's College Hospital London for this study ., Celltrion Healthcare, 12, Funded to attend EULAR convergence in 2023, Eli Lilly, 12, PI at King's College Hospital for MOJAK, funded by Eli Lilly with University of Manchester as the Sponsor. Termination date aproximate, Galapagos, 1, 2, 12, Chief investigator in UK for Galarisso study (NCT05695950); H. Gunawardena: None; N. McHugh: None; S. Tansley: Boehringer-Ingelheim, 1, 6; A. Prabu: None; P. Lanyon: AstraZeneca, 1, CSL Vifor, 5, 6; J. Miller: None; V. Ong: None; A. Isaacs: None; C. Yee: Amgen, 2; C. Cotton: None; P. Kiely: None; E. Stathopoulou: None; J. Taylor: None; R. Jeffery: None; A. Bharadwaj: None; J. Lilleker: None; J. Lamb: Eli Lilly, 5; h. Chinoy: AstraZeneca, 1, Eli Lilly, 5, Janssen, 1, Pfizer, 1.

To cite this abstract in AMA style:

Lyu X, Gordon P, Gunawardena H, McHugh N, Tansley S, Prabu A, Lanyon P, Miller J, Ong V, Isaacs A, Yee C, Cotton C, Kiely P, Stathopoulou E, Taylor J, Jeffery R, Bharadwaj A, Lilleker J, Lamb J, Chinoy h. Evaluating the Efficacy of Rituximab in the Treatment of Refractory Adult Idiopathic Inflammatory Myositis Using Total Improvement Score: Data from a Real-World Multi-Centre Registry in the United Kingdom [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/evaluating-the-efficacy-of-rituximab-in-the-treatment-of-refractory-adult-idiopathic-inflammatory-myositis-using-total-improvement-score-data-from-a-real-world-multi-centre-registry-in-the-united-kin/. Accessed .
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