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Transcript: British Medical Journal Annals of Rheumatoid Disease Synovial membrane inflamed and thickened. Bones and cartilage gradually begin to erode Stratification Change in MRI Erosion Score from baseline to week 24 with the use of Rituximab! Progression of osseous tissue formation, causing fusion of the bones, this reducing mobility and in resulting in pain Other Signs and Symptoms of RA Baseline MRI scan 14 days before 1st infusion. Images scored by 2 independent radiologists In fact, data presents joint improvement! All secondary outcomes lead to development of primary outcome (Joint erosion) van Elteren test Used to determine primary endpoint Percent change from baseline Study did not have true 'normal' Each patient's baseline was their individual 'normal' ANOVA cannot be used Test is considered inferior to others with a true 'normal' What if they're biologically naive? Randomized 1:1:1 Loss of energy Loss of appetite Low fever Dry eyes/mouth (sjorgren's syndrome) Rheumatoid nodules (elbows/hands) To evaluate the effect of Rituximab + MTX in reducing structural damage and joint inflammation vs. MTX alone in patients with active RA. Progression of RA 3. Fibrous Ankylosis MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study Impact Factor: 10.38 Authors Professor Charles Peterfy MD, PhD 1. DiCarlo J. Julie Camille DiCarlo - Publications. Researchgatenet. 2015. Available at: http://www.researchgate.net/profile/Julie_Dicarlo2/publications. Accessed December 1, 2015. 2. Clinicaltrials.gov. A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate - Full Text View - ClinicalTrials.gov. 2015. Available at: https://clinicaltrials.gov/ct2/show/NCT00578305?term=00578305&rank=1. Accessed December 1, 2015. 3. Peterfy C, Emery P, Tak P et al. MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study. Annals of the Rheumatic Diseases. 2014. doi:10.1136/annrheumdis-2014-206015. 4. Vimeo. MabThera (Rituximab) – Mode of action and the role of B cells in rheumatoid arthritis (RA) (1). 2014. Available at: https://vimeo.com/91432523. Accessed December 1, 2015. 5. Netter F, Iannotti J, Parker R. Musculoskeletal System. Philadelphia: Elsevier Saunders; 2013. Significant finding: Rituximab 1000 mg exhibited slower progression of joint erosion. Inclusion Criteria Study Objective American Rheumatology Criteria for ≥3 months and ≤10 years Erosion/signs/symptoms of synovitis in a single joint (MRI) IR to MTX at dose 12.5-25mg/wk ≥ 12wks More Analysis Interactive Voice Response System (IVRS) RA RA! Rituximab Against Rheumatoid Arthritis Discussion History of rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA Previously on another biologic agent that depletes B-cells. Progression of RA 2. Pannus Formation Founder and CEO of Spire Sciences. Attending radiologist at UCSF for 7 years Director of Arthritis Research for the Osteoporosis and Arthritis Research Group. Developed the WOMRS system and co-developed the RAMRIS (Rheumatoid Arthritis MRI Score) and PsAMRIS (Psoriatic Arthritis MRI Score) methods. - Spire Sciences’ mission is to improve world health by helping bring new and better therapies into clinical use faster. They are focused exclusively on central image analysis. <6 months MTX therapy ≥ 6 months MTX therapy +Bone erosion No bone erosion Primary Outcome Article Post-Hoc Analysis CARLOS TDS TIS week 12, 24, and 52 Health Assessment Questionaire Disability Index (HAQ-DI) Antibody to CD-20, which is found on the surface of B-cells Progression of RA 4. Bony Ankylosis Non-Biologic Hydroxychloroquine Sulfasalazine Leflunomide Methotrexate - Drug of Choice for non-biologic DMARDs Folate antimetabolite (anti-inflammatory and immunosuppressive) Most common type of autoimmune arthritis Progression of RA 1. Synovitis Statistical Analysis for Secondary Outcomes Efficacy Assessment Sponsors & Collaborators: Hoffmann-La Roche Rheumatoid Arthritis Symptoms Clinical significance: Rituximab+MTX prevents joint damage in MTX-IR patients with active RA Reductions in synovitis and osteitis --> reduction in erosion and cartilage loss. Will Rituximab slow the progression of joint erosion in patients with active RA, biologically naive, and failed MTX treatment? 75% of those affected are women Preparation Randomization Rheumatoid Arthritis (RA) Genant-Modified Sharp radiographic scoring Range is too narrow (0-4) Study only used biologically naive patients Possible author bias. He co-developed RAMRIS score Research facility focuses on Central Image Analysis Discrepancies between text, tables, and charts. Insignificant p-value in table, while chart and text indicate statistical significance.
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