Cross Autoimmunity Prevention Symposium

In March 2026 BRI investigators, Cate Speake, Carla Greenbaum and Jane Buckner, assembled a group of clinical/translational experts across multiple autoimmune diseases, with biostatisticians who have clinical trials expertise and patient representatives affected by autoimmune disease for a symposium with the goal of fostering collaboration across autoimmune disease research.

Research aiming to prevent or delay progression from pre-clinical to clinical diagnosis has occurred in many autoimmune diseases. However, currently only type 1 diabetes (T1D) has an FDA-approved therapy for the delay of clinical onset. We plan to leverage the progress that has been achieved in T1D across other autoimmune diseases. Symposium attendees aim to develop collaborative strategies to implement prediction and prevention across autoimmune diseases by:

Enabling interoperability and knowledge sharing across studies and diseases
Identification of people at pre-clinical stages of disease
Clinical trial design and recruitment
Pathways for regulatory approval
Perception of the importance and risk/benefit of prediction and prevention by clinicians and patients or at-risk individuals

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Cross Autoimmunity Prevention Symposium attendees can access the members portal:

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Banner Unified Framework for Autoimmune Disease

Unified Framework for Autoimmune Disease Development

We propose that there is a common framework that can be applied to the development of autoimmunity. It is our goal to be able to identify markers of and treatments that can prevent or delay the development of clinical disease.

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Publications of Interest

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Overview Reading

Moscovitz K, Bhavsar D, Tremlett H. Interventional studies targeting the prodromal or preclinical phase of immune-mediated disease to benefit patient outcomes: a scoping review. J Autoimmun. 2026;159:103526.

Type 1 Diabetes

Bingley PJ, Wherrett DK, Shultz A, Rafkin LE, Atkinson MA, Greenbaum CJ. Type 1 Diabetes TrialNet: A Multifaceted Approach to Bringing Disease-Modifying Therapy to Clinical Use in Type 1 Diabetes. Diabetes Care. 2018 Apr;41(4):653-661.

Bonifacio E, Ziegler AG. Type 1 diabetes risk factors, risk prediction and presymptomatic detection: Evidence and guidance for screening. Diabetes Obes Metab. 2025;27 Suppl 6(Suppl 6):28-39.

Insel RA, Dunne JL, Atkinson MA, Chiang JL, Dabelea D, Gottlieb PA, et al. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015 Oct;38(10):1964-74.

Phillip M, Achenbach P, Addala A, Albanese-O’Neill A, Battelino T, Bell KJ, et al. Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes. Diabetes Care. 2024 Aug 1;47(8):1276-1298.

Vercauteren J, consortium EF. Harmonising terminology for type 1 diabetes: the EDENT1FI lexicon initiative. Lancet Diabetes Endocrinol. 2025;13(11):905-7.

Multiple Sclerosis

Laitinen AW, Tozlu C, Roostaei T, Diallo F, Onomichi K, Son J, et al. A Prospective Study of Individuals at Risk of Multiple Sclerosis Informs the Design of Primary Prevention Studies. Annals of Clinical and Translational Neurology. 2026. doi: 10.1002/acn3.70340.

Makhani N, Tremlett H. The multiple sclerosis prodrome. Nat Rev Neurol. 2021;17(8):515-21.

Marrie RA, Allegretta M, Barcellos LF, Bebo B, Calabresi PA, Correale J, et al. From the prodromal stage of multiple sclerosis to disease prevention. Nat Rev Neurol. 2022;18(9):559-72.

Tremlett H, Munger KL, Makhani N. The Multiple Sclerosis Prodrome: Evidence to Action. Front Neurol. 2021;12:761408.

Xia Z, Steele SU, Bakshi A, Clarkson SR, White CC, Schindler MK, et al. Assessment of Early Evidence of Multiple Sclerosis in a Prospective Study of Asymptomatic High-Risk Family Members. JAMA Neurol. 2017;74(3):293-300.

Xia Z, White CC, Owen EK, Von Korff A, Clarkson SR, McCabe CA, et al. Genes and Environment in Multiple Sclerosis project: A platform to investigate multiple sclerosis risk. Ann Neurol. 2016;79(2):178-89.

Rheumatoid Arthritis

Deane KD, Holers VM, Emery P, Mankia K, El-Gabalawy H, Sparks JA, et al. Therapeutic interception in individuals at risk of rheumatoid arthritis to prevent clinically impactful disease. Ann Rheum Dis. 2025;84(1):14-28.

Duquenne L, Hensor EM, Wilson M, Garcia-Montoya L, Nam JL, Wu J, et al. Predicting Inflammatory Arthritis in At-Risk Persons: Development of Scores for Risk Stratification. Ann Intern Med. 2023;176(8):1027-36.

Gerlag DM, Raza K, van Baarsen LG, Brouwer E, Buckley CD, Burmester GR, et al. EULAR recommendations for terminology and research in individuals at risk of rheumatoid arthritis: report from the Study Group for Risk Factors for Rheumatoid Arthritis. Ann Rheum Dis. 2012;71(5):638-41.

Mankia K, Siddle HJ, Kerschbaumer A, Alpizar Rodriguez D, Catrina AI, Cañete JD, et al. EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis. Ann Rheum Dis. 2021;80(10):1286-98.

van Steenbergen HW, Cope AP, van der Helm-van Mil AHM. Rheumatoid arthritis prevention in arthralgia: fantasy or reality? Nat Rev Rheumatol. 2023;19(12):767-77.

van Steenbergen HW, Doornkamp F, Alivernini S, Backlund J, Codreanu C, Cohen SB, et al. EULAR/American College of Rheumatology Risk Stratification Criteria for Development of Rheumatoid Arthritis in the Risk Stage of Arthralgia. Arthritis Rheumatol. 2026 Mar;78(3):523-536.

Crohn’s Disease and Ulcerative Colitis

Lee S-H, Turpin W, Espin-Garcia O, Xu W, Croitoru K, Lee S-H, et al. Development and Validation of an Integrative Risk Score for Future Risk of Crohn’s Disease in Healthy First-Degree Relatives: A Multicenter Prospective Cohort Study. Gastroenterology. 2025;168(1):150-3.e4.

Lee S-H, Lopes EW, Khalili H, Croitoru K, Colombel J-F, Peter I, et al. Prediction and Prevention of Inflammatory Bowel Disease: A Call to Action. Gastroenterology. 2026;170(2):233-9.

Torres J, Moss A. Introduction to the IBD Journal Supplement: “Prevention of IBD: Forecasting and Forestalling Inflammatory Bowel Disease Onset”. Inflammatory Bowel Diseases. 2025;31(Supplement_2):S1-S2.

Turner D, Kenigsberg S, Focht G, Turpin W, Ledder O, Griffiths AM, et al. Preclinical stages of Crohn’s disease defined by faecal calprotectin in asymptomatic first-degree relatives: screening framework for prevention trials. Gut. 2026 Jan 9:gutjnl-2025-336368.

Systemic Lupus Erythematosus

Choi MY, Costenbader KH. Understanding the Concept of Pre-Clinical Autoimmunity: Prediction and Prevention of Systemic Lupus Erythematosus: Identifying Risk Factors and Developing Strategies Against Disease Development. Front Immunol. 2022;13:890522.

James JA. 133 - Preclinical features of lupus. In: Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, editors. Rheumatology (Sixth Edition). Philadelphia: Mosby; 2015. p. 1026-31.

Olsen NJ, Liao D, James JA, Guthridge JM, Arriens C, Kamen D, et al. A Randomized, Placebo-Controlled Trial of Hydroxychloroquine in Incomplete Lupus. Arthritis Rheumatol. 2026 Apr;78(4):870-879.

Slight-Webb S, Bourn RL, Holers VM, James JA. Shared and unique immune alterations in pre-clinical autoimmunity. Curr Opin Immunol. 2019;61:60-8.

Biostatistics

Adaptive Designs for Clinical Trials. E20 Draft Version. Accessed 3/3/2026. Silver Spring (MD).

Adaptive Platform Trials Coalition. Adaptive platform trials: definition, design, conduct and reporting considerations. Nat Rev Drug Discov. 2019 Oct;18(10):797-807.

Bhatt DL, Mehta C. Adaptive Designs for Clinical Trials. N Engl J Med. 2016 Jul 7;375(1):65-74.

Califf RM. Biomarker definitions and their applications. Exp Biol Med (Maywood). 2018 Feb;243(3):213-221.

FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools). Silver Spring (MD): Food and Drug Administration (US); 2016.