Global Consensus Building and Prioritization of Major Challenges in Lupus Diagnosis, Care, Treatment and Research

Karin Tse¹, R. Paola Daly¹, Leslie Hanrahan², Annick Anderson³, Kathleen Arntsen⁴, Sang-Cheol Bae⁵, Ian N. Bruce⁶, Karen Costenbader⁷, Thomas Dörner⁸, Amy H. Kao⁹, Susan Manzi¹⁰, Eric Morand¹¹, Sandra Raymond¹, Brad H. Rovin¹², Laura E. Schanberg¹³, Victoria P. Werth¹⁴, Joan Von Feldt¹⁵ and Kenneth Getz³, ¹Lupus Foundation of America, Washington, DC, ²Lupus Foundation of America, Washington DC, DC, ³Tufts Center for the Study of Drug Development, Boston, MA, ⁴Lupus and Allied Diseases, Inc., Verona, NY, ⁵Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, Republic of (South), ⁶Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, The University of Manchester, Manchester, United Kingdom, ⁷Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, MA, ⁸Charité Universitätsmedizin Berlin and Deutsches Rheuma-Forschungszentrum (DRFZ), Berlin, Germany, ⁹EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), Billerica, MA, ¹⁰Autoimmunity Institute and Medicine Institute, Allegheny Health Network, Pittsburgh, PA, ¹¹Medicine, School of Clinical Sciences at Monash Health, Monash University, Melbourne, Australia, ¹²Ohio State University Medical Center, Columbus, OH, ¹³Duke University Medical Center, Durham, NC, ¹⁴Department of Dermatology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, ¹⁵GlaxoSmithKline, Philadelphia, PA

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Lupus, qualitative, research methods and treatment

Session Information

Date: Monday, October 22, 2018

Title: Systemic Lupus Erythematosus – Clinical Poster – ARHP

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

The Addressing Lupus Pillars for Health Advancement (ALPHA) Project is a global consensus initiative seeking to identify and prioritize top barriers in lupus impacting diagnosis, care, treatment and research, with the goal of improving rates of accurate and timely diagnosis, increasing access to care, and improving short and long-term patient outcomes. This abstract presents Phase I consensus building and prioritization process methodology, and findings of initial project activities.

Methods:

The Lupus Foundation of America and its research partner, Tufts Center for the Study of Drug Development, assembled a Global Advisory Committee (GAC) of 13 lupus experts across 5 countries to provide input and support throughout the effort. A mixed methods approach is being used to elicit concepts seen as major barriers in lupus diagnosis, care, treatment and research, then consolidate and confirm those selected as most urgent. First, a brief web survey was distributed to each GAC member to begin concept elicitation. Identified items were then ranked during a GAC meeting, and will be presented through an in-depth semi-structured interview among 22 stakeholders representing industry, academia, regulatory bodies, patient/advocacy groups, clinicians, and researchers. Finally, an online survey among 200-500 individuals will further validate and demonstrate consensus around top barriers in a broader audience for this Phase I initiative.

Results:

GAC member response rate was 85% for the concept elicitation exercise. Findings are shown in Figure 1. 15 main concepts were identified, with substantial discussion on lupus heterogeneity, lupus as a spectrum of diseases, and the importance of biomarkers in trial design and understanding of the disease. Categorization and prioritization of these concepts is seen in Figure 2. Notably, all GAC members cited issues surrounding disease definition and diagnosis as the most significant burden in lupus. Half also cited clinical trial design and availability and side effects of current medications as significant burdens.

Conclusion:

The ALPHA Project is a collective, iterative research effort among lupus key opinion leaders and diverse stakeholder groups to build consensus and create actionable steps to advance the field. Findings from the GAC meeting showed initial consensus on key priority issues, such as lupus heterogeneity, disease definition, and clinical trial design.

Figure 1. Concept Elicitation of Top Barriers in Lupus Diagnosis, Care, Treatment and Research

Figure 2. Concept Prioritization from GAC Survey of Top Barriers to Lupus Diagnosis, Care, Treatment and Research

Disclosure: K. Tse, None; R. P. Daly, Lupus Foundation of America, 3; L. Hanrahan, None; A. Anderson, None; K. Arntsen, None; S. C. Bae, None; I. N. Bruce, None; K. Costenbader, None; T. Dörner, None; A. H. Kao, EMD Serono Research & Development Institute, Inc. (a business of Merck KGaA, Darmstadt, Germany), 3; S. Manzi, None; E. Morand, None; S. Raymond, None; B. H. Rovin, None; L. E. Schanberg, None; V. P. Werth, None; J. Von Feldt, None; K. Getz, None.

To cite this abstract in AMA style:

Tse K, Daly RP, Hanrahan L, Anderson A, Arntsen K, Bae SC, Bruce IN, Costenbader K, Dörner T, Kao AH, Manzi S, Morand E, Raymond S, Rovin BH, Schanberg LE, Werth VP, Von Feldt J, Getz K. Global Consensus Building and Prioritization of Major Challenges in Lupus Diagnosis, Care, Treatment and Research [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/global-consensus-building-and-prioritization-of-major-challenges-in-lupus-diagnosis-care-treatment-and-research/. Accessed .

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