The ALPHA Project
The First Step to Moving Lupus Research Forward
The ALPHA Project: What is it?
ALPHA stands for Addressing Lupus Pillars for Health Advancement. The Project is a comprehensive, multi-phase, global consensus initiative aimed at identifying and prioritizing the top challenges in the lupus field and creating actionable solutions to address these issues and stimulate progress.
The goal of the ALPHA Project is to bring together international lupus experts to develop and implement strategies to address the critical barriers toward improving outcomes in lupus.
The Project is led by the Lupus Foundation of America in collaboration with a Global Advisory Committee of lupus experts representing industry, academia, and the patient voice. The first two phases of ALPHA were conducted in collaboration with the Tufts University School of Medicine Center for the Study of Drug Development.
Phase I Results
Through Phase I of the ALPHA Project, the international lupus community reached the first-ever agreement on the barriers to lupus drug development, clinical care, and access to care. Using a combination of interviews and a survey with lupus thought leaders in research, clinical practice, biopharmaceutical industry, government and patient advocacy organizations, the ALPHA Project identified the most critical issues facing the field of lupus and published the findings for review by all stakeholders.
Learn about the Phase I Results
- Read the blog post about the Global Advisory Committee Meeting
- Read the media release announcing the results (ENGLISH)
- Lea el comunicado de prensa que anuncia los resultados (ESPAÑOL)
- Read the Open Access scientific paper published on Lupus Science & Medicine
Phase II Results
In Phase II, the Global Advisory Committee of lupus experts established actionable solutions for addressing the top barriers to lupus drug development, clinical care, and access to care, as identified in Phase I. The committee defined success states for each barrier, validated these themes to reflect patients’ perspectives through surveying more than 3,200 persons with lupus and caregivers across 83 countries, and published the findings.
Learn more about the Phase II Results
- Read the Open Access scientific paper in Lupus Science & Medicine
- Read our synopsis of the Phase II results in Inside Lupus Research
Phase III Results
In Phase III, implementation teams comprised of physicians, scientists, and people living with lupus were established to further define and advance implementation of solutions identified in the prior phase. Two reports were published on this work including one focused on consequences of not having adequate diagnostic criteria that would help reduce time to diagnosis and improve long-term lupus outcomes and another highlighting findings from our meeting focused on clinical trial outcome measures.
Learn more about the Phase III Results
- Read "Lupus spectrum ambiguity has long-term negative implications for patients"
- Read "A stakeholder meeting on lupus clinical trial outcome measures and the patient perspective"
Phase IV
In Phase IV, the Global Advisory Committee of lupus experts is using a formative evaluation (mixed methods) approach to understand and apply key relational constructs that mediate the path from health communication to healthcare processes and outcomes. These include mutual respect, trust, trustworthiness, and participation in shared decision-making, which has become a key focus of our ongoing work. Specifically, the ALPHA team is developing a shared decision-making tool for treatment choices for people with lupus based on American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) guidelines.
- Identify knowledge gaps both in clinical care and research
- Create consensus around the fundamental pillars that are missing in the field and stalling drug development and progress
- Pave a path forward for more accurate and timelier diagnosis, greater access to care, and improved treatment options for people with lupus
- Result in an actionable, documented, and published roadmap that is meaningful and useful to everyone in the field, no matter where they are in the world
We know that the level and quality of data and research addressing issues related to lupus care, treatment, and healthcare access are not consistent across the global field. For example, there are differences in opinion when it comes to disease definition, treatment regiments, diagnostic criteria, and clinical trial design. The forum and opportunity to develop consensus around these issues had not existed.
This lack of consensus has led to a poor understanding about lupus, the inability to diagnose lupus in a timely fashion, especially by physicians with less experience in lupus, and a string of clinical trials of potential new treatments that failed to reach their primary endpoints and preventing them from being approved for use in treating lupus.
- Established a geographically and professionally diverse Global Advisory Committee (GAC) of lupus thought leaders to guide and oversee the study
- Conducted in-depth interviews to obtain further opinions and detailed rationale for the most urgent barriers in the field and access the level of existing agreement across the lupus expert community
- Conducted a global online survey of lupus experts focusing on the attitudes and perceptions about lupus and prioritization of the most pressing challenges to improve diagnosis, care, treatment and research
- Analyzed the survey results to identify and prioritize the barriers as ranked by the survey participants
- Global Advisory Committee has met and established next steps for addressing the identified barriers
- Implementation working groups were established for the Clinical Care, Access to Care and Drug Development Pillars
- A global meeting on clinical trial outcome measures was convened to discuss new and newly modified clinical trial outcome measures with a major focus on patient preference and needs for pediatric inclusivity
- A series of meetings were convened to determine challenges related to time to diagnosis and steps required to define the lupus spectrum
Lupus heterogeneity (diversity of the disease and the many manifestations or ways that it can impact the body) was identified as the primary barrier impeding the development of clinically meaningful treatments, the advancement of clinical care, and improvements to access and value. The study validated known challenges in lupus, identifying the five top barriers to improving outcomes in lupus:
- Lack of diagnostic, predictive and prognostic biomarkers for lupus and deficiency of biomarkers to predict drug response in clinical trials;
- Flawed clinical trial design;
- Lack of access to clinicians familiar with lupus/limited awareness of lupus among non-expert medical professionals;
- Barriers to the effective management of lupus due to social determinants of care in predominantly lower socioeconomic status areas;
- And, lack of treatment adherence.
- Drug development: Update current lupus outcome measures and issuing a declarative consensus statement on steroid-sparing drugs.
- Clinical care: Lead the development of a consensus effort to define lupus. The new definition will build on current research definitions to include closely related immune-mediated inflammatory disorders, such as cutaneous variants. After establishing a consensus definition, it will be disseminated through publication and broader discussion.
- Access to care: Spearhead an effort to gain a better understanding of social determinants of health and contributors to health disparities, and investigate the unique access to care issues faced by children with lupus.
- Additional steps: Conduct an assessment of current biomarker development and data-sharing activities and identify gaps. The assessment will lead to the creation of standardized global data-sharing efforts and support international collective research collaborations.
The ALPHA team will continue to engage stakeholders and support further research endeavors to implement solutions focused on accelerating drug development and improving access to high quality care. The Global Advisory Committee (GAC) clinical care and access to care teams will come together to focus on access to care barriers related to patient, provider and policy. The drug development team will continue to implement solutions focused on clinical trial outcome measures that are simplified but also elevate the patient voice.
- Cynthia Aranow, MD | Feinstein Institutes for Medical Research, U.S.
- Sang-Cheol Bae, MD, PhD, MPH | Hanyang University, South Korea
- Ian Bruce, MD, FRCP | University of Manchester, U.K.
- Sarah Connolly | AstraZeneca
- Karen Costenbader, MD, MPH | Brigham and Women’s Hospital, U.S.
- Angel Williams Derricott | Person with Lupus
- Thomas Dörner, MD | Charité University, Germany
- Monique Gore-Massy | Person with Lupus
- Ken Kalunian, MD | UC San Diego Health, U.S.
- Roger Abramino Levy, MD | GSK
- Hetlena Johnson, M.ED | Person with Lupus
- Sue Manzi, MD, MPH | Allegheny Health Network, U.S.
- Eric Morand, MBBS (Hons), FRACP, PhD | Monash University, Australia
- Brad Rovin, MD, FACP, FASN | Ohio State University, U.S.
- Tamar Rubinstein, MD, MS | Children's Hospital at Montefiore, U.S.
- Laura Schanberg, MD | Duke University, U.S.
- Joan Von Feldt, MD, MSEd | Professor Emeritus, University of Pennsylvania, U.S.
- Victoria Werth, MD | University of Pennsylvania and Philadelphia VAMC, U.S.
The ALPHA Project is grateful for support from its past and current sponsors, who have made this multi-phase initiative possible. Sponsors include the Lupus and Allied Diseases Association, AstraZeneca, GSK, and founding partner EMD Serono Research & Development, Inc. (a business of Merck KGaA, Darmstadt, Germany).
The ALPHA Project is garnering widespread recognition and support for the valuable work it represents in advancing the field of lupus research and treatment.
Read the publications and articlesIf you are interested in supporting the ALPHA Project, or if you would like to receive the ALPHA Newsletter, please contact Dr. Michael Fisher at fisher@lupus.org or Dr. Joy Buie at buie@lupus.org.

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