The ALPHA Project: Establishing consensus and prioritisation of global community recommendations to address major challenges in lupus diagnosis, care, treatment and research.

The Addressing Lupus Pillars for Health Advancement (ALPHA) Project is a global consensus effort to identify, prioritise and address top barriers in lupus impacting diagnosis, care, treatment and research. To conduct this process, the ALPHA Project convened a multistakeholder Global Advisory Committee (GAC) of lupus experts and collected input from global audiences, including patients. In phase I, the ALPHA Project used expert interviews and a global survey of lupus experts to identify and categorise barriers into three overarching pillars: drug development, clinical care and access to care. In phase II, reported here, the GAC developed recommended actionable solutions to address these previously identified barriers through an in-person stakeholder meeting, followed by a two-round scoring process. Recommendations were assessed for feasibility, impact and timeline for implementation (FIT), where potential FIT component values were between 1 and 3 and total scores were between 3 and 9. Higher scores represented higher achievability based on the composite of the three criteria. Simplifying and standardising outcomes measures, including steroid sparing as an outcome (drug development) and defining the lupus spectrum (clinical care) ranked as the highest two priority solutions during the GAC meeting and received high FIT scores (7.67 and 7.44, respectively). Leveraging social media (access to care) received the highest FIT score across all pillars (7.86). Cross-cutting themes of many solutions include leveraging digital technology and applying specific considerations for special populations, including paediatrics. Implementing the recommendations to address key barriers to drug development, clinical care and access to care is essential to improving the quality of life of adults and children with lupus. Multistakeholder collaboration and guidance across existing efforts globally is warranted.

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Competing interests: SCR is an employee of the Lupus Foundation of America (LFA). SS, LB, TF and DZ are consultants of Faegre Drinker Consulting, a division of Faegre Drinker Biddle & Reath, a law and consulting firm that represents patient advocacy organisations and sponsors developing drugs. INB receives grant/research support from Genzyme Sanofi, GSK and UCB; is a consultant of Eli Lilly, AstraZeneca, UCB, Iltoo and Merck Serono; and affiliated with speakers bureaus for UCB and AstraZeneca. EC-S is an employee of Mallinckrodt (former). KHC receives grant/research support from Merck and is a consultant of AstraZeneca. BD is an employee of Aurinia (former). TD receives grant/research support from Janssen, Novartis, Roche and UCB; is a consultant of Abbvie, Celgene, Eli Lilly, Roche, Janssen and EMD; and affiliated with speakers bureaus for Eli Lilly, Roche, Samsung and Janssen. KK receives grant/research support from UCB, Novartis and Resolve; and is a consultant of AstraZeneca, Viela Bio, Genentech/Roche, Biogen, Iltoo, GSK, BMS, Janssen, Abbvie, Amgen, Eli Lilly, Kyowa Kirin, Equillium Bio and Celgene. AHK is an employee of EMD Serono. EFM receives grant/research support from AstraZeneca, BMS, Eli Lilly, GSK, Janssen and Merck-Serono; is a consultant of AbbVie, Amgen, AstraZeneca, Biogen, BMS, Eli Lilly, GSK, Janssen, Neovacs and Sandoz; and is affiliated with speaker bureaus for AstraZeneca and Novartis. BHR is a consultant for GSK, Aurinia, AstraZeneca, Novartis, Alexion and BMS. LES receives grant/research support from Sobi, BMS, CARRA Inc.; is a consultant of Aurinia, UCB (DSMB), Sanofi (DSMB) and Sobi. VPW receives grant/research support from Biogen, Celgene, Gilead, Janssen and Viela; and is a consultant of Biogen, Gilead, Janssen, Abbvie, GSK, Resolve, AstraZeneca, Amgen, Eli Lilly, EMD Serono, BMS, Viela and Kyowa Kirin. JMVF is a shareholder and employee of GSK (former). KT and LMH are employees of the LFA (former). SE and AWD are LFA patient ambassadors.