CAR-T lupus therapy: Will patient access be limited?

CAR-T lupus therapy: Will patient access be limited?

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By Julianne Dunphy, PhD, Global Director of Medical Strategy, Evoke Mind+Matter

Last week I attended The American Society of Gene & Cell Therapy (ASGCT) conference in Los Angeles. One of the standout sessions for me led to an interesting discussion on the application of CAR-T cell therapy to treat autoimmune diseases. This was a presentation that focused particularly on systemic lupus erythematosus (SLE) and promising results of using CAR-T therapy for the treatment of refractory SLE that, understandably, caught worldwide attention.[1]

Those working within oncology research or healthcare will be very familiar with the game-changing impact CAR-T cell therapy has had on the treatment of hematologic malignancies.[2] While this technology has the potential to address multiple disease states outside oncology,[3] these results in SLE are an early example of CAR-T therapy being used in an autoimmune disease.[1,2] SLE is a chronic, heterogenous condition characterized by an aberrant B cell-mediated immune response1 that turns against the body’s healthy tissues.[4] Manifestations are multisystemic, painful, life-limiting, and potentially life-threatening.4 Broad4 and targeted immunosuppressive treatment are mainstays of therapy, but certain patients are refractory to treatment and face severe and progressive disease.[2] This small study evaluated the impact of autologous CD19-CAR T cell therapy in 5 adults with refractory SLE.[2] The aim was to dramatically deplete B cells and achieve an “immunological reset.”[2] The study yielded encouraging results: the authors report that the treatment was well-tolerated and that all patients experienced SLE remission and quality of life improvement.[2]

With around 3.41 million SLE patients around the world,[4] many of which are refractory to treatment,[2] there is a massive unmet medical need waiting to be filled. Could CAR-T cell therapy be an option? Scientifically, this is clearly a valid area of research. However, what we also know about SLE is that it disproportionately affects females and people from Black African, Caribbean, and Asian ancestries – young women of colour - who are more likely to experience limited, inequitable access to health care.5,6 CAR-T cell therapy is a complex and costly process. To what extent will the patients of highest need be able to receive such a therapy once available?

The body of literature regarding the profound impact on of social determinants of health, systemic racism, as well as access challenges in low- and middle-income countries on SLE continues to grow.[5,6] We shouldn’t be surprised. Our experience working in sickle cell disease has given us an appreciation of the tragic consequences possible when human health and the healthcare system don’t meet.

New breakthroughs will always grab the headlines – and often raise hopes for the associated patient population. It is critical that alongside the groundbreaking science we also look for new ways to ensure that all patients can access appropriate treatments. It was pleasing to see that these issues were on the agenda at ASGCT, with many productive discussions around challenges with access and affordability of gene and cell therapies, pricing and payment structures, and equitable care. Whether or not CAR-T therapy becomes an approved option for SLE patients, the prospect reminds us acutely of the reality of health inequities in the SLE community, even for basic care.

At Inizio Evoke our goal is to make health more human™ – and key to this is striving for equitable care and access to treatments for all. We continue to work alongside our clients to make healthcare communications more accessible and relevant to all audiences.

At Inizio Evoke, we have custom designed a global DEI strategy comprised of six pillars that are inclusive of our global footprint across many business units and that challenges our commitment to inclusion internally with education, training, action, and accountability of our workforce and externally ensuring our DEI commitment impacts healthcare disparities, community social justice, and client/customer innovation.


1. Mueller F et al. CD19-Targeted CAR-T Cells in Refractory Systemic Lupus Erythematosus: Safety, Efficacy, and Mechanistic Insights from the First Five Patients. Blood 2022;140(Supplement 1): 4562–4563. 2. Mackensen A et al. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med 2022;28:2124–2132. 3. Aghajanian H et al. CAR-based therapies: opportunities for immune-medicine beyond cancer. Nat Med 2022;4:163–169. 4. Tian J et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Annals of the Rheumatic Diseases 2023;82:351–356. 5. Bruce I.N. Health inequalities and systemic lupus erythematosus: a global challenge. Rheumatology 2023;62(Supplement 1): i1–i3. 6. Williams J.N et al. The impact of social determinants of health on the presentation, management and outcomes of systemic lupus erythematosus. Rheumatology (Oxford). 2023;29:62(Supplement 1):i10–i14.