For decades, treating autoimmune diseases like systemic lupus erythematosus (SLE) and rheumatoid arthritis has followed a familiar pattern of cycling through therapies to manage symptoms while leaving the underlying drivers of disease unresolved. Here our goal is shifting toward something different: addressing the B cells and T cells that help sustain autoimmune disease and dysregulated immune responses. This approach is known as immune reset.
The goal is not just to manage signs and symptoms of disease — it’s to fundamentally change its course for patients.
Mary Struthers, scientific vice president in immunology, and Tim Campbell, vice president of hematology and cell therapy early clinical development, discuss how immune reset may shape the future of autoimmune disease treatment.
Mary Struthers: For many patients, autoimmune disease is something they do their best to live with, cycling between periods of control and relapse. Even when treatments are effective, they often need to be taken continuously to keep symptoms in check.
Immune reset starts with a different question: what if we could fundamentally and durably interrupt that cycle, rather than just manage it? It works by identifying and removing, or in some cases reprogramming, the immune cells that drive disease, with the goal of allowing the immune system to reestablish itself with healthier immune regulation.
Instead of broadly suppressing immune activity, this approach targets a key source of immune dysregulation and the drivers of disease. For patients, that could open the door to durable remission, and, in some cases, the potential of a functional cure — where disease remains controlled even after treatment ends.
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Immune reset is about targeting the drivers of chronic disease so the system can be reestablished in a healthier way.
See how we’re pursuing pathbreaking science by pushing the boundaries in immune-mediated diseases with our sequential immunotherapy framework.
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A sequential immunotherapy framework informed by advances in the understanding of human biology aims to rebalance the immune system in patients living with immune-mediated diseases.
Step one is to control inflammation, or treat symptoms. This is accomplished through targeted immune inhibition and is where most currently available therapies focus. These therapies can lead to undesired broad immunosuppression and increased risk for infection, and they don't work in all patients. However, the opportunity exists to innovate through a precision medicine approach.
Step two aims to reset the immune system by eliminating pathogenic immune-memory cells. We believe this can be achieved by depleting autoreactive cells or by promoting immune tolerance. Cell therapy is a platform that has shown early promise in achieving an immune reset and is being explored further.
Finally, the goal of step three is to maintain immune homeostasis and promote tissue repair. This important step helps sustain remission over time by leveraging regulatory mechanisms in the body.
At Bristol Myers Squibb, we believe this sequential immunotherapy approach is enabled by our emphasis on causal human biology. Matched with expertise across an array of innovative modalities, this strategy has the potential to deliver transformational advances for patients, including durable remissions and cures.
Mary Struthers: Translating immune reset into practice means taking what we understand about the immune drivers of disease and acting on it.
To maximize our ability to treat patients with autoimmune diseases, we place immune reset into the context of our sequential immunotherapy framework — control, reset and repair. Instead of relying on a single approach, a range of strategies is required. Some therapies are designed to directly control disease activity, while others aim to target and eliminate disease-driving immune cells to reset the immune system. This represents a shift from managing or controlling disease in the short term to addressing the underlying drivers to support longer-term immune balance. Together, these approaches consider how treatment may evolve over time, enabling us to treat patients where they are in their disease journey.
What changes with immune reset is not just the type of therapies used, but how they are applied. Rather than treating all patients the same, these approaches can be used more precisely based on the biology driving disease in each individual, helping move toward more durable responses and, over time, less dependence on continuous treatment.
“Translating immune reset into practice means building multiple treatment paths so the right approach can be matched to each patient.”
Tim Campbell: What’s beginning to change is what treatment can aim to achieve. Instead of managing disease indefinitely, we’re starting to see that it may be possible to interrupt it more fundamentally.
In cell therapy, that shift is already showing up in clinical trials. Early clinical data in cell therapy are demonstrating the potential for treatment-free remission, with patients able to come off chronic immunosuppressive therapies — something that, until recently, wasn’t thought possible in autoimmune disease.
That’s what makes this moment different. It’s not just a new way to treat disease; it’s an early signal that we may be able to change it in a more lasting way.
Mary Struthers: The focus now is on building on early results and understanding how to deliver more consistent, lasting responses across patients.
What we’re seeing is the beginning of a shift, from demonstrating the potential of immune reset to understanding how to make it more reliable and accessible for patients over time.
We are now beginning to look at what may come next. If immune reset can interrupt disease, the next step is how to treat the damage it has caused — moving into a “repair” phase focused on maintaining immune balance and restoring function for patients over time.
“For patients, the goal is fewer cycles of disease, and more time living without it.”
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. As global citizens, we work sustainably and responsibly to create a positive impact in the communities where we live and work.
