Inaugural issue: a big year in autoimmune

Editor's note, September 2026. This issue was sent on August 26, 2026. On August 24, Novartis paused its CAR-T trials in autoimmune disease after three patient deaths, and Bristol Myers Squibb paused enrollment in a similar trial as a precaution. CAR-T for autoimmune disease remains experimental and is offered only in clinical trials. If you are in or considering a trial, talk with your trial team.

Meredith Nolan (CEO, Founder of Constellate) and Jonathan S. Hausmann, MD

Welcome to the first Constellate newsletter! We have gathered some of the most important developments in autoimmune research and care from the past year, the ones we think are worth your attention. This issue has a clear theme: the field is beginning to shift from holding the immune system down toward trying to reset it.

“When asked, I used to tell my rheumatoid arthritis and lupus patients that a cure was unlikely, that the best we could hope for was a drug-induced remission. With these therapies, some patients in trials appear to be ‘cured’ of their disease, without any medications, at least for now. As a result, I am much more hopeful that at least some of my patients won’t need to take medications for life!”

From Dr. Hausmann's desk

Deep dive

The immune reset, explained

For a long time, living with an autoimmune condition meant taking medicines to keep your immune system suppressed, often for years, to control symptoms. A newer approach asks a different question: instead of holding the immune system down, can you reset it so it stops attacking the body in the first place?

The idea is to thoroughly remove the immune cells (called B cells) that drive many autoimmune diseases, so that the immune system can rebuild itself, or "reboot." The most studied version, CAR-T, does this by taking a person's own T cells, reprogramming them in the lab to hunt down and destroy those B cells, and returning them to the body. It is powerful, but demanding: it requires harvesting a patient's cells, and a round of chemotherapy first so the body will accept the reprogrammed cells.

The published results are striking. In a case series in the New England Journal of Medicine, 15 people with severe lupus, myositis, or scleroderma that had not responded to standard treatment each received a single CAR-T infusion. All of them reached remission or major improvement, and every one was able to stop their immune-suppressing medications.

This is a genuine shift in what looks possible. It is also early. The studies are small, the follow-up is short, the treatment carries real risks, and the cost is high. No one yet knows how long these remissions last. For now, it is being studied in clinical trials for people with severe diseases that have not responded to standard treatments.

New research is also exploring "off-the-shelf" approaches that may also help reset the immune system but are not as toxic or difficult to administer. T-cell engagers, for example, are drugs that direct a patient's own T cells to remove those troublesome B cells without harvesting any cells or using chemotherapy. They may be simpler to use and administer, though their effect may not be as long-lasting as that of CAR-T.

The practical takeaway: if your disease has been hard to control, it is reasonable to ask your doctor whether you may qualify for a clinical trial in this area.

The bottom line: for decades, the goal was drug-induced remission, keeping the disease quiet with ongoing medications. For the first time, some people in these trials are reaching lasting, drug-free remission. It is early, but it is a fundamentally different approach to treatment.

Evidence: published case series, refractory patients · Source: New England Journal of Medicine (2024)

New & emerging treatments

A first real treatment for Sjögren's disease is in sight

Until now, Sjögren's has had no approved treatment for the disease itself. The available options ease symptoms such as dry eyes and mouth, but none change the course of the disease. That may be about to change. A drug called ianalumab was shown to improve disease activity in two large Phase 3 trials and earned a special FDA "breakthrough" designation. If approved, it would be the first treatment aimed at the underlying disease, not just the symptoms.

Why it matters: Real, near-term hope for a common condition that has been badly underserved. Sjögren's is one of the most common conditions among Constellate members.

Evidence: Phase 3 positive; not yet approved · Source: Cleveland Clinic Journal of Medicine

Lupus: a new B-cell treatment, and easier dosing

Obinutuzumab (Gazyva) is now FDA approved for lupus that affects the kidneys (lupus nephritis), where nearly half of the people in its trial saw their kidney function return to near normal. It is the first drug of its kind to show that level of benefit for lupus nephritis in a large trial, and it is under review for lupus more broadly. Separately, an existing lupus drug, Saphnelo, has until now required an infusion at a hospital or clinic; it is now available as an at-home injector pen.

Why it matters: A meaningful new option for a hard-to-treat lupus complication, plus far easier dosing for people already on therapy.

Evidence: Approved (lupus nephritis); under review (broader lupus) · Source: Lupus Foundation of America; Pharmacy Times (Saphnelo)

A genuinely new class of drug for ulcerative colitis

Tulisokibart is the first of a new class of drugs (called anti-TL1A) to succeed in ulcerative colitis. Instead of broadly suppressing the immune system, it blocks a specific signal, TL1A, that drives both inflammation and scarring (fibrosis), while calming an overactive immune response. In its published trial, far more people reached remission on the drug than on placebo. The same approach is now being tested in other autoimmune conditions, including systemic sclerosis, rheumatoid arthritis, and psoriatic arthritis.

Why it matters: A new mechanism means a new chance for people whose current treatment is not working, and possibly beyond the gut.

Evidence: Phase 2 published; Phase 3 goals met · Source: New England Journal of Medicine

The first drug shown to slow MS disability, not just relapses

Tolebrutinib is a pill designed to reach into the brain, where it calms the "smoldering" inflammation thought to drive long-term disability in MS. In a large published trial of people with progressive MS who were not having relapses, it reduced the risk of worsening disability by about a third. It is the first treatment to show this in that group, and it is now under regulatory review.

Why it matters: Progressive MS has had very few options; this targets the part of the disease that has been hardest to treat.

Evidence: Phase 3 published; under regulatory review · Source: New England Journal of Medicine

Guidelines & practice changes

It may be possible to delay rheumatoid arthritis

In patients at high risk of developing rheumatoid arthritis, one year of a medication called abatacept delayed the onset of the disease by several years. The important nuance: it appears to delay RA rather than prevent it outright, with the protection fading over time once the drug is stopped. It is part of a broader shift in rheumatology to act even before a disease takes place.

Why it matters: For people with a family history or early warning signs, delaying disease is becoming a real conversation to have with a rheumatologist.

Evidence: Clinical trial (published in Lancet Rheumatology) · Source: U.S. News (accessible summary)

Save for your next clinic visit

One question worth bringing to your care team: “Given my history, is any of this relevant to me, or worth keeping an eye on?” And if your disease has been hard to control, that is the moment to ask whether a clinical trial might fit.

This is our first issue. And stay tuned: we’re working on building an even more personalized briefing, tailored to you.