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The First Sjögren's Drug "Worked." What It Didn't Fix.

Sjogren's
October 28, 2026•9 min read

The ianalumab trials beat placebo by about one point on a clinician score, and dryness, fatigue, and pain didn't move. Here's my honest read, as a physician, a trial participant, and a patient.

A note before you read: this post discusses end-of-life decisions related to chronic illness. If you or someone you know is struggling, please reach out to the 988 Suicide and Crisis Lifeline by calling or texting 988 (US). In Canada, call or text 9-8-8.

You may have seen the headline: the first big Sjögren's disease drug worked. Here's what the headline didn't tell you.

I read the New England Journal of Medicine paper three times. First as a physician, checking the confidence intervals. Then as a clinical trial participant. Then as a woman who lives with Sjögren's, looking for the line that said dryness, fatigue, and pain might finally get better. It wasn't there.

This disease just keeps coming with the hits. Earlier this month, argenx stopped its phase 3 UNITY trial of efgartigimod after an independent monitoring committee concluded it couldn't meet its primary endpoint. Now the full ianalumab results are out, and even the investigators call the effect small.

I lead a community of patients, and I've spent years being the hopeful one. Right now my optimism and my patience are both being tested. I think my patients deserve to hear me say that out loud. This is the written version of my video, which you can watch here: https://youtu.be/xZW4Zdxl2VE.

One disclosure up front: I have done consulting work with some of the companies that have these medications in clinical trials, and I'm a participant in an ongoing phase 3 trial. Nobody asked for this post and nobody paid for it. It's education, not medical advice for your own care.

What the trials showed

NEPTUNUS-1 and NEPTUNUS-2 enrolled 779 people with active Sjögren's disease (Mariette et al., NEJM 2026). Monthly ianalumab beat placebo on the ESSDAI at 48 weeks. The ESSDAI is a clinician-scored measure of systemic disease activity: it counts what a doctor can see and measure across organ systems, not how you feel.

But placebo patients improved by 5 to 5.5 points on their own, and the drug added about one more. The share of patients with a meaningful 5-point improvement didn't separate significantly. Neither did dryness, fatigue, pain, or salivary flow. The accompanying editorial called it "a first step".

To be fair, two trials with nearly identical results is the most consistent signal our field has had, and serious side effects weren't increased through a year. It also isn't the only news this fall. In September, Amgen announced that dazodalibep met its primary ESSDAI endpoint in its phase 3 OASIZ 301 trial, though the full data haven't been presented yet. Different drugs, aimed at different parts of the immune system, are landing in very different places. If anything, that tells me Sjögren's is several disease processes sharing one name.

Some colleagues are celebrating this week, and I understand why. The first positive phase 3 program in our disease matters. But the patients I'm most worried about weren't in these trials.

The patients these trials left out

I take care of seronegative patients who keep getting worse, with crushing fatigue and painful, disabling neuropathy. (Seronegative means the standard Sjögren's antibodies come back negative even though the disease is there.) I take care of patients whose labs and biopsies point to active, B-cell-driven disease. Many of them would never have qualified for NEPTUNUS.

More than 90% of participants were anti-Ro positive. Qualifying disease activity had to come from a list of organ domains that didn't include the peripheral nerves, so nerve involvement may have been present, but it didn't count toward entry. The trials also enrolled only people diagnosed within the past 7.5 years.

So when someone reads "the effect was small" and concludes treatment isn't worth trying, they're applying a result to people who were never studied. That's my real fear: that these results get used as ammunition to deny care, even by people who mean well. I can already hear it. "Even the new drugs barely work." "It's mostly dryness anyway." I can picture a prior authorization reviewer skimming a headline and denying the off-label therapy a patient fought months to get. I can picture a colleague quietly deciding it isn't worth the risk, or the paperwork.

I understand where that caution comes from. Exposing someone to immunosuppression for a one-point benefit is a real concern, and most doctors who say no are trying to protect their patients. But from the patient's side of the denial, protection and dismissal look exactly the same. They've been hearing "there's nothing more we can do" for years.

Threads of hope

So many of my patients have been holding on by threads of hope, and I'm afraid this fall is going to break some of them. I've heard of people with Sjögren's in Canada pursuing medical assistance in dying because the fatigue and pain had become too much to live with. That should stop all of us cold. It's what's at stake when "modest" gets read as "meaningless."

I'm holding a thread too. I'm in a phase 3 trial for people whose disease lives in fatigue, pain, and dryness rather than on the ESSDAI, and I've been in the open-label extension for about 18 months. I can't tell you what the drug does. My experience isn't data, and the trial deserves to speak for itself. What I can tell you is that I'm scared of a press release deciding whether I keep what I have now. Every trial participant carries that fear. Earlier this month, the people in UNITY found out their study was ending.

What the placebo arm taught me

Placebo patients improved by more than five points. Some of that is the natural ebb of a flare. But I also think about what they received: a year of regular visits with a team that listened and cared.

Most of my patients have never had that, and not because anyone doubts it helps. We don't have enough clinicians to provide it, and we don't pay for listening the way we pay for a procedure. It isn't a drug, and it shouldn't replace one. But we already know how to give it. We've just decided not to fund it.

A disease we've barely studied

Rereading the papers, what strikes me most is how little we understand about how this disease actually does its damage. Ianalumab wiped out circulating B cells, and the authors themselves conclude that peripheral B-cell depletion alone isn't enough. We still have no agreed-upon immunologic explanation for the fatigue, pain, and neuropathy that disable my patients most.

That isn't an accident. In fiscal year 2025, the NIH spent $29.5 million on Sjögren's research, compared with $147.9 million on lupus and $112 million on multiple sclerosis. For decades, we've mostly studied what was easy to measure: tears, saliva, antibodies.

We already have clues that "Sjögren's" is several diseases. JOQUER, a hydroxychloroquine trial, was negative overall. But when researchers re-analyzed it by symptom-based subgroup, patients with a high symptom burden improved on hydroxychloroquine, and the pain-dominant and dryness-dominant groups did not. Molecular studies sort patients into distinct immune profiles, which we call endotypes: some interferon-driven, some B-cell-driven, some with almost no detectable immune signature in the blood. Imagine reading NEPTUNUS that way. A one-point average could hide a real benefit in one endotype and nothing in the others.

What I'm asking for

To sponsors and trialists: enroll the patients we keep leaving out, including people with seronegative and neuropathy-predominant disease. Build trials around what patients actually feel, using composite measures like STAR and CRESS (scores that combine what the doctor measures with what the patient reports). Stratify by endotype and report results for each, so we learn which treatment helps which patient. Publish everything, including the trials that stop. And plan for continued access from day one, both for people who respond and for people whose program ends.

To payers and colleagues: read past the headline. A small average in a selected population says very little about the person sitting in front of you. If caution is the reason for a no, say so, and come with a plan. And reimburse longitudinal, relationship-based care like it matters, because the placebo arm suggests it does.

To the NIH and Congress: fund Sjögren's research in proportion to the millions of people living with it. We can't treat a disease well when we've never invested in understanding how it works.

Why I'm still here

Somewhere in all this I realized I'd been mixing up optimism and hope. Optimism expects the next result to be good. Hope is deciding to keep working because the outcome matters, whatever the next result is.

My optimism is bruised right now. My hope is still here. Not long ago, no drug had ever met a phase 3 endpoint in Sjögren's. Now two have. It's smaller and slower than my patients deserve, but it's movement.

So I'll keep showing up, in clinic, in my trial, and in this community, and I'll keep telling my patients the truth. To everyone holding on by a thread right now: I see you. I'm holding on too.

Your turn

Where are you right now with the new Sjögren's treatments: optimistic, hopeful, or just tired of waiting? Tell me in the comments. Your answer helps the next person who finds this post on a hard day.

A few resources:

If this post hit close to home: in the US, call or text 988. In Canada, call or text 9-8-8. Any time.

And if you want the story of what being in a Sjögren's trial is actually like, start with my video on my clinical trial experience as a doctor and a patient.

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