This Sjögren's Drug Helped With Dryness

The phase 3 results for dazodalibep are starting to come out. Dryness improved nearly twice as much as placebo, and here's how I read the numbers as a physician in the sister trial.

I cried happy tears when these results came out, and I've been waiting years to say that out loud. If you live with Sjögren's disease, I hope you understand why.

Dryness is the symptom almost everyone with Sjögren's lives with every single day. In the biggest Sjögren's drug trial published this fall, dryness didn't separate from placebo. In the new dazodalibep results, it did. On two different dryness measures, dryness improved nearly twice as much as it did on placebo.

I'm going to walk you through the numbers released so far, the gaps we're still waiting on, and what you can do with this information right now. This is the written version of my video, which you can watch here: https://youtu.be/3VqY0Xa9ehI.

One disclosure up front: I am a patient participant in the dazodalibep OASIZ 303 study. This post isn't sponsored, and nobody asked for it or paid for it. It's education, not medical advice for your own care.

How to read any Sjögren's trial result

People on placebo get better too, and sometimes a lot better. In this trial, people on placebo improved almost four points on the disease activity score all on their own. So the question is never "did people improve?" It's "how much more did they improve on the drug?" That gap is what gets credited to the medication.

One more thing before the numbers. The trial in this release, OASIZ 301, enrolled more than 600 people with moderate to severe systemic disease, meaning their Sjögren's was showing up in their organs (an ESSDAI score of 5 or higher). It did not enroll people whose Sjögren's lives mostly in dryness, fatigue, and pain with quieter lab results. That's the group I'm in. That's OASIZ 303, and its results haven't been reported yet.

How dazodalibep works

Your immune cells need permission to switch on. A B cell, the kind of cell that makes antibodies, can't fully activate by itself. It needs a handshake from a T cell, passed through a docking point called CD40. Dazodalibep blocks that handshake from the other side, at CD40 ligand. No handshake, no permission, and the B cell stays calmer (St Clair et al., Nature Medicine 2024).

Here's why that matters for safety. Drugs that blocked the same handshake were tried years ago and ran into blood clots, because platelets carry the same docking partner. Dazodalibep was built differently, without the part of the antibody that grabs onto platelets. Blood clots were one of the first things I looked for in the phase 2 data before I signed up, and they weren't there. In the topline results Amgen released in September, there was no imbalance in blood clots or unusual infections between the drug and placebo.

The five numbers that matter

These come from Amgen's October 27 release, not yet from a full paper, so treat them as a first look.

1. Disease activity dropped 5.6 points versus 3.8 on placebo

This is the ESSDAI, a score your rheumatologist calculates from disease activity across your organ systems at 48 weeks. It measures how inflamed your disease is, not how you feel. The drug was given every 4 weeks, and the gap over placebo was 1.8 points. That was statistically significant, which means it can be credited to the medication. It's the main result the trial was designed to answer, and it was met.

2. An infusion every 12 weeks worked too

The higher dose given every 12 weeks lowered the score by 5.2 points, a gap of 1.4 over placebo, also statistically significant. If this ever reaches the clinic, an infusion four times a year is a very different life than going in every month.

3. Dryness improved nearly twice as much

People rated their own dryness on a 0 to 10 scale called the ESSPRI. On the every-4-week dose, dryness came down 2.5 points. On placebo, it came down 1.3. That's not a cure. But it's the one symptom measure the ianalumab trials couldn't separate from placebo, so this is different from what we saw just a couple of weeks ago.

4. A daily dryness diary agreed

In the study, I logged my dryness in an app every day for a good part of that first year. That diary is called the DASPRI. It showed the same pattern: about 2 points down on the drug and about 1 point on placebo. Two different ways of measuring the same symptom, moving in the same direction. That makes me trust the signal a little more.

5. Side effects were at similar rates

Side effects, serious side effects, and people stopping the drug happened at similar rates on the drug and on placebo. The most common were colds, urinary tract infections, higher blood pressure, and infusion reactions, mostly mild to moderate. One bonus detail: improvement showed up as early as week 4 and held through the year.

Dazodalibep and ianalumab, side by side (but not head to head)

I know many of you are comparing this to ianalumab, and I am too. If you missed it, I read that trial in my video on why the first Sjögren's drug "worked" and what it didn't fix, and in the paper itself (Mariette et al., NEJM 2026). Ianalumab's advantage over placebo was about one point. Here, it was about 1.8.

These were different trials with different people, so you can't line them up head to head. What I can say is that different drugs aimed at different parts of the immune system are going to land in different places. To me, that says Sjögren's is several disease processes sharing one name. About four subgroups have been identified so far (Soret et al., Nature Communications 2021), including one with more B-cell-driven disease and another with more interferon-driven disease. It wouldn't surprise me if each group responds to different treatments in different ways.

What being in the trial has been like for me

I enrolled in June 2024. It was a double-blind, placebo-controlled study, and for the first year neither I nor the trial coordinator knew whether my bag held medication or sugar water. I went every 4 weeks for a 90-minute infusion. I still can't say with certainty what was in it, though I have my suspicions.

After that year, I re-enrolled in the open-label extension, which means I knew I was getting the medication. In May, everyone in the extension was switched to every 12 weeks. And at my most recent infusion, they cut the time from 90 minutes to 60. That was a pleasant surprise.

So what has changed? My dryness, at least in my experience, has been better at baseline than it was before. I don't remember the last time I lost my voice with a cold. That used to happen two or three times a year before I enrolled. My energy and body pain have generally improved from where I started, enough that I'm living a fairly unlimited life, at least in what I've set out for myself to do.

I want to be careful here, because I'm a physician and I know placebo effects are real and powerful. They've shown up in every Sjögren's study we've seen. There's also something powerful about receiving care on a regular basis from a team you know cares about you. So I can't tell you that this drug 100% is the reason I feel better. I still don't know what I was getting from the start. That's exactly why these results matter so much to me, and why I'm watching the dryness number so closely.

What we still don't know

None of these medications is a cure, and that word doesn't belong in the conversation yet. Here's the honest part.

• Fatigue, pain, and joints. The trial measured fatigue and joints, and those numbers haven't been released. That doesn't mean they failed. It means we haven't seen them. I'll be looking for them when the full data is presented at ACR Convergence on Wednesday, November 11, and when it's published.
• Big responders. We don't know how many people had a large response, like a drop of 5 points or more, which is a different question from the average drop.
• People like me. We don't know how the drug works when inflammation is lower but symptom burden is high. OASIZ 303 is expected to finish by the end of 2026, and at least a partial release of that data is expected before the year ends.
• Approval. Dazodalibep isn't approved for any condition. There are still no FDA-approved medicines that treat Sjögren's disease itself. Pilocarpine and cevimeline are approved for dry mouth only. We've been borrowing from lupus and rheumatoid arthritis medicines for years.

Any positive phase 3 result is a real step. But we're not at the point of a prescription.

Three things you can do today

1. Find out which kind of Sjögren's you have. Ask your rheumatologist, "Is my disease showing up as inflammation in my labs and organs, or is it the higher symptom burden kind?" Those two groups are being studied in different trials, and the answer can help you understand which results may apply to you.

2. Track your symptoms the way the trials do. Once a week, rate your dryness, fatigue, and pain from 0 to 10 and write them down. That's essentially the ESSPRI, the same scale these trials used. It turns "I still feel awful" into numbers your doctor can follow over time, and I can see it helping down the road if you're asking insurance to cover these medicines.

3. Look at the trials. Right now, the only door to dazodalibep is a clinical trial, not a prescription. You can search for Sjögren's disease on clinicaltrials.gov and bring that list to your rheumatologist, or reach out to the sites yourself. That's how I found mine: I signed up for trial news from the Sjögren's Foundation, and it landed in my inbox.

If you're going to remember one sentence for your next appointment, make it this one: "I'd like to know how active my Sjögren's disease is. Can we calculate my ESSDAI and my ESSPRI, so we can think about which medication might be a better fit based on the trials coming out?"

You weren't imagining it

If you've spent years feeling like trials were never measuring the thing you actually live with, you weren't imagining it. Dryness, fatigue, and pain are the symptoms that keep getting left behind. Seeing one of them move in a phase 3 trial matters. It's another step forward, and we'll keep asking for more.

I'm so hopeful that we're coming to a point where there's a real surge in available treatments, and I'm ready to have more tools in my toolbox for the people I care for. We deserve to be hopeful, and we deserve the science to back it up.

Your turn

If one symptom could get better first, which would you pick: dryness, fatigue, or pain? Tell me in the comments. Your answers help me know what to dig into next, and when the full results are presented, I'll break down the gaps we're still missing.

A few resources:

• The Sjögren's Treatments and Trials Map: the Immune Confident Institute keeps an updated map of Sjögren's treatments and trials, including the ones in this post. It's free, and we update it as the news comes out: https://immuneconfidentinstitute.com/treatments-trials-map/
• Immune Confident RISE: if you've already got the labs, the specialists, and the folder on your phone, and what you need is someone to tell you which parts matter, that's what RISE is for. One short application, our team reads it, and we point you to the right fit based on your responses and where our clinicians are licensed. No payment or obligation to apply. Start here: https://immuneconfidentinstitute.com/rise/
• The Stronger Holiday Reset, November 9 to 13: five days with me and two trusted colleagues for folks with autoimmune and inflammatory conditions who run the holidays for everyone else. Doors close Sunday, November 8: https://immuneconfidentinstitute.com/holiday-reset/
• Free Lab Conversation Guide, with the exact markers and language to bring to your appointment: https://immuneconfidentinstitute.com/ic-lab-guide
• IC Indicator Quiz, a free two-minute check-in on where your immune health stands right now: https://immuneconfidentinstitute.com/ic-indicator

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

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