For patients, though, information has not caught up with the headlines regarding recent breakthroughs. Detailed trial data are hard to find, and most of what’s public right now lives in short conference summaries rather than full papers. At the same time, the FDA has decided the early evidence looks promising enough to grant the biologic ianalumab both Breakthrough Therapy and Priority Review status, which is a strong sign that the agency sees the data, and the drug’s potential impact, as worth serious attention.

Moving on from the Sjogren’s off-label toolkit

One reason this moment is so remarkable is that, for decades, the treatment options have barely budged. Hydroxychloroquine was adapted for common use for Sjogren’s in the 1990s, borrowed from lupus on the strength of experience in other autoimmune diseases, rather than strong Sjogren’s-specific data. Methotrexate followed by analogy with rheumatoid arthritis; prednisone gets used for flares.

All three are used off‑label and have only limited, mixed trial data for Sjogren’s. Biologics that transformed treatment for related conditions kept falling short for Sjogren’s research. Rituximab (Rituxan) did not show convincing benefits in randomized Sjogren’s trials, and belimumab (Benlysta) reached Phase 2 for Sjogren’s with encouraging signals, but no Phase 3 trial followed, and it has never been submitted for approval in this condition.

That’s the backdrop against which the recent research developments can be appreciated. In August 2025, Novartis announced that NEPTUNUS‑1 and NEPTUNUS‑2, two large, global Phase 3 trials of ianalumab, had both met their primary endpoints in adults with active Sjogren’s, marking the first time a biologic had cleared Phase 3 for this illness. By early 2026, the FDA had granted Breakthrough Therapy and Priority Review, and Novartis had filed for approval in the US, Europe, China, and Japan.

Why write about it now

The short answer is that, while the anticipation for this potential treatment option is highly visible and present, detailed information isn’t. Within the Sjogren’s community, ianalumab comes up in support groups, subreddits, clinic visits, and late‑night searches, yet the only public material for most patients remains a conference abstract providing a top-level overview of Phase 3 results and company press releases.

My own anxious wondering about ianalumab is partly what led me to start this newsletter. I went looking for detailed trial results and kept coming up short, and for a while assumed I wasn’t looking in the right places. With the anticipation around this drug, I’d expected more available data, but the process has its own logic, and the publication of full results is still pending. This post is an attempt to explain what we know currently.

How ianalumab is different in design

Ianalumab and belimumab both act on the BAFF pathway, which helps B cells survive. Belimumab works by binding to BAFF, a signaling protein that tells B cells to stay alive and keep going. Ianalumab works a step later: it binds to BAFF-R, the receptor on B cells that receives that message.

Ianalumab also has a second effect that belimumab does not. Because it attaches to BAFF-R on the surface of B cells, it can help the immune system recognize those cells for destruction. So it does two things at once: it blocks the survival signal and helps clear out the B cells carrying that receptor.

Researchers think this dual approach can be more effective in Sjogren’s disease because B cells can be difficult to suppress completely, and the ones that remain may bounce back and become active again. Ianalumab was formulated to reduce B cells more directly while also keeping BAFF signaling blocked. The Phase 3 trials were designed to see whether that approach leads to meaningful benefit for patients.

What the Phase 3 trials measured

Both NEPTUNUS trials used the same primary measure: a physician-scored disease activity score called ESSDAI, which rates disease activity across twelve organ systems. The trials were designed as companions rather than identical replications. NEPTUNUS-1 compared a monthly dose of ianalumab against the placebo. NEPTUNUS-2 tested two separate dosing schedules—monthly and every three months—against the placebo.

The key question was whether people taking ianalumab showed a bigger drop in that score than people taking the placebo by week 48. The monthly dose met that standard in both trials. The every-three-months dose in NEPTUNUS-2 did not reach statistical significance.

What the numbers showed

The difference between the ianalumab group and the placebo group was 1.3 points in NEPTUNUS-1 and 1.0 points in NEPTUNUS-2 (monthly dose). These differences are real, but they’re modest. For context, they fall below the threshold that researchers have established as the minimum ESSDAI disease activity score change likely to feel meaningful to a patient, which is around 3 points on this scale.

To be clear: this doesn’t mean the drug didn’t work. It means that the size of the additional benefit, compared to the placebo, was smaller than that 3-point benchmark.

Part of the reason the gap is small is that the placebo group did surprisingly well. People assigned to the placebo improved by about 5 points on the disease activity score, which is itself above that 3-point meaningful-change threshold. They were still taking their usual background medications, and being closely monitored in a year-long global trial tends to improve outcomes in both groups. When the placebo group improves that much, showing a large additional benefit from the drug becomes harder to do statistically, even if the drug is having a real effect.

Still, ianalumab added a further, measurable improvement beyond the placebo gains. What that improvement means in practice for individual patients is one of the questions the full Phase 3 results will hopefully make clearer.

What the other measures showed

Results on secondary measures were mixed and varied between the two trials. In NEPTUNUS-1, both the Patient Global Assessment and the Physician Global Assessment, which rate how someone is doing from the patient’s own perspective and the doctor’s, reached statistical significance, suggesting people felt and looked better in ways the disease activity score alone may not have fully captured.

In NEPTUNUS-2, patient-reported outcomes trended toward improvement but did not reach statistical significance. The abstract does not explain why the two trials diverged on this point, and again, it’s another point that the full published data could shed further light on.

The conference abstract does not report results for the ESSPRI symptom score, which asks patients to rate dryness, fatigue, and pain on a zero-to-ten scale. For patients, ESSPRI can represent one of the most personal measures of improvement, because it reflects the symptoms that shape daily life, not just organ involvement measured by a clinician. Whether ianalumab moved that score in a meaningful way remains an open question until fuller results are available.

A note on salivary flow

One earlier Phase 2b finding stands out because it speaks to something many people with Sjogren’s think about all the time: dry mouth. In that smaller study, people taking the 300 mg monthly dose had a statistically significant increase in stimulated salivary flow at 24 weeks, and that improvement kept building through 48 weeks in those who stayed on the drug. It’s not clear, however, whether the Phase 3 trials showed the same benefit, because the conference abstract does not include that detail.

There is one important caveat. Both the Phase 2b study and the Phase 3 trials enrolled people who still had some measurable salivary output. Those selection criteria reflect expectations of how the drug would work. Ianalumab may help preserve gland function, but it cannot bring back tissue that has already been badly damaged. For people who have lived with Sjogren’s for many years and have little or no saliva left, it is unlikely to reverse that loss.

What the safety data show

Safety results from the Phase 3 trials look reassuring, with the caveat that we’re drawing from conference-level data rather than a full report. In both NEPTUNUS trials, overall side effect rates and serious adverse events were similar between the ianalumab and placebo groups, serious infections were uncommon, and no new safety concerns appeared.

The earlier Phase 2B trial results add more detail. The most common side effect was injection site reactions involving redness or discomfort at the injection site, which were mostly mild or moderate. A small number of people developed temporary drops in a type of white blood cell called neutrophils, but these were not linked to serious infections. Understanding the safety picture will require the full Phase 3 report and more follow-up time to gauge long-term effects.

What happens next and how long it might take

In January 2026, the FDA granted ianalumab Breakthrough Therapy designation for Sjogren’s disease. That label means the agency agrees that early data suggest the drug could offer a meaningful advance over what’s currently available. In practical terms, it gives Novartis more frequent FDA input during the review process. It does not lower the bar for approval or guarantee a “yes.” Plenty of drugs with Breakthrough status have still been turned down.

In its Q1 2026 earnings release, Novartis confirmed that regulatory submissions are now complete in the US, Europe, China, and Japan, and that the FDA has granted Priority Review. Priority Review sets a six-month goal date from the point the application is accepted, which makes a regulatory decision in late 2026 a realistic target rather than a best case. That said, timelines can lag for reasons unrelated to the science, and a decision in 2027 remains possible.

(For more on clinical trials and drug approval timelines, see Understanding Clinical Trial Phases, Study Status, and Timelines.)

Because ianalumab would be the first disease-modifying biologic approved for Sjogren’s, the FDA may choose to convene an Advisory Committee, an independent panel of outside experts, to review and advise on the evidence. The modest size of the disease activity differences and the mixed symptom results are the kinds of issues that can prompt an Advisory Committee review. If that happens, the meeting will be open to the public and will give the patient community a closer look at the evidence and how it is being evaluated. These meetings, if scheduled, typically add time to the review process.

If it’s approved, what does access look like

FDA approval and patient access are not the same thing. After an approval, specialty pharmacies need to stock the drug, insurers need to decide whether to cover it and under what conditions, and prior authorization criteria need to be written and applied. That process typically adds weeks to months before a patient can actually receive treatment.

There’s an added complication specific to Sjogren’s. Because no biologic has ever been approved for this condition, insurers will have no existing framework to draw from. Prior authorization rules will be written from scratch. This could mean relatively open access early on, or it could mean tight, inconsistently applied criteria, particularly for patients whose disease profile doesn’t closely match the trial population. How payers will handle this is genuinely uncertain.

(For more on how prior authorization works, appeals, and patient assistance for biologics, see Understanding Biologic Drug Access.)

Other drugs on the horizon

Ianalumab isn’t the only candidate in this pipeline. Telitacicept and nipocalimab are both in late-stage development for Sjogren’s, each working through a different mechanism, and both received significant regulatory attention in 2025. For the full picture on where each stands, see the Sjogren’s pipeline tracker.

A note on what’s next

For a long time, promising leads for Sjogren’s treatments tended to stall out in Phase 3. Though approval is still uncertain, at least that part has changed. Ianalumab is in regulatory review now, and that alone marks a major change in what people with Sjogren’s are waiting for. What that decision will be, and what approval would actually deliver for patients in daily life, are still open questions. I’ll be updating this post as answers to those questions come into clearer view.

Sources & further reading

• NEPTUNUS Phase 3 conference abstract (ACR Convergence 2025)

• “NEPTUNUS: Ianalumab in Sjogren’s,” RheumNow Interview with Dr. Angelika Jahreis, Development Head for Immunology, Novartis, ACR Convergence 2025

• NEPTUNUS-1 and NEPTUNUS-2 trial registration, Clinicaltrials.gov

• Phase 2b trial results, Dörner et al., Arthritis & Rheumatology (2025)

• Phase 2b conference abstract (ACR)

• Novartis Phase 3 primary endpoint announcement (August 2025)

• Novartis Breakthrough Therapy designation announcement (January 2025)

• FDA Advisory Committees overview

Corrections and clarifications always welcome: kelly@theconnectivethread.com.

The Connective Thread is written by a patient, not a clinician or researcher. Nothing here is medical advice.