Ianalumab a new medication currently in trials may finally bring some relief to people living with Sjogren’s syndrome. Sjögren’s syndrome is an autoimmune disease that affects the body’s moisture-producing glands, causing symptoms like dry eyes, dry mouth, fatigue, and joint pain. It can occur by itself as primary Sjögren’s syndrome, or alongside other autoimmune diseases like rheumatoid arthritis as secondary Sjögren’s.
While there are treatments to help manage symptoms, there are currently no approved therapies that target the underlying autoimmune disease process in Sjögren’s syndrome. This represents a major unmet need, as the chronic inflammation caused by Sjögren’s can lead to other serious complications over time if left unchecked. Patients are eager for new treatment options that could offer better disease control.
About the Study
This randomized, double-blind, placebo-controlled phase 2b study aimed to evaluate the efficacy and safety of the monoclonal antibody ianalumab in patients with primary Sjögren’s syndrome.
This trial enrolled patients from different continents and had 3 groups: different amounts of ianalumab compared to a fake treatment. The goal was to find the best dose of ianalumab for treatment and to see how well it worked and how safe it was compared to the fake treatment.
As a phase 2b study, this trial represents an intermediate stage of clinical research. Phase 2 studies gather preliminary data on effectiveness and look at common short-term side effects. If results are favorable, the treatment proceeds to larger and longer phase 3 trials which focus more on safety, efficacy, and optimal dosage.
Study Objective
The main goal of this study was to check if ianalumab, a type of medication, is safe and effective for people with Sjögren’s syndrome. This syndrome is an autoimmune illness that affects the salivary and lacrimal glands, causing dry mouth and dry eyes. Ianalumab targets B-cell activating factor (BAFF), a substance that affects the survival and development of B cells. By targeting BAFF, ianalumab aims to reduce the hyperactivity of B cells, which is linked to Sjögren’s syndrome. Essentially, ianalumab works by breaking B cells and blocking BAFF to stop the development of B cells. This study aimed to find out if treatment with ianalumab could safely improve symptoms and reduce disease activity in Sjögren’s patients compared to a placebo.
Study Participants
The research looked at adults with primary Sjögren’s syndrome, an autoimmune disease that causes long-term inflammation and harm to the glands that produce moisture, such as the salivary and tear glands.
Participants were required to meet the 2016 ACR-EULAR classification criteria for primary Sjögren’s syndrome. They also had to have an ESSDAI (EULAR Sjögren’s Syndrome Disease Activity Index) score of ≥6, indicating active disease.
Key eligibility criteria included:
- Adults aged 18-75 years old
- Confirmed diagnosis of primary Sjögren’s syndrome
- Active disease with ESSDAI score ≥6
- Presence of at least one domain with an ESSDAI score ≥3
- Eligible participants were not allowed corticosteroids exceeding 10mg/day prednisone equivalent.
The study aimed to enroll patients representing the full spectrum of primary Sjögren’s syndrome. Overall, it included adults with active and untreated disease across multiple centers internationally.
Ianalumab Treatment Arms
The study compared 5 treatment arms:
- Placebo – Patients received a placebo injection every 4 weeks
- Ianalumab 5 mg – Patients received 5 mg of ianalumab subcutaneously every 4 weeks
- Ianalumab 50mg – Patients received 50 mg of ianalumab subcutaneously every 4 weeks
- Ianalumab 300 mg – Patients received 300 mg of ianalumab subcutaneously every 4 weeks
Outcome Measures
The main outcome measures for assessing efficacy were the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) at week 24, and patient-reported outcomes using EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and Short Form 36 Health Survey (SF-36) scores at weeks 4 and 24.
The ESSDAI measures disease activity across 12 organ-specific domains including salivary gland, articular, cutaneous, peripheral nervous system, etc. Typically a high ESSDAI is anything above 13, medium is between 5 and 13, and low is less than 5.
ESSPRI is used to measure patient-reported symptoms of dryness, fatigue, and pain. The SF-36 assesses quality of life across 8 domains – physical functioning, bodily pain, vitality, social functioning, emotional role functioning, mental health, general health perceptions, and physical role functioning.
By evaluating a combination of physician-assessed and patient-reported outcomes, the study aimed to provide a comprehensive view of ianalumab’s efficacy in treating both the clinical and symptomatic manifestations of primary Sjögren’s syndrome. The results across these measures would determine whether ianalumab could significantly improve disease activity, symptoms, and quality of life compared to placebo.
Ianalumab Key Results
The key results of the study showed that treatment with ianalumab improved ESSDAI and ESSPRI compared to placebo.
- Patients treated with ianalumab 300mg had statistically significant improvements in ESSDAI scores compared to placebo at week 24.
- Stimulated salivary flow increased with time and was most beneficial with people receiving the 300 mg dose.
- Unfortunately, tear flow did not improve.
So in summary, treatment with ianalumab showed promising efficacy in improving patient-reported symptoms and disease activity in primary Sjögren’s syndrome compared to placebo in this phase 2b study.
Safety
Ianalumab demonstrated a safety profile comparable to placebo in this Phase 2b study. The rates of adverse events were similar between the ianalumab and placebo groups. The majority of adverse events were mild or moderate in severity.
The most common adverse events reported in the ianalumab groups were upper respiratory infections and sinus infections as well as headache, and urinary tract infection. These events occurred at similar frequencies in the placebo group as well.
There wasn’t a clear link between the dose given and the negative effects after using ianalumab. It’s important to note that the serious negative effects and infections were similar in both the ianalumab and placebo groups.
No deaths occurred during this study. Overall, subcutaneous dosing of ianalumab showed no significant safety signals in patients with primary Sjögren’s syndrome.
Next Steps
The results from this study indicate that ianalumab treatment shows promising efficacy in patients with primary Sjögren’s syndrome. Specifically, the 300 mg ianalumab dose significantly reduced ESSDAI scores compared to placebo after 24 weeks of treatment. The ESSDAI is a key outcome measure to assess efficacy of treatments for Sjögren’s syndrome.
Overall, ianalumab demonstrated an acceptable safety profile. While infusion reactions occurred more frequently with ianalumab compared to placebo, they were mostly mild to moderate in severity.
In summary, this phase 2b study provides evidence that targeting the BAFF cytokine with ianalumab could be an effective approach for treating Sjögren’s syndrome. The verdict is still out regarding the effect on fatigue but these results represent an encouraging development for patients with Sjogren’s syndrome.
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Medical Disclaimer
This information is offered to educate the general public. The information posted on this website does not replace professional medical advice, but for general information purposes only. There is no Doctor – Patient relationship established. We strongly advised you to speak with your medical professional if you have questions concerning your symptoms, diagnosis and treatment.