Ianalumab, an Antibody, Eases Sjögren’s Symptoms at High Dose in Trial

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by Somi Igbene |

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Ianalumab (VAY736), an investigational antibody to treat Sjögren’s syndrome, at high dose was well-tolerated by patients using it for one year, and led to reductions in disease activity and significantly greater saliva production, data from a Phase 2b clinical trial show.

Findings were shared at the 2021 American College of Rheumatology Convergence meeting, which took place virtually on Nov. 3–9, in the presentation, “Ianalumab (VAY736) Safety and Efficacy in Patients with Sjogren’s Syndrome: 52 Week Results from a Randomized, Placebo-controlled, Phase 2b Dose-ranging Trial.

Sjögren’s syndrome is an autoimmune condition characterized by the overactivity of B-cells, the immune cells that make antibodies. The production of abnormal antibodies causes inflammation in secretion-producing glands, including the tear and salivary glands, leading to dryness in the eyes and mouth. It currently has no approved treatment.

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Ianalumab is a human monoclonal antibody, being developed by MorphoSys and Novartis, that is designed to eliminate B-cells by targeting a protein called B-cell activating factor protein. By preventing antibody production, the treatment is expected to ease inflammation and symptoms of Sjögren’s.

The Phase 2b trial (NCT02962895) investigated the safety and efficacy of ianalumab in adults with primary Sjögren’s syndrome. A total of 190 patients were enrolled and randomly assigned to one of three doses of ianalumab (5, 50, or 300 mg), or to a placebo, given via monthly under-the-skin injections initially for 24 weeks (about six months).

Results from this first and primary trial part showed that ianalumab, at the highest dose, significantly reduced disease activity, as assessed with the EULAR Sjogren’s Syndrome Disease Activity index (ESSDAI) and Physician’s Global Assessment. A trend toward greater saliva production was also seen.

The treatment, however, failed to improve patient-reported symptoms, as examined with the EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI) and the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F).

In the trial’s second part, placebo-treated participants were switched to ianalumab for an additional 28 weeks, while those previously receiving the 300 mg dose of ianalumab were re-randomized to either continue treatment at that dose or move to a placebo.

After about one year of treatment (week 52), participants who continued on 300 mg ianalumab had sustained improvements from baseline (study start) in ESSDAI, ESSPRI, and in Physician’s and Patient’s Global Assessments — the physician’s and patient’s perceived disease activity, respectively.

Those who switched from ianalumab to placebo, however, lost some of the benefits they had experienced at week 24, while those who switched from placebo to 150 mg ianalumab achieved some clinical benefits.

The most common adverse events injection site reactions were mostly mild to moderate in severity. Infections, particularly the common cold and upper respiratory tract infections, were the most common treatment-related adverse event. Low levels of immune cells, also mostly mild to moderate in severity, were also reported by about one-fifth of patients on ianalumab.

“[Ianalumab] 300 mg was well tolerated up to 52 weeks,” the researchers wrote, adding that continuous subcutaneous dosing “every four weeks provided sustained clinical benefit.”